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Mupirocin

Pronunciation

Class: Antibacterials
ATC Class: D06AX09
VA Class: DE101
Chemical Name: [2S - [2α(E),3β,4β,5α[2R*,3R*,(1R*,2R*)]] - 9 - [3 - Methyl - 1 - oxo - 4 - [tetrahydro - 3,4 - dihydroxy - 5 - [3 - (2 - hydroxy - 1 - methylpropyl)oxiranyl]methyl - 2H - pyran - 2 - yl] - 2 - butenyl]oxy] - nonanoic acid
Molecular Formula: C52H86CaO18•2H2O
CAS Number: 12650-69-0
Brands: Bactroban, Bactroban Nasal, Centany

Introduction

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

Uses for Mupirocin

Skin Infections

Topical treatment of impetigo caused by Staphylococcus aureus and Streptococcus pyogenes (group A β-hemolytic streptococci).1 3 11 16 18 20 28 30 40 41 42 43 44 45 46 47 48 49 50 56 73 79 80 83 84 91 92 93 94 95 A drug of choice, especially when limited numbers of lesions are present.79 80 84 If impetigo is extensive or has not responded to topical anti-infectives, an oral anti-infective active against S. aureus and S. pyogenes (e.g., dicloxacillin, cephalosporins, erythromycin, clindamycin, fixed combination of amoxicillin and clavulanate) should be used.79 84

Topical treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, abrasions) that are ≤10 cm in length or ≤100 cm2 in total area and caused by susceptible S. aureus and S. pyogenes.75 78

Has been used for topical treatment of other primary or secondary superficial skin infections, including ecthyma,2 30 48 54 69 eczema,2 3 11 14 16 20 25 28 36 38 39 40 43 44 47 54 56 69 76 folliculitis,2 3 11 18 20 28 30 46 47 56 69 furunculosis,2 28 30 44 54 56 69 atopic dermatitis,37 69 72 epidermolysis bullosa,29 35 39 56 and minor wounds,3 16 20 38 39 46 54 56 burns,16 39 40 56 and ulcers16 20 35 38 39 44 46 47 56 69 caused by susceptible bacteria.

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May be preferred over systemic anti-infective therapy for treatment of impetigo and other superficial skin infections caused by susceptible bacteria since it may be as effective as and is associated with fewer adverse effects than systemic therapy.3 40 41 43 45 64 70 75 84 However, systemic anti-infectives generally are necessary for the treatment of serious or extensive 84 skin infections.3 64 70 79

Nasal Carriage of Staphylococcus aureus

Temporary elimination of nasal carriage of methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA).2 3 4 16 32 33 34 52 55 61 62 63 74 81 82 85 86 88 Also has been used intranasally to temporarily eliminate nasal carriage of methicillin-susceptible S. aureus.2 3 4 16 32 34 81 85 86 88

Mupirocin ointment for intranasal use (Bactroban Nasal) is labeled by the FDA for elimination of nasal carriage of MRSA in adult patients 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 caused by this pathogen.74

Manufacturer states that data are insufficient to date 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 date to recommend use of the intranasal ointment for general prophylaxis of any infection in any patient population.74

Has been used to eliminate nasal carriage of S. aureus in carriers at high-risk of staphylococcal infections (e.g., surgical patients, cancer patients, hemodialysis patients) in an attempt to decrease the incidence of subsequent staphylococcal infections in these patients.81 85 86 87 89 90 Data are insufficient to support routine use of topical and/or systemic anti-infectives for eradication of MRSA colonization.82 85 86 87 However, some experts suggest that eradication of nasal carriage of S. aureus may be a reasonable strategy in certain patients with multiple documented recurrences of MRSA infection85 and that intranasal mupirocin may be considered for hospitalized surgical, dialysis, and nonsurgical patients at risk of infection if they are known nasal carriers of S. aureus.81 89

Permanent eradication of nasal carriage of S, aureus following topical or systemic anti-infective therapy is unlikely;3 16 33 62 63 recolonization generally occurs in 30–100% of patients regardless of the anti-infective agent used.3 32 33 74

