Vironex 0.5 mg (Tablet)

Indications

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

Pharmacology

• Inhibition of HBV polymerase activity by competing with natural substrate deoxyguanosine triphosphate

Dosage & Administration

• Recommended dose of 0.5 mg once daily for nucleoside-treatment-naive adults and adolescents 16 years of age
• Recommended dose of 1 mg once daily for Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations
• Recommended dose of 1 mg once daily for patients with decompensated liver disease
• Administration on an empty stomach
• Instructions for missed dose

Interaction

• No significant drug interactions with Lamivudine or Adefovir dipivoxil
• Unspecified caution with drugs eliminated through renal or affecting renal function

Contraindications

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

Side Effects

• Headache
• Fatigue
• Dizziness
• Nausea

Pregnancy & Lactation

• No available data on effect on transmission of HBV from mother to infant
• Unknown excretion in human milk
• Recommendation not to breastfeed if taking Entecavir

Precautions & Warnings

• Risk of lactic acidosis and severe hepatomegaly with steatosis
• Risk of exacerbations of hepatitis after discontinuation of treatment

Use in Special Populations

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

Overdose Effects

• No reported experience of Vironex overdosage in patients
• No unexpected adverse events in healthy subjects receiving up to 20 mg daily or single doses up to 40 mg
• Necessary monitoring for evidence of toxicity and standard supportive treatment if overdosage occurs

Therapeutic Class

• Hepatic viral infections (Hepatitis B)

Storage Conditions

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

Related Brands

• Teviral 0.05 mg/ml (Oral Solution) - aci-limited