Generic name: Adefovir Dipivoxil
Brand name:
ADEFO ( Shrooq Pharma)
HEPSERA ( GlaxoSmithKline)
VIRGOCIL ( Goodman Lab)
Chemical Class: Nucleotide analog
Therapeutic Class: Antiviral
Dosage form:
Tabs 10 mg
Cap 10mg
Indications:
Treatment of chronic hepatitis B in adults with evidence of hepatitis B viral replication and either evidence of persistent elevations in serum aminotransferases ( ALT or AST) or histologically active disease.
Reductions in viral replication and improvements in liver function have
also been demonstrated in supportive studies in a limited number of supportive
studies in a limited number of chronic hepatitis B patients with genotypic
evidence of lamivudine-resistance, including patients with compensated or
decompensated liver disease and patients co-infected with HIV.
Dose
By Mouth
Adults: 18-65 years: 100 mg once daily taken orally with or
without food.
Children and adolescent ( < 18 years > or elderly (
>65 years )
Safety and efficacy have not been established
Renal impairment
Adjustments of the dosing interval are required in patients
with a creatinine clearance <50 ml/min . The
recommended dosing frequency according to renal function must not be exceeded
Contra-indications
Patients with known hypersensitivity to adefovir , adefovir
dipivoxil or to any of the excipients.
Warning and precautions:
Doses higher than
those recommended must not be administered.
Renal function:
In patients at risk of, or with a history
of renal dysfunction, routine monitoring for changes in both serum creatinine
and serum phosphate is recommended. The dose should be adjusted in patients
with a creatinine clearance of < 50 ml/min. Care should be taken with
coadministration of 10 mg adefovir dipivoxil and medicinal products that are
eliminated by active tubular secretion, as this may lead to an increase in
serum concentrations of either adefovir or the co-administrated medical
products.
Hepatic functions:
Patients with advanced liver disease or cirrhosis should be
monitored closely during the initiation of therapy. Patients should be closely
monitored for several months after stopping treatment as exacerbations of
hepatitis have occurred after discontinuation of 10 mg adefovir dipivoxil.
Side effects/Adverse reactions
CNS: Headache ( 9% ) , weakness (13%)
GI: Abdominal pain (9%) , diarrhea , dyspepsia , flatulence
,nausea (9%)
GU: Nephrotoxicity ( 4%at weeks, 10 % at 96 weeks)
