Drug Interaction:
Reduced levels /effects with antacids, phenobarbital , carbamazepine, aminogluthimide, phenytoin, rifampicin, naficillin, nevirapine, omeprazole,
Increase serum levels/effects with azole antifungals agents, cimetidine, efavirenz,
Increased serum levels/effects of azithromycin, ca chanl blockers, clarithromycin, corticosteroids ( eg, fluticasone), mitrazipine, nateglinide, nefazodone, cyclosporin
Indication:
HIV infection
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Nelfinavir Anti HIV 02-07-2001
mesylate
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Nelfinavir HIV/AIDS Agouron Pharma 07-10-2013
Adverse Reaction:
Hyperglycemia, dyslipdaemia, and redistribution of body fat , buffalo hump, facial atrophy, and heart engorement, Hypertriglyceridaemia, diarrhoea, rash, nausea, Flatulance, decreased lymphocytes, Decreased neutrophils,
Decreased haemoglobulin, Increased creatinine kinase, Increased transaminases
Contra-Indications:
Hypersensitivity Lactation Severe hepatic impairment
Special precautions-
Pregnancy Interupt treatment if severe hepatotoxicity or life-threatening skin reactions develop. Renal or hepatic insufficiency
Monitor liver function periodically
Dosages/ Overdosage Etc:
HIV infection combined or other antiretroviral
Dosage-
1.25g bid or 0.75g bid child- combined - 2-13yr - 45-55mg bid or 24-35mg /kg tid max dose 0.75g
Patient Information:
1. Inform patients that some HIV medicines, including Nelfinavir may cause a rare but
serious condition called lactic acid acidosis with liver enlargement(hepatomegaly)
2. Nelfinavir 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 Nelfinavir
4.Advice patients that the use of Nelfinavir 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
Pregnancy and lactation:
Use contraindicated. Observe caution
Manufacturer Details