Vimpat Intravenous

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Vimpat Tablets

Pronunciation: la-KOE-sa-mide
Generic Name: Lacosamide
Brand Name: Vimpat
Vimpat is used for:

Treating partial-onset seizures in certain patients with epilepsy. It is used in combination with other medicines.

Vimpat is an anticonvulsant. Exactly how it works is not known, but it may work by slowing abnormal nerve impulses in the brain.

Do NOT use Vimpat if: you are allergic to any ingredient in Vimpat you have severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vimpat:

Some medical conditions may interact with Vimpat. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have diabetes or nerve problems due to diabetes, liver problems, kidney problems, or you are on dialysis if you have a history of heart problems (eg, heart failure, heart block, irregular heartbeat), or heart blood vessel problems if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Vimpat. However, no specific interactions with Vimpat are known at this time.

Ask your health care provider if Vimpat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vimpat:

Use Vimpat as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Vimpat comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Vimpat refilled. Take Vimpat by mouth with or without food. Taking Vimpat at the same time each day will help you remember to take it. Continue to take Vimpat even if you feel well. Do not miss any doses. Do not suddenly stop taking Vimpat. You may have an increased risk of side effects (eg, seizures). If you need to stop Vimpat or add a new medicine, your doctor will gradually lower your dose. If you miss a dose of Vimpat, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Vimpat.

Important safety information: Vimpat may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vimpat with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Lab tests, including electrocardiogram (ECG) or liver or kidney function, may be performed while you use Vimpat. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Vimpat with caution in the ELDERLY; they may be more sensitive to its effects. Vimpat should be used with extreme caution in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vimpat while you are pregnant. It is not known if Vimpat is found in breast milk. Do not breast-feed while taking Vimpat. Possible side effects of Vimpat:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; dizziness; drowsiness; headache; irritability; nausea; tiredness; tremor; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; anxiety; hostility); confusion; dark urine; decreased coordination or loss of balance; double vision or other vision changes; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, new or worsening depression); new or worsening seizures; severe or persistent drowsiness, tiredness, or weakness; shortness of breath; suicidal thoughts or attempts; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Vimpat side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Vimpat:

Store Vimpat at 68 to 77 degrees F (20 to 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vimpat out of the reach of children and away from pets.

General information: If you have any questions about Vimpat, please talk with your doctor, pharmacist, or other health care provider. Vimpat is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vimpat. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Vimpat

Pronunciation: la-KOE-sa-mide
Generic Name: Lacosamide
Brand Name: Vimpat
Vimpat is used for:

Treating partial-onset seizures in certain patients with epilepsy. It is used in combination with other medicines.

Vimpat is an anticonvulsant. Exactly how it works is not known, but it may work by slowing abnormal nerve impulses in the brain.

Do NOT use Vimpat if: you are allergic to any ingredient in Vimpat you have severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vimpat:

Some medical conditions may interact with Vimpat. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have diabetes or nerve problems caused by diabetes, liver problems, kidney problems, or you are on dialysis if you have a history of heart problems (eg, heart block, heart failure, irregular heartbeat), or heart blood vessel problems if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Vimpat. However, no specific interactions with Vimpat are known at this time.

Ask your health care provider if Vimpat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vimpat:

Use Vimpat as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Vimpat comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Vimpat refilled. Vimpat is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Vimpat at home, a health care provider will teach you how to use it. Be sure you understand how to use Vimpat. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Vimpat if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Do not suddenly stop taking Vimpat. You may have an increased risk of side effects (eg, seizures). If you need to stop Vimpat or add a new medicine, your doctor will gradually lower your dose. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Vimpat, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Vimpat.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; dizziness; drowsiness; headache; irritability; mild itching, pain, or redness at the injection site; nausea; tiredness; tremor; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

See also: Vimpat side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Vimpat:

Vimpat is usually handled and stored by a health care provider. If you are using Vimpat at home, store Vimpat as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vimpat out of the reach of children and away from pets.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Vimpat resources Vimpat Side Effects (in more detail) Vimpat Use in Pregnancy & Breastfeeding Drug Images Vimpat Drug Interactions Vimpat Support Group 16 Reviews for Vimpat - Add your own review/rating Vimpat Prescribing Information (FDA) Vimpat Consumer Overview Vimpat Monograph (AHFS DI) Vimpat Advanced Consumer (Micromedex) - Includes Dosage Information Lacosamide Professional Patient Advice (Wolters Kluwer) Compare Vimpat with other medications Seizures

Vimpat Intravenous

Generic Name: lacosamide (Intravenous route)

la-KOE-sa-mide

Commonly used brand name(s)

In the U.S.

Vimpat

Available Dosage Forms:

Solution Uses For Vimpat

Lacosamide injection is used to control certain seizures (convulsions) in the treatment of epilepsy. It acts on the central nervous system (CNS) to reduce the number and severity of seizures.

This medicine is available only with your doctor's prescription.

Before Using Vimpat

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lacosamide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lacosamide injection in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution in patients receiving lacosamide injection.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ketorolac Naproxen Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Diabetic neuropathy or Heart attack or Heart block or Heart failure or Heart or blood vessel disease or Heart rhythm problems (e.g., prolonged PR interval) or Sick sinus syndrome—Use with caution. May make these conditions worse. Kidney disease or Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Liver disease, severe—Should not be used in patients with this condition. Proper Use of Vimpat

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 to 60 minutes.

Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using Vimpat

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you develop any unusual or strange thoughts and behavior while receiving lacosamide injection, be sure to discuss it with your doctor. Some changes that have occurred in people receiving this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become drowsy, dizzy, lightheaded, unconscious, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Lacosamide injection may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you have the following symptoms: fever, dark urine, headache, rash, stomach pain, unusual tiredness, or yellow eyes or skin.

Vimpat Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common Dizziness shakiness and unsteady walk sleepiness or unusual drowsiness trembling or shaking of the hands or feet unsteadiness, trembling, or other problems with muscle control or coordination Less common Being forgetful bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site discouragement feeling sad or empty irritability itching skin lack of appetite loss of balance control loss of interest or pleasure mood or mental changes tearing of the skin tiredness trouble concentrating trouble in walking trouble sleeping Rare Chest pain or discomfort flushing or redness of the skin lightheadedness, dizziness, or fainting shortness of breath slow or irregular heartbeat unusual tiredness unusually warm skin Incidence not known Abnormal or decreased touch sensation black, tarry stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings changes in patterns and rhythms of speech chills continuing ringing or buzzing or other unexplained noise in the ears cough fast, irregular, pounding, or racing heartbeat or pulse feeling drunk fever hearing loss lower back or side pain painful or difficult urination pale skin shortness of breath slurred speech sore throat trouble in speaking trouble performing routine tasks trouble with balance troubled breathing with exertion ulcers, sores, or white spots in the mouth unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Blurred vision double vision headache nausea seeing double vomiting Less common Diarrhea feeling of constant movement of self or surroundings lack or loss of strength sensation of spinning uncontrolled eye movements Incidence not known Acid or sour stomach belching difficulty having a bowel movement (stool) dry mouth heartburn indigestion muscle spasms stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Vimpat Intravenous side effects (in more detail)

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More Vimpat Intravenous resources Vimpat Intravenous Side Effects (in more detail) Vimpat Intravenous Use in Pregnancy & Breastfeeding Drug Images Vimpat Intravenous Drug Interactions Vimpat Intravenous Support Group 16 Reviews for Vimpat Intravenous - Add your own review/rating Compare Vimpat Intravenous with other medications Seizures

lacosamide Intravenous

la-KOE-sa-mide

Commonly used brand name(s)

In the U.S.

