Introduction

Antibacterial; pseudomonic acid antibiotic produced by Pseudomonas fluorescens.

Uses for Mupirocin

Impetigo

Topical treatment of impetigo caused by Staphylococcus aureus and Streptococcus pyogenes (group A β-hemolytic streptococci; GAS).

Although impetigo may be self-limiting, anti-infective treatment usually indicated to reduce duration of symptoms and prevent recurrence or transmission to others. Empiric treatment with an appropriate narrow-spectrum anti-infective generally used for initial treatment and considered reasonable for typical cases. Some clinicians suggest in vitro testing (i.e., Gram stain and culture of pus or exudates from skin lesions) to identify causative organism and confirm in vitro susceptibility, especially if impetigo is extensive and/or failed to respond to initial empiric treatment.

Nonbullous and bullous impetigo have been treated with topical and/or systemic anti-infective therapy. Although comparative efficacy of various regimens not established in well-controlled clinical trials, topical anti-infectives generally used for less extensive disease and systemic anti-infectives generally recommended if impetigo is severe or involves numerous lesions or if an outbreak is affecting multiple individuals (e.g., family members, childcare groups, athletic teams).

When empiric treatment used, select appropriate narrow-spectrum anti-infective based on local patterns of resistance reported for S. aureus and S. pyogenes.

Secondary Skin Infections

Topical treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, abrasions) caused by susceptible S. aureus and S. pyogenes.

Has been used for topical treatment of other primary or secondary superficial skin infections, including ecthyma^{† [off-label]}, eczema^{† [off-label]}, folliculitis^{† [off-label]}, furunculosis^{† [off-label]}, atopic dermatitis^{† [off-label]}, epidermolysis bullosa^†, and minor wounds^†, burns^†, and ulcers^†.

Although it has been suggested that topical mupirocin may be effective for treatment of minor primary or secondary superficial skin infections caused by susceptible bacteria and has the advantage of being associated with fewer adverse effects than systemic anti-infective therapy, experts state that an appropriate oral or parenteral anti-infective should be used for treatment of most purulent skin and skin structure infections (e.g., abscesses, cellulitis, ecthyma, erysipelas, carbuncles, furuncles, wound infections).

Do not apply topically to surgical wounds in an attempt to prevent surgical site infections.

Nasal Carriage of Staphylococcus aureus

Used intranasally for temporary elimination of nasal carriage of methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA). Also has been used intranasally to temporarily eliminate nasal carriage of methicillin-susceptible S. aureus^† (MSSA).

Mupirocin ointment for intranasal use is labeled by FDA for eradication of MRSA nasal colonization in adults and children ≥12 years of age and for use in health-care workers as part of a comprehensive infection control program to reduce risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections caused by this pathogen.

Manufacturer states that data are insufficient to establish whether the intranasal ointment is safe and effective when used as part of an intervention program to prevent autoinfection of high-risk patients from their own nasal colonization with S. aureus and that data are insufficient to recommend use of the intranasal ointment for general prophylaxis of any infection in any patient population.

Has been used to eliminate nasal carriage of S. aureus in carriers at high-risk of staphylococcal infections (e.g., surgical patients, cancer patients, dialysis patients, patients in intensive care units or long-term care settings) in an attempt to decrease the incidence of infections in these patients^†. For preoperative decolonization in patients identified as nasal carriers of MRSA or MSSA^†, intranasal mupirocin has been used with or without a topical agent (e.g., whole-body disinfection with chlorhexidine gluconate skin cleanser, oral cleansing with chlorhexidine gluconate oral rinse).

Has been used to eradicate nasal carriage of MRSA and/or MSSA in neonates and infants^† in neonatal intensive care units (NICUs). Intranasal mupirocin has been included in various decolonization regimens in such neonates and infants in an attempt to reduce rate of S. aureus transmission and rate of clinical infections in this patient population.

Because data are limited or conflicting regarding potential benefits and risks of intranasal mupirocin in nasal carriers of S. aureus and because of concerns about emergence of mupirocin resistance in staphylococci, use of intranasal mupirocin in high-risk patients remains controversial. There is some evidence from controlled studies that use of intranasal mupirocin in S. aureus carriers can reduce the overall S. aureus infection rate in high-risk patients. There also is some evidence that a preoperative decolonization regimen of intranasal mupirocin (with or without a topical agent) in S. aureus carriers may decrease the risk of surgical site infections following certain procedures (e.g., cardiothoracic surgery, neurosurgery, orthopedic surgery) and in hemodialysis and peritoneal dialysis patients. However, some experts state data are insufficient to support routine use of anti-infectives for eradication of S. aureus colonization and that a targeted decolonization strategy in selected patients based on screening and risk assessment is preferred over unrestricted use of decolonization regimens.

