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Triomune-40 contains 40mg Stavudine, 150mg Lamivudine, and 200mg Nevirapine

Description

Triomune is a combination of 3 drugs commonly used in the management of Human Immunodeficiency Virus (HIV) infection. Both stavudine and lamivudine belong to the nucleoside analogue class of antiretroviral drugs. Both drugs act by terminating the growth of the DNA chain and inhibiting the reverse transcriptase of HIV. Nevirapine is a non-nucleoside reverse transcriptase inhibitor. It acts by directly inhibiting reverse transcriptase.

Studies using the combination of stavudine + lamivudine + nevirapine have demonstrated its efficacy in patients with HIV infection. In the study presented by Kaspar et al at the 5th Conference on Retroviruses and Opportunistic Infections, Chicago 1998, 87% of patients had undetectable viral loads at 33-44 weeks. In the study presented by Russell et al at the 7th European Conference on Clinical Aspects and Treatment of HIV Infection, Lisbon 1999, CD4 counts increased by 195 cells/mm3 and 230 cells/mm3 in patients with low (<80,000 copies/ml) and high viral load (>80,000 copies/ml) groups, respectively at the end of 1 year. 72% of patients with low viral loads and 80% of patients with high viral loads had undetectable viral loads at the end of 1 year.

Each tablet of Triomune contains half of the commonly prescribed daily doses of stavudine, lamivudine and nevirapine. All three drugs are to be administered twice daily, permitting a fixed-dose combination to be formulated. With the availability of this combination formulation, patients may be better able to adhere to triple drug regimens, thereby enhancing compliance.

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; see Warnings and Precautions).

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 (see Warnings and Precautions).

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 (See Warnings and Precautions). 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 (see Warnings and Precautions).

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.

No data are available to recommend a dosage of nevirapine in patients with hepatic dysfunction, renal insufficiency or undergoing dialysis.

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. These patients require a lead-in dose of nevirapine 200 mg o.d., whereas this formulation contains the maintenance dose of nevirapine 200 mg b.d. (see Indications).