Short Stature for Age Medications
Definition of Short Stature for Age: Short stature refers to any person who is significantly below the average height for a person of the same age and sex -- specifically, the shortest 3 - 5% of the population. More...
Drugs associated with Short Stature for AgeThe following drugs and medications are in some way related to, or used in the treatment of Short Stature for Age. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Learn more about Short Stature for AgeMedical Encyclopedia:
Short statureDrug List: Accretropin Genotropin Humatrope-Cartridge Norditropin Norditropin-Flexpro Norditropin-Nordiflex Nutropin Nutropin-Aq Nutropin-Depot Omnitrope Saizen Serostim Tev-Tropin Zorbtive
Nutropin AQ
Generic Name: somatropin (soe ma TROE pin)
Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive
Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.
Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.
Somatropin may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Nutropin AQ (somatropin)?Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.
Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.
If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.
Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes. What should I discuss with my healthcare provider before using Nutropin AQ (somatropin)? Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin. You should not use this medication if you are allergic to somatropin, or if you have:diabetic retinopathy (a serious eye condition caused by diabetes);
cancer; or
Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.
You should also not use somatropin if you have a serious medical condition after having:
open heart surgery or stomach surgery;
trauma or other medical emergency; or
breathing problems (such as lung failure).
To make sure you can safely take somatropin, tell your doctor if you have any of these other conditions:
liver disease;
kidney disease (or if you are on dialysis);
diabetes;
a pituitary gland disorder;
scoliosis;
high blood pressure (hypertension);
a pancreas disorder (especially in children);
a history of cancer;
carpal tunnel syndrome;
underactive thyroid; or
a brain tumor or lesion.
FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive. FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby. How should I use Nutropin AQ (somatropin)?Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.
Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested often. Your eyes may also need to be checked. Visit your doctor regularly.
If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.
If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.
How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.
Throw away any somatropin left over after the expiration date on the label has passed.
What happens if I miss a dose?Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Call your doctor if you miss more than 3 doses in a row. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.
What should I avoid while using Nutropin AQ (somatropin)?If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.
Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse. Nutropin AQ (somatropin) side effectsIf you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;
sudden and severe pain behind your eyes, vision changes;
swelling in your head, face, hands, or feet; or
numbness or tingling in your wrist, hand, or fingers.
Less serious side effects may include:
headache, feeling tired;
redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;
pain in your arms or legs, joint stiffness or pain;
muscle pain; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Nutropin AQ (somatropin)?Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.
Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.
Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.
This list is not complete and other drugs may interact with somatropin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Nutropin AQ resources Nutropin AQ Side Effects (in more detail) Nutropin AQ Use in Pregnancy & Breastfeeding Nutropin AQ Drug Interactions Nutropin AQ Support Group 0 Reviews for Nutropin AQ - Add your own review/rating Nutropin AQ MedFacts Consumer Leaflet (Wolters Kluwer) Nutropin AQ Prescribing Information (FDA) Somatropin Professional Patient Advice (Wolters Kluwer) Genotropin Prescribing Information (FDA) Genotropin Advanced Consumer (Micromedex) - Includes Dosage Information Genotropin MedFacts Consumer Leaflet (Wolters Kluwer) Humatrope Prescribing Information (FDA) Humatrope Cartridge MedFacts Consumer Leaflet (Wolters Kluwer) Norditropin MedFacts Consumer Leaflet (Wolters Kluwer) Norditropin Prescribing Information (FDA) Nutropin Prescribing Information (FDA) Nutropin MedFacts Consumer Leaflet (Wolters Kluwer) Nutropin Aq Subcutaneous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information Nutropin Depot Prescribing Information (FDA) Omnitrope Prescribing Information (FDA) Omnitrope Consumer Overview Omnitrope MedFacts Consumer Leaflet (Wolters Kluwer) Saizen MedFacts Consumer Leaflet (Wolters Kluwer) Saizen Prescribing Information (FDA) Serostim MedFacts Consumer Leaflet (Wolters Kluwer) Serostim Prescribing Information (FDA) Tev-Tropin MedFacts Consumer Leaflet (Wolters Kluwer) Tev-Tropin Prescribing Information (FDA) Zorbtive Prescribing Information (FDA) Zorbtive MedFacts Consumer Leaflet (Wolters Kluwer) Zorbtive Consumer Overview Compare Nutropin AQ with other medications Adult Human Growth Hormone Deficiency Growth Retardation, Chronic Renal Failure Hypopituitarism Idiopathic Short Stature Pediatric Growth Hormone Deficiency Short Stature for Age Turner's Syndrome Where can I get more information? Your pharmacist can provide more information about somatropin.See also: Nutropin AQ side effects (in more detail)
Serostim
Generic Name: somatropin (soe ma TROE pin)
Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive
Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.
Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.
Somatropin may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Serostim (somatropin)?Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.
Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.
If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.
Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes. What should I discuss with my healthcare provider before using Serostim (somatropin)? Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin. You should not use this medication if you are allergic to somatropin, or if you have:diabetic retinopathy (a serious eye condition caused by diabetes);
cancer; or
Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.
You should also not use somatropin if you have a serious medical condition after having:
open heart surgery or stomach surgery;
trauma or other medical emergency; or
breathing problems (such as lung failure).
To make sure you can safely take somatropin, tell your doctor if you have any of these other conditions:
liver disease;
kidney disease (or if you are on dialysis);
diabetes;
a pituitary gland disorder;
scoliosis;
high blood pressure (hypertension);
a pancreas disorder (especially in children);
a history of cancer;
carpal tunnel syndrome;
underactive thyroid; or
a brain tumor or lesion.
FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive. FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby. How should I use Serostim (somatropin)?Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.
Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested often. Your eyes may also need to be checked. Visit your doctor regularly.
If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.
If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.
How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.
Throw away any somatropin left over after the expiration date on the label has passed.
What happens if I miss a dose?Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Call your doctor if you miss more than 3 doses in a row. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.
What should I avoid while using Serostim (somatropin)?If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.
Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse. Serostim (somatropin) side effectsIf you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;
sudden and severe pain behind your eyes, vision changes;
swelling in your head, face, hands, or feet; or
numbness or tingling in your wrist, hand, or fingers.
Less serious side effects may include:
headache, feeling tired;
redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;
pain in your arms or legs, joint stiffness or pain;
muscle pain; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Serostim (somatropin)?Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.
Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.
Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.
This list is not complete and other drugs may interact with somatropin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Serostim resources Serostim Side Effects (in more detail) Serostim Use in Pregnancy & Breastfeeding Serostim Drug Interactions Serostim Support Group 1 Review for Serostim - Add your own review/rating Serostim MedFacts Consumer Leaflet (Wolters Kluwer) Serostim Prescribing Information (FDA) Serostim Advanced Consumer (Micromedex) - Includes Dosage Information Somatropin Professional Patient Advice (Wolters Kluwer) Genotropin Prescribing Information (FDA) Genotropin Advanced Consumer (Micromedex) - Includes Dosage Information Genotropin MedFacts Consumer Leaflet (Wolters Kluwer) Humatrope Cartridge MedFacts Consumer Leaflet (Wolters Kluwer) Humatrope Prescribing Information (FDA) Norditropin MedFacts Consumer Leaflet (Wolters Kluwer) Norditropin Prescribing Information (FDA) Nutropin MedFacts Consumer Leaflet (Wolters Kluwer) Nutropin Prescribing Information (FDA) Nutropin AQ MedFacts Consumer Leaflet (Wolters Kluwer) Nutropin AQ Prescribing Information (FDA) Nutropin Depot Prescribing Information (FDA) Omnitrope Prescribing Information (FDA) Omnitrope Consumer Overview Omnitrope MedFacts Consumer Leaflet (Wolters Kluwer) Saizen Prescribing Information (FDA) Saizen MedFacts Consumer Leaflet (Wolters Kluwer) Tev-Tropin Prescribing Information (FDA) Tev-Tropin MedFacts Consumer Leaflet (Wolters Kluwer) Zorbtive Prescribing Information (FDA) Zorbtive Consumer Overview Zorbtive MedFacts Consumer Leaflet (Wolters Kluwer) Compare Serostim with other medications AIDS Related Wasting Cachexia Short Stature for Age Where can I get more information? Your pharmacist can provide more information about somatropin.See also: Serostim side effects (in more detail)
Saizen
Generic Name: somatropin (soe ma TROE pin)
Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive
Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.
Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.
Somatropin may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Saizen (somatropin)?Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.
Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.
If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.
Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes. What should I discuss with my healthcare provider before using Saizen (somatropin)? Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin. You should not use this medication if you are allergic to somatropin, or if you have:diabetic retinopathy (a serious eye condition caused by diabetes);
cancer; or
Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.
You should also not use somatropin if you have a serious medical condition after having:
open heart surgery or stomach surgery;
trauma or other medical emergency; or
breathing problems (such as lung failure).
To make sure you can safely take somatropin, tell your doctor if you have any of these other conditions:
liver disease;
kidney disease (or if you are on dialysis);
diabetes;
a pituitary gland disorder;
scoliosis;
high blood pressure (hypertension);
a pancreas disorder (especially in children);
a history of cancer;
carpal tunnel syndrome;
underactive thyroid; or
a brain tumor or lesion.
FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive. FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby. How should I use Saizen (somatropin)?Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.
Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested often. Your eyes may also need to be checked. Visit your doctor regularly.
If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.
If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.
How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.
Throw away any somatropin left over after the expiration date on the label has passed.
What happens if I miss a dose?Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Call your doctor if you miss more than 3 doses in a row. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.
What should I avoid while using Saizen (somatropin)?If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.
Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse. Saizen (somatropin) side effectsIf you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;
sudden and severe pain behind your eyes, vision changes;
swelling in your head, face, hands, or feet; or
numbness or tingling in your wrist, hand, or fingers.
Less serious side effects may include:
headache, feeling tired;
redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;
pain in your arms or legs, joint stiffness or pain;
muscle pain; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Saizen (somatropin)?Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.
Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.
Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.
This list is not complete and other drugs may interact with somatropin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Saizen resources Saizen Side Effects (in more detail) Saizen Use in Pregnancy & Breastfeeding Saizen Drug Interactions Saizen Support Group 1 Review for Saizen - Add your own review/rating Saizen MedFacts Consumer Leaflet (Wolters Kluwer) Saizen Prescribing Information (FDA) Saizen Subcutaneous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information Somatropin Professional Patient Advice (Wolters Kluwer) Genotropin Prescribing Information (FDA) Genotropin Advanced Consumer (Micromedex) - Includes Dosage Information Genotropin MedFacts Consumer Leaflet (Wolters Kluwer) Humatrope Cartridge MedFacts Consumer Leaflet (Wolters Kluwer) Humatrope Prescribing Information (FDA) Norditropin MedFacts Consumer Leaflet (Wolters Kluwer) Norditropin Prescribing Information (FDA) Nutropin MedFacts Consumer Leaflet (Wolters Kluwer) Nutropin Prescribing Information (FDA) Nutropin AQ MedFacts Consumer Leaflet (Wolters Kluwer) Nutropin AQ Prescribing Information (FDA) Nutropin Depot Prescribing Information (FDA) Omnitrope Prescribing Information (FDA) Omnitrope MedFacts Consumer Leaflet (Wolters Kluwer) Omnitrope Consumer Overview Serostim Prescribing Information (FDA) Serostim MedFacts Consumer Leaflet (Wolters Kluwer) Tev-Tropin Prescribing Information (FDA) Tev-Tropin MedFacts Consumer Leaflet (Wolters Kluwer) Zorbtive Prescribing Information (FDA) Zorbtive Consumer Overview Zorbtive MedFacts Consumer Leaflet (Wolters Kluwer) Compare Saizen with other medications Adult Human Growth Hormone Deficiency Pediatric Growth Hormone Deficiency Short Stature for Age Where can I get more information? Your pharmacist can provide more information about somatropin.See also: Saizen side effects (in more detail)
Malabsorption Syndrome Medications
Definition of Malabsorption Syndrome: A variety of conditions in which digestion and absorption in the small intestine are impaired. Multiple causes including lymphoma, amyloid and other infiltrations, Crohn's disease, gluten sensitive enteropathy and the sprue syndrome in which the villi atrophy for unknown reasons. More...
Topics under Malabsorption Syndrome Short Bowel Syndrome (7 drugs) Whipple's Disease (0 drugs) Learn more about Malabsorption SyndromeMicromedex Care Notes:
Short Bowel SyndromeMedical Encyclopedia:
Malabsorption Blind loop syndrome Tropical sprueDrug List:
Bronchodilators
Bronchodilators are agents that widen the air passages by relaxing the bronchial smooth muscle. Bronchodilators are either short-acting or long-acting beta2-agonists, anticholinergic agents or theophylline. They are used to control symptoms of asthma and chronic obstructive pulmonary diseases.
Short acting bronchodilators are used when needed for quick relief of asthma symptoms and long acting bronchodilators are used regularly to control symptoms of asthma.
See also adrenergic bronchodilators anticholinergic bronchodilators bronchodilator combinations methylxanthines Drug List:Anastrozole tablets
1. Name Of The Medicinal Product
Anastrozole 1 mg, film-coated tablets.
2. Qualitative And Quantitative CompositionEach tablet contains 1 mg anastrozole.
Excipient: each tablet contains 93 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical FormFilm-coated tablet.
White film-coated round biconvex tablets, debossed with “ANA” and “1” on one side.
4. Clinical Particulars 4.1 Therapeutic IndicationsTreatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.
4.2 Posology And Method Of AdministrationAdults including the elderly
One tablet (1 mg) to be taken orally once a day.
Children
Anastrozole is not recommended for use in children due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Renal impairment
No dose change is recommended in patients with mild or moderate renal impairment.
Hepatic impairment
No dose change is recommended in patients with mild hepatic disease.
4.3 ContraindicationsAnastrozole is contraindicated in:
– Premenopausal women.
– Pregnant or lactating women.
– Patients with severe renal impairment (creatinine clearance less than 20 ml/min).
– Patients with moderate or severe hepatic disease.
– Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1.
Oestrogen-containing therapies should not be co-administered with anastrozole as they would negate its pharmacological action.
Concurrent tamoxifen therapy (see section 4.5).
4.4 Special Warnings And Precautions For UseAnastrozole is not recommended for use in children as safety and efficacy have not been established in this group of patients (see section 5.1)
Anastrozole should not be used in boys with growth hormone deficiency in addition to growth hormone treatment. In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1). Since anastrozole reduces estradiol levels, it must not be used in girls with growth hormone deficiency in addition to growth hormone treatment. Long-term safety data in children and adolescents are not available.
The menopause should be defined biochemically in any patient where there is doubt about hormonal status.
There are no data to support the safe use of anastrozole in patients with moderate or severe hepatic impairment, or patients with severe impairment of renal function (creatinine clearance less than 20 ml/min).
Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed by bone densitometry e.g. DEXA scanning at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.
There are no data available for the use of anastrozole with LHRH analogues. This combination should not be used outside clinical trials.
As anastrozole lowers circulating oestrogen levels it may cause a reduction in bone mineral density with a possible consequential increased risk of fracture. The use of bisphosphonates may stop further bone mineral loss caused by anastrozole in postmenopausal women and should be considered.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionAntipyrine and cimetidine clinical interaction studies indicate that the co-administration of anastrozole with other drugs is unlikely to result in clinically significant drug interactions mediated by cytochrome P450
A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with anastrozole who also received other commonly prescribed drugs. There were no clinically significant interactions with bisphosphonates (see section 5.1)
Oestrogen-containing therapies should not be co-administered with anastrozole as they would negate its pharmacological action.
Tamoxifen should not be co-administered with anastrozole, as this may diminish its pharmacological action (see section 4.3).
4.6 Pregnancy And LactationAnastrozole is contraindicated in pregnant and lactating women.
4.7 Effects On Ability To Drive And Use MachinesAnastrozole is unlikely to impair the ability of patients to drive and operate machinery. However, asthenia and somnolence have been reported with the use of anastrozole and caution should be observed when driving or operating machinery while such symptoms persist.
4.8 Undesirable EffectsUnless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9366 postmenopausal women with operable breast cancer treated for five years (ATAC study)
System Organ Class
Frequency
Adverse Reaction
Metabolism and nutrition
Common
(
Anorexia, mainly mild in nature
Hypercholesterolaemia, mainly mild or moderate in nature
Nervous system disorders
Very common
(
Headache, mainly mild or moderate in nature
Common
(
Somnolence, mainly mild or moderate in nature
Carpal Tunnel Syndrome
Vascular disorders
Very common
(
Hot flushes, mainly mild or moderate in nature
Gastrointestinal disorders
Very common
(
Nausea, mainly mild or moderate in nature
Common
(
Diarrhoea, mainly mild or moderate in nature
Vomiting, mainly mild or moderate in nature
Hepatobiliary disorders
Common
(
Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase
Uncommon
(
Increases in gamma-GT and bilirubin Hepatitis
Skin and subcutaneous disorders
Very common
(
Rash, mainly mild or moderate in nature
Common
(
Hair thinning (Alopecia), mainly mild or moderate in nature.
Allergic reactions
Uncommon
(
Urticaria
Rare
(
Erythema multiforme
Anaphylactoid reaction
Not known
Stevens-Johnson syndrome**
Angioedema**
Musculoskeletal and connective tissue disorders
Very common
(
Joint pain/stiffness, mainly mild or moderate in nature
Common
(
Bone pain
Uncommon
(
Trigger finger
Reproductive system and breast disorders
Common
(
Vaginal dryness, mainly mild or moderate in nature
Vaginal bleeding, mainly mild or moderate in nature*
General disorders and administration site conditions
Very common
(
Asthenia, mainly mild or moderate in nature
*Vaginal bleeding has been reported commonly, mainly in patients with advanced breast cancer during the first few weeks after changing from existing hormonal therapy to treatment with anastrozole. If bleeding persists, further evaluation should be considered.
**Cannot be estimated from the available data.
As anastrozole lowers circulating oestrogen levels, it may cause a reduction in bone mineral density placing some patients at a higher risk of fracture (see section 4.4)The table below presents the frequency of pre-specified adverse events in the ATAC study, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.
Undesirable effect
anastrozole (n=3092)
tamoxifen (n=3094)
Hot flushes
1104 (35.7%)
1264 (40.9%)
Joint pain/stiffness
1100 (35.6%)
911 (29.4%)
Mood disturbances
597 (19.3%)
554 (17.9%)
Fatigue/asthenia
575 (18.6%)
544 (17.6%)
Nausea and vomiting
393 (12.7%)
384 (12.4%)
Fractures
315 (10.2%)
209 (6.8%)
Fractures of the spine, hip or wrist/Colles
133 (4.3%)
91 (2.9%)
Wrist/Colles fractures
67 (2.2%)
50 (1.6%)
Spine fractures
43 (1.4%)
22 (0.7%)
Hip fractures
28 (0.9%)
26 (0.8%)
Cataracts
182 (5.9%)
213 (6.9%)
Vaginal bleeding
167 (5.4%)
317 (10.2%)
Ischaemic cardiovascular disease
127 (4.1%)
104 (3.4%)
Angina pectoris
71 (2.3%)
51 (1.6%)
Myocardial infarct
37 (1.2%)
34 (1.1%)
Coronary artery disorder
25 (0.8%)
23 (0.7%)
Myocardial ischaemia
22 (0.7%)
14 (0.5%)
Vaginal discharge
109 (3.5%)
408 (13.2%)
Any venous thromboembolic event
87 (2.8%)
140 (4.5%)
Deep venous thromboembolic events including PE
48 (1.6%)
74 (2.4%)
Ischaemic cerebrovascular events
62 (2.0%)
88 (2.8%)
Endometrial cancer
4 (0.2%)
13 (0.6%)
Fracture rates of 22 per 1000 patient-years and 15 per 1000 patient-years were observed for the anastrozole and tamoxifen groups, respectively, after a median follow-up of 68 months. The observed fracture rate for anastrozole is similar to the range reported in age-matched postmenopausal populations. It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on anastrozole treatment reflect a protective effect of tamoxifen, a specific effect of anastrozole, or both.
The incidence of osteoporosis was 10.5% in patients treated with anastrozole and 7.3% in patients treated with tamoxifen.
4.9 OverdoseThere is limited clinical experience of accidental overdosage.
In animal studies, anastrozole demonstrated low acute toxicity.
Clinical trials have been conducted with various doses of anastrozole, up to 60 mg in a single dose given to healthy male volunteers, and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated. A single dose of anastrozole that results in life-threatening symptoms has not been established.
There is no specific antidote to overdosage and treatment must be symptomatic.
In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken.
Vomiting may be induced if the patient is alert.
Dialysis may be helpful because anastrozole is not highly protein-bound.
General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic group: Enzyme inhibitors
ATC Code: L02B G03
Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor. In postmenopausal women, oestradiol is produced primarily by the conversion of androstenedione to oestrone through the aromatase enzyme complex in peripheral tissues. Oestrone is subsequently converted to oestradiol. Lowering circulating oestradiol levels has been shown to produce a beneficial effect in women with breast cancer.
In postmenopausal women, a daily dose of 1 mg of anastrozole produced oestradiol suppression of greater than 80% using a highly sensitive assay.
Anastrozole does not possess any progestogenic, androgenic or oestrogenic activity.
Daily doses of anastrozole up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard ACTH challenge testing. Corticoid supplements are therefore not needed.
Primary adjuvant treatment of early breast cancer
In a large phase III study conducted in 9366 postmenopausal women with operable breast cancer treated for 5 years, anastrozole was shown to be statistically superior to tamoxifen in disease-free survival. A greater magnitude of benefit was observed for disease-free survival in favour of anastrozole versus tamoxifen for the prospectively defined hormone receptor positive population. Anastrozole was statistically superior to tamoxifen in time to recurrence. The difference was of even greater magnitude than in disease-free survival for both the Intention To Treat (ITT) population and hormone receptor positive population. Anastrozole was statistically superior to tamoxifen in terms of time to distant recurrence. The incidence of contralateral breast cancer was statistically reduced for anastrozole compared to tamoxifen. Following 5 years of therapy, anastrozole is at least as effective as tamoxifen in terms of overall survival. However, due to low death rates, additional follow-up is required to determine more precisely the long-term survival for anastrozole relative to tamoxifen. With 68 months median follow-up, patients in the ATAC study have not been followed up for sufficient time after 5 years of treatment, to enable a comparison of long-term post treatment effects of anastrozole relative to tamoxifen.
ATAC endpoint summary: 5-year treatment completion analysis
Efficacy endpoints
Number of events (frequency)
Intention to treat population
Hormone receptor positive tumour status
anastrozole (n=3125)
tamoxifen (n=3116)
anastrozole (n=2618)
tamoxifen (n=2598)
Disease-free survivala
575 (18.4)
651 (20.9)
424 (16.2)
497 (19.1)
Hazard ratio
0.87
0.83
2-sided 95% CI
0.78 to 0.97
0.73 to 0.94
p-value
0.0127
0.0049
Distant disease-free survivalb
500 (16.0)
530 (17.0)
370 (14.1)
394 (15.2)
Hazard ratio
0.94
0.93
2-sided 95% CI
0.83 to 1.06
0.80 to 1.07
p-value
0.2850
0.2838
Time to recurrencec
402 (12.9)
498 (16.0)
282 (10.8)
370 (14.2)
Hazard ratio
0.79
0.74
2-sided 95% CI
0.70 to 0.90
0.64 to 0.87
p-value
0.0005
0.0002
Time to distant recurrenced
324 (10.4)
375 (12.0)
226 (8.6)
265 (10.2)
Hazard ratio
0.86
0.84
2-sided 95% CI
0.74 to 0.99
0.70 to 1.00
p-value
0.0427
0.0559
Contralateral breast primary
35 (1.1)
59 (1.9)
26 (1.0)
54 (2.1)
Odds ratio
0.59
0.47
2-sided 95% CI
0.39 to 0.89
0.30 to 0.76
p-value
0.0131
0.0018
Overall survival
411 (13.2)
420 (13.5)
296 (11.3)
301 (11.6)
Hazard ratio
0.97
0.97
2-sided 95% CI
0.85 to 1.12
0.83 to 1.14
p-value
0.7142
0.7339
a Disease-free survival includes all recurrence events and is defined as the first occurrence of loco-regional recurrence, contralateral new breast cancer, distant recurrence or death (for any reason).
b Distant disease-free survival is defined as the first occurrence of distant recurrence or death (for any reason).
c Time to recurrence is defined as the first occurrence of loco-regional recurrence, contralateral new breast cancer, distant recurrence or death due to breast cancer.
d Time to distant recurrence is defined as the first occurrence of distant recurrence or death due to breast cancer.
e Number (%) of patients who had died.
As with all treatment decisions, women with breast cancer and their physician should assess the relative benefits and risks of the treatment.
When anastrozole and tamoxifen were co-administered, the efficacy and safety were similar to tamoxifen when given alone, irrespective of hormone receptor status. The exact mechanism of this is not yet clear. It is not believed to be due to a reduction in the degree of estradiol suppression produced by anastrozole.
Adjuvant treatment of early breast cancer for patients being treated with adjuvant tamoxifen
In a phase III trial (ABCSG 8) conducted in 2579 postmenopausal women with hormone receptor positive early breast cancer who had received surgery with or without radiotherapy and no chemotherapy, switching to anastrozole after 2 years adjuvant treatment with tamoxifen was statistically superior in disease-free survival when compared to remaining on tamoxifen, after a median follow-up of 24 months.
Time to any recurrence, time to local or distant recurrence and time to distant recurrence confirmed a statistical advantage for anastrozole, consistent with the results of disease-free survival. The incidence of contralateral breast cancer was very low in the two treatment arms with a numerical advantage for anastrozole. Overall survival was similar for the two treatment groups.
ABCSG 8 trial endpoint and results summary
Efficacy endpoints
Number of events (frequency)
anastrozole (n=1297)
tamoxifen (n=1282)
Disease-free survival
65 (5.0)
93 (7.3)
Hazard ratio
067
2-sided 95% CI
0.49 to 0.92
p-value
0.014
Time to any recurrence
36 (2.8)
66 (5.1)
Hazard ratio
0.53
2-sided 95% CI
0.35 to 0.79
p-value
0.002
Time to local or distant recurrence
29 (2.2)
51 (4.0)
Hazard ratio
0.55
2-sided 95% CI
0.35 to 0.87
p-value
0.011
Time to distant recurrence
22 (1.7)
41 (3.2)
Hazard ratio
0.52
2-sided 95% CI
0.31 to 0.88
p-value
0.015
New contralateral breast cancer
7 (0.5)
15 (1.2)
Odds ratio
0.46
2-sided 95% CI
0.19 to 1.13
p-value
0.090
Overall survival
43(3.3)
45 (3.5)
Hazard ratio
0.96
2-sided 95% CI
0.63 to 1.46
p-value
0.840
Two further similar trials (GABG/ARNO 95 and ITA), in one of which patients had received surgery and chemotherapy, as well as a combined analysis of ABCSG 8 and GABG/ARNO 95, supported these results.
The anastrozole safety profile in these 3 studies was consistent with the known safety profile established in postmenopausal women with hormone receptor positive early breast cancer.
Study of anastrozole with the bisphosphonate risedronate (SABRE)
Bone Mineral Density (BMD)
In the phase III/IV SABRE study, 234 postmenopausal women with hormone receptor positive early breast cancer scheduled for treatment with anastrozole 1mg/day were stratified to low, moderate and high risk groups according to their existing risk of fragility fracture. The primary efficacy parameter was the analysis of lumbar spine bone mass density using DEXA scanning. All patients received treatment with vitamin D and calcium. Patients in the low risk group received anastrozole alone (N=42), those in the moderate group were randomised to anastrozole plus risedronate 35mg once a week (N=77) or anastrozole plus placebo (N=77) and those in the high risk group received anastrozole plus risedronate 35mg once a week (N=38). The primary endpoint was changed from baseline in lumbar spine bone mass density at 12 months.
