Mupirocin

Mupirocin is a prescription medication used to treat impetigo (a type of skin infection) and other small skin infections caused by certain types of bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and Streptococcus pyogenes bacteria.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

No drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with mupirocin including the following:

• hypersensitivity (severe allergic reaction).  Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing
  • fainting
  • rash
• superinfection. Mupirocin should not be used for extended periods. Prolonged use can lead to the growth of dangerous organisms that are resistant or unresponsive to this medication. Use mupirocin for the duration prescribed by your doctor.

Do not take mupirocin if you are allergic to mupirocin or any of its ingredients.  Use caution when applying to face and avoid eye area.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if mupirocin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using mupirocin.

If your doctor prescribes mupirocin to treat an infected or cracked nipple from nursing, you should maintain your milk supply by hand expressing from the infected breast and discarding the milk for the entire course of treatment with mupirocin.

Antibacterial; pseudomonic acid antibiotic produced by Pseudomonas fluorescens.1 2 3 4 5 6 8 12 15 16 17 22 23 30 31 74 78 91 92 93 94 95

Specific Drugs

Storage

Topical

≤25°C; do not freeze.78

20–25°C.1 91 92 93 94 95

Intranasal

20–25°C (may be exposed to 15–30°C).74 Do not refrigerate.74

The following adverse reactions are discussed in more detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following local adverse reactions were reported by at least 1% of subjects in connection with the use of Mupirocin ointment in clinical trials: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects. Rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate were reported in less than 1% of subjects.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of Mupirocin ointment. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to Mupirocin ointment.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see Warnings and Precautions (5.1)].

Pregnancy

Risk Summary

There are insufficient human data to establish whether there is a drug-associated risk with Mupirocin ointment in pregnant women. Systemic absorption of Mupirocin through intact human skin is minimal following topical administration of Mupirocin ointment [see Clinical Pharmacology (12.3)]. 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.

Data

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.

Lactation

Risk Summary

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 Mupirocin ointment [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Mupirocin ointment and any potential adverse effects on the breastfed child from Mupirocin ointment or from the underlying maternal condition.

Clinical Considerations

To minimize oral exposure of the drug to children, a breast and/or nipple being treated with Mupirocin ointment should be thoroughly washed prior to breastfeeding.

Pediatric Use

The safety and effectiveness of Mupirocin ointment have been established in the age range of 2 months to 16 years. Use of Mupirocin ointment in these age-groups is supported by evidence from adequate and well-controlled trials of Mupirocin ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials [see Clinical Studies (14)].

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.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as calcium [strength expressed as base]:

Bactroban: 2% (15 g, 30 g)

Generic: 2% (15 g, 30 g)

Kit, External:

Centany AT: 2% [contains propylene glycol monostearate]

Ointment, External:

Bactroban: 2% (22 g [DSC])

Centany: 2% (30 g) [contains propylene glycol monostearate]

Generic: 2% (15 g, 22 g)

Ointment, Nasal, as calcium [strength expressed as base]:

Bactroban Nasal: 2% (1 g)

• Bactroban
• Bactroban Nasal
• Centany
• Centany AT

Topical infection:

Intranasal: Eradication of nasal colonization with methicillin-resistant S. aureus (MRSA) in adult and pediatric patients ≥12 years of age and health care workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections with this microorganism

Limitations of use: Insufficient data for use as part of an intervention program to prevent autoinfection of high-risk patients from their own S. aureus nasal colonization or for general prophylaxis of any infection in any patient population.

Topical cream: Treatment of secondary infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of S. aureus and S. pyogenes

Topical ointment: Treatment of impetigo due to S. aureus and S. pyogenes

Surgical prophylaxis in methicillin-resistant S. aureus (MRSA) carriers (intranasal administration)

Data from one prospective, controlled, multicenter, interventional cohort study and one randomized, double-blind, placebo-controlled, multicenter study support the use of mupirocin (twice daily in both nares for 5 days) along with other colonization reduction measures in MRSA carriers to reduce MRSA clinical cultures and infection rates [Bode 2010], [Lee 2013].