Baraclude

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|Baraclude

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ENTECAVIR (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Baraclude

Not commercially available in Canada.

Category

  • Antiviral

Description

Entecavir ((en-TE-ka-veer)) is used in the treatment of the infection caused by hepatitis B virus. Entecavir is not a cure for the hepatitis B virus; the long-term effects of the drug on the infection and the liver are unknown at this time.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

  • Oral
  • Oral solution (U.S.)
  • Tablets (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 entecavir, the following should be considered:

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

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

Breast-feeding—Entecavir passes into the milk of rats, it is not known whether entecavir passes into human milk. Entecavir is not recommended during breast-feeding.

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

Older adults—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. Although there is no specific information comparing use of entecavir in the elderly with use in other age groups, the elderly may be more sensitive to the effects of entecavir.

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

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

  • Kidney disease—Your doctor may need to adjust your dose
  • Liver transplant—Your doctor will need to monitor your kidney function

Proper Use of This Medicine

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Importance of taking on an empty stomach.

The importance of reading the patient information leaflet before starting entecavir treatment and each time you refill.

Correctly measuring the oral solution and rinsing the dosing spoon with water after each use.

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

The number of tablets or teaspoonfuls of solution that you take depends on the strength of the medicine.

  • For oral dosage form (tablets):
    • For chronic hepatitis B infection
    • For oral dosage form (oral solution):
      • Adults—0.5 to 1 milligram once daily. You may take less of this medicine or less often if you have kidney problems.
      • Children—Dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—0.5 to 1 milligram once daily. You may take less of this medicine or less often if you have kidney problems.
      • Children—Use and dose must be determined by your doctor.

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.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly.

Consulting physician immediately if symptoms of hepatomegaly or lactic acidosis occur

Liver disease may become worse if treatment with entecavir is stopped. Do not stop taking entecavir unless your doctor tells you to stop.

Treatment with entecavir has not been shown to decrease the chance of giving hepatitis B virus infection to other people through sexual contact or blood contamination.

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.

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

Frequency unknown

Abdominal discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; nausea; right upper abdominal pain and fullness; shortness of breath; sleepiness; unusual tiredness or weakness

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.

Less common

Headache

Rare

Acid or sour stomach; belching; dizziness; heartburn; indigestion; nausea; sleepiness or unusual drowsiness; sleeplessness; stomach discomfort upset or pain; trouble sleeping; vomiting

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

Developed: 05/10/2005

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