RX Pharmacy Drugs List - page 24
 

Navigation
 

Popular pages

We Have Found
 

cerivastatin

Generic Name: cerivastatin (seh RIH va stah tin) Brand Names: Baycol

What is cerivastatin?

Cerivastatin was withdrawn from the U.S. market in 2001.

Cerivastatin blocks the production of cholesterol (a type of fat) in the body.

Cerivastatin is used to reduce the amounts of LDL (bad) cholesterol and total cholesterol in your blood. Cerivastatin also reduces the amounts of triglycerides (another type of fat) and apolipoprotein B (a protein needed to make cholesterol) in your blood and increases the amount of HDL (good) cholesterol in your blood. These actions are important in reducing the risk of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease.

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

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

Cerivastatin was withdrawn from the U.S. market in 2001.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by a fever or flu-like symptoms or yellowing of your skin or eyes. Do not take cerivastatin without first talking to your doctor if you have liver disease. Alcohol and cerivastatin can both damage your liver. Discuss with your doctor the amount of alcohol that you drink so that it can be determined if cerivastatin is the best choice for lowering your cholesterol. Do not take cerivastatin if you are pregnant, if you are planning a pregnancy, or if you are breast-feeding a baby. Who should not take cerivastatin? Do not take cerivastatin without first talking to your doctor if you have liver disease.

Before taking cerivastatin, tell your doctor if you

drink alcoholic beverages,

have kidney disease,

have a chronic muscular disease, or

have seizures or epilepsy.

You may not be able to take cerivastatin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Cerivastatin is in the FDA pregnancy category X. This means that cerivastatin will cause birth defects if it is taken during pregnancy. Cholesterol is very important for the proper development of a baby. Do not take cerivastatin if you are pregnant or are planning a pregnancy. Cerivastatin passes into breast milk and can harm a nursing infant. Do not take cerivastatin if you are breast-feeding a baby. How should I take cerivastatin?

Take cerivastatin exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Eat a low-fat, low-cholesterol diet. To see beneficial effects from cerivastatin, avoid fatty, high-cholesterol foods. Follow your doctor's directions.

Your doctor may want to monitor your liver function with blood tests before starting treatment with cerivastatin, at six and twelve weeks after both the start of your treatment and any increase in dose, and periodically (every 6 months) thereafter. Depending on the results of these tests, your doctor can determine how much monitoring you will require.

Grapefruit and grapefruit juice may interact with cerivastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Do not stop taking cerivastatin without first talking to your doctor. It may be weeks or months before beneficial effects from this medication are seen.

Store cerivastatin at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of cerivastatin.

What happens if I overdose? Seek emergency medical attention.

Symptoms of an overdose of cerivastatin are not known.

What should I avoid while taking cerivastatin? Alcohol and cerivastatin can both damage your liver. Discuss with your doctor the amount of alcohol that you drink so that it can be determined if cerivastatin is the best choice for lowering your cholesterol.

Grapefruit and grapefruit juice may interact with cerivastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Cerivastatin side effects If you experience any of the following serious side effects, stop taking cerivastatin and call your doctor immediately:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

muscle aches, pain, or weakness;

a fever;

"flu-like" symptoms;

decreased urine or rust-colored urine;

blurred vision; or

yellowing of your skin or eyes.

Other, less serious side effects may be more likely to occur. Continue to take cerivastatin and talk to your doctor if you experience

gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, or diarrhea;

dizziness;

headache; or

a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect cerivastatin? Do not take cerivastatin without first talking to your doctor if you are taking any of the following medicines:

cyclosporine (Sandimmune, Neoral);

gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);

niacin (Nicolar, Nicobid, Slo-Niacin, others);

erythromycin (E-Mycin, E.E.S., Ery-Tab, others) or clarithromycin (Biaxin); or

itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral).

The medications listed above may interact with cerivastatin and damage your muscles. Generally, these medicines are not used together.

Drugs other than those listed here may also interact with cerivastatin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More cerivastatin resources Cerivastatin Side Effects (in more detail)Cerivastatin Use in Pregnancy & BreastfeedingCerivastatin Drug InteractionsCerivastatin Support Group0 Reviews for Cerivastatin - Add your own review/rating Baycol Consumer Overview Compare cerivastatin with other medications High CholesterolHyperlipoproteinemia Type IIa, Elevated LDL Where can I get more information? Your pharmacist has additional information about cerivastatin written for health professionals that you may read. What does my medication look like?

Cerivastatin was withdrawn from the U.S. market in 2001.

See also: cerivastatin side effects (in more detail)


Percolone

Generic Name: oxycodone (ox i KOE done) Brand Names: Dazidox, OxyCONTIN, Oxyfast, OxyIR, Percolone, Roxicodone, Roxicodone Intensol

What is Percolone (oxycodone)?

Oxycodone is a narcotic pain reliever similar to morphine.

Oxycodone is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain.

Oxycodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Percolone (oxycodone)? Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking oxycodone. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol. Never take oxycodone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop using oxycodone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using oxycodone. What should I discuss with my healthcare provider before using Percolone (oxycodone)? Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include methadone, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others), or to a narcotic cough medicine that contains codeine, hydrocodone, or dihydrocodeine.

You should also not take oxycodone if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Oxycodone may be habit forming and should be used only by the person it was prescribed for. Never share oxycodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

To make sure you can safely take oxycodone, tell your doctor if you have any of these other conditions:

asthma, COPD, sleep apnea, or other breathing disorders;

liver or kidney disease;

underactive thyroid;

trouble swallowing, or a blockage in your digestive tract (stomach or intestines);

curvature of the spine;

a history of head injury or brain tumor;

epilepsy or other seizure disorder;

low blood pressure;

gallbladder disease;

Addison's disease or other adrenal gland disorders;

enlarged prostate, urination problems;

mental illness; or

a history of drug or alcohol addiction.

FDA pregnancy category B. Oxycodone is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Oxycodone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using oxycodone. Older adults may be more likely to have side effects from this medicine. How should I use Percolone (oxycodone)?

Take exactly as prescribed. Never take oxycodone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. If your doctor has told you to take two or more oxycodone tablets per dose, take the tablets one at a time. Do not wet, presoak, or lick the tablet before placing it in your mouth. Drink plenty of water to make swallowing easier and to prevent choking.

Measure the liquid form of oxycodone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Drink plenty of water daily to help prevent constipation while you are using oxycodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using oxycodone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using oxycodone.

Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of oxycodone and similar prescription drugs.

Store at room temperature, away from heat, moisture, and light.

Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

After you have stopped using this medication, flush any unused pills down the toilet. Throw away any unused liquid oxycodone that is older than 90 days.

What happens if I miss a dose?

Since oxycodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Extended-release oxycodone is not for use on an as-needed basis for pain. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of oxycodone can be fatal.

Overdose symptoms may include extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate, fainting, or coma.

