Entecavir 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).
Entecavir may also be used for purposes not listed in this medication guide.
Indications
Entecavir 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).
Entecavir may also be used for purposes not listed in this medication guide.
Contraindications
You should not take entecavir if you are allergic to it.
You may need to be tested for HIV before you start taking entecavir. Taking medicine to treat chronic hepatitis B can cause HIV infection to become resistant to certain HIV and AIDS medications.
Tell your doctor if you have or have ever had:
HIV or AIDS (or if you have been exposed to HIV); if you also take lamivudine (Epivir, Epzicom , Trizivir ) or telbivudine (Tyzeka); liver problems other than HBV; a liver transplant ; or kidney disease.
Tell your doctor about all medicines you have used to treat hepatitis B in the past. Entecavir may not be the right medication if you have used certain other medicines to treat 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.
Tell your doctor if you are pregnant or breastfeeding.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of entecavir on the baby.
Side Effects
Get emergency medical help if you have signs of an allergic reaction : hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some people taking entecavir develop lactic acidosis . Get emergency medical help if you have symptoms of lactic acidosis 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.
Entecavir 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 side effects of entecavir 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.
Warnings
You may not take entecavir if you have HIV (human immunodeficiency virus) that is not being treated. Ask your doctor about your individual risk.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.
This medication can cause liver problems. Call your doctor if you have swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
If you've had hepatitis B, it may come back or get worse after you stop taking entecavir. You may need frequent liver function tests for several months.
High Risk Groups
You may not take entecavir if you have HIV (human immunodeficiency virus) that is not being treated. Ask your doctor about your individual risk.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.
This medication can cause liver problems. Call your doctor if you have swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
If you've had hepatitis B, it may come back or get worse after you stop taking entecavir. You may need frequent liver function tests for several months.
Adult Dosage
0.1 to 1 mg (0.55 (0.55)) 24 hourly PO —
Scraped Dose — Follow all directions on your prescription label and read all medication guides or instruction sheets. Take the medicine exactly as directed.
Take entecavir on an empty stomach, at least 2 hours after a meal and 2 hours before the next meal.
Measure liquid medicine with the supplied measuring device (not a kitchen spoon).
Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.
Use entecavir regularly to get the most benefit and to keep your condition from getting worse. Call your doctor if your hepatitis symptoms do not improve , or if they get worse.
Do not change your dose or dosing schedule without your doctor's advice. Every person with HBV should remain under the care of a doctor.
If you've had hepatitis B, it may come back or get worse after you stop taking entecavir. You may need frequent liver function tests for several months.
Store tightly closed at room temperature, away from moisture, heat, and light.
Keep liquid medicine in its original carton. Throw away any unused medicine after the expiration date on the label has passed.
Child Dosage
No child dosage information is recorded for this medicine yet.
Neonatal Dosage
No neonatal dosage information is recorded for this medicine yet.
Drug Interactions
Other drugs may affect entecavir, including prescription and over-the-counter medicines, vitamins , and herbal products . Tell your doctor about all other medicines you use.
Storage
Tabs, Soln. Store in a well closed container, at room temperature. Protect from Sunlight, Moisture and Heat.
