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Adefovir

ANTIBIOTICS & ANTIINFECTIVES

ANTIVIRALS - [ ANTIBIOTICS & ANTIINFECTIVES ]

Adefovir is a nucleotide analog of adenosine monophosphate which inhibits viral DNA polymerases and reverse transcriptases and also HBV DNA polymerase. (1)

Treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (2)

Hypersensitivity to Adefovir or its components (2)

Severe acute exacerbations of Hepatitis Nephrotoxicity Asthenia, headache, abdominal pain, nausea, flatulence, diarrhea, dyspepsia Hypophosphatemia and pancreatitis Myopathy, osteomalacia both associated with proximal renal tubulopathy Renal failure, Fanconi syndrome, proximal renal tubulopathy HIV Resistance Lactic acidosis and severe hepatomegaly with steatosis (2)

Coadministration of Adefovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either adefovir and/or these coadministered drugs (2)

Not recommended in children less than 12 years of age Dose adjustment needed in renal impairment Not known whether adefovir is excreted in human milk (2)

10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown. Dose adjustment needed in renal impairment (2)

1. Acosta EP, Flexner C. Antiviral agents (nonretroviral). In: Brunton L, Chabner B, Knollmann B eds. Goodman & Gilman’s The Pharmacological basis of Therapeutics. 12th ed. USA: McGraw Hill; 2011:1593-1622. 2. Hepsera [cited 2013 Aug 26]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021449s020lbl.pdf