Vimpat

Available Dosage Forms:

Solution Uses For lacosamide

Lacosamide injection is used to control certain seizures (convulsions) in the treatment of epilepsy. It acts on the central nervous system (CNS) to reduce the number and severity of seizures.

lacosamide is available only with your doctor's prescription.

Before Using lacosamide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lacosamide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lacosamide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lacosamide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving lacosamide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using lacosamide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ketorolac Naproxen Interactions with Food/Tobacco/Alcohol

Other Medical Problems

The presence of other medical problems may affect the use of lacosamide. Make sure you tell your doctor if you have any other medical problems, especially:

A nurse or other trained health professional will give you lacosamide in a hospital. lacosamide is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 to 60 minutes.

Your doctor may give you a few doses of lacosamide until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using lacosamide

It is very important that your doctor check your progress at regular visits to make sure lacosamide is working properly and to check for unwanted effects.

If you develop any unusual or strange thoughts and behavior while receiving lacosamide injection, be sure to discuss it with your doctor. Some changes that have occurred in people receiving lacosamide are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

lacosamide may cause some people to become drowsy, dizzy, lightheaded, unconscious, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to lacosamide before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

Do not stop taking lacosamide without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

lacosamide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: lacosamide Intravenous side effects (in more detail)

More lacosamide Intravenous resources Lacosamide Intravenous Side Effects (in more detail) Lacosamide Intravenous Use in Pregnancy & Breastfeeding Lacosamide Intravenous Drug Interactions Lacosamide Intravenous Support Group 18 Reviews for Lacosamide Intravenous - Add your own review/rating Compare lacosamide Intravenous with other medications Seizures

lacosamide

la-KOE-sa-mide

Commonly used brand name(s)

In the U.S.

Vimpat

Available Dosage Forms:

Tablet Solution

Therapeutic Class: Anticonvulsant

Uses For lacosamide

Lacosamide is used together with other medicines to help control partial seizures (convulsions) in the treatment of epilepsy. It acts on the central nervous system (CNS) to reduce the number and severity of seizures. However, lacosamide cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

lacosamide is available only with your doctor's prescription.

Before Using lacosamide

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of lacosamide in children younger than 17 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lacosamide in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution in patients receiving lacosamide.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking lacosamide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Ketorolac Naproxen Interactions with Food/Tobacco/Alcohol

Other Medical Problems

The presence of other medical problems may affect the use of lacosamide. Make sure you tell your doctor if you have any other medical problems, especially:

Depression, history of or Heart attack or Heart block or Heart failure or Heart rhythm problems (e.g., prolonged PR interval) or Mental illness, history of or Sick sinus syndrome (type of abnormal heart rhythm), without pacemaker—Use with caution. May make these conditions worse. Diabetic neuropathy (nerve problem caused by diabetes) or Heart or blood vessel disease—May increase risk for more serious side effects. Kidney disease, severe or Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Liver disease, severe—Should not be used in patients with this condition. Phenylketonuria (PKU)—The oral liquid contains aspartame (a source of phenylalanine), which can make this condition worse. Proper Use of lacosamide

Take lacosamide only as directed by your doctor, to help your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

lacosamide should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

lacosamide may be taken with or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Lacosamide may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

Dosing

The dose of lacosamide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of lacosamide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (solution and tablets): For epilepsy: Adults and teenagers 17 years of age and older—At first, 50 milligrams (mg) two times a day. Your doctor may gradually increase your dose as needed and tolerated. However, the dose is usually not more than 400 mg per day. Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of lacosamide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not freeze the oral liquid. Throw away any unused medicine after 7 weeks of first opening the bottle.

Precautions While Using lacosamide

It is very important that your doctor check your progress at regular visits to make sure lacosamide is working properly. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you become pregnant or planning to become pregnant. Your doctor may want you to join the North American Antiepileptic Drug Pregnancy Registry and UCB AED Pregnancy Registry. These registries are used by pregnant patients who are taking lacosamide.

If you develop any unusual or strange thoughts and behavior while taking lacosamide, be sure to discuss it with your doctor. Some changes that have occurred in people taking lacosamide are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

lacosamide may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, sleepiness, or trouble with thinking. Make sure you know how you react to lacosamide before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these side effects are especially bothersome, check with your doctor.

lacosamide can cause changes in heart rhythms, such as a condition called PR prolongation. It may change the way your heart beats and cause lightheadedness, fainting, or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, slow, or irregular heartbeats.

Do not stop taking lacosamide without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Lacosamide may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Stop using lacosamide and check with your doctor right away if you have the following symptoms: fever; dark urine; headache; rash; stomach pain; swollen, painful, or tender lymph glands in the neck, armpit, or groin; unusual tiredness; or yellow eyes or skin.

lacosamide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Dizziness false or unusual sense of well-being shakiness and unsteady walk sleepiness or unusual drowsiness trembling or shaking of the hands or feet unsteadiness, trembling, or other problems with muscle control or coordination Less common Being forgetful discouragement feeling sad or empty irritability itching skin lack of appetite loss of balance control loss of interest or pleasure mood or mental changes tearing of the skin tiredness trouble concentrating trouble with sleeping trouble with walking Incidence not known Abnormal or decreased touch sensation black, tarry stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings changes in patterns and rhythms of speech chills continuing ringing or buzzing or other unexplained noise in the ears cough fast, irregular, pounding, or racing heartbeat or pulse feeling drunk fever hearing loss lower back or side pain painful or difficult urination pale skin shortness of breath slurred speech sore throat trouble performing routine tasks trouble with balance trouble with speaking troubled breathing with exertion ulcers, sores, or white spots in the mouth unusual bleeding or bruising unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: lacosamide side effects (in more detail)

More lacosamide resources Lacosamide Side Effects (in more detail) Lacosamide Use in Pregnancy & Breastfeeding Lacosamide Drug Interactions Lacosamide Support Group 18 Reviews for Lacosamide - Add your own review/rating Lacosamide Professional Patient Advice (Wolters Kluwer) Lacosamide Monograph (AHFS DI) Lacosamide MedFacts Consumer Leaflet (Wolters Kluwer) Vimpat Prescribing Information (FDA) Vimpat Consumer Overview Compare lacosamide with other medications Seizures

Brucellosis Medications

Definition of Brucellosis: Brucellosis is a disease caused by contact with animals carrying the Brucella bacteria.

Drugs associated with Brucellosis

The following drugs and medications are in some way related to, or used in the treatment of Brucellosis. 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 Brucellosis

Medical Encyclopedia:

Brucellosis
Drug List: Ala-Tet Chloromycetin-Oral-Intravenous-Injection Chloromycetin-Sodium-Succinate Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Garamycin-Solution Monodox Ocudox-Convenience-Kit Oraxyl Sumycin Vibra-Tabs Vibramycin

Venofer IV Iron Sucrose

Vifor (International) Inc.

VENOFER 20 mg/ml injection

[Iron sucrose (iron (III) hydroxide sucrose complex)]

Please read this leaflet carefully. It contains a summary of the information available on Venofer 20 mg/ml injection which is part of your hospital treatment. If after reading this you have any questions ask the doctor or nurse.

In this leaflet 1. What Venofer is and what it is used for. 2. Before you receive Venofer. 3. How Venofer is administered. 4. Possible side effects of Venofer. 5. Storing Venofer. What Venofer is and what it is used for

Venofer is a sterile, dark brown, non transparent, aqueous solution of iron intended to be used only for intravenous injection or as a concentrate for solution for infusion which contains the active ingredient iron as a solution of iron sucrose (iron(III)-hydroxide sucrose complex). The solution also contains sodium hydroxide and water for injection.

