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Información de la droga para MUPIROCIN OINTMENT USP, 2% (E. FOUGERA & CO., A division of Nycomed US Inc.): CLINICAL STUDIES
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- CLINICAL STUDIES
- HOW SUPPLIED
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 22 G CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 22 G CARTON
The efficacy of topical mupirocin ointment in impetigo was tested in two studies. In the first, patients with impetigo were randomized to receive either mupirocin ointment or vehicle placebo t.i.d. for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients included) were 71% for mupirocin ointment (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment. In the second study, patients with impetigo were randomized to receive either mupirocin ointment t.i.d. or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) for 8 days. There was a follow-up visit 1 week after treatment ended.
Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric patients included) were 93% for mupirocin ointment (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable patient populations were 100% for both test groups. There were no side effects reported in the mupirocin ointment group.
There were 91 pediatric patients aged 2 months to 15 years in the first study described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment (n=42) and 36% for vehicle placebo (n=49). In the second study described above, all patients were pediatric except two adults in the group receiving mupirocin ointment. The age range of the pediatric patients was 7 months to 13 years.
The clinical efficacy rate for mupirocin ointment (n=27) was 96%, and for erythromycin it was unchanged (78.5%).
- Drug Information Provided by National Library of Medicine (NLM).