What should I avoid while using Percolone (oxycodone)? Do not drink alcohol while you are taking this medication. Dangerous side effects or death can occur when alcohol is combined with oxycodone. Check your food and medicine labels to be sure these products do not contain alcohol. Oxycodone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Percolone (oxycodone) 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. Stop using oxycodone and call your doctor at once if you have a serious side effect such as:

shallow breathing, slow heartbeat;

seizure (convulsions);

cold, clammy skin;

confusion;

severe weakness or dizziness; or

feeling like you might pass out.

Less serious side effects are more likely to occur, such as:

nausea, vomiting, constipation, loss of appetite;

dizziness, headache, tired feeling;

dry mouth;

sweating; or

itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Percolone (oxycodone)? Before using oxycodone, tell your doctor if you regularly use other medicines that make you sleepy or slow your breathing (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

pentazocine (Talwin);

nalbuphine (Nubain);

butorphanol (Stadol); or

buprenorphine (Buprenex, Subutex).

This list is not complete and other drugs may interact with oxycodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Percolone resources Percolone Side Effects (in more detail)Percolone Use in Pregnancy & BreastfeedingDrug ImagesPercolone Drug InteractionsPercolone Support Group0 Reviews for Percolone - Add your own review/rating Dazidox Advanced Consumer (Micromedex) - Includes Dosage Information OxyContin Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) OxyContin Prescribing Information (FDA) Oxycodone Monograph (AHFS DI) Oxycodone MedFacts Consumer Leaflet (Wolters Kluwer) Oxycodone Prescribing Information (FDA) Oxycontin Consumer Overview Oxyfast Concentrate MedFacts Consumer Leaflet (Wolters Kluwer) Roxicodone Prescribing Information (FDA) Compare Percolone with other medications Pain Where can I get more information? Your pharmacist can provide more information about oxycodone.

See also: Percolone side effects (in more detail)


Isonid

Isonid may be available in the countries listed below.

Ingredient matches for Isonid Isoniazid

Isoniazid is reported as an ingredient of Isonid in the following countries:

Bulgaria

International Drug Name Search


Plan B Oral, Parenteral, Vaginal

Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium

In Canada

Alti-Mpa Megace Os

Available Dosage Forms:

Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Uses For Plan B

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate Corpus luteum insufficiency Hot flashes Polycystic ovary syndrome Precocious puberty Before Using Plan B Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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 progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

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

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Boceprevir Dofetilide

Using medicines in this class 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.

Felbamate Isotretinoin Theophylline Tizanidine Tranexamic Acid 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia)—May make this condition worse. Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin

This section provides information on the proper use of a number of products that contain progestin. It may not be specific to Plan B. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class 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 these medicines. 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 medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers—400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults—400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. Missed Dose

If you miss a dose of this medicine, 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.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose 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.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Plan B

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. 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.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Plan B Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath

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

More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk RareFor megestrol—During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or weakness

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 Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing)

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


Synvisc Hylan G-F Injection

Generic Name: hylan polymers a and b (Injection route)

HYE-lan POL-a-mers A and B

Commonly used brand name(s)

In the U.S.

Synvisc Synvisc Hylan G-F Synvisc One

Available Dosage Forms:

Injectable Solution

Therapeutic Class: Cartilaginous Defect Repair Agent

Uses For Synvisc Hylan G-F

Hylan polymers A and B injection is used to treat knee pain caused by osteoarthritis (OA) in patients who have already been treated with pain relievers (e.g., acetaminophen) and other non-drug treatments that did not work well.

Hylan polymers A and B is similar to a substance that occurs naturally in the joints. It works by acting like a lubricant and shock absorber in the joints and helps the joints to work properly.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Synvisc Hylan G-F

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 hylan polymers A and B injection in children up to 21 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of hylan polymers A and B injection in geriatric patients.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

Allergy to bird products such as poultry, feathers, or eggs or Lymphatic or venous stasis (severe swelling or blood clots) in the legs—Use with caution. May make these conditions worse. Allergy to products containing hyaluronan or sodium hyaluronate or Skin or knee joint infections or other problems at the place where the injection is to be given—Should not be given in patients with these conditions. Joint effusion (too much fluid in the knees)—Patients with this condition should be treated first before receiving this medicine. Proper Use of hylan polymers a and b

This section provides information on the proper use of a number of products that contain hylan polymers a and b. It may not be specific to Synvisc Hylan G-F. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into your knee joint. It may take more than one injection for the pain to go away.

Synvisc® is given as a 3-injection regimen. It is usually given once a week and repeated after a week for a total of three injections.

Synvisc-One® is given as a single injection only.

This medicine usually comes with patient information insert. Read the information carefully and make sure you understand it efore receiving this medicine. If you have any questions, ask your doctor.

Precautions While Using Synvisc Hylan G-F

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Temporary pain or swelling in the knee joint may occur after receiving the injection. Call your doctor if the pain or swelling in the knee persists or becomes worse after receiving this medicine.

Do not strain your knee joint for two days after receiving this medicine. Avoid activities such as jogging, soccer, tennis, heavy lifting, or standing on your feet for a long time.

Do not use this medicine with disinfectants containing quaternary ammonium salts (e.g., benzalkonium chloride). This may prevent hylan polymers A and B injection from working properly.

Synvisc Hylan G-F 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 Difficulty with moving fluid build up around the knee muscle pain or stiffness pain and stiffness in the joints Less common Bleeding after defecation bluish color changes in skin color fainting fast, pounding, or irregular heartbeat or pulse pain or aching in the lower legs swelling of the ankles, feet, or legs tenderness uncomfortable swelling around the anus warmth or swelling of the joints Rare Redness in the joints trouble with walking Incidence not known Black, tarry stools bleeding gums bloating or swelling of the face, arms, hands, lower legs, or feet blood in the urine or stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chills difficulty with breathing feeling of warmth general feeling of discomfort or illness muscle cramps pinpoint red spots on the skin rapid weight gain redness of the face, neck, arms, and occasionally, upper chest shortness of breath tingling of the hands or feet unusual bleeding or bruising unusual tiredness or weakness unusual weight gain or loss

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:

Less common Itching of the skin rash sprain in the lower back Rare Pain at the injection site Incidence not known Dizziness headache nausea raised red swellings on the skin, lips, tongue, or in the throat

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


Helixate FS injection

Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor) Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

a history of allergy to antihemophilic factor; or

a history of allergy to products made with human or animal proteins, especially mouse proteins.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature. What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

fast heart rate, chest pain, trouble breathing;

feeling light-headed, fainting; or

pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

unusual taste in your mouth;

cough, runny or stuffy nose;

mild itching;

swelling in your hands, ankles, or feet;

headache or dizziness;

mild nausea, diarrhea, stomach pain;

sweating;

joint pain; or

chills or flushing (warmth or tingly feeling).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information? Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read. What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


Ion-K

Ion-K may be available in the countries listed below.

