Therapeutic Category:

Anti-retroviral reverse transcriptase inhibitor,


Composition:

EMDUO SUSPENSION
Each 5 ml. of reconstituted suspension contains:
Lamivudine IP40 mg
Stavudine IP10 mg

Indication:

Management of Human Immunodeficiency Virus (HIV) infection.


Contraindications:

This fixed dose combination is contraindicated in patients hypersensitive to any of the components of the formulation.


Warnings and precautions:

Lamivudine and Stavudine 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. Lamivudine and Stavudine should be used cautiously in patients with known risk factors for liver disease. Lamivudine and Stavudine treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity. Some patients with HIV infection who have chronic liver disease due to hepatitis B virus infection may experience recurrent hepatitis upon discontinuation of Lamivudine. Motor weakness, peripheral neuropathy, and pancreatitis may occur with Stavudine. The maximum recommended doses of Lamivudine and Stavudine in children are 300 mg and 60 mg respectively, per day.


Drug Interactions:

Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of Lamivudine in combination with zalcitabine is not recommended. Zidovudine may competitively inhibit the intracellular phosphorylation of Stavudine. Therefore, use of Zidovudine in combination with Stavudine is not recommended.


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:

One teaspoonful (5 ml) to be taken twice daily. The dose according to weight will be as per the table below:

Wt.Teaspoonful ( 5 ml) BID Stavudine Lamivudine
7.5-12.5 kg 1 10 mg 40 mg
12.5-17.5 kg 1.5 15 mg 60 mg
17.5-22.5 kg 2 20 mg 80 mg
22.5-27.5 kg 2.5 25 mg 100 mg