Entecavir Solution


|Entecavir Solution

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Entecavir Solution

Generic Name: Entecavir Oral Solution (en-TEK-a-vir)
Brand Name: Baraclude

Entecavir Solution may increase the risk of severe and sometimes fatal lactic acidosis (buildup of lactic acid in the blood) or liver problems when used alone or with other medicines. Contact your doctor immediately if you experience muscle pain, fast or irregular heartbeat, stomach pain, yellowing of the skin or eyes, or dark urine.

A severe worsening of your condition may occur when you stop taking Entecavir Solution. Do not change your dose or stop taking Entecavir Solution without first talking to your doctor. Lab tests, including liver function tests, may be performed for at least several months after you stop taking Entecavir Solution.

Entecavir Solution is used for:

Treating hepatitis B virus infection in certain patients.

Entecavir Solution is a nucleoside analogue. It works by reducing the amount of hepatitis B virus in the blood. It also helps prevent the hepatitis B virus from multiplying and infecting new liver cells.

Do NOT use Entecavir Solution if:

  • you are allergic to any ingredient in Entecavir Solution

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

Before using Entecavir Solution:

Some medical conditions may interact with Entecavir Solution. 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 kidney problems or are on dialysis
  • if you have had a liver transplant

Some MEDICINES MAY INTERACT with Entecavir Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the side effects of Entecavir Solution may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Entecavir Solution 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 Entecavir Solution:

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

  • An extra patient leaflet is available with Entecavir Solution. Talk to your pharmacist if you have questions about this information.
  • Take Entecavir Solution on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal.
  • Use the measuring device marked for dosing supplied with Entecavir Solution. Ask your pharmacist for help if you are unsure of how to measure this dose.
  • Entecavir Solution works best if it is taken at the same time each day.
  • Continue to take Entecavir Solution even if you feel well. Do not miss any doses.
  • If you miss a dose of Entecavir Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

  • Entecavir Solution may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Entecavir Solution. Using Entecavir Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Entecavir Solution does not stop you from spreading hepatitis B virus to others through sex, sharing needles, or being exposed to your blood. Talk with your doctor about safe sexual practices that protect your partner. Never share needles. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razor blades. A vaccine is available to protect people at risk from becoming infected with hepatitis B virus.
  • Entecavir Solution is not a cure for hepatitis B virus infection. Remain under the care of your doctor.
  • Lab tests, including liver and kidney function, may be performed while you use Entecavir Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Entecavir Solution with caution in the ELDERLY; they may be more sensitive to its effects.
  • Entecavir Solution should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, contact your doctor. You will need to discuss the benefits and risks of using Entecavir Solution while pregnant. It is not known if Entecavir Solution is found in breast milk. Do not breast-feed while taking Entecavir Solution.

Possible side effects of Entecavir Solution:

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:

Diarrhea; dizziness; drowsiness; headache; indigestion; nausea; sleepiness; tiredness; trouble sleeping; vomiting.

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); dark-colored urine; difficulty breathing; fast or irregular heartbeat; feeling cold, especially in the arms or legs; light-colored bowel movements; loss of appetite for several days; muscle pain; severe dizziness or lightheadedness; severe or prolonged nausea or vomiting; severe tiredness; stomach pain (with or without nausea or vomiting); weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm ), or emergency room immediately.

Proper storage of Entecavir Solution:

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

General information:

  • If you have any questions about Entecavir Solution, please talk with your doctor, pharmacist, or other health care provider.
  • Entecavir Solution 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 Entecavir Solution. 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: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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