Ingredient matches for Ion-K Potassium Gluconate

Potassium Gluconate is reported as an ingredient of Ion-K in the following countries:

Colombia

International Drug Name Search


Simply Sleep
Pronunciation: DYE-fen-HYE-dra-meenGeneric Name: DiphenhydramineBrand Name: Examples include Nytol and Simply Sleep


Coly-Mycin S Otic
Generic Name: Colistin/Hydrocortisone/Neomycin (koe-LIS-tin/hye-droe-KOR-ti-sone/nee-oh-MYE-sin)Brand Name: Coly-Mycin S Otic Coly-Mycin S Otic is used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Coly-Mycin S Otic is a combination of 2 antibiotics and a corticosteroid. The antibiotics work by killing sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Coly-Mycin S Otic if: you are allergic to any ingredient in Coly-Mycin S Otic, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone) you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles) you have a perforated ear drum

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

Before using Coly-Mycin S Otic:

Some medical conditions may interact with Coly-Mycin S Otic. 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 the blood disease porphyria

Some MEDICINES MAY INTERACT with Coly-Mycin S Otic. Because little, if any, of Coly-Mycin S Otic is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Coly-Mycin S Otic 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 Coly-Mycin S Otic:

Use Coly-Mycin S Otic as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Coly-Mycin S Otic is only for the ear. Do not it in your eyes, nose, or mouth. If you get Coly-Mycin S Otic in your eyes, rinse immediately with cool tap water. Wash your hands before and after using Coly-Mycin S Otic. Wash and dry the outer ear with a sterile cotton applicator. Shake well before each use. Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. Do not heat Coly-Mycin S Otic by any other method because it could decrease its effectiveness. Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from contaminating your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed. To clear up your infection completely, use Coly-Mycin S Otic for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Coly-Mycin S Otic, 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 Coly-Mycin S Otic.

Important safety information: Coly-Mycin S Otic only works against bacteria; it does not treat viral infections (eg, the common cold). Be sure to use Coly-Mycin S Otic for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Coly-Mycin S Otic may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Do NOT take more than the recommended dose or use for longer than 10 days without checking with your doctor. Do not use Coly-Mycin S Otic for other ear conditions at a later time. Tell your doctor or dentist that you take Coly-Mycin S Otic before you receive any medical or dental care, emergency care, or surgery. PREGNANCY and BREAST-FEEDING: It is not known if Coly-Mycin S Otic can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Coly-Mycin S Otic while you are pregnant. It is not known if Coly-Mycin S Otic is found in breast milk. If you are or will be breast-feeding while you are using Coly-Mycin S Otic, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Coly-Mycin S Otic:

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:

Mild, temporary burning or stinging.

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); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; pain, redness, itching, irritation, or swelling not present when you began using Coly-Mycin S Otic; thinning, softening, or discoloration of the skin.

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: Coly-Mycin S Otic 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 Coly-Mycin S Otic:

Store Coly-Mycin S Otic between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Coly-Mycin S Otic out of the reach of children and away from pets.

General information: If you have any questions about Coly-Mycin S Otic, please talk with your doctor, pharmacist, or other health care provider. Coly-Mycin S Otic 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.

This information is a summary only. It does not contain all information about Coly-Mycin S Otic. 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.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Coly-Mycin S Otic resources Coly-Mycin S Otic Side Effects (in more detail)Coly-Mycin S Otic Use in Pregnancy & BreastfeedingColy-Mycin S Otic Drug InteractionsColy-Mycin S Otic Support Group0 Reviews for Coly-Mycin S Otic - Add your own review/rating Compare Coly-Mycin S Otic with other medications Acute Otitis ExternaChronic Otitis MediaOtitis ExternaOtitis Media


Gygel Contraceptive Jelly
1. Name Of The Medicinal Product

GYGEL Contraceptive Jelly

2. Qualitative And Quantitative Composition

The gel contains 2.0% w/w of nonoxinol-9.

3. Pharmaceutical Form

Vaginal gel.

4. Clinical Particulars 4.1 Therapeutic Indications

For use as a spermicidal contraceptive in conjunction with barrier methods of contraception.

4.2 Posology And Method Of Administration

Method of Administration

For vaginal use.

For use by adult females only.

Posology

The gel should be spread over the surface of the diaphragm which will be in contact with the cervix, and on the rim. The diaphragm and spermicide must be allowed to remain undisturbed for at least six to eight hours after coitus. A fresh application of gel or other spermicides, must be made prior to any subsequent acts of coitus within this period of time, without removing the diaphragm. (A vaginal applicator should be used for inserting more jelly.)

Douching is not recommended, but if desired it should be deferred for at least six hours after intercourse.

4.3 Contraindications

Hypersensitivity to nonoxinol-9 or to any component of the preparation.

Patients with absent vaginal sensation e.g. paraplegics and quadriplegics.

4.4 Special Warnings And Precautions For Use

Spermicidal intravaginal preparations are intended for use in conjunction with barrier methods of contraception such as condoms, diaphragms and caps.

Where avoidance of pregnancy is important, the choice of contraceptive method should be made in consultation with a doctor or a family planning clinic.

This product does not protect against HIV (AIDS) or other sexually transmitted diseases (STDs). A latex condom should be used to protect against the spread of STDs. High frequency use of nonoxinol-9 has been reported to cause epithelial damage and increase the risk of HIV infection. Therefore women at risk of HIV/STD infection and who have multiple daily acts of intercourse should be advised to choose another method of contraception. Sexually active women should consider their individual HIV/STD infection risk when choosing a method of contraception.

If vaginal or penile irritation occurs, discontinue use. If symptoms worsen or continue for more than 48 hours, medical advice should be sought.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no evidence from animal and human studies that nonoxinol-9 is teratogenic. Human epidemiological studies have not shown any firm evidence of adverse effects on the foetus, however some studies have shown that nonoxinol-9 may be embryotoxic in animals. This product should not be used if pregnancy is suspected or confirmed. Animal studies have detected nonoxinol-9 in milk after intravaginal administration. Use by lactating women has not been studied.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Nonoxinol-9 has been reported to cause epithelial damage and increase the risk of HIV infection.

It may cause hypersensitivity and application site reactions such as irritation, pain, discomfort, burning sensation, itching, dryness, rash and redness of the vulva, vagina or penis.

4.9 Overdose

If taken orally, the surfactant properties of this preparation may cause gastric irritation. General supportive therapy should be carried out. Hepatic and renal function should be monitored if medically indicated.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The standard in vitro test (Sander-Cramer) evaluating the effect of nonoxinol-9 on animal sperm motility has shown the compound to be a potent spermicide.

The site of action of nonoxinol-9 has been determined as the sperm cell membrane. The lipoprotein membrane is disrupted, increasing permeability, with subsequent loss of cell components and decreased motility. A similar effect on vaginal epithelial and bacterial cells is also found.

