Composition:

EMDUO-N 30/40 KIT
Part APart B
Each uncoated tablet contains:Each uncoated tablet contains:
Stavudine IP - 30/40 mgNevirapine IP - 200 mg
Lamivudine IP - 150 mg

Indication:

In the initial management of Human Immunodeficiency Virus (HIV) infection


Contraindication:

Patients with hypersensitivity 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 has occurred in patients treated with Nevirapine. Severe life-threatening skin reactions have occurred in patients receiving Nevirapine. Treatment with Nevirapine should be withheld in patients with moderate or severe AST and ALT abnormalities. Nevirapine should be discontinued in patients developing signs or symptoms of severe skin reactions.


Pregnancy:

Category C. There are no adequate and well-controlled studies of Stavudine, Lamivudine and Nevirapine in pregnant women. Emduo-N should be used during pregnancy only if the potential benefit justifies the potential risk. Nursing mother: Lamivudine, Stavudine and Nevirapine are known to secrete in breast milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving Emduo-N.


Drug Interactions:

Zidovudine may competitively inhibit the intracellular phosphorylation of Stavudine. Therefore, use of Zidovudine in combination with Stavudine is not recommended. Lamivudine and Zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of Lamivudine in combination with Zalcitabine 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. 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 appetitie, neutopathy, insomnia and other sleep disorders, nasal signs and symptoms, cough, musculoskeletal pain, rash, abnormal liver function tests.


Dosage And Administration:

Emduo-N 30: Emduo-N 40:
For Adult patients < 60 kg weight:
One tablet from Part A [containing Lamivudine (150 mg) and Stavudine (30mg)] is to be taken in the morning and one in the evening. One tablet of Part B [containing Nevirapine (200 mg)] is to be taken once daily in the morning. This initial therapy is for 14 days.

For Adult patients > = 60 kg weight:
One tablet from Part A [containing Lamivudine (150 mg) and Stavudine (40mg)] is to be taken in the morning and one in the evening. One tablet of Part B [containing Nevirapine (200 mg)] is to be taken once daily in the morning. This initial therapy is for 14 days.