"Sage Products announced on July 29 that it is voluntarily recalling one lot of Comfort Shield Barrier Cream Cloths to the distributor and healthcare facility/user level because of product contamination with the bacterium Burkholderia"...
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 cream [see ADVERSE REACTIONS].
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 cream, 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. difficile.
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 BACTROBAN cream may result in overgrowth of nonsusceptible microorganisms, including fungi [see DOSAGE AND ADMINISTRATION].
Risk Associated With Mucosal Use
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
Advise the patient to administer BACTROBAN cream as follows:
- Use BACTROBAN cream only as directed by the healthcare provider. It is for external use only. Avoid contact of BACTROBAN cream with the eyes. If BACTROBAN cream gets in the eyes, rinse thoroughly with water.
- Do not use BACTROBAN cream in the nose.
- Wash your hands before and after applying BACTROBAN cream.
- Use a gauze pad or cotton swab to apply a small amount of BACTROBAN cream 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 cream 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 no improvement is seen in 3 to 5 days, contact the healthcare provider.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium 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 100 mg per kg per day which is 14 times the human topical dose (approximately 60 mg mupirocin per 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 BACTROBAN cream (contains equivalent of 2% mupirocin free acid) in pregnant women. Because animal reproduction 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 160 mg per kg per day in both species. This dose is 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 mupirocin.
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 BACTROBAN cream is administered to a nursing woman.
The safety and effectiveness of BACTROBAN cream have been established in the age-groups 3 months to 16 years. Use of BACTROBAN cream in these age-groups is supported by evidence from adequate and well-controlled trials of BACTROBAN cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see Clinical Studies].
In 2 adequate and well-controlled trials, 30 subjects older than 65 years were treated with BACTROBAN cream. No overall difference in the efficacy or safety of BACTROBAN cream was observed in this patient population when compared with that observed in younger patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/11/2016
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