Agencia Lei Va Hong
Concise Prescribing Info
Adefovir dipivoxil
Chronic hepatitis B in adult w/ compensated liver disease w/ evidence of active viral replication, persistent elevations in serum ALT levels & histological evidence of active liver inflammation & fibrosis when use of an alternative antiviral agent w/ a higher genetic barrier to resistance is not available or appropriate. Chronic hepatitis B in adult w/ decompensated liver disease in combination w/ a 2nd agent w/o cross-resistance to Hepsera.
Dosage/Direction for Use
Adult 10 mg once daily. Patient w/ renal impairment CrCl 30-49 mL/min 10 mg every 48 hr.
May be taken with or without food.
Special Precautions
Risk of HBV transmission; lactic acidosis & severe hepatomegaly w/ steatosis; resistant HIV strains w/ possible cross-resistance to other antivirals. Should not be co-administered w/ tenofovir disoproxil fumarate. Caution in patients receiving medicinal products that may affect renal function or are excreted renally (eg, cyclosporin, tacrolimus, IV aminoglycosides, amphotericin B, foscarnet, pentamidine, vancomycin, cidofovir). Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Renal impairment. Not recommended in patients w/ CrCl <30 mL/min or on dialysis. Patients w/ advanced liver disease or cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation. Women of childbearing potential not using contraception. Pregnancy & lactation. Elderly >65 yr. Childn <18 yr.
Adverse Reactions
Increases in creatinine; asthenia. Headache; diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, flatulence; rash, pruritus; renal failure, abnormal renal function, hypophosphatemia.
Drug Interactions
Co-administration w/ drugs eliminated by tubular secretion or alter tubular secretion may increase serum conc of adefovir or the co-administered drug. Co-administration w/ tacrolimus, cyclosporin & pegylated interferon should be closely monitored.
MIMS Class
ATC Classification
J05AF08 - adefovir dipivoxil ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Hepsera tab 10 mg
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