Entecavir 0.5mg Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ENTECAVIR - ORAL

(en-TEH-cuh-veer)

COMMON BRAND NAME(S): Baraclude

WARNING: Your hepatitis B symptoms may get worse or become very serious if you stop taking entecavir. Talk with your doctor before stopping this medication. Your doctor will perform liver function tests for several months after you stop entecavir. Tell your doctor immediately if you develop symptoms of worsening liver disease, including persistent nausea, stomach/abdominal pain, dark urine, or yellowing eyes/skin. Entecavir has rarely caused serious (possibly fatal) liver enlargement and/or lactic acid build-up in the blood (lactic acidosis). Get medical help right away if you develop any of the following symptoms: unusual tiredness (fatigue), severe drowsiness, muscle pain, difficult or rapid breathing, irregular heartbeat. Lactic acidosis is more likely to occur in patients who have: kidney or liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), excessive alcohol use, a lack of body fluids (dehydration), X-ray or scanning procedure drugs (contrast agents), major surgery, or a serious infection. This medication is not recommended if you have both HIV and hepatitis B and are not receiving effective treatment for HIV. This drug does not treat HIV, and it can cause certain HIV medications to become ineffective. Therefore, have an HIV test before starting this medication, and get tested again anytime you may have become infected. Consult your doctor for more details.

USES: See also Warning section. This medication is used to treat a chronic viral infection of the liver (hepatitis B). It works by slowing the growth of the virus. Entecavir is a nucleoside analog-type (NRTI) medication. Entecavir is not a cure for hepatitis B and does not prevent the spread of hepatitis B to others through sexual contact or blood/body fluid contamination (e.g., sharing used needles). A series of shots (vaccine) are available to protect uninfected people from hepatitis B virus.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using entecavir and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication by mouth on an empty stomach at least 2 hours after a meal and 2 hours before the next meal, usually once daily or as directed by your doctor. If you are taking entecavir oral liquid, carefully measure your dose with the spoon provided. Hold the spoon in an upright position with the volume marks facing you. Slowly fill the spoon to the mark for your prescribed dose. Swallow the medicine directly from the measuring spoon. Do not dilute or mix the medication with water or other liquids. Rinse the spoon with water after each use. Take this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Do not skip any doses. Dosage is based on your medical condition (e.g., kidney function), and response to therapy (including previous use of the drug lamivudine). Take this medication exactly as prescribed. Do not change your dose or stop taking entecavir without talking to your doctor. (See Warning section) Inform your doctor of any new symptoms or if your condition worsens.

SIDE EFFECTS: Headache, fatigue, dizziness, and nausea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking entecavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, kidney disease. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug, and to side effects such as lactic acidosis. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Breast-feeding is not recommended while using this drug if you also have HIV. Otherwise, consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of drugs which may damage the kidney, or drugs removed by the kidney, or drugs that may slow the removal of other drugs by the kidney such as: aminoglycosides (e.g., gentamicin, amikacin, tobramycin), amphotericin B, cyclosporine, non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen), probenecid, tacrolimus. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., kidney and liver tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Entecavir oral solution should be stored in the original carton. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised January 2011. Copyright(c) 2011 First Databank, Inc.