Venofer is supplied in glass ampoules which contain 5ml of solution which is equivalent to 100mg of iron. The product is supplied in cardboard boxes each containing 5 ampoules.

Marketing authorisation holder: Vifor France SA 123, rue Jules Guesde 92300 Levallois-Perret France Manufacturer: ALTANA Pharma AG Byk-Gulden-Str. 2 D-78467 Konstanz Germany

Venofer provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency.

The product is intended for use only in the following circumstances:

in a patient known to be intolerant to iron preparations taken by mouth, in a patient where there is a specific clinical need to deliver iron rapidly to the iron stores, in a patient with active inflammatory bowel disease where iron preparations taken by mouth are ineffective or not tolerated. Before you receive Venofer You should be aware that: a blood test should have been carried out to ensure treatment with this medicine is appropriate, the product should not be given at the same time as other iron preparations taken by mouth, Venofer should not be administered during the first three months of pregnancy and it should be administered with caution during the fourth to ninth month. intramuscular or intravenous iron preparations can cause severe allergic or anaphylactoid reactions which may be potentially fatal. Therefore the medicine should only be given if there are appropriate medical facilities immediately available, allergic reactions, sometimes involving joint pain, have been more commonly observed when the recommended dose is exceeded. the product is not approved for use in children. You should not receive Venofer if: you are known to be sensitive (allergic) to any iron preparations intended for intramuscular or intravenous administration, you have a history of asthma, eczema or other atopic allergies because then you are more susceptible to experience allergic reactions, your anaemia is not due to a shortage of iron, you have a history of cirrhosis or hepatitis or have increased liver enzymes, you have any acute or chronic infections because these may be worsened by giving intramuscular or intravenous iron. How Venofer is administered

Venofer should only be administered by the intravenous route by slow intravenous injection or by intravenous drip infusion which is the preferred route. The product must not be administered by intramuscular or subcutaneous injection. For intravenous infusion the 5ml ampoule (100mg iron) should be diluted in 0.9% saline. No other intravenous dilution solutions or therapeutic agents should be used.

Before receiving your first dose, you should receive a small "test dose" which may help reduce the chance of a serious reaction occurring.

The total dose of Venofer you require is given in single doses of one ampoule not more than three times per week. This may be increased to two ampoules not more than three times per week depending on the severity of your iron deficiency. Your doctor will take responsibility for calculating the appropriate dose and frequency of injections.

Possible side effects of Venofer

The most commonly reported side effects of Venofer are temporary changes in taste, low blood pressure, fever, shivering, injection site reactions and nausea. Non-serious allergic reactions occurred rarely. In general, allergic reactions are potentially the most serious side effects. In these reactions, very rarely symptoms of low blood pressure, facial swelling and difficulty in breathing can be involved. See ‘Before you receive Venofer’ section 2.

The following possible side effects have been reported following the administration of Venofer:

Nervous system disorders

Common (greater than or equal to 1% and less than 10%): temporary changes in taste (in particular metallic taste).

Uncommon (greater than or equal to 0.1% and less than 1%) : headache; dizziness.

Rare (greater than or equal to 0.01% and less than 0.1%): tingling, “pins and needles”

Isolated cases: decreased alertness, light-headed feeling, confusion.

Heart and blood vessel disorders

Uncommon: low blood pressure and collapse; rapid heart beat, palpitations.

Lungs and airways disorders

Uncommon: wheezing, difficulty in breathing.

Stomach and intestine disorders

Uncommon: nausea; vomiting; abdominal (e.g. stomach) pain; diarrhoea.

Skin disorders

Uncommon: itching; hives; rash, redness.

Muscle, bone and joint disorders

Uncommon: muscle cramps, muscle pain.

Isolated cases: swelling of joints.

General disorders and administration site disorders

Uncommon: fever, shivering, flushing; chest pain and chest tightness. Burning, swelling and similar reactions (sometimes involving veins) around the site of injection.

Rare: allergic reactions (rarely involving joint pain); swelling of hands and feet; tiredness, weakness; general feeling of illness.

Isolated cases: face and tongue swelling.

Storing Venofer

Venofer is to be kept out of the reach and sight of children.

The product should not be used after the expiry date printed on the label. The ampoules should be stored below 25°C in the original cartons. The product should not be frozen. Once the ampoules have been opened they should be used immediately. After dilution with 0.9% saline the solution should be used immediately or within 3 hours if stored at room temperature.

Further information

This leaflet does not tell you everything about Venofer. If you have any questions or are not sure about receiving treatment with this medicine, then ask your doctor. Please keep this leaflet until your course of treatment with Venofer has been completed.

This Leaflet was approved:

United Kingdom: December 2003

Skeletal muscle relaxants

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Skeletal muscle relaxants are centrally acting agents that work by reducing the tone of skeletal muscle causing muscle to relax. There are many classes of drugs that are classed as skeletal muscle relaxants and how they work may differ. These drugs are used to relieve skeletal muscle spasms due to spastic conditions and can be used to relieve musculoskeletal pain and spasms.

Zinacef

ZINACEF 1.5 g, 750 mg and 250 mg

cefuroxime sodium powder for injection

Please read this leaflet carefully before starting to take your medicine. Keep it safe, as you may want to read it again. This leaflet contains important information about Zinacef injection. If you want to know more about your illness or your medicine, ask your pharmacist or doctor.

What is Zinacef?

Zinacef contains cefuroxime, which is an antibiotic belonging to the cephalosporin class. Antibiotics are used to kill the bacteria or “germs” which cause infections.

What Zinacef contains

Each vial contains:

The active ingredient - cefuroxime 250 mg or 750 mg or 1.5 g (as sodium salt).

Other ingredients - none.

Zinacef is supplied in single vials of cefuroxime 250 mg, 750 mg or 1.5 g.

Product licence holder and manufacturer Product licence held by Glaxo Operations UK Ltd. trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Manufactured by GlaxoSmithKline Manufacturing S.p.A. Verona Italy What Zinacef does

This medicine is used to treat infections of the airways; ear, nose and throat; urinary tract; bones and joints; pelvis; blood and wounds; gonorrhoea and meningitis.

Your doctor has decided to give you Zinacef because you have an infection or to protect you from infection before an operation or during dialysis. Sometimes Zinacef is used at the same time as other antibiotics and the correct dose is checked by blood tests.

Before having Zinacef Make sure your doctor knows: if you think you may be pregnant if you are breast-feeding if you have been told that you are allergic to Zinacef, cefuroxime or other antibiotics e.g. penicillin if you have been told that your kidneys are not working as well as they should be if you are taking a diuretic such as furosemide if you are taking an aminoglycoside type antibiotic or any other antibiotics. You and your doctor should also know that: if your urine is tested for sugar, Zinacef does not normally cause a false positive result as occurs with some other cephalosporin antibiotics if you have any blood tests, Zinacef can cause changes to the results.

Like other medicines used to treat meningitis, Zinacef may take a while to clear the body of all the meningitis infection. Because of this, hearing loss caused by meningitis has occurred in a few patients after using Zinacef to treat the disease.

Dosage and administration

The correct dose of Zinacef will be decided by your doctor and depends on the type of infection and your weight and age. Zinacef will usually be given by a doctor or nurse either directly into a vein or into a muscle. In some cases, it may be added to a “drip” intravenous infusion. Zinacef is made up by adding the following amount of sterile water or other recommended diluting solution.

