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 treated with
formulations of BACTROBAN, including BACTROBAN ointment [see ADVERSE
Avoid contact with the eyes. In case of accidental
contact, rinse well with water.
In the event of a sensitization or severe local
irritation from BACTROBAN ointment, usage 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. Hypertoxinproducing 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
BACTROBAN ointment may result in overgrowth of nonsusceptible microorganisms,
including fungi [see DOSAGE AND ADMINISTRATION].
Risk Associated With Mucosal Use
BACTROBAN ointment is not formulated for use on mucosal
surfaces. Intranasal use has been associated with isolated reports of stinging
and drying. A separate formulation, BACTROBAN® (mupirocin calcium) nasal
ointment, is available for intranasal use.
Risk Of Polyethylene Glycol Absorption
Polyethylene glycol can be absorbed from open wounds and
damaged skin and is excreted by the kidneys. In common with other polyethylene
glycol-based ointments, BACTROBAN ointment should not be used in conditions
where absorption of large quantities of polyethylene glycol is possible,
especially if there is evidence of moderate or severe renal impairment.
Risk Associated With Use at Intravenous Sites
BACTROBAN ointment should not be used with intravenous
cannulae or at central intravenous sites because of the potential to promote
fungal infections and antimicrobial resistance.
Patient Counseling Information
Advise the patient to read the FDA-approved patient
labeling (PATIENT INFORMATION).
Advise the patient to administer BACTROBAN ointment as
- Use BACTROBAN ointment only as directed by the healthcare
provider. It is for external use only. Avoid contact of BACTROBAN ointment with
the eyes. If BACTROBAN ointment gets in the eyes, rinse thoroughly with water.
- Do not use BACTROBAN ointment in the nose.
- Wash your hands before and after applying BACTROBAN
- Use a gauze pad or cotton swab to apply a small amount of
BACTROBAN ointment to the affected area. The treated area may be covered by
gauze dressing if desired.
- Report to the healthcare provider any signs of local
adverse reactions. BACTROBAN ointment should be stopped and the healthcare
provider contacted if irritation, severe itching, or rash occurs.
- Report to the healthcare provider or go to the nearest
emergency room if severe allergic reactions, such as swelling of the lips,
face, or tongue, or wheezing occur [see WARNINGS AND PRECAUTIONS].
- If impetigo has not improved in 3 to 5 days, contact the
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.
In a fertility/reproductive performance study (with
dosing through lactation), mupirocin administered subcutaneously to male and
female rats at doses up to 100 mg per kg per day which is 14 times the human
topical dose (approximately 60 mg mupirocin per day) based on calculations of
dose divided by the entire body surface area, did not result in impaired
fertility or impaired reproductive performance attributable to mupirocin.
Use In Specific Populations
There are insufficient human data to establish whether
there is a drug-associated risk with BACTROBAN ointment in pregnant women.
Systemic absorption of mupirocin through intact human skin is minimal following
topical administration of mupirocin ointment [see CLINICAL PHARMACOLOGY].
No developmental toxicity was observed in rats or rabbits treated with
mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg
per day, respectively (22 and 11 times the human topical dose based on
calculations of dose divided by the entire body surface area).
The estimated background risk of major birth defects and
miscarriages for the indicated population is unknown. The estimated background
risk in the U.S. general population of major birth defects is 2% to 4% and of
miscarriage is 15% to 20% of clinically recognized pregnancies.
Animal Data: Developmental toxicity studies have
been performed with mupirocin administered subcutaneously to rats and rabbits
at doses up to 160 mg per kg per day during organogenesis. This dose is 22 and
43 times, respectively, the human topical dose (approximately 60 mg mupirocin
per day) based on calculations of dose divided by the entire body surface area.
Maternal toxicity was observed (body weight loss/decreased body weight gain and
reduced feeding) in both species with no evidence of developmental toxicity in
rats. In rabbits, excessive maternal toxicity at the high dose precluded the
evaluation of fetal outcomes. There was no developmental toxicity in rabbits at
40 mg per kg per day, 11 times the human topical dose based on calculations of
dose divided by the entire body surface area.
Mupirocin administered subcutaneously to rats in a
pre-and postnatal development study (dosed during late gestation through
lactation) was associated with reduced offspring viability in the early
postnatal period at a dose of 106.7 mg per kg, in the presence of injection
site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the
human topical dose based on calculations of dose divided by the entire body
surface area. The no-observed adverse effect level in this study was 44.2 mg
per kg per day, which is 6 times the human topical dose.
It is not known whether mupirocin is present in human
milk, has effects on the breastfed child, or has effects on milk production.
However, breastfeeding is not expected to result in exposure of the child to
the drug due to the minimal systemic absorption of mupirocin in humans
following topical administration of BACTROBAN ointment [see CLINICAL
PHARMACOLOGY]. The developmental and health benefits of breastfeeding
should be considered along with the mother's clinical need for BACTROBAN
ointment and any potential adverse effects on the breastfed child from
BACTROBAN ointment or from the underlying maternal condition.
To minimize oral exposure of the drug to children, a
breast and/or nipple being treated with BACTROBAN ointment should be thoroughly
washed prior to breastfeeding.
The safety and effectiveness of BACTROBAN ointment have
been established in the age range of 2 months to 16 years. Use of BACTROBAN
ointment in these age-groups is supported by evidence from adequate and
well-controlled trials of BACTROBAN ointment in impetigo in pediatric subjects
studied as a part of the pivotal clinical trials [see Clinical Studies].