Retapamulin warnings and precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Warnings and Precautions
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)].
Not for Systemic or Mucosal Use
ALTABAX is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use. The efficacy and safety of ALTABAX on mucosal surfaces have not been established.
Epistaxis has been reported with the use of ALTABAX on nasal mucosa.
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.
Use in Specific Populations
Pregnancy Category: B
Effects on embryo-fetal development were assessed in pregnant rats given 50, 150, or 450 mg/kg/day by oral gavage on days 6 to 17 postcoitus. Maternal toxicity (decreased body weight gain and food consumption) and developmental toxicity (decreased fetal body weight and delayed skeletal ossification) were evident at doses ≥150 mg/kg/day. There were no treatment-related malformations observed in fetal rats.
Retapamulin was given as a continuous intravenous infusion to pregnant rabbits at dosages of 2.4, 7.2, or 24 mg/kg/day from day 7 to 19 of gestation. Maternal toxicity (decreased body weight gain, food consumption, and abortions) was demonstrated at dosages ≥7.2 mg/kg/day (8-fold the estimated maximum achievable human exposure, based on AUC, at 7.2 mg/kg/day). There was no treatment-related effect on embryo-fetal development.
There are no adequate and well-controlled trials in pregnant women. Because animal reproduction studies are not always predictive of human response, ALTABAX should be used in pregnancy only when the potential benefits outweigh the potential risk.
Nursing Mother
It is not known whether retapamulin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALTABAX is administered to a nursing woman. The safe use of retapamulin during breastfeeding has not been established.
Pediatric Use
The safety and effectiveness of ALTABAX in the treatment of impetigo have been established in pediatric patients aged 9 months to 17 years. Use of ALTABAX in pediatric patients (9 months to 17 years) is supported by evidence from adequate and well-controlled trials of ALTABAX in which 588 pediatric subjects received at least one dose of retapamulin ointment, 1% [see Adverse Reactions (6.1), Clinical Studies (14)]. The magnitude of efficacy and the safety profile of ALTABAX in pediatric subjects 9 months and older were similar to those in adults.
The safety and effectiveness of ALTABAX in pediatric patients younger than 9 months of age have not been established. An open-label clinical trial of topical treatment with ALTABAX (twice daily for 5 days) was conducted in patients aged 2 to 24 months. Plasma samples were obtained from 79 subjects. In these pediatric subjects, systemic exposure of retapamulin was higher compared with subjects aged 2 to 17 years. Furthermore, a higher proportion of pediatric subjects aged 2 to 9 months had measurable concentrations (>0.5 ng/mL) of retapamulin compared with subjects aged 9 to 24 months [see Pharmacokinetics (12.3)]. The highest levels were seen in subjects aged 2 to 6 months [see Pharmacokinetics (12.3)]. The use of retapamulin is not indicated in pediatric patients younger than 9 months.
Geriatric Use
Of the total number of subjects in the adequate and well-controlled trials of ALTABAX, 234 subjects were 65 years of age and older, of whom 114 subjects were 75 years of age and older. No overall differences in effectiveness or safety were observed between these subjects and younger adult subjects.[1]
References
Adapted from the FDA Package Insert.