5.2 Pharmacokinetic Properties

The intravaginal absorption and excretion of radiolabelled (14C) nonoxinol-9 has been studied in non-pregnant rats and rabbits and in pregnant rats. No appreciable difference was found in the extent or rate of absorption in pregnant and non-pregnant animals. Plasma levels peaked at about one hour and recovery from urine as unchanged nonoxinol-9 accounted for approximately 15-25% and faeces approximately 70% of the administered dose as unchanged nonoxinol-9. Less than 0.3% was found in the milk of lactating rats. No metabolites were detected in any of the samples analysed.

5.3 Preclinical Safety Data

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Methyl parahydroxybenzoate (E 218)

Sorbitol solution (E 420)

Lactic acid

Povidone K30

Propylene glycol

Sodium carboxymethylcellulose

Sorbic acid (E 200)

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Do not store above 25?C.

6.5 Nature And Contents Of Container

Epoxy resin lined aluminium tubes with polyethylene caps. Available in 30 and 81 gram packs; an applicator is available separately if required.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data 7. Marketing Authorisation Holder

Marlborough Pharmaceuticals Ltd

35A High Street

Marlborough

Wilts

SN8 1LW

UK

8. Marketing Authorisation Number(S)

PL 23138/0010

9. Date Of First Authorisation/Renewal Of The Authorisation

12 September 1995/17 July 1996

10. Date Of Revision Of The Text

9th September 2009

11 LEGAL CATEGORY

GSL


Nor-QD
Pronunciation: nor-eth-IN-droneGeneric Name: NorethindroneBrand Name: Examples include Nor-QD and Ortho Micronor


tetanus immune globulin Intramuscular

TET-a-nus i-MUNE GLOB-ue-lin

Commonly used brand name(s)

In the U.S.

Baytet HyperTET S/D

Available Dosage Forms:

Solution

Therapeutic Class: Immune Serum

Uses For tetanus immune globulin

Tetanus immune globulin is used to prevent tetanus infection (also known as lockjaw). Tetanus is a serious illness that causes convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30 to 40 percent of cases.

In recent years, two thirds of all tetanus cases have been in persons 50 years of age and older. A tetanus infection in the past does not make you immune to tetanus in the future.

Tetanus immune globulin works by giving your body the antibodies it needs to protect it against tetanus infection. This is called passive protection. This passive protection lasts long enough to protect your body until your body can produce its own antibodies against tetanus.

Tetanus immune globulin is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using tetanus immune globulin

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 tetanus immune globulin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tetanus immune globulin 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 tetanus immune globulin in children with use in other age groups, tetanus immune globulin 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 tetanus immune globulin in the elderly with use in other age groups. However, there is no evidence that the effects of tetanus immune globulin in older adults differ from those in younger persons.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 tetanus immune globulin. Make sure you tell your doctor if you have any other medical problems.

Proper Use of tetanus immune globulin Dosing

The dose of tetanus immune globulin 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 tetanus immune globulin. 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 injection dosage form: For preventing tetanus infection: Adults and children—250 units injected into a muscle. tetanus immune globulin 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:

Rare Difficulty in breathing or swallowing hives itching, especially of soles or palms reddening of skin, especially around ears swelling of eyes, face, or inside of nose unusual tiredness or weakness, sudden and severe

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: tetanus immune globulin Intramuscular side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More tetanus immune globulin Intramuscular resources Tetanus immune globulin Intramuscular Side Effects (in more detail)Tetanus immune globulin Intramuscular Use in Pregnancy & BreastfeedingTetanus immune globulin Intramuscular Drug InteractionsTetanus immune globulin Intramuscular Support Group0 Reviews for Tetanus immune globulin Intramuscular - Add your own review/rating Compare tetanus immune globulin Intramuscular with other medications TetanusTetanus Prophylaxis


Torsemide Solution
Pronunciation: TORE-se-mideGeneric Name: TorsemideBrand Name: Generic only. No brands available.


E-Z-Cat oral and rectal

Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate) Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen

What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

Barium sulfate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about barium sulfate? You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation What should I discuss with my health care provider before using barium sulfate? You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:

asthma, eczema, or allergies;

a blockage in your stomach or intestines;

cystic fibrosis;

a colostomy;

rectal cancer;

heart disease or high blood pressure;

Hirschsprung's disease (a disorder of the intestines);

a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);

a recent history of surgery on your esophagus, stomach, or intestines;

a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;

if you have recently had a rectal biopsy;

if you have ever choked on food by accidentally inhaling it into your lungs;

if you are allergic to simethicone (Gas-X, Phazyme, and others); or

if you are allergic to latex rubber.

It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby. How should I use barium sulfate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use. What happens if I miss a dose?

If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.

What should I avoid before or after using barium sulfate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Barium sulfate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

severe stomach pain;

severe cramping, diarrhea, or constipation;

sweating;

ringing in your ears;

confusion, fast heart rate; or

pale skin, weakness.

Less serious side effects may include:

mild stomach cramps;

nausea, vomiting;

loose stools or mild constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect barium sulfate?

There may be other drugs that can interact with barium sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More E-Z-Cat resources E-Z-Cat Side Effects (in more detail)E-Z-Cat Use in Pregnancy & BreastfeedingE-Z-Cat Support Group0 Reviews for E-Z-Cat - Add your own review/rating Compare E-Z-Cat with other medications Computed Tomography Where can I get more information? Your doctor or pharmacist can provide more information about barium sulfate.

See also: E-Z-Cat side effects (in more detail)


Exparel
Dosage Form: injection, suspension, liposomalFULL PRESCRIBING INFORMATION 1. INDICATIONS AND USAGE

Exparel is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia.

Exparel has not been studied for use in patients younger than 18 years of age.

2. DOSAGE AND ADMINISTRATION

Exparel is intended for single-dose administration only. The recommended dose of Exparel is based on the surgical site and the volume required to cover the area.

1Infiltrate 7 mL of Exparel into the tissues surrounding the osteotomy and 1 mL into the subcutaneous tissue. 2Dilute 20 mL of Exparel with 10 mL of saline, for a total of 30 mL, and divide the mixture into six 5 mL aliquots. Perform the anal block by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers. Surgery Dose of Exparel Volume of Exparel Bunionectomy1 106 mg 8 mL Hemorrhoidectomy2 266 mg 20 mL Injection Instructions

Exparel should be injected slowly into soft tissues of the surgical site with frequent aspiration to check for blood and minimize the risk of intravascular injection.

