Introduction:

Pediatric tuberculosis has been a global epidemic hidden for decades with difficulties in its control, among which is difficult compliance with treatment due to the correct administration of treatment in children who cannot swallow solid pharmaceutical presentations. The treatment of tuberculosis is a combined therapy, so its design must take into account the final volume to be administered of all the formulations as well as its palatability to promote therapeutic adherence.

Objective:

Evaluation of the effectiveness and safety of a magisterial formula of isoniazid 50 mg/mL.

Material and methods:

A 5-year retrospective observational study, including all patients who received this formula. The following variables were recorded: age, sex, indication, adverse reactions and evolution. Databases: Silicon® (dispensing computer support) and IANUS® (electronic medical record). The effectiveness was assessed using clinical, radiological and/or analytical criteria. To detect adverse reactions, blood tests were performed and the appearance of symptoms associated with the intake of sorbitol containing the formula was evaluated.

Results:

Composition of the formula (100 mL): isoniazid 5 g, preservative water 50 mL (contains Nipagin® 0.08% and Nipasol® 0.02%) and sorbitol 70% 50 mL.

The established expiration period was 30 days, coinciding with that referenced in the bibliography. The pH of the elaborated liquid oral formula (LOF) was 6.45±0.05, which corresponds to the maximum stability of the active principle.

A total of 43 patients (22 women) with a median age of 0.87 (0.1-6) years received isoniazid treatment, 62.8% received as prophylaxis and 37.1% as treatment. 88.4% of the cases were resolved favorably. 3 patients suspended treatment due to not requiring continuation of prophylaxis, 1 patient due to resistance of the microorganism and 1 patient due to hepatotoxicity.

Conclusions:

Isoniazid 50 mg/mL has proven to be a safe and effective magisterial formula for prophylaxis and treatment of tuberculosis in pediatric age.

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