Adefovir Dipivoxil

Indications
 Oral
Chronic hepatitis B
Adult: >18 yr: 10 mg once daily.
Renal impairment: Haemodialysis patients: 10 mg every 7 days after dialysis.
CrCl (ml/min)Dosage Recommendation
20-4910 mg every 48 hr.
10-1910 mg every 72 hr.


Special Populations: Renal impairment: Creatinine clearance 20-49 mL/min: 10 mg every 48 hrs; 10-19 mL/min: 10 mg every 72 hrs. Haemodialysis: 10 mg every 7 days (following dialysis).
Contraindications
 Lactation.
Warnings / Precautions
 Pregnancy; elderly; child; renal or hepatic impairment. HIV antibody testing to be performed before initiation due to possible resistance development in untreated HIV infection. Increased risk of hepatotoxicity in females, obese patients and with prolonged treatment. Monitor renal function every 3 mth; hepatitis B biochemical, viral and serological markers every 6 mth and LFTs. Discontinue therapy if liver function worsens, severe hepatomegaly, steatosis or unexplained metabolic or lactic acidosis. Monitor hepatic function for several mth in patients whose antihepatitis therapy is discontinued as acute exacerbations of hepatitis may occur.
Adverse Reactions
 Nausea, dyspepsia, abdominal pain, flatulence, diarrhoea, asthenia, headache. Pruritus, skin rashes, and respiratory effects e.g. cough, pharyngitis and sinusitis.
Potentially Fatal: Lactic acidosis, severe hepatomegaly with steatosis, hepatotoxicity, nephrotoxicity.
Overdose Reactions
 Monitor for signs of toxicity, apply supportive treatment when necessary.
Drug Interactions
 Increased risk of nephrotoxicity with nephrotoxic drugs e.g. aminoglycosides, ciclosporin, NSAIDs, vancomycin, tacrolimus. Ibuprofen increases bioavailability of adefovir.
See Below for More adefovir dipivoxil Drug Interactions
Food Interactions
 Increased risk of hepatotoxicty with alcohol in hepatitis B infection.
Mechanism of Actions
 Adefovir dipivoxil is an acyclic nucleoside reverse transciptase inhibitor. The diester function is hydrolyzed and subsequently phosphorylated to the active adefovir diphosphate. The active metabolite inhibits HBV DNA polymerase (reverse transcriptase) and hence inhibits viral replication. It can be used in patients with lamivudine-resistant hepatitis B.
Absorption: Rapidly converted to adefovir after oral admin. Bioavailability 59%. Plasma concentration peaks after 0.6-4 hr.
Distribution: Widely distributed to body tissues. Protein binding: >4%.
Excretion: Renal. Terminal elimination half-life: 7 hr.
Administration
 May be taken with or without food.
Storage Conditions
 Oral: Store between 15-30°C (59-86°F).
ATC Classification
 J05AF08 - adefovir dipivoxil ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Storage
 Oral: Store between 15-30°C (59-86°F).
Available As
  • Adefovir Dipivoxil 10 mg

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