Composition:

EMTRI SUSPENSION
Each 5 ml of reconstituted suspension contains:
Nevirapine70 mg
Lamivudine40 mg
Stavudine10 mg

Indication:

Management of Human Immunodeficiency Virus (HIV) infection.


Contraindications:

Contraindicated in patients hypersensitive to any of the components of the formulation.


Warnings and Precautions:

Lamivudine, Stavudine and Nevirapine should be used with caution in patients with hepatic disease or in those with known risk factors for liver disease. Lamivudine should be used with caution in patients with impaired renal function, including renal failure. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including Lamivudine, Stavudine alone or in combination with other antiretrovirals. Treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity. Motor weakness, Peripheral neuropathy, and pancreatitis may occur with Stavudine. Severe or life-threatening hepatotoxicity, including fatal fulminant hepatitis and severe life-threatening skin reactions have occurred in patients receiving Nevirapine. Monitoring of hepatic transaminases is strongly recommended during first six months of Nevirapine treatment. Treatment with Nevirapine should be withheld in patients with moderate or severe AST and ALT abnormalities and in patients developing signs or symptoms of severe skin reactions. The maximum recommended doses of Nevirapine, Lamivudine and Stavudine in children are 400 mg, 300 mg and 60 mg respectively, per day.


Drug Interactions:

Zidovudine may competitively inhibit the intracellular phosphorylation of Stavudine. Therefore, use of Zidovudine in combination with Stavudine is not recommended. The induction of CYP3A by Nevirapine may result in lower plasma concentrations of other concomitantly administered drugs that are extensively metabolized by CYP3A4. Thus, if a patient has been stabilized on a dosage regimen for a drug metabolized by CYP3A4 and begins treatment with Nevirapine, dose adjustments may be necessary. There are insufficient data to assess whether dose adjustments are necessary when Nevirapine and rifampin or rifabutin are co-administered. Co-administration of Nevirapine and Ketoconazole results in a significant reduction in Ketoconazole plasma concentrations. Nevirapine may decrease plasma concentrations of oral contraceptives; therefore, these drugs should not be administered concomitantly with Nevirapine.


Adverse Reactions:

Lactic acidosis, headache, malaise, fatigue, fever, chills, diarrhea, nausea, vomiting, anorexia and/or decreased appetite, peripheral neuropathy, insomnia and other sleep disorders, nasal signs and symptoms, cough, musculoskeletal pain, rash, abnormal liver function tests.


Dosage And Administration:

For children aged 3 months to less than 8 years, the dose according to weight will be as per the table below:

Weight Teaspoonful (5 ml) BID Stavudine Lamivudine Nevirapine
7.5-12.5 kg 1 10 mg 40 mg 70 mg
12.5-17.5 kg 1.5 15 mg 60 mg 105 mg
17.5-22.5 kg 2 20 mg 80 mg 140 mg
22.5-27.5 kg 2.5 25 mg 100 mg 175 mg