Vial Size 250mg Intramuscular injection (suspension): 1ml Intravenous injection (solution): 2ml Intravenous infusion (solution): - Vial Size 750mg Intramuscular injection (suspension): 3ml Intravenous injection (solution): 6ml Intravenous infusion (solution): - Vial Size 1.5g Intramuscular injection (suspension): - Intravenous injection (solution): 15ml Intravenous infusion (solution): - Vial Size 1.5g infusion Intramuscular injection (suspension): - Intravenous injection (solution): - Intravenous infusion (solution): 50ml

The usual adult dose is from 750 mg to 1.5 g three times a day: bigger or more frequent doses are sometimes needed. The duration of treatment depends on the type of infection. In special cases, just one 1.5 g dose is sufficient.

To treat pneumonia in adults, the usual dose of Zinacef is 1.5 g, twice a day for 2 to 3 days, followed by a 7 day course of the oral form of Zinacef, called Zinnat (cefuroxime axetil).

To treat a sudden worsening of chronic bronchitis, the usual dose of Zinacef is 750 mg, twice a day for 2 to 3 days, followed by a 5 to 7 day course of Zinnat.

The duration of your treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment.

For infants and children, the dose is based on body weight and is usually between 30 mg to 100 mg per kilogram daily divided into three or four separate doses. For newborn children the dose is as for infants and children, but is divided into 2 or 3 doses.

The daily dose depends on whether it is a simple or complicated infection and on whether other antibiotics are being used at the same time.

For patients with kidney problems the dose of Zinacef will be reduced.

Your medication will usually be given to you by a health professional. However if you think you may have missed a dose or have received too much medicine please tell your doctor or nurse.

Zinacef Side Effects

Along with its needed effects, a medicine may cause unwanted effects. Most people given Zinacef find it causes no problems.

A few people can be allergic to antibiotics, if any of the following rare side effects appear soon after having your injection, tell your doctor immediately:

sudden wheeziness, chest tightness, pain or collapse, as these may be symptoms of an acute allergic reaction to your medicine. The more common side effects of Zinacef that could happen to between in 1 in 10 and 1 in 100 people taking it include: changes to “blood counts” or tests used to measure the functioning of organs in the body such as the liver pain or inflammation at the site of injection (thrombophlebitis). Uncommon side effects that could happen to between 1 in 100 and 1 in 1,000 people taking Zinacef include: skin lumps or hives skin rash (red spots), itchiness diarrhoea or vomiting. Rare side effects that could happen to between 1 in 1,000 and 1 in 10,000 people include: as with other antibiotics after long courses of treatment, thrush in the vagina or mouth can occur easy bruising (thrombocytopenia) fever. Very rare side effects that could happen to less 1 in 10,000 taking Zinacef include: swelling of eyelids, face or lips severe diarrhoea from colitis (lower end of the bowel inflamed) kidney inflammation blistering or peeling skin.

If you feel unwell or have any unusual discomfort you do not understand, tell the doctor as soon as possible.

Storage

If you keep the vials at home, keep them away from heat and light which could spoil them. As with all medicines, keep Zinacef vials safely away from children. Store any unopened vials at room temperature below 25°C (77°F). Store reconstituted vials in a fridge at 2-8°C for no longer than 24 hours. Do not autoclave (a method of sterilization often used in hospitals).

What to do with any unused medication

If you are at home and your doctor stops your treatment, return any unused Zinacef vials to a pharmacist for disposal. Only keep your medication if your doctor tells you to. Do not use the unopened vials after the expiry date on the label or carton.

Further information

Remember this medicine is for you. Only a doctor can prescribe it for you.

This leaflet does not tell you everything about your medication. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

You may be able to find out more about prescribed medicines from books in public libraries.

Leaflet last updated 3 May 2006

The information provided applies only to Zinacef

Zinacef and Zinnat are registered trademarks of the GlaxoSmithKline group of companies

iobenguane i 131 Intravenous

eye-oh-BEN-gwane I 131

Available Dosage Forms:

Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses For iobenguane i 131

Radioiodinated iobenguane is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

Radioiodinated iobenguane is used to treat certain kinds of cancer of the adrenal glands.

When very small doses of radioiodinated iobenguane are given, the radioactivity taken up by the adrenal gland helps find tumors of the adrenal glands. An image of the gland on film or on a computer screen can be provided to help with the diagnosis.

The information that follows applies only to the use of radioiodinated iobenguane in treating cancer of the adrenal gland.

Radioiodinated iobenguane is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using iobenguane i 131

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For iobenguane i 131, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to iobenguane i 131 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children and adolescents are especially sensitive to the effects of radiation. This may increase the chance of side effects during and after treatment. Be sure you have discussed this with your doctor.

Geriatric

Radioiodinated iobenguane has been used in older people and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking iobenguane i 131, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using iobenguane i 131 with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Labetalol Interactions with Food/Tobacco/Alcohol

Other Medical Problems

The presence of other medical problems may affect the use of radioiodinated iobenguane. Make sure you tell your doctor if you have any other medical problems.

Proper Use of iobenguane i 131 Dosing

The dose of iobenguane i 131 will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of iobenguane i 131. If your dose is different, do not change it unless your doctor tells you to do so.

iobenguane i 131 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare Pale skin sore throat and fever unusual bleeding or bruising unusual tiredness or weakness

Less common or rare Flushing of skin nausea slight and temporary increase in blood pressure

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

More iobenguane i 131 Intravenous resources Iobenguane i 131 Intravenous Drug Interactions Iobenguane i 131 Intravenous Support Group 0 Reviews for Iobenguane i31 Intravenous - Add your own review/rating Compare iobenguane i 131 Intravenous with other medications Diagnosis and Investigation

Pabrinex Intravenous High Potency Injection

1. Name Of The Medicinal Product

Pabrinex Intravenous High Potency, Solution for injection

2. Qualitative And Quantitative Composition

Each presentation (carton) contains either 5ml or 10ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2.

Each No 1 ampoule contains: 5ml ampoule 10ml ampoule Thiamine Hydrochloride BP 250mg 500mg Riboflavin (as Phosphate Sodium BP) 4mg 8mg Pyridoxine Hydrochloride BP 50mg 100mg Each No 2 ampoule contains: 5ml ampoule 10ml ampoule Ascorbic Acid BP 500mg 1000mg Nicotinamide BP 160mg 320mg Anhydrous Glucose BP 1000mg 2000mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection

4. Clinical Particulars 4.1 Therapeutic Indications

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy; after acute infections, post-operatively and in psychiatric states. Also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.

4.2 Posology And Method Of Administration

Pabrinex is also available as an Intramuscular High Potency Injection. Therefore before administration, ensure that both the Summary of Product Characteristics and ampoule labels refer to the INTRAVENOUS injection.

1) The preferred method of administration of Pabrinex Intravenous High Potency is by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50ml to 100ml physiological saline or glucose 5% and infused over 30 minutes (see “Special Precautions for Storage” section).

2) For a combined injection volume of not more than 10ml (e.g. the contents of one 5ml ampoule number 1 and one 5ml ampoule number 2) the contents of the ampoules are drawn up into a syringe to mix them just before use, then injected slowly, over a period of 10 minutes, into a vein.

Adults:

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy

10ml solution from Ampoule

Number 1

PLUS

10ml solution from Ampoule

Number 2

15ml solution from Ampoule

Number 1

PLUS

15ml solution from Ampoule

Number 2

2 to 3 pairs of 5ml ampoules* (1 pair = ampoule 1 + ampoule 2) diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) and administered over 30 minutes every 8 hours, or at the discretion of the physician.