Exparel is intended for single-dose infiltration only. Exparel should be administered with a 25 gauge or larger bore needle. The maximum dosage of Exparel should not exceed 266 mg (20 mL, 1.3% of undiluted drug). Do not administer Exparel if the product is discolored. Do not administer Exparel if it is suspected that the vial has been frozen as reflected by the temperature indicator or exposed to high temperature (greater than 40°C or 104°F) for an extended period. Exparel can be administered undiluted or diluted up to 0.89 mg/mL (i.e. 1:14 dilution by volume) with preservative-free normal (0.9%) sterile saline for injection. Vials of Exparel should be inverted multiple times to re-suspend the particles immediately prior to withdrawal from the vial. Diluted suspensions of Exparel should be used within 4 hours of preparation in a syringe. Administration Precautions

Some physicochemical incompatibilities exist between Exparel and certain other drugs. Direct contact of Exparel with these drugs results in a rapid increase in free (unencapsulated) bupivacaine, altering Exparel characteristics and potentially affecting the safety and efficacy of Exparel. Therefore, admixing Exparel with other drugs prior to administration is not recommended [See Drug Interactions (7)].

Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from Exparel if administered together locally. The administration of Exparel may follow the administration of lidocaine after a delay of 20 minutes or more. Bupivacaine HCl, when injected immediately before Exparel, may impact the pharmacokinetic and/or physicochemical properties of the drugs when the milligram dose of bupivacaine HCl solution exceeds 50% of the Exparel dose. Exparel contains bupivacaine; therefore, coadministration of both drugs will increase the overall exposure to bupivacaine. When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before Exparel is administered into the surgical site. Exparel should not be allowed to come into contact with antiseptics such as povidone iodine in solution.

Studies conducted with Exparel demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of Exparel any more than they are by saline. None of the materials studied had an adverse effect on Exparel.

When administered in recommended doses and concentrations, bupivacaine HCl does not ordinarily produce irritation or tissue damage and does not cause methemoglobinemia.

Non-Interchangeability with Other Formulations of Bupivacaine

Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to Exparel and vice versa.

Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug's functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.

Dosing in Special Populations

Exparel has not been studied in patients younger than 18 years of age, pregnant patients or patients who are nursing.

3. DOSAGE FORMS AND STRENGTHS

Exparel (bupivacaine liposome injectable suspension)

10 mL single use vial, 1.3% (13.3 mg/mL) 20 mL single use vial, 1.3% (13.3 mg/mL) 4. CONTRAINDICATIONS

Exparel is contraindicated in obstetrical paracervical block anesthesia. While Exparel has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death.

5. WARNINGS AND PRECAUTIONS Warnings and Precautions for Bupivacaine containing Products

The safety and effectiveness of bupivacaine and other amide-containing products depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, any bupivacaine-containing product should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [See Overdosage (10)].

Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after injection of bupivacaine and other amide-containing products. Restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity.

Bupivacaine and other amide-containing products should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of AV conduction produced by these drugs.

Injection of multiple doses of bupivacaine and other amide-containing products may cause significant increases in plasma concentrations with each repeated dose due to slow accumulation of the drug or its metabolites, or to slow metabolic degradation. Tolerance to elevated blood concentrations varies with the status of the patient.

Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, these drugs should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.

Central Nervous System Reactions

The incidences of adverse neurologic reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Many of these effects may be related to local anesthetic techniques, with or without a contribution from the drug. Neurologic effects following infiltration of soft tissue may include persistent anesthesia, paresthesias, weakness, and paralysis, all of which may have slow, incomplete, or no recovery.

Central nervous system reactions are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. Other central nervous system effects may be nausea, vomiting, chills, and constriction of the pupils. The incidence of convulsions associated with the use of local anesthetics varies with the procedure used and the total dose administered.

Cardiovascular System Reactions

Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure [See Warnings and Precautions (5.1) and Overdosage (10)].

Allergic Reactions

Allergic-type reactions are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly anaphylactoid-like symptoms (including severe hypotension). Cross-sensitivity among members of the amide-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitively established.

Chondrolysis

Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been postmarketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humerol chondrolysis have been described in pediatric patients and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness, and loss of motion can be variable, but may begin as early as the second month after surgery. Currently, there is no effective treatment for chondrolysis; patients who have experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.

Warnings and Precautions Specific for Exparel

As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, Exparel should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity [See Overdosage (10)].

Caution should be taken to avoid accidental intravascular injection of Exparel. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amide-containing products.

Using Exparel followed by other bupivacaine formulations has not been studied in clinical trials. Other formulations of bupivacaine should not be administered within 96 hours following administration of Exparel [See Clinical Pharmacology (12.3)].

Exparel has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration.

epidural intrathecal regional nerve blocks intravascular or intra-articular use

Exparel has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups.

patients younger than 18 years old pregnant patients nursing patients

The ability of Exparel to achieve effective anesthesia has not been studied. Therefore, Exparel is not indicated for pre-incisional or pre-procedural loco-regional anesthetic techniques that require deep and complete sensory block in the area of administration.

6. ADVERSE REACTIONS General

The most commonly encountered acute adverse experiences to bupivacaine and all amide-type local anesthetics that demand immediate counter-measures are related to the central nervous and cardiovascular systems.

High plasma concentrations of bupivacaine can occur from overdosage, unintended intravascular injection, or accumulation of bupivacaine in plasma secondary to decreased hepatic metabolic degradation of the drug or diminished plasma protein binding capacity due to acidosis, pathologically lowered plasma protein production, or competition with other drugs for protein binding sites. Although rare, some individuals have a lower tolerance to and are supersensitive to bupivacaine and other amide-type local anesthetics and may rapidly develop signs of toxicity at low doses [See Overdosage (10)].

Adverse Reactions Reported in All Wound Infiltration Clinical Studies

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The safety of Exparel was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of Exparel. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following Exparel administration were nausea, constipation, and vomiting.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following Exparel administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.

The less common/rare adverse reactions (incidence less than 2%) following Exparel administration were chills, erythema, bradycardia, anxiety, urinary retention, pain, edema, tremor, dizziness postural, paresthesia, syncope, incision site edema, procedural hypertension, procedural hypotension, procedural nausea, muscular weakness, neck pain, pruritus generalized, rash pruritic, hyperhidrosis, cold sweat, urticaria, bradycardia, palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, ventricular tachycardia, hypertension, pallor, anxiety, confusional state, depression, agitation, restlessness, hypoxia, laryngospasm, apnea, respiratory depression, respiratory failure, body temperature increased, blood pressure increased, blood pressure decreased, oxygen saturation decreased, urinary retention, urinary incontinence, vision blurred, tinnitus, drug hypersensitivity, and hypersensitivity.

Neurological and Cardiac Adverse Reactions Reported in All Wound Infiltration Clinical Studies

In the Exparel wound infiltration studies, adverse reactions with an incidence greater than or equal to 1% in the Nervous System Disorders system organ class following Exparel administration were dizziness (6.2%), headache (3.8%), somnolence (2.1%), hypoesthesia (1.5%), and lethargy (1.3%). The adverse reactions with an incidence greater than or equal to 1% in the Cardiac Disorders system organ class following Exparel administration were tachycardia (3.9%) and bradycardia (1.6%).

