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Product
Antiretroviral products (Triomune)
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Antiretroviral products (Triomune)
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Triomune
Triomune
Tablets .
COMPOSITION
Triomune-30
Each tablet contains Stavudine 30 mg, Lamivudine 150 mg, Nevirapine
200 mg
Triomune-40
Each tablet contains Stavudine 40 mg, Lamivudine 150 mg, Nevirapine
200 mg
Indications
Triomune is indicated for the treatment of HIV infection, once patients have
been stabilized on the maintenance regimen of nevirapine 200 mg bd, and
have demonstrated adequate tolerability to nevirapine.
Dosage and Administration
Adults
Triomune-30
1 tablet twice daily for patients weighing <60 kg
Triomune-40
1 tablet twice daily for patients weighing >60 kg
Triomune should not be administered to patients who have just initiated
therapy with nevirapine. This is because an initial lead-in dosing of 200 mg
nevirapine once daily for 2 weeks is recommended. Following this lead-in
dose, a dose escalation (maintenance dose) to 200 mg nevirapine bd may
be carried out in the absence of any hypersensitivity reactions (e.g. rash,
liver function test abnormalities).
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MONITORING OF PATIENTS
Clinical chemistry tests, which include liver function to
performed prior to initiating lead-in nevirapine therapy and at appropriate
intervals during therapy.
DOSAGE ADJUSTMENT
Because it is a fixed-dose combination, Triomune should not be prescribed
for patients requiring dosage adjustment, such as those with low body
weight (<50 kg).
Triomune should be discontinued if patients experience severe rash or a
rash accompanied by constitutional findings. Patients experiencing mild to
moderate rash during the 14-day lead-in period of 200 mg/day should not
have their nevirapine dose increased or start therapy with Triomune until
the rash has resolved (see Warnings and Precautions).
Triomune administration should be interrupted in patients experiencing
moderate or severe liver function tests abnormalities (excluding GGT),
until the liver function test elevations have returned to baseline. Nevirapine
(using Nevimune Tablets) may then be restarted at 200 mg per day.
Increasing the daily dose to 200 mg twice daily (using Triomune) should
be done with caution, after extended observation. Nevirapine should be
permanently discontinued if moderate or severe liver function test
abnormalities recur
Contraindications
Triomune is contraindicated in patients with clinically significant
hypersensitivity to any of the components contained in the formulation.
Triomune is also contraindicated for patients who are just initiating therapy
with nevirapine.
Presentation
Triomune-30 Container of 30 tablets
Triomune-40 Container of 30 tablets
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