* or equivalent volume of 5ml and/or 10ml ampoules

Psychosis following narcosis or E.C.T; toxicity from acute infections

5ml Ampoule Number 1

PLUS

5ml Ampoule Number 2

10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes twice daily for up to 7 days.

Haemodialysis

5ml Ampoule Number 1

PLUS

5ml Ampoule Number 2

10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes once every two weeks at the end of dialysis.

Elderly: as for adults.

Children: Pabrinex Intravenous High Potency is rarely indicated for administration to children, however suitable doses are as follows:

Under 6 years quarter of the adult dose 6 - 10 years third of the adult dose 10 - 14 years half to two thirds of the adult dose 14 years and over as for the adult dose 4.3 Contraindications

Known hypersensitivity to any of the active constituents or to the excipients.

4.4 Special Warnings And Precautions For Use

Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential. Initial warning signs of a reaction to Pabrinex are sneezing or mild asthma and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intravenous High Potency is administered. To minimise the risk of such events with Pabrinex Intravenous High Potency, the preferred mode of administration is by infusion over a period of 30 minutes.

This medicine is for injection into a vein only and should not be given by any other route

Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended – reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.

4.6 Pregnancy And Lactation

No adverse effects have been noted at recommended doses when used as clinically indicated.

However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. However given the nature of the product, no effects are anticipated.

4.8 Undesirable Effects

Occasionally, hypotension and mild paraesthesia from continued high doses of thiamine; occasionally mild ache at local site of injection.

4.9 Overdose

In the unlikely event of overdosage, treatment is symptomatic and supportive.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pabrinex Intravenous High Potency contains vitamins B1, B2, B6, nicotinamide, vitamin C and glucose.

ATC code: A11EB

5.2 Pharmacokinetic Properties

Not supplied.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Edetic acid

Sodium hydroxide

Water for Injections

6.2 Incompatibilities

If it is necessary to administer Pabrinex Intravenous High Potency in infusion, it is recommended that Pabrinex IV HP is administered in physiological saline or glucose 5%.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the container in the outer carton. Do not freeze.

Storage of diluted Pabrinex Intravenous High Potency

The stability of Pabrinex Intravenous High Potency in intravenous infusion fluids, at room temperature, is as follows:

Intravenous infusion fluid

In the light

Glucose 5%

7 hours

Physiological saline (sodium chloride 0.9%)

7 hours

Glucose 4.3% with sodium chloride 0.18%

4 hours

Glucose 5% with potassium chloride 0.3%

4 hours

Sodium lactate M/6

7 hours

Although no further specific data are available, the solutions are expected to be stable for longer periods when protected from light. Store diluted solutions at 2°C to 8°C if not used immediately. Do not freeze.

6.5 Nature And Contents Of Container

Pabrinex Intravenous High Potency is supplied in pairs of amber glass ampoules of 5ml or 10ml. Pack sizes contain ten pairs of 5ml or five pairs of 10ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

7. Marketing Authorisation Holder

Archimedes Pharma UK Limited

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

8. Marketing Authorisation Number(S)

PL 12406/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: October 1993

Date of the latest renewal: October 2003

10. Date Of Revision Of The Text

22 July 2010

nesiritide Intravenous

ne-SIR-i-tide

Commonly used brand name(s)

In the U.S.

Natrecor

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Natriuretic Peptide

Uses For nesiritide

Nesiritide is used for patients who have severe congestive heart failure that has recently become worse. Nesiritide is for patients who are short of breath while at rest or with minimal activity.

Before Using nesiritide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nesiritide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nesiritide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on nesiritide have been done only in adult patients, and there is no specific information comparing use of nesiritide in children with use in other age groups.

Geriatric

nesiritide has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking nesiritide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using nesiritide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Benazepril Captopril Cilazapril Enalapril Maleate Fosinopril Lisinopril Quinapril Ramipril Zofenopril Interactions with Food/Tobacco/Alcohol

Other Medical Problems

The presence of other medical problems may affect the use of nesiritide. Make sure you tell your doctor if you have any other medical problems, especially:

Heart disease (other than congestive heart failure)—Nesiritide may make heart problems worse. Low blood pressure—Nesiritide may make this condition worse. Proper Use of nesiritide Dosing

The dose of nesiritide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of nesiritide. If your dose is different, do not change it unless your doctor tells you to do so.

For injection dosage form: For congestive heart failure: Adults—Dose is based on your weight and must be determined by your doctor. Children—Use and dose must be determined by your doctor. nesiritide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Low blood pressure Less common Bluish lips or skin chest pain, tightness, or discomfort cool, clammy skin difficulty in breathing or shortness of breath dizziness fainting lightheadedness fast, slow, or irregular heartbeat unusual tiredness or weakness

More common Headache Less common Abdominal or stomach pain anxiety back pain burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings on the skin change in vision confusion coughing or spitting up blood fever increased cough itching skin leg cramps nausea pain or irritation at the injection site pale skin, unusual bleeding or bruising rash sleepiness or unusual drowsiness sleeplessness sweating trembling or shakiness vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: nesiritide Intravenous side effects (in more detail)

More nesiritide Intravenous resources Nesiritide Intravenous Side Effects (in more detail) Nesiritide Intravenous Use in Pregnancy & Breastfeeding Nesiritide Intravenous Drug Interactions Nesiritide Intravenous Support Group 0 Reviews for Nesiritide Intravenous - Add your own review/rating Compare nesiritide Intravenous with other medications Heart Failure

clevidipine Intravenous

klev-ID-i-peen

Commonly used brand name(s)

In the U.S.

Cleviprex

Available Dosage Forms:

Emulsion

Therapeutic Class: Antihypertensive

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Dihydropyridine

Uses For clevidipine

Clevidipine is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Clevidipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, clevidipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

clevidipine is available only with your doctor's prescription.

Before Using clevidipine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For clevidipine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to clevidipine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of clevidipine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clevidipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving clevidipine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving clevidipine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using clevidipine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Indinavir Interactions with Food/Tobacco/Alcohol

Other Medical Problems

The presence of other medical problems may affect the use of clevidipine. Make sure you tell your doctor if you have any other medical problems, especially:

Allergy to soybeans, soy products, eggs, or egg products or Aortic stenosis (narrowing of a valve in your heart), severe or Lipid metabolism problems (high blood fats) (e.g., hyperlipemia, lipoid nephrosis, pancreatitis with high blood lipids)—Should not be used in patients with these conditions. Heart failure or Hypotension (low blood pressure)—Use with caution. May make these conditions worse. Proper Use of clevidipine

A nurse or other trained health professional will give you clevidipine. clevidipine is given through a needle placed into one of your veins.

Precautions While Using clevidipine

Your doctor will only give you a few doses of clevidipine until your condition improves, and then you will be switched to another medicine that works the same way. If you have any concerns about this, talk to your doctor.

clevidipine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common Agitation confusion decreased urine output depression dizziness fainting fast or irregular heartbeat headache hostility irritability lethargy loss of consciousness muscle twitching nausea rapid weight gain seizures (convulsions) stupor swelling of the face, ankles, or hands unusual tiredness or weakness Rare Chest pain or discomfort difficult or labored breathing pain or discomfort in the arms, jaw, back, or neck shortness of breath stopping of the heart sweating tightness in the chest unconsciousness very low blood pressure or pulse vomiting wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: clevidipine Intravenous side effects (in more detail)

More clevidipine Intravenous resources Clevidipine Intravenous Side Effects (in more detail) Clevidipine Intravenous Use in Pregnancy & Breastfeeding Clevidipine Intravenous Drug Interactions Clevidipine Intravenous Support Group 0 Reviews for Clevidipine Intravenous - Add your own review/rating Compare clevidipine Intravenous with other medications High Blood Pressure Hypertensive Emergency

Spondylolisthesis Medications

Definition of Spondylolisthesis: Spondylolisthesis is a condition in which a bone (vertebra) in the lower part of the spine slips forward and onto a bone below it.

