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|Oseltamivir

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OSELTAMIVIR (Systemic)

Some commonly used brand names are:

In the U.S.—

Tamiflu

In Canada—

Tamiflu

Description

Oseltamivir (Oh-sel-TAM-i-veer)belongs to the family of medicines called antivirals, which are used to treat infections caused by viruses. Oseltamivir is used in the treatment of the infection caused by the flu virus (influenza A and influenza B). Oseltamivir may reduce flu symptoms (weakness, headache, fever, cough, and sore throat) by 1 day. Oseltamivir is also used to prevent influenza infection if you have come into close contact with someone who has the flu.

If you receive the flu vaccine every year, continue to do so. Oseltamivir is not a substitute for your yearly flu shot.

Oseltamivir is available only with your doctor"s prescription in the following dosage form:

Oral
Capsules (U.S. and Canada)
Oral suspension (U.S.)

Before Using This Medicine

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 oseltamivir, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to oseltamivir. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Oseltamivir has not been studied in pregnant women. However, studies in animals have shown that oseltamivir causes problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether oseltamivir passes into human breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—This medicine has not been tested in children younger than 1 year of age.

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

Other 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 oseltamivir it is especially important that your doctor and pharmacist know if you are taking any of the following:

Probenecid (e.g., Benemid)—Co-administration may result in higher blood levels of the active metabolite of oseltamivir

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

Kidney disease or
Heart disease or
Illnesses caused by viruses other than influenza Type A or B or
Liver disease or
Lung disease or
Serious medical problems that may need admission to a hospital—Safety of this medicine for people with these conditions is not established.

Proper Use of This Medicine

Talk to your doctor about the possibility of getting a flu shot if you have not had one yet. Patient information about oseltamivir is available. Read this information carefully.

For patients taking oseltamivir for treatment of the flu: This medicine works best if taken within 2 days of having flu symptoms (weakness, headache, fever, cough, and sore throat). Oseltamivir capsules may be taken with meals or on an empty stomach. Taking oseltamivir with food may lessen the possibility of stomach upset. This medicine should be taken for 5 days. Continue taking this medicine for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking this medicine too soon, your symptoms may return.

For patients taking oseltamivir for prevention of the flu after exposure: The medicine should be taken within 2 days of being exposed to the flu. Oseltamivir capsules may be taken with meals or on an empty stomach. Taking oseltamivir with food may lessen the possibility of stomach upset. This medicine should be taken for at least 10 days.

For patients taking the oral suspension form of this medicine:

This medicine is to be taken only by mouth. Use the specially marked measuring device that is given to you with the medicine to measure each dose accurately. The average household spoon may not hold the right amount of liquid. If the measuring device provided with the medicine is lost or damaged, contact your pharmacist or doctor to find out the appropriate doses.
Do not use after the expiration date on the label. The medicine may not work properly after that date. If you have any questions about this, check with your pharmacist.

Dosing—The dose of oseltamivir 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 oseltamivir. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage forms (capsules and oral suspension):
- For treatment of the flu:
  - Adults and teenagers: 75 milligrams (mg) two times a day for five days.
  - Children 1 year of age or older: Dose is based on body weight and must be determined by your doctor. It is usually between 30 and 75 mg two times a day for five days.
  - Children up to 1 year of age: Use and dose must be determined by your doctor.
- For prevention of the flu:
  - Adults and teenagers: 75 mg once a day for at least ten days.
  - Children 1 year of age or older: Dose is based on body weight and must be determined by your doctor. It is usually between 30 and 75 mg one time a day for ten days.
  - Children up to 1 year of age: Use and dose must be determined by your doctor.

Missed dose—This medicine works best when there is a constant amount in the body. To help keep the amount constant, do not miss any doses. If you miss a dose, take as soon as possible, except if it is near the next dose (within 2 hours). Then go back to your regular dosing schedule. Do not double doses. If you have missed several doses, inform your doctor and follow the advice given to you.

Storage—To store this medicine:

Keep out of the reach of children.
Do not store the capsules in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Store the oral suspension at room temperature or in the refrigerator. However, keep the medicine from freezing.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your symptoms do not improve after you finish taking the medicine, or if they become worse, check with your doctor.

Side Effects of This Medicine

Side Effects of This Medicine

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.

Stop using this medicine and get emergency help immediately if any of the following side effects occur:

Less common

Phlegm producing cough; wheezing

Rare

Abdominal or stomach cramps or tenderness; arm, back or jaw pain; bloating; chest pain or discomfort; chest tightness or heaviness; diarrhea, watery and severe, which may also be bloody; drooling; facial swelling; fast or irregular heartbeat; fever; hoarseness; humerus fracture (broken forearm); increased thirst; pain; shortness of breath; tender glands of jaw and throat; unusual tiredness or weakness; unusual weight loss

Incidence not known

Blistering, peeling, loosening of skin; chills; convulsions; dark urine; difficulty swallowing; fainting; fast, slow or irregular heartbeat; general tiredness and weakness; hives or welts; itching; itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; joint or muscle pain; light-colored stools; loss of bladder control; loss of consciousness; muscle spasm or jerking of all extremities; red irritated eyes; red skin lesions, often with a purple center; redness of skin; shortness of breath; skin rash; skin rash or itching over the entire body; sore throat; sores, ulcers, or white spots in mouth or on lips; sudden loss of consciousness; sweating; swelling of the face or tongue; tightness in chest; unusual tiredness or weakness; upper right abdominal pain; weakness; yellow eyes and skin

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Diarrhea; nausea; vomiting

Less common

Abdominal or stomach pain; bloody nose or unexplained nosebleeds (occurs mainly in children); burning, dry or itching eyes, redness, pain, swelling of eye or eyelid, or excessive tearing (occurs mainly in children); cough; dizziness; ear disorder (occurs mainly in children); fatigue; headache; trouble in sleeping

Rare

Pale skin; sneezing; tightness in chest; troubled breathing; troubled breathing with exertion; unusual bleeding or bruising

Incidence not known

Blistering, crusting, irritation, itching, or reddening of skin; blurred vision; cracked, dry, scaly skin; dry mouth; flushed, dry skin; fruit-like breath odor; increased hunger; increased urination; mood or mental changes; skin rash encrusted, scaly and oozing; stomachache; swelling; unexplained weight loss

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

Developed: 01/13/2000
Revised: 01/12/2006

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