Replivir 1 mg (Tablet)

Indications

• Treatment of chronic hepatitis B virus infection in adults
• Treatment of chronic hepatitis B virus infection in pediatric patients 2 years of age and older

Pharmacology

• Competes with natural substrate deoxyguanosine triphosphate
• Inhibits all three activities of the HBV polymerase

Dosage & Administration

• Recommended dose is 0.5 mg once daily for adults and adolescents 16 years of age
• Recommended dose is 1 mg once daily for Lamivudine-refractory patients
• Recommended dose is 1 mg once daily for patients with decompensated liver disease
• Administer on an empty stomach

Interaction

• No significant drug interactions with Lamivudine or Adefovir dipivoxil

Contraindications

• Contraindicated in patients with hypersensitivity to Entecavir or any component of the product

Side Effects

• Common adverse events include headache, fatigue, dizziness, and nausea

Pregnancy & Lactation

• No data on the effect of Entecavir on HBV transmission from mother to infant
• Not known whether it is excreted in human milk
• Mothers should not breastfeed if taking Entecavir

Precautions & Warnings

• Lactic acidosis and severe hepatomegaly with steatosis reported with the use of nucleoside analogues
• Exacerbations of hepatitis after discontinuation of treatment reported

Use in Special Populations

• Safety and effectiveness in pediatric patients below the age of 2 years not established
• Insufficient data on subjects aged 65 years and over
• Dose adjustment recommended for patients with renal impairment

Overdose Effects

• No experience of Replivir overdosage reported in patients
• Standard supportive treatment necessary if overdosage occurs

Therapeutic Class

• Hepatic viral infections (Hepatitis B)

Storage Conditions

• Keep in a dry place
• Store below 30°C
• Protect from light
• Keep out of the reach of children

Related Brands

• Vironex 0.5 mg (Tablet) - everest-pharmaceuticals-ltd
• Teviral 0.05 mg/ml (Oral Solution) - aci-limited