Adverse Reactions Reported in Placebo-Controlled Wound Infiltration Clinical Studies

Adverse reactions with an incidence greater than or equal to 2% reported by patients in clinical studies comparing 8 mL Exparel 1.3% (106 mg) to placebo and 20 mL Exparel 1.3% (266 mg) to placebo are shown in Table 1.

Table 1: Treatment-Emergent Adverse Reactions (TEAE) with an Incidence Greater than or Equal to 2%: Placebo Controlled Studies a Study 1: Bunionectomy b Study 2: Hemorrhoidectomy At each level of summation (overall, system organ class, preferred term), patients are only counted once.


Terra-Cortril
Dosage Form: Ophthalmic Suspension Terra-Cortril Description

Terra-Cortril suspension combines the antibiotic, oxytetracycline HCl (C22H24N2O9•HCl) and the adrenocorticoid, hydrocortisone acetate (C23H32O6). Each ml of Terra-Cortril contains Terramycin (oxytetracycline HCl) equivalent to 5 mg of oxytetracycline, and 15 mg of Cortril (hydrocortisone acetate) incorporated in mineral oil with aluminum tristearate.

For Ophthalmic Use Only.

Terra-Cortril - Clinical Pharmacology

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

The anti-infective component in the combination is included to provide action against specific organisms susceptible to it.

Terramycin is considered active against the following microorganisms:

Rickettsiae (Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers), Mycoplasma pneumoniae (PPLO, Eaton Agent), Agents of psittacosis and ornithosis, Agents of lymphogranuloma venereum and granuloma inguinale, The spirochetal agent of relapsing fever (Borrelia recurrentis).

The following gram-negative microorganisms:

Haemophilus ducreyi (chancroid), Pasteurella pestis and Pasteurella tularensis, Bartonella bacilliformis, Bacteroides species, Vibrio comma and Vibrio fetus, Brucella species (in conjunction with streptomycin).

Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended.

Oxytetracycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

Escherichia coli, Enterobacter aerogenes (formerly Aerobacter aerogenes), Shigella species, Mima species and Herellea species, Haemophilus influenzae (respiratory infections), Klebsiella species (respiratory and urinary infections).

Oxytetracycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:

Streptococcus species:

Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive.

For upper respiratory infections due to Group A beta-hemolytic streptococci, pencillin is the usual drug of choice, including prophylaxis of rheumatic fever.

Diplococcus pneumoniae,

Staphylococcus aureus, skin and soft tissue infections. Oxytetracycline is not the drug of choice in the treatment of any type of staphylococcal infections.

When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of infections due to:

Neisseria gonorrhoeae, Treponema pallidum and Treponema pertenue (syphilis and yaws), Listeria monocytogenes, Clostridium species, Bacillus anthracis, Fusobacterium fusiforme (Vincent's infection), Actinomyces species.

Tetracyclines are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.

Inclusion conjunctivitis may be treated with oral tetracyclines or with a combination of oral and topical agents.

When a decision to administer both a corticoid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drug are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

Indications and Usage for Terra-Cortril

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation, thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

Staphylococcus aureus Streptococci, including Streptococcus pneumoniae Escherichia coli Neisseria species

The product does not provide adequate coverage against:

Haemophilus influenzae Klebsiella/Enterobacter species Pseudomonas aeruginosa Serratia marcescens Contraindications

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.

Warnings

Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Employment of steroid medication in the treatment of herpes simplex requires great caution.

Precautions

The initial prescription and renewal of the medication order beyond 20 milliliters should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.

Adverse Reactions

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection

The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

Terra-Cortril Dosage and Administration

Instill 1 or 2 drops of Terra-Cortril Ophthalmic Suspension into the affected eye three times daily.

Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in "Precautions" above.

How is Terra-Cortril Supplied

Terra-Cortril Ophthalmic Suspension (NDC 0049-0670-48) is supplied in 5 ml vials with separate sterile dropper.

LAB-0194-2.0


Milrinone Lactate in Dextrose Injection
Dosage Form: injectionMilrinone Lactate in 5% Dextrose Injection

in INTRAVIA Plastic Container

Milrinone Lactate in Dextrose Injection Description

Milrinone lactate is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4’-bipyridine]-5-carbonitrile lactate and has the following structure:

Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone is available as sterile aqueous solutions of the lactate salt of milrinone for infusion intravenously. The flexible containers provide two ready-to-use dilutions of milrinone in volumes of 100 mL and 200 mL of 5% Dextrose Injection. Each mL contains milrinone lactate equivalent to 200 mcg milrinone. The nominal concentration of lactic acid is 0.282 mg/mL. Each mL also contains 54.3 mg Dextrose Hydrous, USP. The pH is adjusted with lactic acid and/or sodium hydroxide pH 3.5 (3.2 - 4.0). The flexible container is manufactured from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The flexible container has a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution.

Milrinone Lactate in Dextrose Injection - Clinical Pharmacology

Milrinone is a positive inotrope and vasodilator, with little chronotropic activity different in structure and mode of action from either the digitalis glycosides or catecholamines. Milrinone, at relevant inotropic and vasorelaxant concentrations, is a selective inhibitor of peak III cAMP phosphodiesterase isozyme in cardiac and vascular muscle. This inhibitory action is consistent with cAMP mediated increases in intracellular ionized calcium and contractile force in cardiac muscle, as well as with cAMP dependent contractile protein phosphorylation and relaxation in vascular muscle. Additional experimental evidence also indicates that milrinone is not a beta-adrenergic agonist nor does it inhibit sodium-potassium adenosine triphosphatase activity as do the digitalis glycosides.

Clinical studies in patients with congestive heart failure have shown that milrinone produces dose-related and plasma drug concentration-related increases in the maximum rate of increase of left ventricular pressure. Studies in normal subjects have shown that milrinone produces increases in the slope of the left ventricular pressure-dimension relationship, indicating a direct inotropic effect of the drug. Milrinone also produces dose-related and plasma concentration-related increases in forearm blood flow in patients with congestive heart failure, indicating a direct arterial vasodilator activity of the drug.

Both the inotropic and vasodilatory effects have been observed over the therapeutic range of plasma milrinone concentrations of 100 ng/mL to 300 ng/mL.

In addition to increasing myocardial contractility, milrinone improves diastolic function as evidenced by improvements in left ventricular diastolic relaxation.

The acute administration of intravenous milrinone has also been evaluated in clinical trials in excess of 1600 patients, with chronic heart failure, heart failure associated with cardiac surgery, and heart failure associated with myocardial infarction. The total number of deaths, either on therapy or shortly thereafter (24 hours) was 15, less than 0.9%, few of which were thought to be drug-related.

