This combination is indicated for treatment of HIV infection in children.

bPlease email for Dosage Chart. /b

Each Uncoated Dispersible Tablet contains :
b
Lamivudine 30mg
Stavudine 6mg
Nevirapine 50mg
/b

Before initiating therapy with this combination bplease consult your health care professional about lead in dosages. Lead in dosages are important so the body adjusts to this combination drug therapy./b Please consult your health care professional before starting this medication as this is a fixed dosage medication and take exactly as prescribed by your health care professional.

bWomen and patients with higher CD4 counts are at increased risk of these hepatic events. Women with CD4 counts 250 cell/MM3 including pregnant women are at considerably higher risk of these events. Patients with signs or symptoms of Hepatitis must discontinue Nevirapine and seek Medical Evaluation IMMEDIATELY. /b

bNevirapine : /b As this is a fixed dose combination this medication should not be taken by anyone requiring a dosage adjustment and it should be discontinued if the child experiences severe rash during thier lead in dosing of Nevirapine until the rash has resolved the patient should not start therapy with this combination treatment for children twice daily until the rash has resolved. If clinical hepatitis occurs nevirapine should be permanently discontinued and not restarted after recovery.

bStavudine :/b Patients should be monitored for the development of peripheral neuropathy which is usually manifested by numbness tingling or pain in the feet or hands. These symptoms maybe difficult to detect in young children. If these symptoms develop during therapy stavudine treatment should be stopped. Symptoms may resolve if therapy is withdrawn promptlyin some cases they may worsen temporarily. If symptoms resolve completely patients may tolerate resumption of treatment at one half the recommended dose.

This Combination is contra indicated in patients with clinically significant hypersensitvity to any of the components contained in the formula.

b Lamivudine : /b There is no known antitode for Lamivudine. It is not known whether lamivudine can be removed by peritoneal dialysis or haemodyalisis.

b Stavudine :/b Experience with adults treated with 12 to 24 times the recommended dosage revealed no acute toxicity. Complications of chronic overdosage include peripheral neuropathy and hepatic toxicity. Stavudine can be removed by heamodyalisis.

b Nevirapine : /b There is no known antidote for Nevirapine.

Severe life-threatining and in some cases fatal heptotoxicity including fulminant and cholestatic hepatitis hepttic necrosis and hepatic failure have been reported in patients treated with nevirapine. The risk is greatest during the first 6 weeks of therapy and continues through 18 weeks of treatment. However hepatitic events may occur at any time during the treatment. In some cases patients presented with non-specific prodormal signs or symptoms of fatigue malaise anorexia nausea jaundice liver tenderness or hepatomegaly with or without initially abnormal seum transaminase levels.

Some of these events have progressed to hepatic failure with transaminase elevation with or without hyperbilirubinase levels prolonged partial thromboplastin time or eosinophilia. Rash and fever accompanied some of these hepatic events.

Patients with signs or symptoms of hepatitis must be advised to bdiscontinue/b this medication and immediately seek medical evaluation which should include liver funstion tests.

Do not double dose to make up for the missed dose. Consult your doctor for dosages and take exactly as directed.

When initiating therapy with this medicine for the treatment of HIV it is important to follow the lead in dosing recommendations.

Store in a cool dry place.

Intensive clinical and laboratory monitoring including liver function tests is important at baseline and during the first 18 weeks of treatment.

Monitoring should continue at regular intervals thereafter. Liver function tests should also be obtained for all patients who develop a rash in the first 18 weeks of treatment.

Physicians and Patients should be vigilant for the appearance of signs or symptoms of hepatitis such as fatigue malaise anorexia nausea jaundice bilirubinaria acholic stools liver tenderness or hepatomegaly. If Clinical hepatitis occurs this medication should be permanently discontinued and not restarted after recovery.