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Triomune 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.

Triomune Dosage

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.

Monitoring of patients
Clinical chemistry tests, which include liver function tests, should be performed prior to initiating lead-in nevirapine therapy and at appropriate intervals during therapy.

Dosage Adjustment
Lamivudine
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).

Nevirapine
No data are available to recommend a dosage of nevirapine in patients with hepatic dysfunction, renal insufficiency or undergoing dialysis.
Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing, using one 200 mg Nevimune tablet daily for the first 14 days (lead-in) in combination with the other antiretrovirals, followed by 200 mg twice daily using Triomune in the absence of any signs of hypersensitivity.
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 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.
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.

Triomune Contraindications


Triomune is contraindicated:
- in patients with clinically significant hypersensitivity to any of the components contained in the formulation.
- for patients who are just initiating therapy with nevirapine. These patients require a lead-in dose of nevirapine 200 mg o.d., which has been shown to reduce the incidence of rash and development of hypersensitivity. Once patients have demonstrated adequate tolerability to Nevirapine during this time period, they can then be switched to Triomune, which contains the maintenance dose of nevirapine 200 mg b.d.
Thus, it is recommended that patients initiate therapy using a combination of Lamivir-S and Nevimune during the first two weeks, and then switch to Triomune once adequate tolerability is demonstrated.


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