The 12-month main analysis has shown that patients already at moderate to high risk of fragility fracture showed no decrease in their bone mass density (assessed by lumbar spine bone mineral density using DEXA scanning) when managed by using anastrozole 1mg/day in combination with risedronate 35mg once a week. In addition, a decrease in BMD which was not statistically significant was seen in the low risk group treated with anastrozole 1mg/day alone. These findings were mirrored in the secondary efficacy variable of change from baseline total hip BMD at 12 months.
This study provides evidence that the use of bisphosphonates should be considered in the management of possible bone mineral loss in postmenopausal women with early breast cancer scheduled to be treated with anastrozole.
Lipids
In the SABRE study there was a neutral effect on plasma lipids in those patients treated with anastrozole plus risedronate.
Paediatrics
Anastrozole is not indicated for use in children. Efficacy has not been established in the paediatric populations studied (see below). The number of children treated was too limited to draw any reliable conclusions on safety. No data on the potential long-term effects of anastrozole treatment in children are available (see also section 5.3)
The European Medicines Agency has waived the obligation to submit the results of studies with anastrozole in one or several subsets of the paediatric population in short stature due to growth hormone deficiency (GHD), testotoxicosis, gynaecomastia, and McCune-Albright syndrome.
Short stature due to Growth Hormone Deficiency
A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11-16 years inclusive) with GHD treated for 12 to 36 months with anastrozole 1mg/day or placebo in combination with growth hormone. Only 14 subjects on anastrozole completed 36 months. After 3 years anastrozole was found to statistically significantly slow bone maturation in pubertal boys on growth hormone therapy. No statistically significant difference with placebo was observed for the growth related parameters of predicted adult height, height, height SDS and height velocity. Final height data were not available. While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the anastrozole arm compared to placebo.
Testotoxicosis
An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2-9) with familial male-limited precocious puberty, also known as testotoxicosis, treated with a combination of anastrozole and bicalutamide. The primary objective was to assess the efficacy and safety of this combination regimen over 12 months. Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up). There was no significant difference in growth rate after 12 months of treatment, relative to the growth rate during the 6 months prior to entering the study.
Gynaecomastia studies
Trial 0006 was a randomised, double-blind, multi-centre study of 82 pubertal boys (aged 11-18 years inclusive) with gynaecomastia of greater than 12 months duration treated with anastrozole 1mg/day or placebo daily for up to 6 months. No significant difference in the number of patients who had a 50% or greater reduction in total breast volume after 6 months of treatment was observed b
Anastrozole 1mg film-coated tablets (medac GmbH)
1. Name Of The Medicinal Product
Anastrozole 1 mg film-coated tablets
2. Qualitative And Quantitative CompositionOne film-coated tablet contains 1 mg of anastrozole.
Excipients: Lactose monohydrate 92.75 mg
For full list of excipients, see section 6.1
3. Pharmaceutical FormFilm-coated tablet.
White, round, biconvex tablets with imprint 'A1' on one side.
4. Clinical Particulars 4.1 Therapeutic Indications• Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.
4.2 Posology And Method Of AdministrationAdults including the elderly:
One film-coated tablet (1 mg) to be taken orally once a day.
Children and adolescents:
Anastrozole is not recommended for use in children due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Renal and hepatic impairment:
No dose change is recommended in patients with mild or moderate renal impairment.
No dose change is recommended in patients with mild hepatic disease.
4.3 ContraindicationsAnastrozole is contraindicated in:
• premenopausal women
• pregnant or lactating women
• patients with severe renal impairment (creatinine clearance less than 20 ml/min)
• patients with moderate or severe hepatic disease
• patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1
Oestrogen-containing therapies should not be co-administered with Anastrozole as they would negate its pharmacological action.
Concurrent tamoxifen therapy (see section 4.5).
4.4 Special Warnings And Precautions For UseAnastrozole is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
Anastrozole should not be used in boys with growth hormone deficiency in addition to growth hormone treatment. In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1). Since anastrozole reduces estradiol levels, Anastrozole must not be used in girls with growth hormone deficiency in addition to growth hormone treatment. Long-term safety data in children and adolescents are not available.
The menopause should be defined biochemically in any patient where there is doubt about hormonal status.
There are no data to support the safe use of Anastrozole in patients with moderate or severe hepatic impairment, or patients with severe impairment of renal function (creatinine clearance less than 20 ml/min).
Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed by bone densitometry e.g. DEXA scanning at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.
There are no data available for the use of anastrozole with LHRH analogues. This combination should not be used outside clinical trials.
As anastrozole lowers circulating oestrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionPhenazone and cimetidine clinical interaction studies indicate that the co-administration of anastrozole with other drugs is unlikely to result in clinically significant drug interactions mediated by cytochrome P450.
A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with anastrozole who also received other commonly prescribed drugs.
Oestrogen-containing therapies should not be co-administered with anastrozole as they would negate its pharmacological action.
Tamoxifen should not be co-administered with anastrozole, as this may diminish its pharmacological action (see section 4.3).
4.6 Pregnancy And LactationAnastrozole is contraindicated in pregnant and lactating women (see section 4.3).
4.7 Effects On Ability To Drive And Use MachinesAnastrozole is unlikely to impair the ability of patients to drive and operate machinery. However, asthenia and somnolence have been reported with the use of anastrozole and caution should be observed when driving or operating machinery while such symptoms persist.
4.8 Undesirable EffectsRates of incidence:
very common
(> 1/10)
common
(
uncommon
(
rare
(
very rare
(
Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in postmenopausal women with operable breast cancer treated for five years.
very common
common
uncommon
rare
not known
Nervous system disorders
Headache, mainly mild or moderate in nature
Somnolence, mainly mild or moderate in nature, Carpal tunnel syndrome
Gastrointestinal disorders
Nausea, mainly mild or moderate in nature
Diarrhoea, mainly mild or moderate in nature, vomiting, mainly mild or moderate in nature
Skin and subcutaneous tissue disorders
Rash, mainly mild or moderate in nature
Hair thinning (alopecia), mainly mild or moderate in nature, allergic reactions
Urticaria
Erythema multiforme, anaphylactoid reactions
Stevens-Johnson syndrome**, Angioedema**
Musculo-skeletal, connective tissue and bone disorders
Joint pain/stiffness, mainly mild or moderate in nature, arthritis
Bone pain
Trigger finger
Metabolism and nutrition disorders
Anorexia, mainly mild or moderate in nature, hypercholesterolaemia, mainly mild or moderate in nature
Vascular disorders
Hot flushes, mainly mild or moderate in nature
General disorders and administration site conditions
Asthenia, mainly mild or moderate in nature
Hepatobiliary disorders
Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase
Increases in gamma-GT and bilirubin, hepatitis
Reproductive system and breast disorders
Vaginal dryness, mainly mild or moderate in nature, Vaginal bleeding*, mainly mild or moderate in nature
*Vaginal bleeding has been reported uncommonly, mainly in patients with advanced breast cancer during the first few weeks after changing from existing hormonal therapy to treatment with anastrozole. If bleeding persists, further evaluation should be considered.
** Cannot be estimated from the available data.
As anastrozole lowers circulating oestrogen levels, it may cause a reduction in bone mineral density placing some patients at a higher risk of fracture (see section 4.4).
The table below presents the frequency of pre-specified adverse events in a study, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.
Adverse event
Anastrozole
(N = 3092)
Tamoxifen
(N = 3094)
Hot flushes
1104 (35.7%)
1264 (40.9%)
Joint pain/stiffness
1100 (35.6%)
911 (29.4%)
Mood disturbances
597 (19.3%)
554 (17.9%)
Fatigue/asthenia
575 (18.6%)
544 (17.6%)
Nausea and vomiting
393 (12.7%)
384 (12.4%)
Fractures
315 (10.2%)
209 (6.8%)
Fractures of the spine, hip, or wrist/Colles fractures
133 (4.3%)
91 (2.9%)
Wrist/Colles fractures
67 (2.2%)
50 (1.6%)
Spine fractures
43 (1.4%)
22 (0.7%)
Hip fractures
28 (0.9%)
26 (0.8%)
Cataracts
182 (5.9%)
213 (6.9%)
Vaginal bleeding
167 (5.4%)
317 (10.2%)
Ischaemic cardiovascular disease
127 (4.1%)
104 (3.4%)
Angina pectoris
71 (2.3%)
51 (1.6%)
Myocardial infarct
37 (1.2%)
34 (1.1%)
Coronary artery disorder
25 (0.8%)
23 (0.7%)
Myocardial ischaemia
22 (0.7%)
14 (0.5%)
Vaginal discharge
109 (3.5%)
408 (13.2%)
Any venous thromboembolic event
87 (2.8%)
140 (4.5%)
Deep venous thromboembolic events including pulmonary embolism
48 (1.6%)
74 (2.4%)
Ischaemic cerebrovascular events
62 (2.0%)
88 (2.8%)
Endometrial cancer
4 (0.2%)
13 (0.6%)
Fracture rates of 22 per 1000 patient-years and 15 per 1000 patient-years were observed for the anastrozole and tamoxifen groups, respectively, after a median follow-up of 68 months. The observed fracture rate for anastrozole is similar to the range reported in age-matched postmenopausal populations. It has not been determined whether the rates of fracture and osteoporosis seen in patients on anastrozole treatment reflect a protective effect of tamoxifen, a specific effect of anastrozole, or both.
The incidence of osteoporosis was 10.5% in patients treated with anastrozole and 7.3% in patients treated with tamoxifen.
4.9 OverdoseThere is limited clinical experience of accidental overdose. In animal studies, anastrozole demonstrated low acute toxicity.
Clinical trials have been conducted with various dosages of anastrozole, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated. A single dose of anastrozole that results in life-threatening symptoms has not been established. There is no specific antidote to overdose and treatment must be symptomatic.
In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because anastrozole is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic group: Enzyme inhibitors
ATC Code: L02B G03
Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor. In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues. Estrone is subsequently converted to estradiol. Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer. In postmenopausal women, anastrozole at a daily dose of 1 mg produced estradiol suppression of greater than 80% using a highly sensitive assay method.
Anastrozole does not possess any progestogenic, androgenic or oestrogenic activity.
Daily doses of anastrozole up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard ACTH challenge testing. Corticoid supplements are therefore not needed.
Paediatrics
Anastrozole is not indicated for use in children. Efficacy has not been established in the paediatric populations studied (see below). The number of children treated was too limited to draw any reliable conclusions on safety. No data on the potential long-term effects of anastrozole treatment in children are available (see also section 5.3).
The European Medicines Agency has waived the obligation to submit the results of studies with anastrozole in one or several subsets of the paediatric population in short stature due to growth hormone deficiency (GHD), testotoxicosis, gynaecomastia, and McCune-Albright syndrome.
Short stature due to Growth Hormone Deficiency
A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11
After 3 years anastrozole was found to statistically significantly slow down bone maturation in pubertal boys on growth hormone therapy. No statistically significant difference with placebo was observed for the growth related parameters of predicted adult height, height, height SDS, and height velocity. Final height data were not available. While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the anastrozole arm compared to placebo.
Testotoxicosis
An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2
Gynaecomastia studies
Trial 0006 was a randomised, double-blind, multi-centre study of 82 pubertal boys (aged 11
Trial 0001 was an open-label, multiple-dose pharmacokinetic study of anastrozole 1 mg/day in 36 pubertal boys with gynaecomastia of less than 12 months duration. The secondary objectives were to evaluate the proportion of patients with reductions from baseline in the calculated volume of gynaecomastia of both breasts combined of at least 50% between day 1 and after 6 months of study treatment, and patient tolerability and safety.
A pharmacodynamic subpopulation of 25 boys was selected in this study to explore the potential benefits of anastrozole. It was noted a decrease in total breast volume of 50% or greater at 6 months was seen in 55.6% (as measured by ultrasound) and 77.8% (as measured by caliper) of the boys (observational data only, no statistical analysis conducted on these results).
McCune-Albright Syndrome study
Trial 0046 was an international, multi-centre, open-label exploratory trial of anastrozole in 28 girls (aged 2 to
No statistically significant change in the frequency of vaginal bleeding days on treatment was observed. There were no clinically significant changes in Tanner staging, mean ovarian volume or mean uterine volume. No statistically significant change in the rate of increase in bone age on treatment compared to the rate during baseline was observed. Growth rate (in cm/year) was significantly reduced (p < 0.05) from pre-treatment through month 0 to month 12, and from pre-treatment to the second 6 months (month 7 to month 12). Of the patients with baseline vaginal bleeding, 28% experienced a
The overall assessment of the adverse events in children less than 18 years of age raised no safety or tolerability concerns.
5.2 Pharmacokinetic PropertiesAbsorption
Absorption of anastrozole is rapid and maximum plasma concentrations typically occur within two hours of dosing (under fasted conditions). Food slightly decreases the rate but not the extent of absorption. The small change in the rate of absorption is not expected to result in a clinically significant effect on steady-state plasma concentrations during once daily dosing of Anastrozole tablets. Approximately 90 to 95% of plasma anastrozole steady-state concentrations are attained after 7 daily doses. There is no evidence of time or dose-dependency of anastrozole pharmacokinetic parameters.
Distribution
Anastrozole is only 40% bound to plasma proteins.
Elimination
Anastrozole is eliminated slowly with a plasma elimination half-life of 40 to 50 hours.
The apparent oral clearance of anastrozole in volunteers with stable hepatic cirrhosis or renal impairment was in the range observed in healthy volunteers.
Metabolism
Anastrozole is extensively metabolised by postmenopausal women with less than 10% of the dose excreted in the urine unchanged within 72 hours of dosing. Metabolism of anastrozole occurs by N
Age dependency of pharmacokinetics
Anastrozole pharmacokinetics are independent of age in postmenopausal women.
