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warnings and cautions
5 WARNINGS AND PRECAUTIONS 5.1 Local Irritation In the event of sensitization or severe local irritation from ALTABAX, usage should be discontinued, the ointment wiped off, and appropriate alternative therapy for the infection instituted [see Patient Counseling Information (17)] . 5.2 Not for Systemic or Mucosal Use ALTABAX is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use. ALTABAX has not been evaluated for use on mucosal surfaces [see Patient Counseling Information (17)] . 5.3 Potential for Microbial Overgrowth The use of antibiotics may promote the selection of nonsusceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken. Prescribing ALTABAX in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
6 ADVERSE REACTIONS 6.1 Clinical Studies Experience The safety profile of ALTABAX was assessed in 2,115 adult and pediatric patients ≥9 months who used at least one dose from a 5-day, twice a day regimen of retapamulin ointment. Control groups included 819 adult and pediatric patients who used at least one dose of the active control (oral cephalexin), 172 patients who used an active topical comparator (not available in the US), and 71 patients who used placebo. Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of patients treated with retapamulin ointment, 6.6% (54/819) of patients receiving cephalexin, and 2.8% (2/71) of patients receiving placebo. The most common drug-related adverse events (≥1% of patients) were application site irritation (1.4%) in the retapamulin group, diarrhea (1.7%) in the cephalexin group, and application site pruritus (1.4%) and application site paresthesia (1.4%) in the placebo group. Because clinical studies are conducted under varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Adults The adverse events, regardless of attribution, reported in at least 1% of adults (18 years of age and older) who received ALTABAX are listed in Table 1. Table 1. Adverse Events Reported by Greater Than or Equal To 1% of Adult Patients Treated With ALTABAX in Phase 3 Clinical Studies Adverse Event ALTABAX N = 1,527 % Cephalexin N = 698 % Headache 2.0 2.0 Application site irritation 1.6 Less than 1.0 Diarrhea 1.4 2.3 Nausea 1.2 1.9 Nasopharyngitis 1.2 Less than 1.0 Creatinine phosphokinase increased Less than 1.0 1.0 Pediatrics The adverse events, regardless of attribution, reported in at least 1% of pediatric patients aged 9 months to 17 years who received ALTABAX are listed in Table 2. Table 2. Adverse Events Reported by Greater Than or Equal To 1% in Pediatric Patients Aged 9 Months to 17 Years Treated With ALTABAX in Phase 3 Clinical Studies Adverse Event ALTABAX N = 588 % Cephalexin N = 121 % Placebo N = 64 % Application site pruritus 1.9 0 0 Diarrhea 1.7 5.0 0 Nasopharyngitis 1.5 1.7 0 Pruritus 1.5 1.0 1.6 Eczema 1.0 0 0 Headache 1.2 1.7 0 Pyrexia 1.2 Less than 1.0 1.6 Other Adverse Events Application site pain, erythema, and contact dermatitis were reported in less than 1% of patients in clinical studies.