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Entec 0.5/1

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EntecavirTablets0.5 mg

Entecavir Tablets 1.0 mg

 

Composition

Each film coated tablet contains

Entecavir…….0.5 mg / 1.0 mg

 

Description

Entecavir is an antiviral drug. Entecavir, a guanosine nucleoside analogue with activityagainst HBV reverse transcriptase (rt), is efficiently phosphorylated to the activetriphosphate form, which has an intracellular half-life of 15 hours. By competing with thenatural substrate, deoxyguanosine triphosphate, entecavir triphosphate functionallyinhibits all three activities of the HBV reverse transcriptase: (1) Base priming, (2)reverse transcription of the negative strand from the pregenomic messenger RNA, and(3) synthesis of the positive strand of HBV DNA.

 

Indications

ENTEC- 0.5/ ENTEC-1 is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on histologic, virologic, biochemical, and serologic responses after one year of treatment in nucleoside-treatment-naive and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease and on more limited data in adult patients with HIV/HBV co-infection who have received prior lamivudine therapy.

 

Dosage and Administration

ENTEC- 0.5/ ENTEC-1Tabletsshould be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

 

Recommended Dosage

Compensated Liver DiseaseThe recommended dose of entecavir for chronic hepatitis B virus infection in nucleosidetreatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.

The recommended dose of entecavir in adults and adolescents (at least 16 years ofage) with a history of hepatitis B viremia while receiving lamivudine or known lamivudineor telbivudine resistance mutations is 1 mg once daily.

 

Decompensated Liver DiseaseThe recommended dose of entecavir for chronic hepatitis B virus infection in adults withdecompensated liver disease is 1 mg once daily.

 

Duration of TherapyThe optimal duration of treatment with entecavir for patients with chronic hepatitis Bvirus infection and the relationship between treatment and long-term outcomes such ascirrhosis and hepatocellular carcinoma are unknown.

 

WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted

AdverseEffects:

The most common adverse events with ENTEC- 0.5/ ENTEC-1were headache, fatigue, dizziness, and nausea.

 

Drug Interactions:

Co-administration of entecavir with lamivudine, adefovirdipivoxil or tenofovirdisoproxilfumarate did not result in significant drug interactions.

The effects of co-administrationof ENTEC- 0.5/ ENTEC-1 tabletswith other drugs that are renally eliminated or are known to affect renal function have not been evaluated, and patients should be monitored closely foradverse events when ENTEC- 0.5/ ENTEC-1tabletsis co-administered with such drugs.

 

Presentation:

Pack of30Tablets ofENTEC- 0.5/ ENTEC-1

 

 


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