Baraclude

Generic name: Entecavir
Drug class: Nucleoside reverse transcriptase inhibitors (NRTIs)

Usage of Baraclude

Baraclude is an antiviral medication. Entecavir prevents certain virus cells from multiplying in your body.

Baraclude is an antiviral medicine that is used to treat chronic hepatitis B virus (HBV) in adults and children who are at least 2 years old and weigh at least 22 pounds (10 kilograms).

Baraclude is not a cure for hepatitis. It is not known whether this medicine will prevent cirrhosis or liver cancer.

Baraclude side effects

Get emergency medical help if you have signs of an allergic Reaction to Baraclude: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using Baraclude develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

unusual muscle pain;

feeling cold;

trouble breathing;

feeling dizzy, light-headed, tired, or very weak;

stomach pain, vomiting; or

fast or irregular heartbeats.

Baraclude may also cause severe liver symptoms. Call your doctor at once if you have: swelling around your midsection, nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Baraclude side effects may include:

nausea;

dizziness, tired feeling; or

headache.

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.

Before taking Baraclude

You should not take Baraclude if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated.

You may need to be tested for HIV before you start taking Baraclude. Taking medicine to treat chronic hepatitis B can cause HIV infection to become resistant to certain HIV and AIDS medications.

To make sure Baraclude is safe for you, tell your doctor if you have ever had:

HIV or AIDS (or if you have been exposed to HIV);

kidney disease;

liver problems other than HBV;

a liver transplant; or

if you also take lamivudine (Epivir, Epzicom, Trizivir) or Telbivudine (Tyzeka).

Tell your doctor about all medicines you have used to treat hepatitis B in the past. Baraclude may not be the right medication if you have used certain other medicines for HBV.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you are overweight, if you've taken antiviral medication for a long time, or if you are a woman. Ask your doctor about your risk.

It is not known whether entecavir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of entecavir on the baby.

It may not be safe to breast-feed while using Baraclude. Ask your doctor about any risk.

Relate drugs

How to use Baraclude

Usual Adult Dose of Baraclude for Chronic Hepatitis B:

Compensated Liver Disease: -Nucleoside-inhibitor-therapy-naive: 0.5 mg orally once a day -History of hepatitis B viremia while using lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L: 1 mg orally once a day Decompensated Liver Disease: 1 mg orally once a day Use: For the treatment of chronic HBV infection in patients with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease

Usual Pediatric Dose of Baraclude for Chronic Hepatitis B:

2 to 15 years: Therapy-naive: 10 to 11 kg: 0.15 mg orally once a day Greater than 11 to 14 kg: 0.2 mg orally once a day Greater than 14 to 17 kg: 0.25 mg orally once a day Greater than 17 to 20 kg: 0.3 mg orally once a day Greater than 20 to 23 kg: 0.35 mg orally once a day Greater than 23 to 26 kg: 0.4 mg orally once a day Greater than 26 to 30 kg: 0.45 mg orally once a day Greater than 30 kg: 0.5 mg orally once a day Lamivudine-experienced: 10 to 11 kg: 0.3 mg orally once a day Greater than 11 to 14 kg: 0.4 mg orally once a day Greater than 14 to 17 kg: 0.5 mg orally once a day Greater than 17 to 20 kg: 0.6 mg orally once a day Greater than 20 to 23 kg: 0.7 mg orally once a day Greater than 23 to 26 kg: 0.8 mg orally once a day Greater than 26 to 30 kg: 0.9 mg orally once a day Greater than 30 kg: 1 mg orally once a day Comments: -The oral solution is recommended for patients up to 30 kg. 16 years or older: Compensated Liver Disease: -Nucleoside-inhibitor-therapy-naive: 0.5 mg orally once a day -History of hepatitis B viremia while using lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L: 1 mg orally once a day Use: For the treatment of chronic HBV infection in patients with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease

Warnings

You should not take Baraclude if you have HIV (human immunodeficiency virus) that is not being treated.

Symptoms of hepatitis B can come back or get worse after you stop taking Baraclude. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Baraclude may also cause severe liver symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.

Some people with hepatitis B develop liver symptoms after they stop taking Baraclude, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits

Hepatitis B may become active or get worse after you stop using entecavir. You may need frequent liver function tests for several months.

What other drugs will affect Baraclude

Other drugs may interact with entecavir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.