July 25, 2016
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Bactroban Nasal

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Bactroban Nasal




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Severe Allergic Reactions

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of BACTROBAN [see ADVERSE REACTIONS].

Eye Irritation

Avoid contact with the eyes. In case of accidental contact, rinse well with water. Application of BACTROBAN nasal ointment to the eye under testing conditions has caused severe symptoms such as burning and tearing. These symptoms resolved within days to weeks after discontinuation of the ointment.

Local Irritation

In the event of a sensitization or severe local irritation from BACTROBAN nasal ointment, usage should be discontinued.

Clostridium Difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including BACTROBAN nasal ointment, 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 nasal ointment may result in overgrowth of nonsusceptible microorganisms, including fungi [see DOSAGE AND ADMINISTRATION].

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).

Advise the patient to administer BACTROBAN nasal ointment as follows:

  • Apply approximately one-half of the ointment from the single-use tube directly into 1 nostril and the other half into the other nostril.
  • Press the sides of the nose together and gently massage after application to spread the ointment throughout the inside of the nostrils.
  • Avoid contact of the medication with the eyes; if BACTROBAN nasal ointment gets in or near the eyes, rinse thoroughly with water.
  • Discard the tube after using. Do not re-use.
  • Discontinue usage of the medication and call the healthcare practitioner if sensitization or severe local irritation occurs.
  • It is important that you take the full course of BACTROBAN nasal ointment. Do not stop early because the amount of bacteria in your nose may not be reduced.

Nonclinical Toxicology

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 40 times the human intranasal dose (approximately 20 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

Pregnancy Category B

There are no adequate and well-controlled studies of BACTROBAN nasal ointment (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 65 and 130 times, respectively, the human intranasal dose (approximately 20 mg mupirocin per day) based on body surface area. There was no evidence of fetal harm due to mupirocin.

Nursing Mothers

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 nasal ointment is administered to a nursing woman.

Pediatric Use

Safety and efficacy in children younger than 12 years have not been established [see CLINICAL PHARMACOLOGY].

Pharmacokinetic data in neonates and premature infants indicate that, unlike in adults, significant systemic absorption occurred following intranasal administration of BACTROBAN nasal ointment in this population.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/26/2015

Warnings
Precautions

Bactroban Nasal - User Reviews

Bactroban Nasal User Reviews

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