Description
Indications
Virodip 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.
Pharmacology
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.
Dosage & Administration
The recommended dose of Adefovir in chronic hepatitis B patients with adequate renal function is 10 mg, once daily, taken orally, without regard to food.
Interaction
The pharmacokinetics of adefovir was unchanged when Virodip was coadministered with lamivudine, trimethoprim/ sulfamethoxazole and acetaminophen. When Virodip was co-administered with ibuprofen (800 mg three times daily), increases in adefovir Cmax (33%), AUC (23%) and urinary recovery were observed due to higher oral bioavailability of adefovir.
Contraindications
Adefovir dipivoxil is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.
Side Effects
The most common side effects of Virodip 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 Virodip. In patients at risk of or having underlying renal dysfunction, chronic administration of Virodip 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.





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