Permanent eradication of nasal carriage of S. aureus following intranasal or systemic anti-infective therapy unlikely; recolonization generally occurs in 30–100% of patients regardless of anti-infective agent or regimen used.

Mupirocin Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as an ointment for dermatologic use containing 2% mupirocin in a water-miscible vehicle containing polyethylene glycol (PEG) (generic), an ointment for dermatologic use containing 2% mupirocin in a vehicle without PEG (Centany), or a cream for dermatologic use containing 2% mupirocin in an oil and water-based vehicle (Bactroban, generic).

Do not apply ointment or cream for dermatologic use to eyes or mucous membranes; do not administer these preparations intranasally.

Apply small amount of ointment or cream to affected area using a gauze pad or cotton swab.

Treated areas of skin may be covered with sterile gauze dressing, if desired.

Wash hands before and after applying ointment or cream, unless the hands are being treated.

Do not apply concurrently with any other lotions, creams, or ointments.

Intranasal Administration

Apply intranasally as ointment specifically formulated for intranasal use containing 2% mupirocin in a soft white ointment vehicle of paraffin and a mixture of glycerin esters (Bactroban Nasal).

Intranasal ointment is commercially available in single-dose tubes and is for topical intranasal application to nasal mucous membranes only; avoid contact with eyes.

Administer ointment for intranasal use by placing one-half (approximately 0.25 g) of the ointment contained in a single-dose tube into each nostril. Distribute the ointment evenly throughout the nares by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. Discard the single-use tube after application; do not reuse.

Wash hands before and after applying ointment for intranasal use.

Do not apply concurrently with other intranasal preparations.

Although commercially available mupirocin ointment for dermatologic use has been used intranasally^†, the manufacturers and some clinicians state that commercially available mupirocin ointment for dermatologic use (formulated with or without PEG) should not be substituted for mupirocin ointment for intranasal use. (See Precautions Related to Intranasal Administration under Cautions.)

Dosage

Available as mupirocin and mupirocin calcium; dosage expressed in terms of mupirocin.

Pediatric Patients

Skin Infections

Impetigo

Pediatric patients ≥2 months of age (2% ointment for dermatologic use): Apply small amount to affected area 3 times daily.

Manufacturers state may be used for up to 10 days; has been used for 3–14 days for topical treatment of impetigo.

If no clinical response within 3–5 days, reevaluate patient.

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)

Pediatric patients ≥3 months of age (2% cream for dermatologic use): Apply small amount to affected area 3 times daily for 10 days.

If no clinical response within 3–5 days, reevaluate patient.

Nasal Carriage of Staphylococcus aureus

Intranasal

Children ≥12 years of age (2% ointment for intranasal use): Apply one-half (approximately 0.25 g) of ointment from a single-use tube into each nostril twice daily (morning and evening) for 5 days. (See Intranasal Administration under Dosage and Administration.)

Manufacturer states safety and efficacy of >5 days of treatment with mupirocin intranasal ointment not established.

Adults

Skin Infections

Impetigo

2% ointment for dermatologic use: Apply small amount to affected area 3 times daily.

Manufacturers state may be used for up to 10 days; has been used for 3–14 days for topical treatment of impetigo.

If no clinical response within 3–5 days, reevaluate patient.

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)

2% cream for dermatologic use: Apply small amount to affected area 3 times daily for 10 days.

If no clinical response within 3–5 days, reevaluate patient.

Nasal Carriage of Staphylococcus aureus

Intranasal

2% ointment for intranasal use: Apply one-half (approximately 0.25 g) of ointment from a single-use tube into each nostril twice daily (morning and evening) for 5 days.

Manufacturer states safety and efficacy of >5 days of treatment with mupirocin intranasal ointment not established.

Prescribing Limits

Pediatric Patients

Skin Infections

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)

2% cream for dermatologic use: Maximum treatment area 10 cm in length or 100 cm² in total area.

Adults

Skin Infections

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)

2% cream for dermatologic use: Maximum treatment area 10 cm in length or 100 cm² in total area.

Contraindications

• Hypersensitivity to mupirocin or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Systemic allergic reactions (e.g., anaphylaxis, urticaria, angioedema, generalized rash) reported with mupirocin ointment or cream for dermatologic use and with mupirocin ointment for intranasal use.

Mupirocin appears to have minimal potential for inducing allergic contact sensitization following topical application; unlikely to cause phototoxicity or photoallergic dermatitis.

Although causal relationship not established, allergic contact dermatitis reported rarely in patients receiving topical mupirocin.

If sensitization or severe local irritation occurs or if manifestations suggesting systemic allergic reaction (e.g., anaphylaxis, urticaria, angioedema, rash, wheezing, or swelling of lips, face, or tongue) occur, discontinue and institute appropriate alternative anti-infective therapy.

Precautions Related to Topical Administration

Mupirocin ointment and cream for dermatologic use: Use only for topical application to skin; do not use on mucous membranes (including intranasal mucous membranes).

Avoid contact with the eyes. If contact with the eyes occurs, thoroughly rinse eyes with water.

Do not use with IV cannulae or at central IV sites because of potential to promote fungal infection and anti-infective resistance.

Ointments Formulated with PEG

Some preparations of mupirocin ointment for dermatologic use contain the drug in a PEG vehicle.

Possibility that some adverse local effects reported with topical mupirocin ointment may be related to the PEG vehicle rather than the drug itself.

Prolonged or repeated application of a PEG-containing ointment to large areas of damaged skin (e.g., burns) and open wounds may result in systemic absorption of potentially toxic amounts of PEG. Following percutaneous absorption, PEG is excreted by the kidneys. Rarely, renal failure and death have been associated with topical application of PEG-containing ointments in burn patients and in animal burn models.

Do not use mupirocin ointment for dermatologic use containing the drug in a PEG vehicle in conditions where absorption of large quantities of PEG is possible, especially if there is evidence patient has moderate or severe renal impairment.

Precautions Related to Intranasal Administration

Mupirocin ointment for intranasal use: Use only for topical intranasal application to mucous membranes of the nose.

Avoid contact with eyes. When applied to the eye under testing conditions, severe symptoms (e.g., burning, tearing) occurred; symptoms resolved within days to weeks after the ointment discontinued. If contact with the eyes occurs, thoroughly rinse eyes with water.

Although mupirocin ointment for dermatologic use containing the drug in a PEG vehicle has sometimes been used intranasally^†, such use has caused irritation of nasal mucosa and other adverse local effects (e.g., stinging, drying, pruritus) that may be related to the PEG vehicle. Manufacturers and some clinicians state do not use mupirocin ointments for dermatologic use (formulated with or without PEG) intranasally.

Selection and Use of Anti-infectives

Staphylococci, including MRSA, with high-level resistance to mupirocin reported and have been associated with treatment failure (see Actions and Spectrum).

Appropriate in vitro testing using standardized procedures to detect high-level mupirocin resistance in staphylococci and evaluate local patterns of resistance may be indicated prior to use of mupirocin. Evaluate clinical importance of results of resistance testing with regard to nasal decolonization regimens at each medical facility in conjunction with laboratory, medical, and infection control staff.

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible overgrowth of nonsusceptible organisms, including fungi, with prolonged therapy. Discontinue mupirocin and institute appropriate therapy if superinfection occurs.

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy discontinued.

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. Initiate appropriate anti-infective therapy directed against C. difficile (e.g., vancomycin, fidaxomicin, metronidazole), appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), and surgical evaluation as clinically indicated.

Specific Populations

Pregnancy

Data insufficient to determine whether there is a drug-associated risk with use of mupirocin in pregnant women. Animal studies have not revealed any evidence of developmental toxicity or harm to the fetus.

Mupirocin ointment or cream for dermatologic use: Systemic absorption of mupirocin is minimal following topical application to intact skin. One manufacturer states use during pregnancy only if clearly needed.

Mupirocin ointment for intranasal use: Systemic absorption of mupirocin is negligible following intranasal application in adults, but dosage regimen studied did not mimic recommended intranasal dosage.

Lactation

Not known whether systemically absorbed mupirocin distributed into human milk, affects milk production, or affects the breast-fed infant.

Because systemic absorption of mupirocin is minimal following topical application, manufacturers state mupirocin exposure in breast-feeding infants not expected.

Consider benefits of breast-feeding and importance of mupirocin to the woman; also consider potential adverse effects on breast-fed child from the drug or underlying maternal condition.

Mupirocin ointment for dermatologic use: One manufacturer states use with caution in nursing women.

Mupirocin ointment or cream for dermatologic use: If breast and/or nipple is being treated, wash treated area well prior to breast-feeding to minimize oral exposure in breast-feeding infant.

Pediatric Use

Mupirocin ointment for dermatologic use: Safety and efficacy not established in children <2 months of age.

Mupirocin cream for dermatologic use: Safety and efficacy not established in children <3 months of age.

