For the treatment of Human Immunodeficiency Virus (HIV) infection
Patients hypersensitive to any of the components of the formulation
Lactic acidosis, headache, malaise, fatigue, fever, chills, diarrhea, nausea, vomiting, anorexia and/ or decreased appetitie, neutopathy, insomnia and other sleep disorders, nasal signs and symptoms, cough, musculoskeletal pain, rash, headache, abnormal liver function tests.
Lamivudine, stavudine and nevirapine should be used with caution in patients with hepatic disease or in those with known risj factors for liver disease. Lamivudine should be used with caution in patients with impaired renal function, including renal failure.
The formulation should be used with caution in pregnancy. Because of both the potential of HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving the formulation.
Lactic acidosis and severe hepatomega;y with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combinations including stavudine and other antiretrovirals. Hepatotoxicity,motor weakness, peripheral neuropathy and pancreatitis may occur with stavudine. Severe or life threatening hepatotoxicity including fatal fulminant hepatitis (transaminase elevations, with or without hyperbilirubinemia, prolonged partial thromboplastin time, or eosinophilia), has occurred in patients treated with lamivudine. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination including lamivudine.
Zidovudine may competitively inhibit the intracellular phosphorylation of stavudine. Therefore combination of Zidovudine with stavudine is not recommended. The induction of CYP3A by nevirapine may result in lower plasma concentrations of the other concomitantly administered drugs that are extensively metabolized by C.P.A. Thus, if a patient has been stabilized on a dosage regimen of a drug metabolized by C.P.A begin treatment with nevirapine, dose adjustments may be necessary.
There are insufficient data to assess whether the dose adjustments are necessary when nevirapine and rifampin or rifabutin are coadminsitered. Therefore, these drugs should only be used in combination if clearly indicated and with careful monitoring. Coadminsitration of nevirapine with ketoconazole or oral contraceptives resulted in a significant reduction in plasma concentrations; therefore these drugs should not be administered with nevirapine.
One tablet to be administered twice daily for patients < 60 kg
One tablet to be administered twice daily for patients > 60 kg
Store in a cool, dark and dry place.