Abridged Prescribing Information: Emduo Junior Dispersible Tablet


Composition:

Each uncoated dispersible tablet contains Lamivudine IP 40 mg and Stavudine IP 10 mg.


Indications:

Management of Human Immunodeficiency Virus (HIV) infection in combination with other antiretroviral agents, in children.


Dosage and Administration:

For children aged 3 months to less than 8 years, dose is according to weight.
Weight 7.5-12.5 kg: 1 tablet twice daily;
Weight 12.5 -17.5 kg: 1 ½ tablets twice daily;
Weight 17.5 - 22.5 kg: 2 tablets twice daily;
Weight 22.5 - 27.5 kg: 2 ½ tablets twice daily.


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 / severe hepatomegaly with steatosis have been reported with the use of Lamivudine, Stavudine alone or in combination with other antiretroviral. 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 Interaction:

Use of Lamivudine in combination with Zalcitabine is not recommended. Zidovudine may competitively inhibit the intracellular phosphorylation of Stavudine. 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, headache, abnormal liver function tests.


Contraindications:

Patients with known hypersensitivity to any of the components of the formulation.


Overdosage:

Stavudine can be removed by hemodialysis. There is no known antidote for Lamivudine overdosage.


Storage:

Store in a cool and dry place.


Presentation:

Blister strip of 10 tablets. For further information, please consult the full prescribing information.