Drug Interaction:
Cisapride, midalazom, ergot alkaloids, triazolam, voriconazole, itraconazole, ketoconazole
Posoconazole , pimozide, bepredil, ethinyl estradiol,
Inducers of substrates of CYP3A4 (cytosporine, sirolimus, tacrolimus)
Axatanavir, amprenavir, indinavir, ritonavir, saquinavir,
Nelfinavir, lopinavir, losamprenavir, darunavir,
Rifamicin, clarithromycin, oral contraceptives, warfarin, phenytoin, phenobarbitone,
Cabamazepine, setraline, methadone,
Atrovasatin, pravasastain, simavastatin,
Diltiazem
Avoid alcohol and/or hepatoxic drugs
Grape fruit,
St.Johns Wart
Indication:
HIV infection
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Efavirenz Anti-HIV 6-06-2001
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Combikit of Efavirenz 600mg 20-09-2004
1 Tablet of Lamivudine 300mg &
1 Capsule of Didavosine 250mg/400mg) delayed release
For the treatment of HIV infection
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Efavirenz HIV/AIDS DuPont 21-05-2013
Adverse Reaction:
Skin rash, discontinue if severe photoallergic dermatitis
Nervous system reactions such as abnormal dreams
Dizziness, insomnia, somnolence, impaire concentrations
Severe psychotic reactions including anxiety and depression
Disturbances n attention
Suicidal ideation/attempt
Agression, parania, delusions
GI upset, headache, drowsiness,
Fatigue, fever, cough, dyspnoea
Hepatic failure
Contra-Indications:
Moderate to severe hepatic impairment
Concurrent admin. of cisapride, ergots, midalozam, triazolam
Voriconazole, beppridil, pimozide
Pregnancy (adequate contraceptive measures for 12 weeks after discontinuation of therapy)
Lactation
Special precautions-
Mild liver impairment
Hepatitis B or C
Combination anri-retroviral or concurrent anti-hepatitis B or C therapy
Risk of potentially fatal hepatic events
Monitor liver enzymes
Consider withdrwal if transaminase 5x normal
Severe renal impairment monitor closely
Risk of lipoystrophy and metabolic abnormalites
Dosages/ Overdosage Etc:
To treat with other antivirals HIV infection
Dosage-
Adults - 600mg once daily
Children under 3 years of age or 13kg - not recommended
Patient Information:
1. Inform patients that some HIV medicines, including Efavirenz may cause a rare but
serious condition called lactic acid acidosis with liver enlargement(hepatomegaly)
2. Efavirenz 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 Efavirenz
4.Advice patients that the use of Efavirenz 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
Pharmacology/ Pharmacokinetics:
To treat with other antivirals HIV infection
Pregnancy and lactation:
Observe caution-
Pregnancy (adequate contraceptive measures for 12 weeks after discontinuation of therapy)
Lactation
Manufacturer Details