Pharmacokinetics in children and adolescents
In boys with pubertal gynaecomastia, anastrozole was rapidly absorbed, was widely distributed, and was eliminated slowly with a half-life of approximately 2 days. Clearance of anastrozole was lower in girls than in boys and exposure higher. Anastrozole in girls was widely distributed and slowly eliminated, with an estimated half-life of approximately 0.8 days.
5.3 Preclinical Safety DataIn animal studies, toxicity related to the pharmacodynamic action was only seen at high doses.
In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks. Measured mean plasma concentrations were 44.4 (± 14.7) ng/ml and 165 (± 90) ng/ml respectively. Mating indices were adversely affected in both dose groups, whilst a reduction in fertility was evident only at the 400 mg/l dose level. The reduction was transient as all mating and fertility parameters were similar to control group values following a 9
Oral administration of anastrozole to female rats produced a high incidence of infertility at 1 mg/kg/day and increased pre-implantation loss at 0.02 mg/kg/day. These effects occurred at clinically relevant doses. An effect in man cannot be excluded. These effects were related to the pharmacology of the compound and were completely reversed after a 5-week compound withdrawal period.
Oral administration of anastrozole to pregnant rats and rabbits caused no teratogenic effects at doses up to 1.0 and 0.2 mg/kg/day respectively. Those effects that were seen (placental enlargement in rats and pregnancy failure in rabbits) were related to the pharmacology of the compound.
The survival of litters born to rats given anastrozole at 0.02 mg/kg/day and above was compromised. These effects were related to the pharmacological effects of the compound on parturition.
Genetic toxicology studies with anastrozole show that it is neither a mutagen nor a clastogen.
Carcinogenicity studies have been performed in rats and mice.
In rats, increases in the incidence of hepatic neoplasms and uterine stromal polyps in females and thyroid adenomas in males were observed at a dose which represents 100
In mice induction of benign ovarian tumours and a disturbance in the incidence of lymphoreticular neoplasms (fewer histiocytic sarcomas in females and more deaths as a result of lymphomas) were observed. These changes are considered to be mouse-specific effects of aromatase inhibition and not clinically relevant.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsTablet core:
Lactose monohydrate
Sodium starch glycolate (Type A)
Povidone K
Magnesium stearate
Film coating:
Hypromellose
Macrogol 6000
Cottonseed oil, hydrogenated
Starch, pregelatinised modified (origin: maize)
Titanium dioxide E171
6.2 IncompatibilitiesNot applicable.
6.3 Shelf Life4 years.
6.4 Special Precautions For StorageThis medicinal product does not require any special storage conditions.
6.5 Nature And Contents Of ContainerPVC/Aluminium blister
The following pack sizes are available:
20, 28, 30, 84, 98, 100 or 300 film-coated tablets.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other HandlingNo special requirements.
7. Marketing Authorisation Holdermedac
Gesellschaft f?r klinische
Spezialpr?parate mbH
Fehlandtstr. 3
20354 Hamburg
Germany
8. Marketing Authorisation Number(S)PL 11587/0064
9. Date Of First Authorisation/Renewal Of The Authorisation28/05/2009
10. Date Of Revision Of The Text26/11/2010
Pro-Banthine
propantheline bromide
Dosage Form: Tablets
Pro-Banthine Description
Pro-Banthine®(propantheline bromide) oral tablets contain 15 mg or 7.5 mg of the anticholinergic propantheline bromide, (2-hydroxyethyl) diisopropylmethylammonium bromide xanthene-9-carboxylate.
The structural formula of propantheline bromide is:
Propantheline bromide is very soluble in water, alcohol, and chloroform, but it is practically insoluble in ether and in benzene. Its molecular weight is 448.40.
Inactive Ingredients: include calcium carbonate, castor oil, corn starch, lactose anhydrous, light mineral oil, magnesium carbonate, magnesium stearate, saccharin sodium, sucrose, talc, titanium dioxide, and waxes. The 15-mg tablet also contains cosmetic ochre and cosmetic red as coloring agents.
Pro-Banthine - Clinical PharmacologyPropantheline bromide inhibits gastrointestinal motility and diminishes gastric acid secretion. The drug also inhibits the action of acetylcholine at the post-ganglionic nerve endings of the parasympathetic nervous system.
Propantheline bromide is extensively metabolized in man primarily by hydrolysis to the inactive compounds xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide. After a single 30-mg oral dose given as two 15-mg tablets, the mean peak plasma concentration of propantheline was 21 ng/mL at 1 hour in 6 healthy subjects.
The plasma elimination half-life of propantheline is about 1.6 hours. Approximately 70% of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of propantheline is about 3% after oral tablet administration.
Indications and Usage for Pro-BanthinePro-Banthine® (propantheline bromide) tablets are as effective as adjunctive therapy in the treatment of peptic ulcer.
ContraindicationsPropantheline bromide is contraindicated in patients with:
Glaucoma, since mydriasis is to be avoided. Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc.) Obstructive uropathy (e.g., bladder-neck obstruction due to prostatic hypertrophy). Intestinal atony of elderly or debilitated patients. Severe ulcerative colitis or toxic megacolon complicating ulcerative colitis. Unstable cardiovascular adjustment in acute hemorrhage. Myasthenia gravis. WarningsIn the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of Pro-Banthine®.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with propantheline bromide would be inappropriate and possibly harmful.
With overdosage, a curare-like action may occur (i.e., neuromuscular blockage leading to muscular weakness and possible paralysis).
Propantheline bromide may cause increased heart rate and, therefore, should be used with caution in patients with heart disease.
Precautions GeneralPropantheline bromide should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, or hiatal hernia associated with reflux esophagitis, since anticholinergics may aggravate this condition.
In patients with ulcerative colitis, large doses of propantheline bromide may suppress intestinal motility to the point of producing paralytic ileus and, for this reason, may precipitate or aggravate toxic megacolon, a serious complication of the disease.
Information for patientsPropantheline bromide may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work, while taking this drug product.
Drug InteractionsAnticholinergics may delay absorption of other medication given concomitantly.
Excessive cholinergic blockade may occur if propantheline bromide is given concomitantly with belladonna alkaloids, synthetic or semisynthetic anticholinergic agents, narcotic analgesics such as meperidine, Type 1 antiarrhythmic drugs (e.g. disopyramide, procainamide or quinidine), antihistamines, phenothiazines, tricyclic antidepressants, or other psychoactive drugs. Propantheline bromide may also potentiate the sedative effect of phenothiazines. Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.
Concurrent use of propantheline bromide with slow-dissolving tablets of digoxin may cause increased serum digoxin levels. This interaction can be avoided by using only those digoxin tablets that rapidly dissolve by USP standards.
Carcinogenesis, mutagenesis, impairment of fertilityNo long-term fertility, carcinogenicity, or mutagenicity studies have been done with propantheline bromide.
Pregnancy Pregnancy Category CAnimal reproduction studies have not been conducted with propantheline bromide. It is also not known whether propantheline bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Propantheline bromide should be given to a pregnant woman only if clearly needed.
Nursing mothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.
Pediatric UseSafety and effectiveness in pediatric patients have not been established.
Adverse ReactionsVarying degrees of drying of salivary secretions may occur as well as decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia and increased ocular tension. Other reported adverse reactions include urinary hesitancy and retention, tachycardia, palpitations, loss of the sense of taste, headache, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, bloated feeling, impotence, suppression of lactation, and allergic reactions or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations.
OverdosageThe symptoms of overdosage with propantheline bromide progress from an intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma.
Measures to be taken are (1) immediate induction of emesis or lavage of the stomach, (2) injection of physostigmine 0.5 to 2 mg intravenously, repeated as necessary up to a total of 5 mg, and (3) monitoring of vital signs and managing as necessary.
Fever may be treated symptomatically (cooling blanket or alcohol sponging). Excitement of a degree which demands attention may be managed with thiopental sodium 2% solution given slowly intravenously, or diazepam, 5 to 10 mg intravenously or 10 mg intramuscularly. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, mechanical respiration should be instituted and maintained until effective respiratory action returns.
The oral LD50 of propantheline bromide is 780 mg/kg in the mouse and 370 mg/kg in the rat.
Pro-Banthine Dosage and AdministrationThe usual initial adult dosage of Pro-Banthine®tablets is 15 mg taken 30 minutes before each meal (3 times daily), and 30 mg at bedtime (a total of 75 mg daily). Subsequent dosage adjustment should be made according to the patient's individual response and tolerance. The administration of one 7.5-mg tablet 30 minutes before each meal (3 times daily) is convenient for patients with mild manifestations, for geriatric patients, and for those of small stature.
How is Pro-Banthine SuppliedPro-Banthine®15-mg tablets are round, peach-colored, sugar-coated, with RPC imprinted on one side and 074 on the other side. Bottles of 100 (NDC 54092-074-01).
Pro-Banthine® 7.5-mg tablets are round, white, sugar-coated, with RPC imprinted on one side and 073 on the other side. Bottles of 100 (NDC 54092-073-01).
Store below 25°C (77°F).
Rev. 2/00 073 0117 004
PRO-BANTHINE
propantheline bromide tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54092-074 Route of Administration ORAL DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength propantheline bromide (propantheline) Active 15 MILLIGRAM In 1 TABLET calcium carbonate Inactive castor oil Inactive corn starch Inactive lactose anhydrous Inactive light mineral oil Inactive magnesium carbonate Inactive magnesium stearate Inactive saccharin sodium Inactive sucrose Inactive talc Inactive titanium dioxide Inactive waxes Inactive cosmetic ochre Inactive cosmetic red Inactive Product Characteristics Color PINK (PEACH) Score no score Shape ROUND Size 6mm Flavor Imprint Code RPC;074 Contains Coating true Symbol false Packaging # NDC Package Description Multilevel Packaging 1 54092-074-01 100 TABLET In 1 BOTTLE None
PRO-BANTHINE
propantheline bromide tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54092-073 Route of Administration ORAL DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength propantheline bromide (propantheline) Active 7.5 MILLIGRAM In 1 TABLET calcium carbonate Inactive castor oil Inactive corn starch Inactive lactose anhydrous Inactive light mineral oil Inactive magnesium carbonate Inactive magnesium stearate Inactive saccharin sodium Inactive sucrose Inactive talc Inactive titanium dioxide Inactive waxes Inactive Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code RPC;073 Contains Coating true Symbol false Packaging # NDC Package Description Multilevel Packaging 1 54092-073-01 100 TABLET In 1 BOTTLE None
Revised: 03/2007Shire US Manufacturing Inc More Pro-Banthine resources Pro-Banthine Side Effects (in more detail)Pro-Banthine DosagePro-Banthine Use in Pregnancy & BreastfeedingPro-Banthine Drug InteractionsPro-Banthine Support Group0 Reviews for Pro-Banthine - Add your own review/rating Pro-Banthine MedFacts Consumer Leaflet (Wolters Kluwer) Pro-Banthine Concise Consumer Information (Cerner Multum) Propantheline Bromide Monograph (AHFS DI) Compare Pro-Banthine with other medications Peptic Ulcer
Saizen 3.33mg
1. Name Of The Medicinal Product
Saizen 3.33 mg powder and solvent for solution for injection
2. Qualitative And Quantitative CompositionEach vial of Saizen 3.33 mg contains somatropin* (recombinant human growth hormone).
*produced by recombinant DNA technology in mammalian cells
After reconstitution with the enclosed solvent, each vial shall contain
For a full list of excipients, see section 6.1.
3. Pharmaceutical FormPowder and solvent for solution for injection
Appearance of the powder: white lyophilised powder.
Appearance of the solvent: clear colourless solution.
The pH of the reconstituted solution is 7.4 - 8.5.
4. Clinical Particulars 4.1 Therapeutic IndicationsSaizen is indicated in the treatment of:
Children:
- Growth failure in children caused by decreased or absent secretion of endogenous growth hormone.
- Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.
- Growth failure in prepubertal children due to chronic renal failure (CRF).
- Growth disturbance (current height SDS <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last year) by 4 years of age or later.
Adults:
- Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfil the following criteria:
- Childhood Onset:
Patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with Saizen is started.
- Adult Onset:
Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.
4.2 Posology And Method Of AdministrationBenzyl alcohol as a preservative in bacteriostatic sodium chloride solution may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates. Saizen may be reconstituted with Sodium Chloride Injection BP or Sterile Water for Injections for immediate use when administering to children under 3 years of age.
Saizen 3.33 mg is intended for multiple dose use.
Saizen dosage should be individualised for each patient based on body surface area (BSA) or on body weight (BW).
It is recommended that Saizen be administered at bedtime according to the following dosage:
Children and adolescents:
- Growth failure due to inadequate endogenous growth hormone secretion:
0.7-1.0 mg/m2 body surface area (BSA) per day or 0.025-0.035 mg/kg body weight (BW) per day by subcutaneous or intramuscular administration.
- Growth failure in girls due to gonadal dysgenesis (Turner Syndrome)
1.4 mg/m2 body surface area (BSA) per day or 0.045-0.050 mg/kg body weight (BW) per day by subcutaneous administration.
- Concomitant therapy with non-androgenic anabolic steroids in patients with Turner Syndrome can enhance the growth response.
- Growth failure in prepubertal children due to chronic renal failure (CRF):
1.4 mg/m2 body surface area (BSA), approximately equal to 0.045-0.050 mg/kg body weight (BW), per day by subcutaneous administration.
- Growth failure in short children born small for gestational age (SGA):
The recommended daily dose is 0.035 mg/kg body weight (or 1 mg/m2/day, equal to 0.1 U/kg/day or 3 IU/m2/day) per day, by subcutaneous administration.
Treatment should be discontinued when the patient has reached a satisfactory adult height, or the epiphyses are fused.
For growth disturbance in short children born SGA, treatment is usually recommended until final height is reached. Treatment should be discontinued after the first year if height velocity SDS is below +1. Treatment should be discontinued when final height is reached (defined as height velocity <2 cm/year), and if confirmation is required if bone age is>14 years (girls) or>16 years (boys), corresponding to closure of the epiphyseal growth plates.
