Brand name – Baraclude
Generic name – Entecavir
Manufacturer – BMS India Pvt Ltd
Salt composition – Entecavir (0.5 mg)
Storage – Store at room temperature
Dosage form – Oral
Strength – 0.5 mg
Packaging – Bottle of tablets
Active ingredient – Entecavir
Indication – treatment of chronic hepatitis B virus infection in adults and pediatric patients (2 years of age and older)
Description
Entecavir is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25° C ± 0.5° C.
Baraclude film-coated tablets are for oral administration in strengths of 0.5 mg and 1 mg of entecavir. Baraclude 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol 400, polysorbate 80 (0.5 mg tablet only), and iron oxide red (1 mg tablet only). Baraclude Oral Solution is available for oral administration as a ready-to-use solution containing 0.05 mg of entecavir per milliliter. Baraclude Oral Solution contains the following inactive ingredients: maltitol, sodium citrate, citric acid, methylparaben, propylparaben, and orange flavor.
Baraclude is a Hepatitis B virus nucleoside analogue reverse transcriptase inhibitor, which is indicated for the treatment of chronic hepatitis B virus infection in adults and children, provided at least 2 years of age with an evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. It is not known that Baraclude is safe for children below 2 years of age. Baraclude will not cure HPV. It may decrease the ability of HPV to multiply.
Pharmacodynamics
Primary Pharmacodynamics
Entecavir is phosphorylated to the active triphosphate form (ETV-TP) by cellular nucleoside kinases. This was shown in different cell systems including infected hepatoma cell lines but the extent of phosphorylation of entecavir was dependent on cell-type. The triphosphate competes with the natural substrate, deoxyguanosine triphosphate (dGTP), of human HBV polymerase. In vitro studies on mechanism of action indicated that the three enzymatic activities of the viral polymerase were inhibited 1) priming activity, 2) reverse transcriptase activity resulting in first strand DNA synthesis and 3) DNA dependent DNA polymerase activity resulting in second-strand DNA synthesis.
Secondary Pharmacodynamics
Entecavir did not show any significant potential for interactions in an in vitro receptor/channel ligand binding screen or enzyme-system assays at concentrations up to 100 µM. Unlike lamivudine or adefovir, ETV has no relevant activity against HIV-1 (EC50 > 10 µM).
Pharmacodynamics Drug Interactions
In vitro, co-administration of stavudine, didanosine, abacavir and zidovudine had no effect on HBV assays containing entecavir at the EC50. Entecavir at 0.8 to 4.2 x Cmax had no significant effects on EC50 values of stavudine, didanosine, abacavir, zidovudine, lamivudine and tenofovir in cells infected with three HIV strains.
Usage Of Medicine
Baraclude is used in the treatment of chronic Hepatitis B virus infection in adults and children provided at least 2 years of age.
Alternate Brands
Side Effects
Common Side Effects
- Headache
- Nausea
- Rashes
- Vomiting
- Fatigue
- Stomach ache
- Diarrhea
- Dizziness
- Tiredness
Serious Side Effects
- Low fever
- Loss of appetite
- Dark-colored urine
- Clay-colored stools
- Jaundice
- Unusual muscle pain
- Fast or irregular heartbeat
- Feeling cold
- Trouble in breathing
- Feeling light-headed
- Feeling weak
Dosage
The dosage is based on your medical conditions. Please consult your healthcare provider for the same.
Warnings And Precautions
- Do not stop this medicine, unless your healthcare provider asks you.
- This medicine does not treat HIV.
- Seek help from your healthcare provider, if you experience (mentioned or other) side effects.
