Baraclude

The usual recommended dose for adults and adolescents 16 years of age and older is 0.5 mg once daily. People who have experienced active disease while taking a similar medication called lamivudine may need to take 1 mg once daily. People with reduced kidney function may require a lower dose, as directed by their doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Entecavir should be taken on an empty stomach, at least 2 hours before a meal or 2 hours after a meal. The tablet should be swallowed whole with water.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Baraclude at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Tablets

Each white-to-off-white, triangular, film-coated tablet debossed with "BMS" on one side and "1611" on the other contains 0.5 mg of entecavir. Nonmedicinal ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone; coating: hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

Do not take entecavir if you are allergic to entecavir or any ingredients of the medication.

There may be an interaction between entecavir and any of the following:

• Orlistat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Baraclude. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Baraclude.

Hepatitis B transmission: Treatment with entecavir does not reduce the risk of passing on hepatitis B to other people through sexual contact and blood transfer. You should continue to take measures to prevent giving hepatitis B to other people (e.g., using condoms) while taking Baraclude.

Human immunodeficiency virus (HIV): People with HIV infection should discuss with their doctor how Baraclude may affect their medical condition. If you are taking entecavir for chronic hepatitis B and are not taking any medications for HIV at the same time, some HIV medications that you take in the future may not work as well to treat HIV. Entecavir has not been studied for the treatment of HIV. Your doctor may test you for HIV before beginning treatment with entecavir. If you think that you might have HIV, contact your doctor immediately to get tested.

Kidney function: Baraclude is removed from the body by the kidneys. If the kidneys are not working properly, entecavir may build up in the body and cause side effects. People with reduced kidney function may need a different dose of the medication. If you have decreased kidney function or Kidney Disease, discuss with your doctor how Baraclude may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Baraclude, and whether any special monitoring is needed.

Lactic acidosis and enlarged liver: Entecavir can cause a rare but serious condition called lactic acidosis (buildup of lactic acid in the blood) together with an enlarged liver and fat in the liver. If you experience any of the following symptoms, call your doctor immediately:

• abdominal pain, swelling, or bloating
• dark-coloured urine
• diarrhea
• fatigue
• feeling unwell
• light-coloured stools
• loss of appetite for several days
• nausea
• shortness of breath
• vomiting
• weakness
• weight loss
• yellow skin or whites of eyes

Your doctor will periodically monitor you and perform laboratory tests to check your liver function.

Lactose intolerance: Entecavir tablets contain lactose. If you have been told that you are intolerant to lactose, contact your doctor before taking Baraclude.

Liver transplant: The safety and effectiveness of entecavir has not been tested in people who have had a liver transplant. It is not known if entecavir will interact with anti-rejection medications (i.e., Cyclosporine, Tacrolimus) commonly used after an organ transplant. If you have had a liver transplant, discuss with your doctor how Baraclude may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Baraclude, and whether any special monitoring is needed.

Stopping the medication: If you stop taking entecavir, your hepatitis B infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: Baraclude should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Baraclude, contact your doctor immediately.

Breast-feeding: It is not known if entecavir passes into breast milk. If you are a breast-feeding mother and are taking Baraclude, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Baraclude have not been established for children less than 16 years of age.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication should not be taken with food. It is best taken on an empty stomach, 2 hours before or after a meal.