Adults:
- Growth Hormone Deficiency in adults:
At the start of somatropin therapy, low doses of 0.15-0.3 mg are recommended, given as a daily subcutaneous injection. The dose should be adjusted stepwise, controlled by Insulin-like Growth Factor 1 (IGF-1) values. The recommended final GH dose seldom exceeds 1.0mg/day. In general the lowest efficacious dose should be administered. In older or overweight patients, lower doses may be necessary.
The powder for solution for injection should be used with the enclosed solvent for parenteral use. The reconstituted solution for injection should be clear with no particles. For instructions for preparation, please see section 6.6.
4.3 ContraindicationsHypersensitivity to the active substance or to any of the excipients.
Somatropin should not be used for growth promotion in children with closed epiphyses.
Any evidence of active malignant tumours. Intracranial neoplasm must be inactive and antitumor therapy should be completed prior to institution of therapy.
Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions should not be treated with somatropin.
In children with chronic renal disease, treatment with somatropin should be discontinued at renal transplantation.
4.4 Special Warnings And Precautions For UseTreatment should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of patients with growth hormone deficiency.
Patients with an intra or extracranial neoplasia in remission who are receiving treatment with growth hormone should be examined carefully and at regular intervals by the physician.
Patients with growth hormone deficiency secondary to an intracranial tumour should be examined frequently for progression or recurrence of the underlying disease process.
Prader-Willi Syndrome
Saizen is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi Syndrome, unless they also have a diagnosis of growth hormone deficiency. There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi Syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Leukaemia
Leukaemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.
Insulin sensitivity
Because somatropin may reduce insulin sensitivity , patients should be monitored for evidence of glucose intolerance. For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin containing product therapy is instituted. Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy.
Stable background retinopathy should not lead to discontinuation of somatropin replacement therapy. In case of development of preproliferative changes and the presence of proliferative retinopathy somatropin replacement therapy should be discontinued.
Thyroid function
Growth hormone increases the extra thyroid conversion of T4 to T3 and may, as such, unmask incipient hypothyroidism. Monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered.
Benign intracranial hypertension
In case of severe or recurrent headache, visual problems, nausea and/or vomiting, fundoscopy for papille oedema is recommended. If papille oedema is confirmed a diagnosis of benign intracranial hypertension (or pseudotumor cerebri) should be considered and if appropriate, Saizen treatment should be discontinued. At present there is insufficient evidence to guide clinical decision-making in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary
Antibodies
As with all somatropin containing products, a small percentage of patients may develop antibodies to somatropin. The binding capacity of these antibodies is low and there is no effect on growth rate. Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy.
Slipped capital femoral epiphysis is often associated with endocrine disorders such as growth hormone deficiency and hypothyroidism, and with growth spurts. In children treated with growth hormone, slipped capital femoral epiphysis may either be due to underlying endocrine disorders or to the increased growth velocity caused by the treatment. Growth spurts may increase the risk of joint-related problems, the hip joint being under particular strain during the prepubertal growth spurt. Physicians and parents should be alert to the development of a limp or complaints of hip or knee pain in children treated with Saizen.
Patients with growth failure due to chronic renal failure should be examined periodically for evidence of progression of renal osteodystrophy. Slipped capital femoral epiphysis or avascular necrosis of the femoral head may be seen in children with advanced renal osteodystrophy and it is uncertain whether these problems are affected by growth hormone therapy. X-rays of the hip should be obtained prior to initiating therapy.
In children with chronic renal failure, renal function should have decreased to below 50% of normal before therapy is instituted. To verify the growth disturbance, growth should have been followed for a year before institution of therapy. Conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism and nutritional status for one year prior to the treatment) should have been established and should be maintained during treatment. Treatment should be discontinued at the time of renal transplantation.
In short children born SGA other medical reasons or treatments that could explain growth disturbance should be ruled out before starting treatment.
For SGA patients it is recommended to measure fasting insulin and blood glucose before start of treatment and annually thereafter. In patients with increased risk for diabetes mellitus (e.g. familial history of diabetes, obesity, increased body mass index, severe insulin resistance, acanthosis nigricans) oral glucose tolerance testing (OGTT) should be performed. If overt diabetes occurs, growth hormone should not be administered.
For SGA patients it is recommended to measure IGF-I level before start of treatment and twice a year thereafter. If on repeated measurements IGF-I levels exceed +2 SD compared to references for age and pubertal status, the IGF-I/IGFBP-3 ratio could be taken into account to consider dose adjustment.
Experience in initiating treatment in SGA patients near onset of puberty is limited. It is therefore not recommended to initiate treatment near onset of puberty. Experience with SGA patients with Silver-Russel syndrome is limited.
Some of the height gain obtained with treating short children born SGA with somatropin may be lost if treatment is stopped before final height is reached.
Fluid retention is expected during growth hormone replacement therapy in adults.
In case of persistent oedema or severe paraesthesia the dosage should be decreased in order to avoid the development of carpal tunnel syndrome.
The injection site should be varied to prevent lipoatrophy.
Benzyl alcohol as a preservative in bacteriostatic sodium chloride solution may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates. Saizen may be reconstituted with Sodium Chloride Injection BP or Sterile Water for Injections for immediate use when administering to children under 3 years of age.
Growth Hormone Deficiency in the Adult is a lifelong condition and should be treated accordingly, however experience with patients over sixty years and experience with prolonged treatment is limited
In all patients developing acute critical illness, the possible benefit of treatment with somatropin must be weighed against the potential risk involved.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionConcomitant treatment with glucocorticoids inhibits the growth-promoting effects of somatropin containing products. Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth hormone.
Data from an interaction study performed in growth hormone deficient adults, suggests that somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes. The clearance of compounds metabolised by cytochrome P 450 3A4 (e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially increased resulting in lower plasma levels of these compounds. The clinical significance of this is unknown.
4.6 Pregnancy And LactationPregnancy:
Animal studies are insufficient and/or animal data is not available with regard to effects on pregnancy, embryofoetal development, parturition or postnatal development (See section Preclinical safety data 5.3) No clinical data on exposed pregnancies are available. Therefore, somatropin containing products are not recommended during pregnancy and in woman of childbearing potential not using contraception
Lactation:
There have been no clinical studies conducted with somatropin in breast-feeding women. It is not known whether somatropin is excreted in human milk. Therefore caution should be exercised when somatropin is administered to breast-feeding women.
4.7 Effects On Ability To Drive And Use MachinesSomatropin-containing products have no influence on the ability to drive and use machines.
4.8 Undesirable EffectsUp to 10 % of patients may experience redness and itching at the site of injection, particularly when the subcutaneous route is used.
Fluid retention is expected during growth hormone replacement therapy in adults. Oedema, joint swelling, arthralgias, myalgias and paresthesias may be clinical manifestations of fluid retention. However, these symptoms / signs are usually transient and dose dependent.
Adult patients with growth hormone deficiency, following diagnosis of growth hormone deficiency in childhood, reported side-effects less frequently than those with adult onset growth hormone deficiency.
Antibodies to somatropin can form in some patients; the clinical significance of these antibodies is unknown, though to date the antibodies have been of low binding capacity and have not been associated with growth attenuation except in patients with gene deletions. In very rare instances, where short stature is due to deletion of the growth hormone gene complex, treatment with growth hormone may induce growth attenuating antibodies.
Leukaemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class
Common
(
Uncommon
(
Very rare
(<1/10,000)
Frequency unknown
Nervous system disorders
Idiopathic intracranial hypertension (benign intracranial hypertension)
Carpal tunnel syndrome
(Isolated) headache
Musculoskeletal and connective tissue disorders
Slipped capital femoral epiphysis (Epiphysiolysis capitis femoris), or avascular necrosis of the femoral head
Endocrine disorders
Hypothyroidism
Metabolism and nutrition disorders
In adults: Fluid retention: peripheral oedema, stiffness, arthralgia, myalgia, paresthesia.
In children: Fluid retention: peripheral oedema, stiffness, arthralgia, myalgia, paresthesia.
Insulin resistance can result in hyperinsulinism and in rare cases in hyperglycemia.
General disorders and administration site conditions
Injection site reactions: Localized lipoatrophy, which can be avoided by varying the site of injection
4.9 Overdose
No cases of acute overdose has been reported. However, exceeding the recommended doses can cause side effects. Overdosage can lead to hypoglycaemia and subsequently to hyperglycaemia. Moreover, somatropin overdose is likely to cause manifestations of fluid retention.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmaco-therapeutic group: Anterior pituitary lobe hormones and analogues, ATC code: H01AC01.
Saizen contains recombinant human growth hormone produced by genetically engineered mammalian cells.
It is a peptide of 191 amino acids identical to human pituitary growth hormone with respect to aminoacid sequence and composition as well as peptide map, isoelectric point, molecular weight, isomeric structure and bioactivity.
Growth hormone is synthesised in a transformed murine cell line that has been modified by the addition of the gene for pituitary growth hormone.
Saizen is an anabolic and anticatabolic agent, which exerts effects not only on growth but also on body composition and metabolism. It interacts with specific receptors on a variety of cell types including myocytes, hepatocytes, adipocytes, lymphocytes and hematopoietic cells. Some, but not all of its effects are mediated through another class of hormones known as somatomedins (IGF-1 and IGF-2).
Depending on the dose, the administration of Saizen elicits a rise in IGF-1, IGFBP-3, non-esterified fatty acids and glycerol, a decrease in blood urea, and decreases in urinary nitrogen, sodium and potassium excretion. The duration of the increase in GH levels may play a role in determining the magnitude of the effects. A relative saturation of the effects of Saizen at high doses is probable. This is not the case for glycemia and urinary C-peptide excretion, which are significantly elevated only after high doses (20 mg).
In a randomized clinical trial, three years treatment of pre-pubertal short children born SGA with a dose of 0.067 mg/kg/day resulted in a mean gain of +1.8 height-SDS. In those children who did not receive treatment beyond 3 years, part of the treatment benefit was lost, but the patients retained a significant gain of +0.7 height-SDS at final height (p<0.01 compared to baseline). Patients who received a second treatment course after a variable period of observation experienced a total gain of +1.3 height-SDS (p=0.001 compared to baseline) at final height. (The mean cumulative treatment duration in the latter group was 6.1 years). The gain in height-SDS (+1.3±1.1) at final height in this group was significantly (p<0.05) different from the gain in height-SDS obtained in the first group (+0.7±0.8) that received only 3.0 years of treatment on average.
A second clinical trial investigated two different dose regimens over four years. One group was treated with 0.067 mg/kg/day for 2 years and then observed without treatment for 2 years. The second group received 0.067 mg/kg/day in the first and third year and no treatment in the second and fourth year. Either treatment regimen resulted in a cumulative administered dose of 0.033 mg/kg/day over the four-year study period. Both groups showed a comparable acceleration of growth and a significant improvement of +1.55 (p<0.0001) and + 1.43 (p<0.0001) height-SDS respectively at the end of the four year study period. Long-term safety data are still limited.
5.2 Pharmacokinetic PropertiesThe pharmacokinetics of Saizen are linear at least up to doses of 8 IU (2.67 mg). At higher doses (60 IU/20 mg) some degree of non-linearity cannot be ruled out, however with no clinical relevance.
Following IV administration in healthy volunteers the volume of distribution at steady-state is around 7 L, total metabolic clearance is around 15 L/h while the renal clearance is negligible, and the drug exhibits an elimination half-life of 20 to 35 min.
Following single-dose SC and IM administration of Saizen, the apparent terminal half-life is much longer, around 2 to 4 hours. This is due to a rate limiting absorption process.
Maximum serum growth hormone (GH) concentrations are reached after approximately 4 hours and serum GH levels return to baseline within 24 hours, indicating that no accumulation of GH will occur during repeated administrations.
The absolute bioavailability of both routes is 70-90 %.
5.3 Preclinical Safety DataNon-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Formal carcinogenicity bioassays were not performed. This is justified, given the proteinous nature of the drug substance and the negative outcome of the genotoxicity testing. The potential effects of r-hGH on the growth of pre-existing tumours have been evaluated through in vitro and in vivo experiments which have shown that r-hGH is not expected to cause or stimulate tumours in patients.
Reproductive toxicology studies do not indicate any adverse effect on fertility and reproduction, despite administration of doses sufficiently high to produce some pharmacological effects on growth.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsPowder:
- Mannitol, Disodium phosphate dihydrate, Sodium dihydrogen phosphate monohydrate
Solvent:
- sodium chloride (0.9 % w/v) and benzyl alcohol (0.9 % w/v, as preservative) solution for injection
6.2 IncompatibilitiesIn the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf Life2 years.
After reconstitution, the product may be stored for a maximum of 7 days in a refrigerator (2°C
6.4 Special Precautions For StorageStore in a refrigerator (2°C
For storage conditions of the reconstituted medicinal product, see section 6.3
Store the reconstituted product in a refrigerator (2°C
Do not freeze.
6.5 Nature And Contents Of ContainerThe 10 ml vials containing 3.33 mg of powder and the 5 ml vials containing 5 ml of solvent are of neutral glass (Type I). The vials are closed by rubber stoppers.
Saizen 3.33 mg is available in the following pack sizes:
1 vial of Saizen 3.33 mg product and 1 vial of bacteriostatic solvent.
5 vials of Saizen 3.33 mg product and 5 vials of bacteriostatic solvent.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other HandlingTo reconstitute Saizen, inject 1 ml of the bacteriostatic solvent into the vial of Saizen 3.33 mg aiming the liquid against the glass wall. Swirl the vial with a gentle rotary motion until the content is dissolved completely. Avoid vigorous shaking. Discard any unused solvent.