Drugs associated with Spondylolisthesis

The following drugs and medications are in some way related to, or used in the treatment of Spondylolisthesis. 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 Spondylolisthesis

Medical Encyclopedia:

Spondylolisthesis
Drug List: A-G-Profen Actiprofen Addaprin Advil Children-S-Advil-Chewable-Tablets Advil-Infants-Concentrated-Drops Advil-Junior-Strength Advil-Liqui-Gels Advil-Migraine Aflaxen Aleve All-Day-Pain-Relief All-Day-Relief Anaprox Anaprox-Ds Caldolor Children-S-Motrin-Chewable-Tablets Childrens-Ibuprofen-Berry Comfort-Pac-With-Naproxen Ec-Naprosyn-Enteric-Coated-Tablets Genpril Haltran Ibu Ibu-200 Leader-Naproxen-Sodium Lyrica Midol-Extended-Relief Midol-Ib Midol-Maximum-Strength-Cramp-Formula Motrin Motrin-Childrens Motrin-Ib Motrin-Infant-Drops Motrin-Junior-Strength-Chewable-Tablets Motrin-Migraine-Pain Naprelan-Sustained-Release-Tablets Naprosyn Neoprofen-Intravenous Nuprin Q-Profen

antivenin (crotalidae) polyvalent immune fab Intravenous

an-tye-VEN-in (kroe-TAL-i-dee) pol-ee-VAY-lent i-MUNE fab

Commonly used brand name(s)

In the U.S.

Crofab

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antivenom

Uses For antivenin (crotalidae) polyvalent immune fab

Pit viper antivenin is a medicine used to treat the bites of certain poisonous snakes called pit vipers (crotalids), which are native to North America. This particular pit viper antivenin is made from the blood of sheep and is used to treat the bites of the following types of pit viper: the Western Diamondback, Eastern Diamondback, and Mojave rattlesnakes, and the Copperhead snake or Water Moccasin.

Pit viper antivenin is to be used only by or under the supervision of a doctor.

Before Using antivenin (crotalidae) polyvalent immune fab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For antivenin (crotalidae) polyvalent immune fab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to antivenin (crotalidae) polyvalent immune fab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of pit viper antivenin in children with use in other age groups, antivenin (crotalidae) polyvalent immune fab is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pit viper antivenin in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

The presence of other medical problems may affect the use of antivenin (crotalidae) polyvalent immune fab. Make sure you tell your doctor if you have any other medical problems, especially:

Snake bite, previous— During previous treatment, your body may have developed antibodies (proteins produced by the immune system that help the body fight infection and are involved in allergic reactions), which may cause a serious reaction with current treatment Proper Use of antivenin (crotalidae) polyvalent immune fab Dosing

The dose of antivenin (crotalidae) polyvalent immune fab will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of antivenin (crotalidae) polyvalent immune fab. If your dose is different, do not change it unless your doctor tells you to do so.

antivenin (crotalidae) polyvalent immune fab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Unexplained bleeding or bruising Less common Cough difficulty in breathing difficulty in swallowing dizziness or lightheadedness fast heartbeat fever hives or welts itching of skin joint pain large, hive-like swellings on the eyelids, face, lips, mouth, and/or tongue muscle pain noisy breathing redness of skin shortness of breath skin rash wheezing

Check with your doctor as soon as possible if any of the following side effects occur:

Less common Areas of pain, redness, and swelling chest pain chills discharge from wound pain, tenderness, and warmth at wound site unusual tiredness or weakness

More common Nausea Less common

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: antivenin (crotalidae) polyvalent immune fab Intravenous side effects (in more detail)

Back pain generalized numbness, tingling, crawling, prickling, “pins and needles” feelings hard bumps under the skin loss of appetite nervousness numbness and tingling around the mouth increased amount of phlegm

More antivenin (crotalidae) polyvalent immune fab Intravenous resources Antivenin (crotalidae) polyvalent immune fab Intravenous Side Effects (in more detail) Antivenin (crotalidae) polyvalent immune fab Intravenous Use in Pregnancy & Breastfeeding Antivenin (crotalidae) polyvalent immune fab Intravenous Drug Interactions Antivenin (crotalidae) polyvalent immune fab Intravenous Support Group 0 Reviews for Antivenin (crotalidae) polyvalent immune fab Intravenous - Add your own review/rating Compare antivenin (crotalidae) polyvalent immune fab Intravenous with other medications Venomous Snake Bite

fospropofol Intravenous

fos-proe-POE-fol

Commonly used brand name(s)

In the U.S.

Lusedra

Available Dosage Forms:

Solution

Therapeutic Class: Sedative-Hypnotic

Uses For fospropofol

Fospropofol is used to make a person relax or sleep (be unconscious) before and during surgery or procedures. fospropofol is a strong sedative.

fospropofol is available only with your doctor's prescription.

Before Using fospropofol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fospropofol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fospropofol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fospropofol in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fospropofol in the elderly. However, elderly patients are more likely to have age-related heart disease, which may require an adjustment in the dose for patients receiving fospropofol.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving fospropofol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fospropofol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil Alprazolam Amobarbital Barbital Butabarbital Butorphanol Chloral Hydrate Chlordiazepoxide Clonazepam Clorazepate Diazepam Dichloralphenazone Estazolam Eszopiclone Fentanyl Hexobarbital Hydrocodone Hydromorphone Levorphanol Lorazepam Meperidine Mephobarbital Meprobamate Methadone Midazolam Nalbuphine Oxazepam Oxycodone Oxymorphone Paraldehyde Pentazocine Prazepam Propoxyphene Napsylate Ramelteon Remifentanil Secobarbital Sufentanil Temazepam Triazolam Zaleplon Zolpidem Zopiclone Interactions with Food/Tobacco/Alcohol

Other Medical Problems

The presence of other medical problems may affect the use of fospropofol. Make sure you tell your doctor if you have any other medical problems, especially:

Breathing problems or Heart disease or Hypotension (low blood pressure) or Hypoxemia (low oxygen in the blood)—Use with caution. May make these conditions worse. Proper Use of fospropofol

A nurse or other trained health professional will give you fospropofol in a hospital or surgery clinic. fospropofol is given through a needle placed in one of your veins.

Precautions While Using fospropofol

It is very important that your doctor check your progress while you are using fospropofol. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

fospropofol may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel dizzy or lightheaded when getting up suddenly from a lying or sitting position, so get up slowly.

fospropofol may cause your skin to itch and a side effect called paresthesias. This may cause burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings on your skin. Check with your doctor if you have these symptoms after receiving the injection.

fospropofol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings Less common Bluish lips or skin blurred vision confusion dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly sweating unusual tiredness or weakness Rare Difficult or troubled breathing irregular, fast or slow, or shallow breathing pale or blue lips, fingernails, or skin shortness of breath

More common Itching skin Less common Headache nausea vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: fospropofol Intravenous side effects (in more detail)

More fospropofol Intravenous resources Fospropofol Intravenous Side Effects (in more detail) Fospropofol Intravenous Use in Pregnancy & Breastfeeding Fospropofol Intravenous Drug Interactions Fospropofol Intravenous Support Group 0 Reviews for Fospropofol Intravenous - Add your own review/rating Compare fospropofol Intravenous with other medications Anesthesia Sedation

iobenguane i 123 Intravenous

eye-oh-BEN-gwane I 123

Commonly used brand name(s)

In the U.S.

