Post-authorization Study of Cefixime 100 mg Powder for Oral Suspension

Abstract

Introduction: Cephalosporins, broad-spectrum antibiotics of the third-generation beta-lactam group administered orally are used to treat infections by Gram-positive and Gram-negative germs and their prescription is approved to treat upper and lower respiratory tract, urinary tract and digestive tract infections.

Objective: To study the post-authorization use of cefixime 100 mg powder for oral suspension according to its characterization, effectiveness and adverse reactions during pediatric clinical practice.

Methods: A descriptive, cross-sectional, observational, descriptive, cross-sectional study of drug utilization was carried out, which classifies as prescription-indication with elements of therapeutic scheme and practical consequences, on prescription of cefixime 100 mg at the William Soler University Pediatric Hospital, during a period of 3 months with a population of 24 hospitalized patients who had treatment with the antimicrobial, age between 3 months and 10 years of life. The information was obtained by means of a data collection sheet prepared as described in the protocol for the post-authorization study of use.

Results: The study population consisted of 15 girls (62.5%) and 9 boys (37.5%), aged between 3 months and 10 years. Prevalent age was one year (16.7 %). According to the therapeutic indications section of the summary of product characteristics of cefixime 100 mg, it was considered that its indication, dosage and duration of treatment were adequate to treat the diseases suffered by the patients, and demonstrated the effectiveness of the antimicrobial. Adverse reactions reported, the most frequent being skin reactions and urticaria.

Conclusions: The prescription of the drug was correct in the usual pediatric clinical practice of the selected health institution and the cefixime under study in all patients treated manifested effectiveness or achieved effective treatment, while the adverse reactions to the drug reported correspond to those described in the reference standard of the product.