Benzyl alcohol as a preservative in bacteriostatic sodium chloride solution may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates. Saizen may be reconstituted with Sodium Chloride Injection BP or Sterile Water for Injections for immediate use when administering to children under 3 years of age.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation HolderSerono Ltd
Bedfont Cross
Stanwell Road
Feltham
Middlesex
TW14 8NX
8. Marketing Authorisation Number(S)PL 03400/0034
9. Date Of First Authorisation/Renewal Of The Authorisation23 April 2009
10. Date Of Revision Of The Text04/2009
Murine irritation & redness relief 0.012% w / v eye drops
1. Name Of The Medicinal Product
Murine irritation & redness relief.
2. Qualitative And Quantitative CompositionNaphazoline hydrochloride 0.012 %w/v
Also contains Benzalkonium Chloride
For full list of excipients, see section 6.1
3. Pharmaceutical FormEye drops solution (eye drops)
Clear, colourless liquid.
4. Clinical Particulars 4.1 Therapeutic IndicationsRedness and minor irritations of the eye caused by, for example, dusty atmosphere, wind, swimming, smoke, air pollutants, and close work.
4.2 Posology And Method Of AdministrationOcular
Adults and children 12 years and over
The recommended dosage is one or two drops into each eye two or three times daily.
Children under 12 years: Not recommended. There is no recorded experience with the product in this age group.
4.3 ContraindicationsGlaucoma, corneal damage, acute iritis and other serious eye disease.
Hypersensitivity to any ingredient.
Do not use at the same time as contact lenses. It is generally recommended that a short interval be allowed between the use of Murine and replacement of contact lenses, and that the duration of this 'short interval' should be about 15 minutes.
This product should not be used prior to peripheral iridectomy in eyes susceptible to angle closure because mydriatic action may precipitate angle block.
4.4 Special Warnings And Precautions For UseMurine should not be used if there is an eye condition characterised by continued redness, pain or blurring of vision.
Murine should not be used if there is raised pressure inside the eyeball (glaucoma), damage to the corneas, inflammation of the iris (acute iritis) or any other serious eye disease.
If there is any eye pain, vision changes, continued redness or irritation of the eye, or if the condition worsens or persists for more than 24 hours, use of the product should be discontinued and the doctor or pharmacist should be informed.
Discontinue use prior to use of anaesthetics which sensitise the myocardium to sympathomimetics (e.g. cyclopropane, halothane).
As with other symptathomimetics, use with caution in the presence of hypertension, diabetes, hyperthyroidism, cardiovascular abnormalities and arteriosclerosis.
Contains benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses, remove contact lenses prior to application and wait at least 15 minutes before re-insertion; known to discolour soft contact lenses.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionCurrently there is no information regarding the use of Murine and the absorption of concomitant ocular products. However, patients should be advised to leave a short interval between the administration of Murine and other ocular products. It is generally recommended that this interval should be of about 15 minutes duration.
4.6 Pregnancy And LactationNo special precautions.
4.7 Effects On Ability To Drive And Use MachinesDo not drive or operate machinery if vision is blurred.
4.8 Undesirable EffectsMay cause slight dilation of pupil.
4.9 OverdoseOverdose or accidental administration by mouth may cause depression of CNS, reduction of body temperature, bradycardia, sweating, drowsiness and coma, particularly in children. Hypertension may be followed by rebound hypotension. In addition, overdosage may cause increased redness of the eye. Treatment of side-effects is symptomatic.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesATC Code: S01GA01
Naphazoline is a sympathomimetic agent with marked alpha-adrenergic activity. It is a vasoconstrictor with a rapid and prolonged action in reducing swelling and congestion when applied to mucous membranes.
5.2 Pharmacokinetic PropertiesAbsorbed following instillation into conjunctival sacs.
5.3 Preclinical Safety DataThere are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsBenzalkonium chloride, boric acid (E284), borax (E285), purified water and disodium edetate.
6.2 IncompatibilitiesNone known
6.3 Shelf LifeUnopened: 24 months
Opened: 1 month
6.4 Special Precautions For StorageDo not store above 25°C. Do not refrigerate or freeze.
6.5 Nature And Contents Of Container10 ml of liquid in a plastic bottle, drop-forming plug and cap.
6.6 Special Precautions For Disposal And Other HandlingDo not use if the solution changes colour or becomes cloudy.
7. Marketing Authorisation HolderPrestige Brands (UK) Limited
3 Scotlands Drive
Farnham Common
Slough
Berkshire SL2 3ES
United Kingdom
8. Marketing Authorisation Number(S)PL18259/0003
9. Date Of First Authorisation/Renewal Of The Authorisation15 October 2003
10. Date Of Revision Of The Text5th May 2010
11 DOSIMETRY (IF APPLICABLE)Not applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)Not applicable
Recent History:
5th May 2010 – 0034 - Type IB Az Group – Sections 2, 3, 4.2, 5.1
31st March 2010 – 0033 - Type IB A.2.b – Section 1
NutreStore
Generic Name: glutamine (GLOO ta meen)
Brand Names: GlutaSolve, NutreStore, SYMPT-X G.I., SYMPT-X Glutamine
Glutamine is an amino acid that affect the processes of growth and function of cells in the stomach and intestines.
Glutamine is a medical food product that is used to supplement dietary sources of glutamine, to treat a glutamine deficiency, or to treat a loss of glutamine caused by injury or illness.
Glutamine is also used in combination with human growth hormone to treat short bowel syndrome.
Glutamine may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about NutreStore (glutamine)?Before you take glutamine, tell your doctor if you have liver or kidney disease.
The number of times per day you take glutamine depends on the reason you are using it. Always follow your doctor's instructions.
Take glutamine oral powder with a meal or snack unless directed otherwise. Take glutamine tablets on an empty stomach, at least 1 hour before or 2 hours after a meal.Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using glutamine.
Do not pour dry glutamine powder directly into a tube feeding formula. Always mix the powder with water and infuse it directly into the feeding tube using a syringe.Glutamine may be only part of a complete program of treatment that may also include a special diet, tube feedings, and IV fluids. It is very important to follow the diet and medication plan created for you by your doctor or nutrition counselor.
What should I discuss with my health care provider before taking NutreStore (glutamine)?Before you take glutamine, tell your doctor if you have liver or kidney disease. You may need a dose adjustment or special tests to safely use this medication.
FDA pregnancy category C. It is not known whether glutamine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether glutamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take NutreStore (glutamine)?Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.
When treating short bowel syndrome, you may need to take glutamine 6 times per day for up to 16 weeks.
The number of times per day you take glutamine depends on the reason you are using it. Always follow your doctor's instructions.
Take glutamine oral powder with a meal or snack unless directed otherwise. Take glutamine tablets on an empty stomach, at least 1 hour before or 2 hours after a meal. Dissolve your dose of glutamine oral powder in at least 8 ounces of hot or cold liquid. You may also mix the powder with a soft food such as pudding, applesauce, or yogurt. Stir this mixture and use all of it right away. Do not pour dry glutamine powder directly into a tube feeding formula. Always mix the powder with water and infuse it directly into the feeding tube using a syringe.To be sure this medication is not causing harmful effects, your kidney and liver function may need to be checked with blood or urine tests on a regular basis. Do not miss any scheduled appointments.
Glutamine may be only part of a complete program of treatment that may also include a special diet, tube feedings, and IV fluids. It is very important to follow the diet and medication plan created for you by your doctor or nutrition counselor.
Store glutamine at room temperature away from moisture and heat. Keep each dose of the oral powder in its packet until you are ready to use the medication. What happens if I miss a dose?Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?An overdose of glutamine is not expected to produce life-threatening symptoms.
What should I avoid while taking NutreStore (glutamine)?Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using glutamine.
NutreStore (glutamine) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:chest pain;
hearing problems; or
signs of infection such as fever, chills, sore throat, flu symptoms, mouth sores, unusual weakness.
Less serious side effects may include:
nausea, vomiting, stomach pain, gas;
dry mouth, runny nose;
swelling in your hands or feet;
muscle or joint pain, back pain;
headache, dizziness, tired feeling;
mild skin rash or itching; or
increased sweating.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect NutreStore (glutamine)?There may be other drugs that can interact with glutamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
More NutreStore resources NutreStore Side Effects (in more detail) NutreStore Use in Pregnancy & Breastfeeding NutreStore Support Group 0 Reviews for NutreStore - Add your own review/rating glutamine Advanced Consumer (Micromedex) - Includes Dosage Information Nutrestore Prescribing Information (FDA) Compare NutreStore with other medications Anemia, Sickle Cell Dietary Supplementation Short Bowel Syndrome Where can I get more information? Your pharmacist can provide more information about glutamine.See also: NutreStore side effects (in more detail)
gadoxetate
Generic Name: gadoxetate (gad OX e tate)
Brand Names: Eovist
Gadoxetate is a contrast agent that produces magnetic effects. It is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI.
Gadoxetate is used to help diagnose certain disorders of the liver.
Gadoxetate may also be used for purposes not listed in this medication guide.
What is the most important information I should know about gadoxetate? Gadoxetate can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:burning, itching, swelling, scaling, and tightening or hardening of your skin;
muscle weakness;
joint stiffness in your arms, hands, legs, or feet;
deep bone pain in your ribs or your hips;
trouble moving; or
skin redness or discoloration.
Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadoxetate. Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions. What should I discuss with my health care provider before receiving gadoxetate? Gadoxetate can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:burning, itching, swelling, scaling, and tightening or hardening of your skin;
muscle weakness;
joint stiffness in your arms, hands, legs, or feet;
deep bone pain in your ribs or your hips;
trouble moving; or
skin redness or discoloration.
Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive an MRI with gadoxetate.
To make sure you can safely receive this medication, tell your doctor if you have any of these other conditions:
diabetes;
high blood pressure;
liver disease (or liver transplant);
asthma, hay fever, or a history of food or drug allergies;
if you are over 60 years old;
if you have ever had a reaction to a contrast agent; or
if you have recently had an injury, surgery, or severe infection.
FDA pregnancy category C. It is not known whether gadoxetate is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant. It is not known whether gadoxetate passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby. How is gadoxetate given?Gadoxetate is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting during your MRI.
Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.
Gadoxetate can cause you to have unusual results with certain medical tests for at least 24 hours after your MRI. Tell any doctor who treats you that you have received gadoxetate
What happens if I miss a dose?Since gadoxetate is used only during your MRI, you will not be on a dosing schedule.
What happens if I overdose?Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid after receiving gadoxetate?Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Gadoxetate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.Some of the side effects of gadoxetate can occur up to several days after you have received the medication.
Call your doctor at once if you have a serious side effect such as:urinating less than usual or not at all;
drowsiness, confusion, mood changes, increased thirst, loss of appetite;
swelling, weight gain, feeling short of breath; or
swelling, irritation, or skin changes where the injection was given.
Less serious side effects may include:
headache;
changes in your sense of taste or smell;
nausea, vomiting;
flushing (warmth, redness, or tingly feeling);
feeling unusually hot; or
cold feeling, pain, or mild burning around the IV needle when the medicine is injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Gadoxetate Dosing InformationUsual Adult Dose for Liver Magnetic Resonance Imaging:
0.1 mL/kg body weight(0.025 mmol/kg body weight) administered undiluted as a single intravenous bolus injection at a flow rate of approximately 2 mL/second.
What other drugs will affect gadoxetate?Tell your doctor if you are also taking rifampin (Rifadin, Rifater, Rifamate).
Gadoxetate can harm the kidneys in certain people, and this effect may be increased if you also use other medicines harmful to the kidneys. Before you receive gadopentetate dimeglumine, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.
There may be other drugs that can affect gadoxetate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More gadoxetate resources Gadoxetate Side Effects (in more detail) Gadoxetate Dosage Gadoxetate Use in Pregnancy & Breastfeeding Gadoxetate Drug Interactions Gadoxetate Support Group 1 Review for Gadoxetate - Add your own review/rating gadoxetate Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Eovist Prescribing Information (FDA) Eovist Consumer Overview Compare gadoxetate with other medications Liver Magnetic Resonance Imaging Where can I get more information? Your doctor or pharmacist can provide more information about gadoxetate.See also: gadoxetate side effects (in more detail)
Sevoflurane
Please read this leaflet carefully before you receive Sevoflurane. It gives a summary of the information available on Sevoflurane. If you have any questions or are not sure about anything, ask your ward doctor, surgeon or anaesthetist.
What’s in Sevoflurane?Sevoflurane is a clear colourless liquid. Water is present at a sufficient concentration to provide protection from environmental Lewis acids (substances that can cause the breakdown of Sevoflorane). When it is put into a special anaesthetic machine (vaporiser) it becomes a gas that mixes with the oxygen you will be breathing.
Sevoflurane comes in brown bottles of 250ml, and can only be given to you by a qualified anaesthetist.
Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder Abbott Laboratories Ltd. Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UK Manufacturer Aesica Queenborough Limited Queenborough Kent ME11 5EL UK What is Sevoflurane used for?Sevoflurane is a breathed in (inhalation) anaesthetic, used to induce and maintain a deep, pain-free sleep (general anaesthesia) in adults and children during an operation.
Before receiving SevofluraneTell your doctor, surgeon or anaesthetist if you have been told that you are sensitive or have an allergy to Sevoflurane or any other anaesthetic, or if you know you or any member of your family has experienced a condition called malignant hyperthermia (rapid rise in body temperature) during an operation.
Under certain clinical circumstances, Sevoflurane forms low levels of by-products. One of these has been shown to cause some harm to the kidneys of some rats when given in high doses, but this has not been found in man during clinical trials.
Tell your ward doctor, surgeon or anaesthetist if you have previously had general anaesthetics, particularly if repeated over a short period of time. Some anaesthetics can occasionally cause problems in the liver which can cause yellowing of the skin (jaundice).
Tell your ward doctor, surgeon or anaesthetist if you are suffering from any illness, other than those connected with your operation, such as any kidney, brain or heart problems, severe headaches, nausea, vomiting, or a neuromuscular disease (a condition that affects muscles e.g Duchenne muscular dystrophy).
As with all drugs, it is important that you tell your ward doctor or anaesthetist which medications you are taking and if you are pregnant, could be pregnant or if you are breast feeding.
