TRIOMUNE BABY Tablets
Each tablet contains:
Stavudine ……. .. 6 mg
Lamivudine …. .. 30 mg
Nevirapine …….. 50 mg

TRIOMUNE JUNIOR Tablets
Each tablet contains:
Stavudine ……….. 12 mg
Lamivudine ……... 60 mg
Nevirapine ……… 100 mg

TRIOMUNE BABY/JUNIOR Tablets are indicated for the treatment of HIV-1 infection in children less than 30 kg, once patients have demonstrated adequate tolerability to nevirapine during the lead-in dosing period (see DOSAGE AND ADMINISTRATION ).

• The 14-day lead-in period with nevirapine once daily dosing has been demonstrated to reduce the frequency of rash ( see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS ).
• If rash persists beyond the 14 day lead-in period, do not dose escalate to TRIOMUNE BABY/JUNIOR Tablets twice daily. The lead-in dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought.

Lead-in d osing

For the first 14 days of therapy with TRIOMUNE BABY /JUNIOR Tablets , it is important to follow the dosing recommendations given below.

For Children <30 kg

Lamivir-S Baby/Junior tablets should be administered to patients who are initiating therapy with TRIOMUNE BABY/JUNIOR Tablets , as per the schedule given in Table 2 below. This is to facilitate the 14-day lead-in dosing for nevirapine.

Table 2: Lead-in dosage schedule for children weighing <30 kg

For Children ≥30 kg

Lamivir-S 30 tablets should be administered to patients who are initiating therapy with Triomune-30 tablets , as per the schedule given below in Table 3. This is to facilitate the 14-day lead-in dosing for nevirapine.

Table 3: Lead-in dosage schedule for children weighing ≥ 30 kg  

Chronic Dosing

Following this lead-in dose, treatment with TRIOMUNE BABY/JUNIOR Tablets or Triomune-30 tablets (based on the weight of the child) twice daily may be carried out in the absence of any hypersensitivity reactions (eg, rash, liver function test abnormalities; see WARNINGS AND PRECAUTIONS ). Table 4 lists the dosage schedule for TRIOMUNE BABY/JUNIOR Tablets twice daily.

Table 4: Chronic dosage schedule for TRIOMUNE BABY/JUNIOR Tablets  

For c hildren ≥ 30 kg

For children with higher body weights, Triomune-30 tablets twice daily may be used, as per the schedule given below in Table 5.

Table 5: Continuous dosage schedule for Triomune-30 tablets

Method of Preparation

For children unable to swallow tablets, disperse one tablet in two teaspoonfuls (10 ml) of drinking water and administer. The dispersion should be drunk immediately and is palatable with a bland taste.

Monitoring of Patients

Intensive clinical and laboratory monitoring, including liver function tests, is essential at baseline and during the first 18 weeks of treatment with TRIOMUNE BABY/JUNIOR Tablets . The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver function tests at baseline, prior to dose escalation, and at 2 weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment. In some cases, hepatic injury has progressed despite discontinuation of treatment.

Stavudine

Patients should be monitored for the development of peripheral neuropathy, which is usually manifested by numbness, tingling or pain in the feet or hands. These symptoms may be difficult to detect in young children. If these symptoms develop during treatment, stavudine therapy should be interrupted. Symptoms may resolve if therapy is withdrawn promptly. In some cases, symptoms may worsen temporarily following discontinuation of therapy. If symptoms resolve completely, patients may tolerate resumption of treatment at one half the recommended dose.

Nevirapine

Nevirapine should be discontinued if patients experience severe rash or a rash accompanied by constitutional findings (see WARNINGS AND PRECAUTIONS ). Patients experiencing rash during the once daily 14-day lead-in period with TRIOMUNE BABY/JUNIOR Tablets should not shift to twice-daily maintenance dosing of TRIOMUNE BABY/JUNIOR Tablets until the rash has resolved (see WARNINGS AND PRECAUTIONS ). The total duration of the once daily lead-in dosing period should not exceed 28 days, at which point an alternative regimen should be sought.

If clinical (symptomatic ) hepatitis occurs, nevirapine should be permanently discontinued and not restarted after recovery.

Patients who interrupt the dosing of TRIOMUNE BABY/JUNIOR Tablets for more than 7 days should restart the recommended dosing, using TRIOMUNE BABY/JUNIOR Tablets once daily for the first 14 days (lead-in) in combination with stavudine and lamivudine, followed by Triomune Baby/Junior Tablets in the absence of any signs of hypersensitivity.

TRIOMUNE BABY/JUNIOR Tablets are contraindicated in patients with clinically significant hypersensitivity to any of the components contained in the formulation.

TRIOMUNE BABY/JUNIOR Tablets are also contraindicated in patients who are just initiating therapy with nevirapine. These patients require a lead-in dose of nevirapine o.d. (see Indications ).

TRIOMUNE BABY/JUNIOR Tablets are contraindicated in patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment ( see WARNINGS AND PRECAUTIONS ) .

Triomune Baby Tablets .........................Container of 60 tablets
Triomune Junior Tablets .......................Container of 60 tablets