Therapeutic Category:

Anti-retroviral


Composition:Each kit contains

Part A: Each uncoated tablet contains Stavudine IP 30/40 mg and Lamivudine IP 150 mg.

Part B: Each film-coated tablet contains: Efavirenz IP 600 mg.


Indications:

For the treatment of Human Immunodeficiency Virus (HIV) infection in adults.


Dosage and Administration:

One tablet from part A is to be taken once in the morning and once in the evening. One tablet of part B is to be taken once daily on an empty stomach, preferably at bed-time.


Warnings and Precautions:

Use Lamivudine with extreme caution in pediatric patients with a history of prior antiretroviral nucleoside exposure, pancreatitis or other risk factors for developing pancreatitis, patients with known risk factors for liver disease. Treatment with Lamivudine should be suspended in any patient who develops lactic acidosis or hepatotoxicity. This product should be used with caution in patients with hepatic disease or in those with known risk factors for liver disease.


Drug Interaction:

Combination of Zidovudine with Stavudine is not recommended. Concomitant use of this product with Zidovudine, Doxorubicin, Ribavirin, Midazolam, Triazolam, Zalcitabine, Astemizole, Cisapride and ergot derivatives should be avoided.


Adverse Reactions:

Adverse effects of Lamivudine include stomatitis, hyperglycemia, anemia, lymphadenopathy, splenomegaly, diarrhea, headache, fatigue, insomnia, arthralgia, myalgia, neuropathy, skin rash, post treatment exacerbation of hepatitis B, fever with or without chills and rarely neutropenia. Lactic acidosis and severe hepatomegaly with steatosis, including pancreatitis have been reported. Adverse events observed with Efavirenz are nervous system symptoms, psychiatric symptoms and rash. Other side effects are allergic reactions, asthenia, ataxia, convulsions, hypoesthesia, paraesthesia, neuropathy, asymptomatic increases in serum amylase levels, tremor, gynaecomastia, constipation, malabsorption, flushing, palpitations, hepatic failure, pancreatitis hypercholesterolaemia, hypertriglyceridaemia, arthralgia, myalgia, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, dyspnoea, erythema multiforme Stevens-Johnson Syndrome and tinnitus. Adverse effects of Stavudine include fever with or without chills, anorexia and/ or decreased appetitie, neuropathy, insomnia and other sleep disorders, musculoskeletal pain, rash, neutropenia, thrombocytopenia. Lactic acidosis, severe hepatomegaly with steatosis and recurrent hepatitis following discontinuation of therapy has also been reported.


Pregnancy:

Category D. Nursing mothers: Mothers should be instructed not to breast feed if they are receiving this kit.


Contraindications:

Patients hypersensitive to any of the components of the formulation. Efavirenz must not be administered concurrently with Astemizole, Cisapride, Midazolam, Triazolam or ergot alkaloids.


Overdosage:

Treatment of overdose should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. Administration of activated charcoal may be used. There is no specific antidote for overdose with this product.


Storage:

Store in a cool and dry place, protect from moisture.


Presentation:

Blister strip of 5 kits. For further information, please consult the full prescribing information.