Your ability to drive or to operate machinery may be impaired for some time after the procedure for which you have received Sevoflurane. You should not drive until your doctor advises that you may do so.
Receiving SevofluraneThe dose of Sevoflurane that you receive will be decided by your anaesthetist and will vary depending on your age, weight and the type of operation that you are having.
Sevoflurane is a breathed in (inhalation) anaesthetic gas. Sevoflurane liquid is changed to gas in a vaporiser. Occasionally patients may be asked to breathe in the Sevoflurane gas via a mask but usually they will receive an injection of another anaesthetic to make them go to sleep before they receive Sevoflurane. Sevoflurane has a pleasant smell and you will go to sleep very rapidly and smoothly.
What problems can Sevoflurane cause?Like all medicines, Sevoflurane can cause side effects, although not everybody gets them. It is however, important to consult your ward doctor or anaesthetist if you are feeling unwell.
The frequency of side effects is classified as follows;
Very common: more than 1 out of 10 persons treated;
Common: less than 1 out of 10, but more than 1 out of 100 persons treated;
Uncommon: less than 1 out of 100, but more than 1 out of 1,000 persons treated;
Rare: less than 1 out of 1,000 but more than 1 out of 10,000 persons treated.
Very common side effects of Sevoflurane include;
restlessness (Agitation)
slow heart rate (Bradycardia)
low blood pressure (Hypotension)
coughing
nausea and vomiting
Common side effects of sevoflurane include;
drowsiness (somnolence)
dizziness
headache
fast heart rate (tachycardia)
increased blood pressure (hypertension)
slow shallow breathing (respiratory depression), wheezing or breathlessness
throat spasm
watering Mouth (salivary hypersecretion)
chills
fever (pyrexia)
low body temperature (hypothermia)
abnormal sugar (glucose) level
abnormal liver function test*
white blood cell count abnormal
blood fluoride increased **
* If you have a blood or urine test, you may be told that you have raised liver enzymes, raised creatinine or raised levels of white blood cells. These will not normally cause any symptoms.
** Levels of fluoride in the blood may be raised slightly during and immediately after anaesthesia, due to the body breaking down Sevoflurane, but these levels are not believed to be harmful and soon return to normal.
Other occasional side-effects seen in clinical trials were: palpitations or irregular heart beat, wheezing and breathlessness, confusion, difficulty in passing water. Malignant hyperthermia, kidney failure, allergic reactions, such as contact dermatitis, rash, shortness of breath, wheezing, chest discomfort, swelling face and itching of the skin, and very severe allergic reactions (anaphylaxis) have been reported very rarely.
Liver problems have been reported rarely. Repeated exposure to Sevoflurane within a short space of time may increase the risk of damage to the liver. Accumulation of fluid in the lungs may occur extremely rarely. Convulsions, particularly in children, may also occur extremely rarely. Twitching and jerking movements, may also occur, in children, but these are short term with no long term harmful effects. Isolated cases of increased heart rate have been reported in children with Pompe's disease.
Other side effects which may occur while you are under the anaesthetic will be managed by your doctor, as necessary.
After receiving Sevoflurane.
You will come round or wake up within a few minutes. Children in particular, may be restless on awakening. Tell your doctor or anaesthetist if you need additional pain relief.
If you have any other unusual or unexpected symptoms after receiving Sevoflurane anaesthesia, tell your ward doctor or anaesthetist immediately.
If you have any questions about Sevoflurane which are not answered by this leaflet, ask your ward doctor or anaesthetist.
How should Sevoflurane be stored ?Do not store above 25°C. The product should be stored in a tightly closed container and should not be refrigerated.
Product will not be used after the expiry date shown on the product label.
This leaflet applies only to Sevoflurane and was prepared in January 2010.
velaglucerase alfa
Generic Name: velaglucerase alfa (VEL a GLOO ser ase AL fa)
Brand Names: VPRIV
Velaglucerase is a man-made form of an enzyme that occurs naturally in the body. It is used as an enzyme replacement in people with Type I Gaucher disease.
Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.
Velaglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, velaglucerase is not a cure for this condition.Velaglucerase may also be used for purposes not listed in this medication guide.
What is the most important information I should know about velaglucerase alfa? You should not use velaglucerase alfa if you are allergic to it. Some people receiving a velaglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection. Velaglucerase is not a cure for Gaucher disease. What should I discuss with my health care provider before receiving velaglucerase alfa? You should not use velaglucerase alfa if you are allergic to it. FDA pregnancy category B. Velaglucerase alfa is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether velaglucerase alfa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is velaglucerase alfa given?Velaglucerase alfa is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Velaglucerase alfa must be given slowly, and the IV infusion can take at least 1 hour to complete.
Velaglucerase alfa is usually given every other week. Follow your doctor's dosing instructions very carefully.
Your doctor may occasionally change your dose to make sure you get the best results.
What happens if I miss a dose?Call your doctor for instructions if you miss an appointment for your velaglucerase alfa injection.
What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while receiving velaglucerase alfa?Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Velaglucerase alfa side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Some people receiving a velaglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.Less serious side effects may include:
headache;
low fever;
dizziness, tired feeling;
nausea, stomach pain;
knee pain, back pain; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Velaglucerase alfa Dosing InformationUsual Adult Dose for Gaucher Disease:
For use in the treatment of type 1 Gaucher disease:
Recommended dose: 60 Units/kg administered as a 60 minute intravenous infusion every other week
Usual Pediatric Dose for Gaucher Disease:
For use in the treatment of type 1 Gaucher disease:
Recommended dose: 60 Units/kg administered as a 60 minute intravenous infusion every other week
There may be other drugs that can interact with velaglucerase alfa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More velaglucerase alfa resources Velaglucerase alfa Side Effects (in more detail) Velaglucerase alfa Dosage Velaglucerase alfa Use in Pregnancy & Breastfeeding Velaglucerase alfa Support Group 0 Reviews for Velaglucerase alfa - Add your own review/rating velaglucerase alfa Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Velaglucerase alfa MedFacts Consumer Leaflet (Wolters Kluwer) Velaglucerase alfa Professional Patient Advice (Wolters Kluwer) VPRIV Consumer Overview Vpriv Prescribing Information (FDA) Compare velaglucerase alfa with other medications Gaucher Disease Where can I get more information? Your doctor or pharmacist can provide more information about velaglucerase alfa.See also: velaglucerase alfa side effects (in more detail)
Krystexxa
Generic Name: pegloticase (peg LOE ti kase)
Brand Names: Krystexxa
Pegloticase is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine.
Pegloticase is used to treat chronic gout. Pegloticase is usually given after other gout medications have been tried without successful treatment of symptoms.
Pegloticase may also be used for purposes not listed in this medication guide.
What is the most important information I should know about pegloticase? You should not receive pegloticase if you are allergic to it, or if you have glucose-6-phosphate dehydrogenase deficiency (G6PD).To make sure you can safely receive pegloticase, tell your doctor if you have congestive heart failure.
You may be given other medications to prevent certain side effects of pegloticase. You may need to start taking these medications at least a week before you receive your pegloticase injection. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Tell your caregiver right away if you feel itchy, nervous, light-headed, short of breath, or have a fast heartbeat, chest discomfort, or redness of your skin when the medicine is injected into your vein. What should I discuss with my healthcare provider before taking pegloticase? You should not receive pegloticase if you are allergic to it, or if you have glucose-6-phosphate dehydrogenase deficiency (G6PD).To make sure you can safely take pegloticase, tell your doctor if you have any of these other conditions:
congestive heart failure;
other heart problems; or
high blood pressure.
FDA pregnancy category C. It is not known whether pegloticase will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether pegloticase passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using pegloticase. How should I take pegloticase?Pegloticase is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Pegloticase must be given slowly, and the IV infusion can take at least 2 hours to complete.
You may be given other medications to prevent certain side effects of pegloticase. You may need to start taking these medications at least a week before you receive your pegloticase injection. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.Pegloticase is usually given once every 2 weeks. Follow your doctor's dosing instructions very carefully.
When you first start using pegloticase, you may have an increase in gout flares. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 3 months of treatment.Your doctor may recommend other gout medications during the first 6 months of your treatment with pegloticase.
To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with pegloticase. Visit your doctor regularly.
See also: Krystexxa dosage (in more detail)
What happens if I miss a dose?Since pegloticase is given by a healthcare professional, you are not likely to miss a dose.
What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking pegloticase?Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Pegloticase side effects Some people receiving a pegloticase injection have had a reaction to the infusion (when the medicine is injected into the vein). Infusion reactions may also occur after the injection is given. Tell your caregiver right away if you feel itchy, nervous, light-headed, short of breath, or have a fast heartbeat, chest discomfort, or redness of your skin during the injection. Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:chest pain; or
flushing (warmth, redness, or tingly feeling).
Less serious side effects may include:
new gout flares;
nausea, vomiting, constipation;
easy bruising; or
stuffy nose, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect pegloticase?There may be other drugs that can interact with pegloticase. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More Krystexxa resources Krystexxa Side Effects (in more detail) Krystexxa Dosage Krystexxa Use in Pregnancy & Breastfeeding Krystexxa Drug Interactions Krystexxa Support Group 2 Reviews for Krystexxa - Add your own review/rating Krystexxa Prescribing Information (FDA) Krystexxa Monograph (AHFS DI) Krystexxa Advanced Consumer (Micromedex) - Includes Dosage Information Krystexxa Consumer Overview Krystexxa MedFacts Consumer Leaflet (Wolters Kluwer) Pegloticase Professional Patient Advice (Wolters Kluwer) Compare Krystexxa with other medications Gout Where can I get more information? Your pharmacist can provide more information about pegloticase.See also: Krystexxa side effects (in more detail)
Sominex Tablets (Actavis UK Ltd)
Sominex
(promethazine hydrochloride)
Important information about Sominex This medicine is used as a night time sleep aid for short term use. It can be taken by people over 16 years. Do not take If you are under 16 years old. If you are pregnant. See section 2. Do not drink alcohol when taking this medicine. Do not use for longer than 7 days.See section 3.
Now read the rest of the leaflet before you use this medicine. It includes other information which might be especially important for you.
Keep this leaflet. You may need to read it again. Ask your pharmacist if you need any more information or advice. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. What the medicine is forSominex tablets contain promethazine hydrochloride, an antihistamine, which has a sedative effect. The medicine is used as a night time sleep aid, to correct temporary disturbances of sleep pattern where there is difficulty in going to sleep or staying asleep, caused for example by alteration of normal routine.
Before you use this medicine Do not use the medicine if you have An allergy to any of the ingredients listed in section 6. An allergy to Phenothiazine drugs (used to treat mental illness, severe nausea/vomiting or vertigo, e.g. chlorpromazine, pericyazine). Concussion, light headedness, drowsiness, dizziness or a recent head injury. Taken MAOIs (monoamine oxidase inhibitors) for depression within the last two weeks. This medicine is for short term sleeping problems. It should not be used for more than 7 days without talking to the doctor. Do not drink alcohol when taking Sominex. Talk to your doctor or pharmacist if you have Asthma. Breathing problems or bronchitis. Epilepsy. Difficulty passing urine. Glaucoma (raised pressure inside the eyeball). Prostate trouble. Kidney or liver problems. Heart problems. A blocked intestine. Talk to your doctor or pharmacist if you are taking Other medicines which make you drowsy (e.g. sedatives or relaxants). MAOIs (monoamine oxidase inhibitors) for depression. Medicines which may give you a dry mouth or blurred vision (e.g. atropine or antidepressants). Pregnancy tests based on urine samples, as they may give false positive or negative results if used when taking this medicine. Pregnant or breastfeedingAsk your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding.
Sominex should not be used in pregnancy unless the doctor has told you to do so.
Driving and using machinesThese tablets will cause drowsiness and you should not drive or operate machinery until the effects have worn off.
Important information about some of the ingredients This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. How to use this medicineTake this medicine by mouth
Adults, the elderly and children over 16 Take one tablet at bedtime. It may be taken up to one hour after going to bed when you can’t go to sleep. Do not use this medicine for more than 7 days in a row. If natural sleep does not return within 7 days or you have repeated bouts of sleeplessness talk to your doctor. Children under 16 yearsDo not give to children under 16 unless your doctor tells you to.
If you take too manyIf you accidentally take too many tablets, see a doctor straight away. Take the pack with you to show which medicine you have swallowed.
Possible side effectsLike all medicines, Sominex can have side effects, although these don’t affect everyone.
Important side effectsIf you think you have any of the following side effects or symptoms, stop using this medicine immediately and see a doctor as soon as possible
Allergic reactions which cause difficulty in breathing, swelling of the mouth or skin, vomiting or stomach pain. Jaundice (yellowing of the skin and eyes). Palpitations or abnormal heart rhythm. Low blood pressure (dizziness and lightheadedness). Blurred or reduced vision or pain in the eye. Anaemia or listlessness and lack of energy. Other possible side effects Drowsiness. Dizziness. Headache. Clumsiness. Shaking and trembling. Stomach upsets. Dry mouth. Difficulty in passing urine. Restlessness. Disorientation. Sensitivity to sunlight.If you notice these or any other side effect not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.
Elderly people may be more susceptible to the side effects or confusion when taking this medicine.
Storing this medicine There are no special conditions for storing this medicine. Keep it out of the reach and sight of children. Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month. Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine. These measures will help to protect the environment. Further information What is in this medicineThe active ingredient per tablet is: promethazine hydrochloride 20mg
The other ingredients are: lactose, maize starch, croscarmellose sodium, magnesium stearate.
What the medicine looks likeSominex tablets are white flat tablets with bevelled edges and are embossed ‘S’ on one side.
They are supplied in blister packs of 8 and 16 tablets.
Marketing authorisation holder Actavis Group PTC ehf Reykjav?kurvegi 76-78 220 Hafnarfjordur Iceland Manufacturer Custom Pharmaceuticals Ltd. Conway Street Hove East Sussex BN3 3LWThis leaflet was revised in October 2008
Sominex is a trade mark of Actavis Group PTC ehf.
