BD MediAdefovir Dipivoxil
Hepatic viral infections (Hepatitis B)
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📋 Indications & Uses Dosage & Administration⚠️ Contraindications⚡ Side Effects & Adverse Reactions🛡️ Warnings & Precautions🔬 Pharmacology & Mechanism
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📖 Official Clinical Monograph
DGDA Approved Prescribing GuidelinesInfovir is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Dosage & AdministrationThe recommended dose of Adefovir in chronic hepatitis B patients with adequate renal function is 10 mg, once daily, taken orally, without regard to food.
Adefovir dipivoxil is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.
The most common side effects of Infovir are weakness, headache, stomach pain and nausea. Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with Infovir. In patients at risk of or having underlying renal dysfunction, chronic administration of Infovir may result in nephrotoxicity. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.
Patients who discontinued Infovir should be monitored at repeated intervals over a period of time for hepatic function. The patients at risk of or having underlying renal dysfunction should be monitored closely for renal function and may require dose adjustment.
Adefovir dipivoxil is a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). Adefovir is phosphorylated to the active metabolite, adefovir diphosphate, by cellular kinases. Adefovir diphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate deoxyadenosine triphosphate and by causing DNA chain termination after its incorporation into viral DNA. The approximate oral bioavailability of adefovir from a 10 mg single dose is 59%. In vitro binding of adefovir to human plasma or human serum proteins is 4%. Adefovir is excreted through renal route by a combination of glomerular filtration and active tubular secretion.