PHARMACOKINETICS

Following intravenous injections of 12.5 mcg/kg to 125 mcg/kg to congestive heart failure patients, milrinone had a volume of distribution of 0.38 liters/kg, a mean terminal elimination half-life of 2.3 hours, and a clearance of 0.13 liters/kg/hr. Following intravenous infusions of 0.20 mcg/kg/min to 0.70 mcg/kg/min to congestive heart failure patients, the drug had a volume of distribution of about 0.45 liters/kg, a mean terminal elimination half-life of 2.4 hours, and a clearance of 0.14 liters/kg/hr. These pharmacokinetic parameters were not dose-dependent, and the area under the plasma concentration versus time curve following injections was significantly dose-dependent.

Milrinone has been shown (by equilibrium dialysis) to be approximately 70% bound to human plasma protein.

The primary route of excretion of milrinone in man is via the urine. The major urinary excretions of orally administered milrinone in man are milrinone (83%) and its O-glucuronide metabolite (12%). Elimination in normal subjects via the urine is rapid, with approximately 60% recovered within the first two hours following dosing and approximately 90% recovered within the first eight hours following dosing. The mean renal clearance of milrinone is approximately 0.3 liters/min, indicative of active secretion.

PHARMACODYNAMICS

In patients with heart failure due to depressed myocardial function, milrinone produced a prompt dose and plasma concentration related increase in cardiac output and decreases in pulmonary capillary wedge pressure and vascular resistance, which were accompanied by mild-to-moderate increases in heart rate. Additionally, there is no increased effect on myocardial oxygen consumption. In uncontrolled studies, hemodynamic improvement during intravenous therapy with milrinone was accompanied by clinical symptomatic improvement, but the ability of milrinone to relieve symptoms has not been evaluated in controlled clinical trials. The great majority of patients experience improvements in hemodynamic function within 5 to 15 minutes of initiation of therapy.

In studies in congestive heart failure patients, milrinone when administered as a loading injection followed by a maintenance infusion produced significant mean initial increases in cardiac index of 25 percent, 38 percent, and 42 percent at dose regimens of 37.5 mcg/kg/0.375 mcg/kg/min, 50 mcg/kg/0.50 mcg/kg/min, and 75 mcg/kg/ 0.75 mcg/kg/min, respectively. Over the same range of loading injections and maintenance infusions, pulmonary capillary wedge pressure significantly decreased by 20 percent, 23 percent, and 36 percent, respectively, while systemic vascular resistance significantly decreased by 17 percent, 21 percent, and 37 percent. Mean arterial pressure fell by up to 5 percent at the two lower dose regimens, but by 17 percent at the highest dose. Patients evaluated for 48 hours maintained improvements in hemodynamic function, with no evidence of diminished response (tachyphylaxis). A smaller number of patients have received infusions of milrinone for periods up to 72 hours without evidence of tachyphylaxis.

The duration of therapy should depend upon patient responsiveness.

Milrinone has a favorable inotropic effect in fully digitalized patients without causing signs of glycoside toxicity. Theoretically, in cases of atrial flutter/fibrillation, it is possible that milrinone may increase ventricular response rate because of its slight enhancement of AV node conduction. In these cases, digitalis should be considered prior to the institution of therapy with milrinone.

Improvement in left ventricular function in patients with ischemic heart disease has been observed. The improvement has occurred without inducing symptoms or electrocardiographic signs of myocardial ischemia.

The steady-state plasma milrinone concentrations after approximately 6 to 12 hours of unchanging maintenance infusion of 0.50 mcg/kg/min are approximately 200 ng/mL. Near maximum favorable effects of milrinone on cardiac output and pulmonary capillary wedge pressure are seen at plasma milrinone concentrations in the 150 ng/mL to 250 ng/mL range.

Indications and Usage for Milrinone Lactate in Dextrose Injection

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life-threatening ventricular arrythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.

Contraindications

Milrinone is contraindicated in patients who are hypersensitive to it.

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings

Whether given orally or by continuous or intermittent intravenous infusion, milrinone has not been shown to be safe or effective in the longer (greater than 48 hours) treatment of patients with heart failure. In a multicenter trial of 1088 patients with Class III and IV heart failure, long-term oral treatment with milrinone was associated with no improvement in symptoms and an increased risk of hospitalization and death. In this study, patients with Class IV symptoms appeared to be at particular risk of life-threatening cardiovascular reactions. There is no evidence that milrinone given by long-term continuous or intermittent infusion does not carry a similar risk.

The use of milrinone both intravenously and orally has been associated with increased frequency of ventricular arrhythmias, including nonsustained ventricular tachycardia. Long-term oral use has been associated with an increased risk of sudden death. Hence, patients receiving milrinone should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.

Precautions General

Milrinone should not be used in patients with severe obstructive aortic or pulmonic valvular disease in lieu of surgical relief of the obstruction. Like other inotropic agents, it may aggravate outflow tract obstruction in hypertrophic subaortic stenosis.

Supraventricular and ventricular arrhythmias have been observed in the high-risk population treated. In some patients, injections of milrinone and oral milrinone have been shown to increase ventricular ectopy, including nonsustained ventricular tachycardia. The potential for arrhythmia, present in congestive heart failure itself, may be increased by many drugs or combinations of drugs. Patients receiving milrinone should be closely monitored during infusion.

Milrinone produces a slight shortening of AV node conduction time, indicating a potential for an increased ventricular response rate in patients with atrial flutter/fibrillation which is not controlled with digitalis therapy.

During therapy with milrinone, blood pressure and heart rate should be monitored and the rate of infusion slowed or stopped in patients showing excessive decreases in blood pressure. If prior vigorous diuretic therapy is suspected to have caused significant decreases in cardiac filling pressure, milrinone should be cautiously administered with monitoring of blood pressure, heart rate, and clinical symptomatology.

There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. Cases of infusion site reaction have been reported with intravenous milrinone therapy (see ADVERSE REACTIONS). Consequently, careful monitoring of the infusion site should be maintained to avoid possible extravasation.

Use in Acute Myocardial Infarction

No clinical studies have been conducted in patients in the acute phase of post myocardial infarction. Until further clinical experience with this class of drugs is gained, milrinone is not recommended in these patients.

Laboratory Tests

Fluid and electrolytes: Fluid and electrolyte changes and renal function should be carefully monitored during therapy with milrinone. Improvement in cardiac output with resultant diuresis may necessitate a reduction in the dose of diuretic. Potassium loss due to excessive diuresis may predispose digitalized patients to arrhythmias. Therefore, hypokalemia should be corrected by potassium supplementation in advance of or during use of milrinone.

Drug Interactions

No untoward clinical manifestations have been observed in limited experience with patients in whom milrinone was used concurrently with the following drugs: digitalis glycosides; lidocaine, quinidine; hydralazine, prazosin; isosorbide dinitrate, nitroglycerin; chlorthalidone, furosemide, hydrochlorothiazide, spironolactone; captopril; heparin, warfarin, diazepam, insulin; and potassium supplements.

