Drug Interaction:
Drugs excreted by or which affect affect renal tubular excretion
Other nephrotoxic drugs eg. cyclosporine, tacrolimus, aminoglycosides, NSAIDs
Indication:
Treatment of chronic Hepatitis B in adults with compensated liver disease
LIST OF DRUGS DURING 2004
Sr.No- 191
Name of the Drug- Adefovir Dipivoxil
Pharmacological Classification- Anti-Viral (Hepatitis- B)
Date of Approval- 04-03-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Adefovir dipivixil Anti-viral (Hepatitis-B) 04-03-2004
Adverse Reaction:
GI upset, asthenia, headache, abdominal pain, raised serum creatinine levels,
Renal insufficiency, renal failure
Pruritus, lactic acidosis, severe hepatomegaly,
Post treatment excaberation of hepatitis, pancreatitis,
Hypophosphatomia, nephrotoxicity ( prolonged use )
Contra-Indications:
Monitor patients every 3 months for hepatitis B biochemical , virological, and serological markers to determine tratment duration
Renal impairmen- t Monitor renal function prior to initiation of therapy, then every 3 months.
Cirrhosis, monitor closely for hepatic decompensation
Monitor patients for several months after stopping therapy for acute excaberationof hepatitis particularly obese women with hepatomegaly, hepatitis or other factors for liver disease,
Risk of lactic acidosis, sometimes fatal.
Co-infection with hepatitis C or D or HIV.
Elderly
Pregnancy, labour delivery
Dosages/ Overdosage Etc:
Indication-
Treatment of chronic Hepatitis B in adults with compensated liver disease
Dosage-
Take with or without food
1 tablet daily Use in combination with lamivudine to reduce risk of redsistence
Not recommended for patients below 18 years
Patient Information:
1. Inform patients that some HIV medicines, including Adefovir may cause a rare but
serious condition called lactic acid acidosis with liver enlargement(hepatomegaly)
2. Adefovir is not a cure for HIV infection, and patients may continue to experience
illness associated with HIV infection, including oppurtunistic infection.
3.Patients should remain under the care of a healthcare provider when using Adefovir
4.Advice patients that the use of Adefovir has not shown to reduce the risk of
transmission of HIV to others through sexual contact or blood donation.
5.Inform patients that redistribution or body fat may occur in patients receiving
antiretroviral therapy, and the cause and long term health effects of these
conditions are not known at this time.
6. Advice patients of the importance of taking HIV medicines as prescribed
Interaction with Food:
Take with or without food
Pregnancy and lactation:
Observe caution if required to be used during or labour and delivery
Manufacturer Details