ADEFOVIR DIPIVOXIL

Indications & Dose:

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 chronic hepatitis B patients with genotypic evidence of lamivudineresistance, including patients with compensated or decompensated liver disease and patients coinfected with HIV.

• BY MOUTH

Adults (18-65 years): 10mg once daily taken orally with or without food.

Children and adolescents (<18 years) or elderly (>65years)

Safety and efficacy have not been established.

Renal impairment Adjustments of the dosing interval are required in patients with a creatinine clearance <50ml/min, as detailed in Table 1. The recommended dosing frequency according to renal function must not be exceeded.

Contraindications:

 Patients with known hypersensitivity to adefovir, adefovir dipivoxil or to any of the excipients. 

Side Effects:

CNS: Headache (9%) weakness (13%).
GI: Abdominal pain (9%), diarrhea, dyspepsia, flatulence. nausea (9%)
GU: Nephrotoxicity (4% at 48 weeks, 10% at 96 weeks) 

Cautions:

Precautions:

Interaction:

Warnings:

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 djusted in patients with a creatinine clearance of < 50ml/minute. Care should be taken with coadministration of 10mg 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-administered medical product.

Hepatic function: 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 10mg adefovir dipivoxil. 

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: