Each gram of Bactroban Ointment (mupirocin ointment), 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is (E)-(2S,3R,4R,5S) -5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl] tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C₂₆H₄₄O₉ and the molecular weight is 500.63. The chemical structure is:

Last updated on RxList: 11/7/2007

Bactroban Ointment (mupirocin ointment), 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.

A small amount of Bactroban Ointment should be applied to the affected area three times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

Bactroban Ointment (mupirocin ointment), 2% is supplied in 22 gram tubes.

NDC 0029-1525-44 (22 gram tube)

Store at controlled room temperature 20° to 25°C (68° to 77°F).

DATE OF ISSUANCE NOV. 2001. GlaxoSmithKline., Research Triangle Park, NC 27709. FDA rev date: 11/9/2001

Last updated on RxList: 11/7/2007

The following local adverse reactions have been reported in connection with the use of Bactroban Ointment : burning, stinging, or pain in 1.5% of patients; itching in 1% of patients; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of patients. Systemic reactions to Bactroban Ointment have occurred rarely.

The effect of the concurrent application of Bactroban Ointment and other drug products has not been studied.

Last updated on RxList: 11/7/2007

Bactroban Ointment is not for ophthalmic use.

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Bactroban Ointment (mupirocin ointment) 2%, treatment should be discontinued and appropriate alternative therapy for the infection instituted.

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

Bactroban Ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A paraffin-based formulation - Bactroban Nasal® (mupirocin calcium ointment) - is available for intranasal use.

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.

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 in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m²basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

Pregnancy

Teratogenic Effects

Pregnancy Category B: Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m² basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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 Ointment is administered to a nursing woman.

Pediatric Use: 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 studies of Bactroban Ointment in impetigo in pediatric patients studied as a part of the pivotal clinical trials. (See CLINICAL STUDIES.)

Last updated on RxList: 11/7/2007

NO INFORMATION PROVIDED.

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.

Last updated on RxList: 11/7/2007

Application of ¹⁴C-labeled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption ( < 1.1 nanogram mupirocin per milliliter of whole blood). Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application.

Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a study conducted in seven healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency.

Microbiology: Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes of antimicrobial agents.

Resistance occurs rarely. However, when mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC > 1024 mcg/mL) has been reported in some strains of S. aureus and coagulase-negative staphylococci.

Mupirocin is bactericidal at concentrations achieved by topical administration. However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally eight-fold to thirty-fold higher than the minimum inhibitory concentration (MIC). In addition, mupirocin is highly protein bound ( > 97%), and the effect of wound secretions on the MICs of mupirocin has not been determined.

Mupirocin has been shown to be active against most strains of Staphylococcus aureus and Streptococcus pyogenes, both in vitro and in clinical studies. (See INDICATIONS AND USAGE.) The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus.

Clinical Studies

The efficacy of topical Bactroban Ointment in impetigo was tested in two studies. In the first, patients with impetigo were randomized to receive either Bactroban Ointment or vehicle placebo t.i.d. for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric patients included) were 71% for Bactroban Ointment (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for Bactroban Ointment and 62% for vehicle placebo. There were no side effects reported in the group receiving Bactroban Ointment .

In the second study, patients with impetigo were randomized to receive either Bactroban Ointment t.i.d. or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded study) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric patients included) were 93% for Bactroban Ointment (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable patient populations were 100% for both test groups. There were no side effects reported in the Bactroban Ointment group.

Pediatrics

There were 91 pediatric patients aged 2 months to 15 years in the first study described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for Bactroban Ointment (n=42) and 36% for vehicle placebo (n=49). In the second study described above, all patients were pediatric except two adults in the group receiving Bactroban Ointment . The age range of the pediatric patients was 7 months to 13 years. The clinical efficacy rate for Bactroban Ointment (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

Last updated on RxList: 11/7/2007

Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes. The medication should be stopped and your healthcare practitioner contacted if irritation, severe itching, or rash occurs.

If impetigo has not improved in 3 to 5 days, contact your healthcare practitioner.

Last updated on RxList: 11/7/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

MUPIROCIN OINTMENT - TOPICAL

(myou-PEER-oh-sin)

COMMON BRAND NAME(S): Bactroban

USES: Mupirocin is used to treat certain skin infections (e.g., impetigo). It is an antibiotic that works by stopping the growth of certain bacteria.

HOW TO USE: Use this medication only on the skin. Clean and dry the affected area first. Then apply a small amount of ointment to the area 3 times a day, or as directed by your doctor. You may cover the treated area with a bandage.

Use this medication regularly in order to get the most benefit from it. Continue to use it for the full amount of time prescribed. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Avoid using this medication around your eyes, nose, mouth, or on large areas of damaged or broken skin unless otherwise directed by your doctor.

Inform your doctor if your condition does not improve in 3-5 days.

SIDE EFFECTS: This medication may cause burning, stinging, itching or pain at first as your body adjusts to it. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if a rash or severe itching occurs.

Use of this medication for prolonged or repeated periods may result in a new infection (e.g., fungal infection). Contact your doctor if you notice signs of a new infection.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using mupirocin, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol found in some brands; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (if you are using a brand of mupirocin that contains polyethylene glycol).

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: chloramphenicol.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C). Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.