Chemical Interactions

There is an immediate chemical interaction which is evidenced by the formation of a precipitate when furosemide is injected into an intravenous line of an infusion of milrinone. Therefore, furosemide should not be administered in intravenous lines containing milrinone.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Twenty-four months of oral administration of milrinone to mice at doses up to 40 mg/kg/day (about 50 times the human oral therapeutic dose in a 50 kg patient) was unassociated with evidence of carcinogenic potential. Neither was there evidence of carcinogenic potential when milrinone was orally administered to rats at doses up to 5 mg/kg/day (about 6 times the human oral therapeutic dose) for twenty-four months or at 25 mg/kg/day (about 30 times the human oral therapeutic dose) for up to 18 months in males and 20 months in females. Whereas the Chinese Hamster Ovary Chromosome Aberration Assay was positive in the presence of a metabolic activation system, results from the Ames Test, the Mouse Lymphoma Assay, the Micronucleus Test, and the in vivo Rat Bone Marrow Metaphase Analysis indicated an absence of mutagenic potential. In reproductive performance studies in rats, milrinone had no effect on male or female fertility at oral doses up to 32 mg/kg/day.

Animal Toxicity

Oral and intravenous administration of toxic dosages of milrinone to rats and dogs resulted in myocardial degeneration/fibrosis and endocardial hemorrhage, principally affecting the left ventricular papillary muscles. Coronary vascular lesions characterized by periarterial edema and inflammation have been observed in dogs only. The myocardial/endocardial changes are similar to those produced by beta-adrenergic receptor agonists such as isoproterenol, while the vascular changes are similar to those produced by minoxidil and hydralazine. Doses within the recommended clinical dose range (up to 1.13 mg/kg/day) for congestive heart failure patients have not produced significant adverse effects in animals.

Pregnancy Category C

Oral administration of milrinone to pregnant rats and rabbits during organogenesis produced no evidence of teratogenicity at dose levels up to 40 mg/kg/day and 12 mg/kg/day, respectively. Milrinone did not appear to be teratogenic when administered intravenously to pregnant rats at doses up to 3 mg/kg/day (about 2.5 times the maximum recommended clinical intravenous dose) or pregnant rabbits at doses up to 12 mg/kg/day, although an increased resorption rate was apparent at both 8 mg/kg/day and 12 mg/kg/day (intravenous) in the latter species. There are no adequate and well-controlled studies in pregnant women. Milrinone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Caution should be exercised when milrinone is administered to nursing women, since it is not known whether it is excreted in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Use in Elderly Patients

There are no special dosage recommendations for the elderly patient. Ninety percent of all patients administered milrinone in clinical studies were within the age range of 45 to 70 years, with a mean age of 61 years. Patients in all age groups demonstrated clinically and statistically significant responses. No age-related effects on the incidence of adverse reactions have been observed. Controlled pharmacokinetic studies have not disclosed any age-related effects on the distribution and elimination of milrinone.

Adverse Reactions Cardiovascular Effects

In patients receiving milrinone in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (2 patients experienced more than one type of arrhythmia). Holter recordings demonstrated that in some patients injection of milrinone increased ventricular ectopy, including nonsustained ventricular tachycardia. Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g. hypokalemia), abnormal digoxin levels and catheter insertion. Milrinone was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving milrinone. The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.

Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%.

In the post-marketing experience, there have been rare cases of “torsades de pointes” reported.

CNS Effects

Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving milrinone.

Other Effects

Other adverse reactions reported, but not definitely related to the administration of milrinone include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.

Post-Marketing Adverse Event Reports

In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with Milrinone:

Isolated spontaneous reports of bronchospasm and anaphylactic shock.

Liver function test abnormalities and skin reactions such as rash.

Administration site conditions: Infusion site reaction.

Overdosage

Doses of milrinone may produce hypotension because of its vasodilator effect. If this occurs, administration of milrinone should be reduced or temporarily discontinued until the patient's condition stabilizes. No specific antidote is known, but general measures for circulatory support should be taken.

Milrinone Lactate in Dextrose Injection Dosage and Administration

Milrinone should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines:

Loading Dose

50 mcg/kg: Administer slowly over 10 minutes

Note: Milrinone (200 mcg/mL) in INTRAVIA Plastic Container is for intravenous infusion only.

Dosage recommendations using a 1 mg/mL concentration of milrinone are included for informational purposes only.

The table below shows the loading dose in milliliters (mL) of milrinone (1mg/mL) by patient body weight (kg).

Loading Dose (mL) Using 1 mg/mL Concentration Patient Body Weight (kg) kg 30 40 50 60 70 80 90 100 110 120 mL 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0

The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see appropriate package insert for diluents) may simplify the visualization of the injection rate.

Maintenance Dose   Infusion Rate Total Daily Dose


Watson Pharmaceuticals, Inc.
Address Watson Pharmaceuticals, Inc. , 311 Bonnie Circle Corona, California 92880 Contact DetailsPhone: (951) 493-5300


Tamiflu Suspension
Pronunciation: OH-sel-TAM-i-virGeneric Name: OseltamivirBrand Name: Tamiflu


palonosetron

Generic Name: palonosetron (PAL oh NOE se tron) Brand Names: Aloxi

What is palonosetron?

Palonosetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Palonosetron is used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy).

Palonosetron may be used for other purposes not listed in this medication guide.

What is the most important information I should know about palonosetron? You should not use this medication if you are allergic to palonosetron or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or ondansetron (Zofran).

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.

What should I discuss with my health care provider before taking palonosetron? You should not use this medication if you are allergic to palonosetron or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or ondansetron (Zofran). FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether palonosetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take palonosetron?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Palonosetron is usually taken 1 hour before chemotherapy. Follow your doctor's instructions.

Store palonosetron at room temperature away from moisture and heat.

See also: Palonosetron dosage (in more detail)

What happens if I miss a dose?

Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of palonosetron is not expected to produce life-threatening symptoms.

What should I avoid while taking palonosetron?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Palonosetron 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.

Less serious side effects may include:

headache;

constipation; or

tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Palonosetron Dosing Information

Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

Parenteral: 0.25 mg IV as a single dose 30 minutes before the start of chemotherapy.Oral: 0.5 mg orally administered approximately 1 hour prior to the start of chemotherapy.

Usual Adult Dose for Nausea/Vomiting -- Postoperative:

0.075 mg IV as a single dose immediately before induction of anesthesia.

Usual Pediatric Dose for Nausea/Vomiting -- Chemotherapy Induced:

The dosing information for children and adolescents for prevention of acute chemotherapy-induced nausea and vomiting is based on clinical trials:



← Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
24
25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 ... 248 Next →


Search


 

Popular Search

 

Partners

 

RX Pharmacy Drugs List - Buy Pills Online

Site Map | PageMap

Copyright © RX Pharmacy Drugs List. All rights reserved.