AdreView

Available Dosage Forms:

Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses For iobenguane i 123

Iobenguane I 123 is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

Iobenguane I 123 is used to find certain kinds of cancer of the adrenal glands.

When very small doses of iobenguane I 123 are given, the radioactivity taken up by the adrenal gland helps find tumors of the adrenal glands. An image of the gland on film or on a computer screen can be provided to help with the diagnosis.

Iobenguane I 123 is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using iobenguane i 123

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to iobenguane i 123 or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of iobenguane I 123 in infants below 1 month of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iobenguane I 123 in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving iobenguane I 123.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using iobenguane i 123.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

Hypertension (high blood pressure) or Thyroid problems—Use with caution. May make these conditions worse. Kidney disease, severe—Use with caution. The effects of iobenguane i 123 may be increased because of slower removal from the body. Proper Use of iobenguane i 123

Your doctor or other trained health professional will give you iobenguane i 123. iobenguane i 123 is given through a needle placed in one of your veins.

Precautions While Using iobenguane i 123

It is very important that your doctor check your progress at regular visits to make sure iobenguane i 123 is working properly.

iobenguane i 123 contains benzyl alcohol which may cause serious reactions to premature or low-birthweight infants. Discuss this with your doctor if you are concerned.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

iobenguane i 123 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known Difficulty in breathing and/or swallowing fever hives nausea reddening of the skin, especially around ears swelling of eyes, face, or inside of nose unusual tiredness or weakness

Less common Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site dizziness feeling of warmth or redness of the face, neck, arms and occasionally, upper chest skin rash or itching

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

More iobenguane i 123 Intravenous resources Iobenguane i 123 Intravenous Drug Interactions Iobenguane i 123 Intravenous Support Group 0 Reviews for Iobenguane i23 Intravenous - Add your own review/rating Compare iobenguane i 123 Intravenous with other medications Diagnosis and Investigation

fomepizole

Generic Name: fomepizole (foe MEP i zole)
Brand Names: Antizol

What is fomepizole?

Fomepizole is an antidote to certain types of poison.

Fomepizole is used to treat poisoning with ethylene glycol (antifreeze) or methanol (contained in solvents, fuels, and other household or automotive chemicals). Fomepizole is sometimes used together with hemodialysis to rid the body of a poison.

Fomepizole may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about fomepizole?

In a poisoning situation, it may not be possible to tell your caregivers that you are pregnant or breast-feeding before you are treated with fomepizole. However, make sure any doctor caring for your pregnancy or your baby knows that you have received the medication.

Tell your caregivers at once if you have any burning, swelling, or skin changes where the medicine was injected.

To be sure this medication is helping your condition, your blood and urine will need to be tested often. This will help your doctor determine how long to treat you with fomepizole. You will also be watched for any effects of the poisoning, such as problems with vision, breathing, or urination.

What should I discuss with my health care provider before receiving fomepizole? You should not receive this medication if you are allergic to fomepizole. FDA pregnancy category C. This medication may be harmful to an unborn baby and is not recommended in pregnant women unless clearly needed. It is not known whether fomepizole passes into breast milk or if it could harm a nursing baby.

How is fomepizole given?

Fomepizole is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or emergency setting. The medicine must be given slowly through an IV infusion, and each dose can take up to 30 minutes to complete.

What happens if I miss a dose?

Since fomepizole is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose? Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include nausea, dizziness, or a spinning sensation.

What should I avoid while receiving fomepizole?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you are treated with fomepizole.

Fomepizole 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. Tell your caregivers at once if you have any of these serious side effects (some are effects of the poison and not of fomepizole):

burning, swelling, or skin changes where the medicine was injected;

urinating less than usual or not at all;

fast or slow heart rate, feeling like you may pass out; or

skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

mild skin rash;

heartburn, nausea, vomiting, diarrhea;

loss of appetite;

dizziness, drowsiness, anxiety, or headache;

metallic taste in your mouth;

hangover feeling;

back pain;

sore throat;

ringing in your ears; or

changes in vision, changes in smell or taste senses.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Fomepizole Dosing Information

Usual Adult Dose for Methanol Poisoning:

Patients not requiring hemodialysis:
Initial dose: 15 mg/kg IV followed by 4 doses of 10 mg/kg IV every 12 hours
Maintenance dose: 15 mg/kg IV every 12 hours thereafter until levels of ethylene glycol or methanol are reduced below 20 mg/dL, and the patient is asymptomatic with normal pH
All doses should be administered as a slow intravenous infusion over 30 minutes.

Usual Adult Dose for Ethylene Glycol Poisoning:

Usual Pediatric Dose for Methanol Poisoning:

Children and adolescents not requiring hemodialysis:
Initial dose: 15 mg/kg IV followed by 4 doses of 10 mg/kg IV every 12 hours
Maintenance dose: 15 mg/kg IV every 12 hours thereafter until levels of ethylene glycol or methanol are reduced below 20 mg/dL, and the patient is asymptomatic with normal pH
All doses should be administered as a slow intravenous infusion over 30 minutes.
Not FDA approved; however, safe and effective use in pediatric patients has been reported.

Usual Pediatric Dose for Ethylene Glycol Poisoning:

What other drugs will affect fomepizole?

Tell your doctor if you have recently used any of the following drugs:

phenytoin (Dilantin);

carbamazepine (Carbatrol, Tegretol);

cimetidine (Tagamet); or

ketoconazole (Nizoral).

There may be other drugs that can affect fomepizole. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors.

More fomepizole resources Fomepizole Side Effects (in more detail)Fomepizole DosageFomepizole Use in Pregnancy & BreastfeedingFomepizole Drug InteractionsFomepizole Support Group0 Reviews for Fomepizole - Add your own review/rating Fomepizole Monograph (AHFS DI) Fomepizole Prescribing Information (FDA) Antizol Prescribing Information (FDA) Compare fomepizole with other medications Ethylene Glycol PoisoningMethanol Poisoning Where can I get more information? Your doctor or pharmacist can provide more information about fomepizole.

See also: fomepizole side effects (in more detail)

Calcium Chloride BP Sterile Solution (UCB Pharma Limited)

1. Name Of The Medicinal Product

Calcium Chloride BP Sterile Solution

2. Qualitative And Quantitative Composition

Calcium Chloride Dihydrate BP 13.4% w/v

'For excipients, see 6.1'

3. Pharmaceutical Form

Sterile solution for slow intravenous injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Calcium Chloride Sterile Solution is indicated for the treatment of acute hypocalcaemia where there is a requirement for the rapid replacement of calcium, e.g. severe hypocalcaemic tetany or hypoparathyroidism, or where the oral route is inappropriate due to malabsorption.

4.2 Posology And Method Of Administration

Route of Administration: Slow intravenous injection.

Adults

A typical dose is 2.25 to 4.5 mmol of calcium given by slow intravenous injection not exceeding 1 ml per minute and repeated as necessary.

Children

The cause of the hypocalcaemia must be fully assessed before starting therapy including dietary review, measurement of vitamin D and PTH, together with regular serum calcium and phosphate levels. For children with hypocalcaemic tetany a dosage of 0.25 to 0.35 mmol/kg of calcium given by slow intravenous injection may be given, repeated every six to eight hours until a response is seen. For other hypocalcaemia conditions initial doses of 0.5 to 3.5 mmol of calcium may be given to elevate serum calcium concentrations.