CUSPL003
PM/20/311
Mydriacyl 1%
1. Name Of The Medicinal Product
MYDRIACYL 1%
2. Qualitative And Quantitative CompositionTropicamide 1.0% w/v
3. Pharmaceutical FormEye Drops, Solution
4. Clinical Particulars 4.1 Therapeutic IndicationsTropicamide is a short acting anticholinergic agent used as a mydriatic and cycloplegic. It is indicated for topical use for:
Diagnostic purposes for fundoscopy and cycloplegic refraction.
Use in pre- and post-operative states where a short acting mydriatic is required.
4.2 Posology And Method Of AdministrationAdults, Elderly and children:
Fundoscopy:
One or two drops of 0.5% solution instilled into the eyes 15 to 20 minutes prior to examination.
Cycloplegic Refraction:
One or two drops of 1% solution repeated after 5 minutes. If the patient is not seen within 20 to 30 minutes an additional drop may be instilled to prolong the effect.
Use in Children:
Tropicamide has been reported to be inadequate for cycloplegia in children. A more powerful cycloplegic agent such as atropine may be required.
4.3 ContraindicationsGlaucoma or a tendency towards glaucoma (e.g. Narrow anterior chamber angle). Hypersensitivity to any component. This preparation contains benzalkonium chloride and should not be used where soft contact lenses are worn.
4.4 Special Warnings And Precautions For UseBecause of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the angle of the anterior chamber should be made before use.
Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Parents should be warned of the oral toxicity of this preparation for children and advised to wash their hands after use.
Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.
To reduce systemic absorption the lacrimal sac should be compressed at the medial canthus by digital pressure for at least one minute after instillation of the drops.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionThe effect of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as amantadine, some anti-histamines, butyrophenones, phenothiazines and tricyclic anti-depressants.
4.6 Pregnancy And LactationThere is insufficient evidence as to drug safety in pregnancy and lactation. This product should be used during pregnancy only when it is considered essential by a physician.
4.7 Effects On Ability To Drive And Use MachinesMay cause blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear. Complete recovery from the effects of tropicamide eyedrops may take up to six hours.
4.8 Undesirable EffectsLocal: increased intraocular pressure, transient stinging and sensitivity to light secondary to pupillary dilation. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.
Systemic: Systemic anti-cholinergic toxicity is manifested by dryness of the mouth, flushing, dryness of the skin, bradycardia followed by tachycardia with palpitations and arrythmias, urinary urgency, difficulty and retention, reduction in the tone and motility of the gastrointestinal tract leading to constipation.
Vomiting, giddiness and staggering may occur, a rash may be present in children and abdominal distention in infants.
Psychotic reactions, behavioural disturbances and cardio-respiratory collapse may occur in children.
4.9 OverdoseSystemic toxicity may occur following topical use, particularly in children, it is manifested by flushing and dryness of the skin, ( a rash may be present in children), blurred vision, a rapid and irregular pulse, fever abdominal distention in infants, convulsions and hallucinations and the loss of neuro-muscular co-ordination.
Treatment is supportive, (there is no evidence that physostigmine is superior to supportive management). In infants and small children the body surface must be kept moist. If accidentally ingested, induce emesis or perform gastric lavage.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesOphthalmologicals; Mydriatics and Cycloplegics
ATC Code: S01F A06
Tropicamide is an anticholinergic which blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation thus dilating the pupil (mydriasis). At higher concentrations (1%), tropicamide also paralyses accommodation. This preparation acts rapidly and has a relatively short duration of action.
5.2 Pharmacokinetic PropertiesTropicamide administered topically to the human eye does not bind to tissues as firmly as does atropine. The wash out time for half recovery of carbachol responsiveness was shown to be less than 15 minutes for non-pigmented iris and 30 minutes for pigmented iris.
5.3 Preclinical Safety DataThere are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsBenzalkonium chloride, Disodium edetate, Sodium chloride, Sodium Hydroxide and/or Hydrochloric acid and Purified water.
6.2 IncompatibilitiesNone known
6.3 Shelf Life36 months (unopened). 4 weeks (after first opening)
6.4 Special Precautions For StorageDo not store above 25oC.
Do not refrigerate or freeze.
Keep container in the outer carton.
Keep container tightly closed.
Discard contents 4 weeks after opening.
6.5 Nature And Contents Of ContainerPack size - 5 ml.
Drop-Tainer - Natural Low Density Polyethylene Bottle and Plug.
Polystyrene or Polypropylene cap.
6.6 Special Precautions For Disposal And Other HandlingDo not touch dropper tip to any surface as this may contaminate the contents.
7. Marketing Authorisation HolderAlcon Laboratories (UK) Ltd.,
Pentagon Park,
Boundary Way,
Hemel Hempstead,
HP2 7UD.
8. Marketing Authorisation Number(S)PL 0649/5918R
9. Date Of First Authorisation/Renewal Of The Authorisation5th February 2002
10. Date Of Revision Of The TextApril 2010
Mydriacyl 0.5%
1. Name Of The Medicinal Product
MYDRIACYL 0.5%
2. Qualitative And Quantitative CompositionTropicamide 0.5% w/v
3. Pharmaceutical FormEye Drops, Solution
4. Clinical Particulars 4.1 Therapeutic IndicationsTropicamide is a short acting anticholinergic agent used as a mydriatic and cycloplegic. It is indicated for topical use for:
Diagnostic purposes for fundoscopy and cycloplegic refraction.
Use in pre- and post-operative states where a short acting mydriatic is required.
4.2 Posology And Method Of AdministrationAdults, Elderly and children:
Fundoscopy:
One or two drops of 0.5% solution instilled into the eyes 15 to 20 minutes prior to examination.
Cycloplegic Refraction:
One or two drops of 1% solution repeated after 5 minutes. If the patient is not seen within 20 to 30 minutes an additional drop may be instilled to prolong the effect.
Use in Children:
Tropicamide has been reported to be inadequate for cycloplegia in children. A more powerful cycloplegic agent such as atropine may be required.
4.3 ContraindicationsGlaucoma or a tendency towards glaucoma (e.g. Narrow anterior chamber angle). Hypersensitivity to any component. This preparation contains benzalkonium chloride and should not be used where soft contact lenses are worn.
4.4 Special Warnings And Precautions For UseBecause of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the angle of the anterior chamber should be made before use.
Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Parents should be warned of the oral toxicity of this preparation for children and advised to wash their hands after use.
Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.
To reduce systemic absorption the lacrimal sac should be compressed at the medial canthus by digital pressure for at least one minute after instillation of the drops.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionThe effect of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as amantadine, some anti-histamines, butyrophenones, phenothiazines and tricyclic anti-depressants.
4.6 Pregnancy And LactationThere is insufficient evidence as to drug safety in pregnancy and lactation. This product should be used during pregnancy only when it is considered essential by a physician.
4.7 Effects On Ability To Drive And Use MachinesMay cause blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear. Complete recovery from the effects of tropicamide eyedrops may take up to six hours.
4.8 Undesirable EffectsLocal: increased intraocular pressure, transient stinging and sensitivity to light secondary to pupillary dilation. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.
Systemic: Systemic anti-cholinergic toxicity is manifested by dryness of the mouth, flushing, dryness of the skin, bradycardia followed by tachycardia with palpitations and arrythmias, urinary urgency, difficulty and retention, reduction in the tone and motility of the gastrointestinal tract leading to constipation.
Vomiting, giddiness and staggering may occur, a rash may be present in children and abdominal distention in infants.
Psychotic reactions, behavioural disturbances and cardio-respiratory collapse may occur in children.
4.9 OverdoseSystemic toxicity may occur following topical use, particularly in children, it is manifested by flushing and dryness of the skin, ( a rash may be present in children), blurred vision, a rapid and irregular pulse, fever abdominal distention in infants, convulsions and hallucinations and the loss of neuro-muscular co-ordination.
Treatment is supportive, (there is no evidence that physostigmine is superior to supportive management). In infants and small children the body surface must be kept moist. If accidentally ingested, induce emesis or perform gastric lavage.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesOphthalmologicals; Mydriatics and Cycloplegics
ATC Code: S01F A06
Tropicamide is an anticholinergic which blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation thus dilating the pupil (mydriasis). At higher concentrations (1%), tropicamide also paralyses accommodation. This preparation acts rapidly and has a relatively short duration of action.
5.2 Pharmacokinetic PropertiesTropicamide administered topically to the human eye does not bind to tissues as firmly as does atropine. The wash out time for half recovery of carbachol responsiveness was shown to be less than 15 minutes for non-pigmented iris and 30 minutes for pigmented iris.
5.3 Preclinical Safety DataThere are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsBenzalkonium chloride, Disodium edetate, Sodium chloride, Sodium Hydroxide and/or Hydrochloric acid and Purified water.
6.2 IncompatibilitiesNone known
6.3 Shelf Life36 months (unopened). 4 weeks (after first opening)
6.4 Special Precautions For StorageDo not store above 25oC.
Do not refrigerate or freeze.
Keep container in the outer carton.
Keep container tightly closed.
Discard contents 4 weeks after opening.
6.5 Nature And Contents Of ContainerPack size - 5 ml.
Drop-Tainer - Natural Low Density Polyethylene Bottle and Plug.
Polystyrene or Polypropylene cap.
6.6 Special Precautions For Disposal And Other HandlingDo not touch dropper tip to any surface as this may contaminate the contents.
7. Marketing Authorisation HolderAlcon Laboratories (UK) Ltd.,
Pentagon Park,
Boundary Way,
Hemel Hempstead,
HP2 7UD.
8. Marketing Authorisation Number(S)PL 0649/5917R
9. Date Of First Authorisation/Renewal Of The Authorisation5th February 2002
10. Date Of Revision Of The TextApril 2010
Adipost
Generic Name: phendimetrazine (fen di MEH tra zeen)
Brand Names: Adipost, Bontril PDM, Bontril Slow Release, Melfiat
Phendimetrazine is similar to an amphetamine. Phendimetrazine stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.
Phendimetrazine is used as a short-term supplement to diet and exercise in the treatment of obesity.
Phendimetrazine may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Adipost (phendimetrazine)? Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Phendimetrazine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine. Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. What should I discuss with my healthcare provider before taking Adipost (phendimetrazine)? Do not use phendimetrazine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to phendimetrazine, or if you have:coronary artery disease (hardening of the arteries);
heart disease;
severe or uncontrolled high blood pressure;
heart murmur or heart valve disorder;
pulmonary arterial hypertension (PAH);
overactive thyroid;
glaucoma;
severe agitation or nervousness;
if you have a history of drug or alcohol abuse; or
if you are allergic to other diet pills, amphetamines, stimulants, or cold medications.
To make sure you can safely take phendimetrazine, tell your doctor if you have any of these other conditions:
high blood pressure;
diabetes;
an anxiety disorder;
epilepsy or seizure disorder; or
if you have used other diet pills in the past year (prescription, over-the-counter, or herbal products).
It is not known whether phendimetrazine will harm an unborn baby. Do not take phendimetrazine without first talking to your doctor if you are pregnant. It is also not known whether phendimetrazine passes into breast milk. Do not take phendimetrazine without first talking to your doctor if you are breast-feeding a baby. How should I take Adipost (phendimetrazine)?Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Phendimetrazine should be taken only for a short time, such as a few weeks.
Phendimetrazine is usually taken once daily. Follow your doctor's instructions.
Take phendimetrazine on an empty stomach, 30 to 60 minutes before your morning meal. Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You should lose at least 4 pounds during the first 4 weeks of taking phendimetrazine and eating a low calorie diet. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks. Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine. Never take more of this medication than is prescribed for you. Too much phendimetrazine could be very dangerous to your health. Talk with your doctor if you have increased hunger or if you otherwise think the medication is not working properly. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. What happens if I miss a dose?Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
A dose taken too late in the day will cause insomnia. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phendimetrazine can be fatal.Overdose symptoms of a phendimetrazine overdose include nausea, vomiting, diarrhea, stomach cramps, confusion, panic, hallucinations, extreme restlessness, feeling tired or depressed, ringing in your ears, chest pain, slow heart rate, weak pulse, fainting, seizure, or slow breathing (breathing may stop).
What should I avoid while taking Adipost (phendimetrazine)? Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Adipost (phendimetrazine) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using phendimetrazine and call your doctor at once if you have a serious side effect such as:feeling short of breath, even with mild exertion;
chest pain, feeling like you might pass out;
swelling in your ankles or feet;
pounding heartbeats or fluttering in your chest;
confusion or irritability, unusual thoughts or behavior;
feelings of extreme happiness or sadness; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
feeling restless or hyperactive;
headache, dizziness, tremors;
sleep problems (insomnia);
flushing (warmth, redness, or tingly feeling);
dry mouth;
diarrhea or constipation, upset stomach; or
increased or decreased interest in sex, impotence.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Adipost (phendimetrazine)?Tell your doctor about all other medicines you use, especially:
insulin; or
any other diet pills.
This list is not complete and other drugs may interact with phendimetrazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Adipost resources Adipost Side Effects (in more detail) Adipost Use in Pregnancy & Breastfeeding Adipost Drug Interactions Adipost Support Group 1 Review for Adipost - Add your own review/rating Phendimetrazine Prescribing Information (FDA) Bontril PDM Advanced Consumer (Micromedex) - Includes Dosage Information Bontril PDM MedFacts Consumer Leaflet (Wolters Kluwer) Phendimetrazine Tartrate Monograph (AHFS DI) Compare Adipost with other medications Obesity Where can I get more information? Your pharmacist can provide more information about phendimetrazine.See also: Adipost side effects (in more detail)
Related Posts Short Stature for Age Medications:
 |
 |
Search |  |
 |
 |
||
 |
 |
Popular Search |  |
|
|
|
||||
 |
 |
|||
|
|
Partners | |
|
|
|
||||
|
|
|||
Site Map | PageMap
Copyright © RX Pharmacy Drugs List. All rights reserved.