Included as part of the PRECAUTIONS section.
Severe Allergic Reactions
Systemic allergic reactions, including anaphylaxis,
urticaria, angioedema, and generalized rash have been reported in patients with
mupirocin formulations. [see ADVERSE REACTIONS].
Eye and Nose Irritation
CENTANY® ointment is not for ophthalmic use or nasal use
or on mucosal surfaces. If this product comes in contact with the eyes, rinse
thoroughly with water.
If a reaction suggesting sensitivity or chemical
irritation should occur with the use of CENTANY® ointment treatment should be
discontinued and appropriate alternative therapy for the infection instituted.
Clostridium Difficile-associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD)
has been reported with use of nearly all antibacterial agents, and may range in
severity from mild diarrhea to fatal colitis. Treatment with antibacterial
agents alters the normal flora of the colon leading to overgrowth of C.
C. difficile produces toxins A and B which
contribute to the development of CDAD. Hypertoxin-producing strains of C.
difficile cause increased morbidity and mortality, as these infections can
be refractory to antimicrobial therapy and may require colectomy. CDAD must be
considered in all patients who present with diarrhea following antibacterial
drug use. Careful medical history is necessary since CDAD has been reported to
occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial
drug use not directed against C. difficile may need to be discontinued. Appropriate
fluid and electrolyte management, protein supplementation, antibacterial
treatment of C. difficile, and surgical evaluation should be instituted
as clinically indicated.
Potential For Microbial Overgrowth
As with other antibacterial products, prolonged use of
CENTANY® ointment may result in overgrowth of nonsusceptible microorganisms, including
fungi [see DOSAGE AND ADMINISTRATION].
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies in animals to evaluate carcinogenic
potential of mupirocin have not been conducted.
Results of the following studies performed with mupirocin
calcium or mupirocin sodium in vitro and in vivo did not indicate a potential
for genotoxicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis
for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation
assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone
marrow micronuclei assay in mice.
Reproduction studies were performed with mupirocin
administered subcutaneously to male and female rats at doses up to 14 times the
human topical dose (approximately 60 mg mupirocin/day) based on body surface
area. Neither evidence of impaired fertility nor impaired reproductive
performance attributable to mupirocin was observed.
Use In Specific Populations
Pregnancy Category B
There are no adequate and well-controlled studies of
CENTANY® ointment in pregnant women. Because animal studies are not always predictive
of human response, this drug should be used during pregnancy only if clearly
needed. Developmental toxicity studies have been performed with mupirocin administered
subcutaneously to rats and rabbits at doses up to 22 and 43 times,
respectively, the human topical dose (approximately 60 mg mupirocin per day)
based on body surface area. There was no evidence of fetal harm due to
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when CENTANY® ointment is administered to a nursing woman.
The safety and effectiveness of CENTANY® ointment have
been established in the age range of 2 months to 16 years. Use of CENTANY® ointment
in these age groups is supported by evidence from adequate and well-controlled
studies of CENTANY® ointment in impetigo in pediatric patients studied as a
part of the pivotal clinical trials [see Clinical Studies].