Infants

Calcium chloride has been given to infants at doses of under 0.5 mmol of calcium, but calcium gluconate is usually preferred due to the irritancy of calcium chloride.

4.3 Contraindications

Parenteral calcium therapy is contraindicated in patients receiving cardiac glycosides. Unsuitable for the treatment of hypocalcaemia caused by renal insufficiencies.

In cardiac resuscitation, the use of calcium is contraindicated in the presence of ventricular fibrillation.

Ceftriaxone is contraindicated in premature newborns up to a corrected age of 41 weeks (weeks of gestation + weeks of life) and full-term newborns (up to 28 days of age) if they require (or are expected to require) IV calcium treatment, or calcium-containing infusions because of the risk of precipitation of ceftriaxone-calcium (see sections 4.4 and 4.5).

The treatment of asystole and electromechanical dissociation.

Hypersensitivity to any component.

4.4 Special Warnings And Precautions For Use

Calcium chloride can cause gastro-intestinal irritation due to the stimulatory effects of calcium on gastric acid production. However, the effect would be most likely with oral administration.

Close monitoring of serum calcium levels is essential following IV administration of calcium.

Calcium salts should be used with caution in patients with impaired renal function, cardiac disease or sarcoidosis.

Because it is acidifying, calcium chloride should be used cautiously in patients with respiratory acidosis or respiratory failure.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than newborns, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products.

In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions, even via different infusion lines or at different infusion sites. However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used, or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion, considering the advice to flush infusion lines between solutions.

Calcium chloride injection is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, IV administration at that site should be discontinued at once. Local infiltration of the affected area with 1 % procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For interaction between calcium containing products and ceftriaxone, please see sections 4.3 and 4.4 above.

Calcium-containing products may decrease the effectiveness of calcium channel blockers.

Calcium salts reduce the absorption of a number of drugs such as bisphosphonates, fluoride, some fluoroquinolones and tetracyclines; administration should be separated by at least 3 hours.

Calcium chloride infusion reduces the cardiotonic effects of dobutamine.

The effects of digitalis can be increased by increases in blood calcium levels, and the administration of intravenous calcium may result in the development of potentially life-threatening digitalis induced heart arrhythmias.

Thiazide diuretics decrease urinary calcium excretion, and caution is required if such drugs are administered with both calcium chloride and other calcium-containing preparations.

4.6 Pregnancy And Lactation

Calcium chloride has no known effects on the foetus or infant, but as with all drugs it should not be administered during pregnancy or breast feeding unless considered essential.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Rapid intravenous injection may cause vasodilation, decreased blood pressure, bradycardia and arrhythmias.

The patient may complain of tingling sensations, a chalky 'calcium' taste and a sense of oppression or 'heat wave'.

Irritation can occur after intravenous injection. Extravasation can cause burning, necrosis and sloughing of tissue, cellulitis and soft tissue calcification.

Hypertension

Venous thrombosis

Hypercalcemia

4.9 Overdose

Excessive administration of calcium salts leads to hypercalcaemia. Too rapid injection of calcium salts may also lead to many of the symptoms of hypercalcaemia as well as chalky taste, hot flushes and peripheral vasodilation. Treatment of hypercalcaemia is by the administration of sodium chloride by intravenous infusion. Cardiac arrhythmia and cardiac arrest may occur.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code:A12 A07

Calcium is an essential electrolyte involved in the function of nervous, muscular and skeletal systems, cell membrane and capillary permeability. The cation is also an important activator in many enzymatic reactions and plays a regulatory role in the release and storage of neurotransmitters and hormones.

5.2 Pharmacokinetic Properties

Intravenously administered calcium will be absorbed directly into the blood system. Serum calcium levels will increase immediately and may return to normal values in thirty minutes to two hours depending on the rate of renal clearance.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide

Hydrochloric acid

Water for injections

6.2 Incompatibilities

Calcium salts are incompatible with oxidising agents, citrates, soluble carbonates, bicarbonates, phosphates, tartrates and sulphates.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

10ml neutral Type 1 glass ampoules in packs of 10.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3 WE

8. Marketing Authorisation Number(S)

PL 00039/5888R

9. Date Of First Authorisation/Renewal Of The Authorisation

18 February 1993, 17 February 2003

10. Date Of Revision Of The Text

January 2010

nitroglycerin Intravenous

nye-troe-GLIS-er-in

Commonly used brand name(s)

In the U.S.

Nitro-Bid

Available Dosage Forms:

Solution Kit Injectable

Therapeutic Class: Coronary Vasodilator

Chemical Class: Nitrate

Uses For nitroglycerin

Nitroglycerin injection is used to treat hypertension (high blood pressure) during surgery or to control congestive heart failure in patients who have had a heart attack. It may also be used to produce hypotension (low blood pressure) during surgery. Nitroglycerin injection is sometimes used to treat angina (chest pain) in patients who have been treated with other medicines that did not work well.

Nitroglycerin injection belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load.

nitroglycerin is available only with your doctor's prescription.

Before Using nitroglycerin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nitroglycerin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nitroglycerin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin injection.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving nitroglycerin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using nitroglycerin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Sildenafil Tadalafil Vardenafil

Using nitroglycerin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alteplase, Recombinant Heparin

Using nitroglycerin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetylcysteine Aspirin Dihydroergotamine Pancuronium Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of nitroglycerin. Make sure you tell your doctor if you have any other medical problems, especially:

Constrictive pericarditis (a heart disease) or Pericardial tamponade (a heart disease) or Restrictive cardiomyopathy (a heart disease)—Should not be used in patients with these conditions. Hypertrophic cardiomyopathy (a heart disease) or Hypotension (low blood pressure) or Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse. Proper Use of nitroglycerin

A nurse or other trained health professional will give you nitroglycerin in a hospital. nitroglycerin is given through a needle placed in one of your veins.

Precautions While Using nitroglycerin

It is very important that your doctor check your progress closely while you are receiving nitroglycerin to make sure it is working properly.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using nitroglycerin. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

nitroglycerin may cause headaches. These headaches are a sign that the medicine is working. If you have severe pain, talk with your doctor.

nitroglycerin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare Bluish-colored lips, fingernails, or palms dark urine difficulty with breathing dizziness or lightheadedness fever headache pale skin rapid heart rate shortness of breath sore throat unusual bleeding or bruising unusual tiredness or weakness Incidence not known Arm, back, or jaw pain blurred vision chest pain or discomfort chest tightness or heaviness confusion dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly fainting fast or irregular heartbeat sweating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Blurred or loss of vision bulging soft spot on the head of an infant change in consciousness change in the ability to see colors, especially blue or yellow cold, clammy skin convulsions disturbed color perception double vision feeling of constant movement of self or surroundings flushed skin halos around lights headache, severe and throbbing increased sweating loss of appetite loss of consciousness nausea or vomiting night blindness overbright appearance of lights paralysis sensation of spinning slow or irregular heartbeat tunnel vision wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: nitroglycerin Intravenous side effects (in more detail)

More nitroglycerin Intravenous resources Nitroglycerin Intravenous Side Effects (in more detail) Nitroglycerin Intravenous Use in Pregnancy & Breastfeeding Drug Images Nitroglycerin Intravenous Drug Interactions Nitroglycerin Intravenous Support Group 6 Reviews for Nitroglycerin Intravenous - Add your own review/rating Compare nitroglycerin Intravenous with other medications Anal Fissure and Fistula Angina Angina Pectoris Prophylaxis Heart Attack Heart Failure High Blood Pressure Raynaud's Syndrome

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