Mupirocin ointment for intranasal use: Safety and efficacy not established in children <12 years of age.

Geriatric Use

Mupirocin cream for dermatologic use: No overall differences in efficacy and safety in patients >65 years of age relative to younger adults.

Renal Impairment

Mupirocin ointment for dermatologic use formulated in a PEG vehicle: Use with caution in patients with moderate or severe renal impairment. (See Ointments Formulated with PEG under Cautions.)

Common Adverse Effects

Topical administration to skin: Local effects (burning, stinging, pain, pruritus, rash), nausea, headache.

Intranasal administration: Headache, rhinitis, respiratory disorder (including upper respiratory tract congestion), pharyngitis, taste perversion, cough, local effects (burning/stinging, pruritus).

Administration

Topical Administration

Apply topically to the skin as an ointment for dermatologic use containing 2% mupirocin in a water-miscible vehicle containing polyethylene glycol (PEG) (generic), an ointment for dermatologic use containing 2% mupirocin in a vehicle without PEG (Centany), or a cream for dermatologic use containing 2% mupirocin in an oil and water-based vehicle (Bactroban, generic).

Do not apply ointment or cream for dermatologic use to eyes or mucous membranes; do not administer these preparations intranasally.

Apply small amount of ointment or cream to affected area using a gauze pad or cotton swab.

Treated areas of skin may be covered with sterile gauze dressing, if desired.

Wash hands before and after applying ointment or cream, unless the hands are being treated.

Do not apply concurrently with any other lotions, creams, or ointments.

Intranasal Administration

Apply intranasally as ointment specifically formulated for intranasal use containing 2% mupirocin in a soft white ointment vehicle of paraffin and a mixture of glycerin esters (Bactroban Nasal).

Intranasal ointment is commercially available in single-dose tubes and is for topical intranasal application to nasal mucous membranes only; avoid contact with eyes.

Administer ointment for intranasal use by placing one-half (approximately 0.25 g) of the ointment contained in a single-dose tube into each nostril. Distribute the ointment evenly throughout the nares by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. Discard the single-use tube after application; do not reuse.

Wash hands before and after applying ointment for intranasal use.

Do not apply concurrently with other intranasal preparations.

Although commercially available mupirocin ointment for dermatologic use has been used intranasally^†, the manufacturers and some clinicians state that commercially available mupirocin ointment for dermatologic use (formulated with or without PEG) should not be substituted for mupirocin ointment for intranasal use. (See Precautions Related to Intranasal Administration under Cautions.)

Dosage

Available as mupirocin and mupirocin calcium; dosage expressed in terms of mupirocin.

Pediatric Patients

Skin Infections

Impetigo

Pediatric patients ≥2 months of age (2% ointment for dermatologic use): Apply small amount to affected area 3 times daily.

Manufacturers state may be used for up to 10 days; has been used for 3–14 days for topical treatment of impetigo.

If no clinical response within 3–5 days, reevaluate patient.

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)

Pediatric patients ≥3 months of age (2% cream for dermatologic use): Apply small amount to affected area 3 times daily for 10 days.

If no clinical response within 3–5 days, reevaluate patient.

Nasal Carriage of Staphylococcus aureus

Intranasal

Children ≥12 years of age (2% ointment for intranasal use): Apply one-half (approximately 0.25 g) of ointment from a single-use tube into each nostril twice daily (morning and evening) for 5 days. (See Intranasal Administration under Dosage and Administration.)

Manufacturer states safety and efficacy of >5 days of treatment with mupirocin intranasal ointment not established.

Adults

Skin Infections

Impetigo

2% ointment for dermatologic use: Apply small amount to affected area 3 times daily.

Manufacturers state may be used for up to 10 days; has been used for 3–14 days for topical treatment of impetigo.

If no clinical response within 3–5 days, reevaluate patient.

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)

2% cream for dermatologic use: Apply small amount to affected area 3 times daily for 10 days.

If no clinical response within 3–5 days, reevaluate patient.

Nasal Carriage of Staphylococcus aureus

Intranasal

2% ointment for intranasal use: Apply one-half (approximately 0.25 g) of ointment from a single-use tube into each nostril twice daily (morning and evening) for 5 days.

Manufacturer states safety and efficacy of >5 days of treatment with mupirocin intranasal ointment not established.

Prescribing Limits

Pediatric Patients

Skin Infections

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)

2% cream for dermatologic use: Maximum treatment area 10 cm in length or 100 cm² in total area.

Adults

Skin Infections

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)

2% cream for dermatologic use: Maximum treatment area 10 cm in length or 100 cm² in total area.