Mupirocin Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as 2% ointment for dermatologic use in a water-miscible vehicle containing polyethylene glycol (PEG) (Bactroban, various generic preparations),1 92 93 94 95 2% ointment for dermatologic use in a vehicle without PEG (Centany),91 96 or 2% cream for dermatologic use in an oil and water-based vehicle (Bactroban).1 78

Do not apply ointment or cream for dermatologic use to eyes or mucous membranes; do not administer these preparations intranasally.1 78 91 92 93 94 95

Treated areas of skin may be covered with sterile gauze dressing if desired.1 78 91 92 93 94 95

Intranasal Administration

Apply intranasally as 2% ointment for intranasal use.74

The commercially available intranasal ointment is intended for topical intranasal application to nasal mucous membranes only; do not apply to eyes.74

Administer mupirocin ointment for intranasal use by placing one-half (approximately 0.25 g) of the ointment contained in the single-dose tube into each nostril.74 Distribute the ointment evenly throughout the nares by pressing together and releasing the sides of the nose repetitively for approximately 1 minute.74 Discard the single-use tube after application; do not reuse.74

Do not apply concurrently with other intranasal preparations.74 (See Intranasal Preparations under Interactions.)

Although mupirocin ointment for dermatologic use has been used intranasally,3 33 52 85 the manufacturers and some clinicians state that the ointment for dermatologic use (formulated with or without PEG) should not be used intranasally.1 3 16 18 51 52 66 70 91 92 93 94 95 Intranasal use of ointments formulated in a PEG vehicle may irritate mucous membranes.1 3 16 18 51 52 66 70 92 93 94 95 (See Precautions Related to Polyethylene Glycol Vehicle under Cautions.)

Dosage

Available as mupirocin1 91 92 93 94 95 and mupirocin calcium74 78 ; dosage expressed in terms of mupirocin.1 74 78 91 92 93 94 95

Pediatric Patients

Skin Infections
Impetigo
Topical

2% ointment for dermatologic use in children 2 months to 16 years of age: Apply small amount to affected area 3 times daily.1 91 92 93 94 95

Usual duration of treatment is about 7 days (5–10 days).40 41 43 47 48 79 80 83 If clinical response not evident within 3–5 days, clinician should be contacted and the infection reevaluated.1 91 92 93 94 95

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)
Topical

2% cream for dermatologic use in children 3 months to 16 years of age: Apply small amount to affected area 3 times daily for 10 days.78

If clinical response not evident within 3–5 days, clinician should be contacted and the infection reevaluated.78

Nasal Carriage of Staphylococcus aureus
Intranasal

2% ointment for intranasal use in children ≥12 years of age: Apply one-half (approximately 0.25 g) of the intranasal ointment from a single-use tube into each nostril twice daily (morning and evening) for 5 days.74

Manufacturer states safety and efficacy of >5 days of treatment with the intranasal ointment not established.74

Adults

Skin Infections
Impetigo
Topical

2% ointment for dermatologic use: Apply small amount to affected area 3 times daily.1 91 92 93 94 95

Usual duration of treatment is about 7 days (5–10 days).40 41 43 47 48 79 80 83 If clinical response not evident within 3–5 days, clinician should be contacted and the infection reevaluated.1 91 92 93 94 95

Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)
Topical

2% cream for dermatologic use: Apply small amount to affected area 3 times daily for 10 days.78

If clinical response not evident within 3–5 days, clinician should be contacted and the infection reevaluated.78

Nasal Carriage of Staphylococcus aureus
Intranasal

2% ointment for intranasal use: Apply one-half (approximately 0.25 g) of the intranasal ointment from a single-use tube into each nostril twice daily (morning and evening) for 5 days.74

Manufacturer states safety and efficacy of >5 days of treatment with the intranasal ointment not established.74

Prescribing Limits

Pediatric Patients

Skin Infections
Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)
Topical

2% cream for dermatologic use: Maximum treatment area 10 cm in length or 100 cm2 in total area.78

Adults

Skin Infections
Secondary Skin Infections (Lacerations, Sutured Wounds, Abrasions)
Topical

2% cream for dermatologic use: Maximum treatment area 10 cm in length or 100 cm2 in total area.78

Cautions for Mupirocin

Contraindications

  • Hypersensitivity to mupirocin or any ingredient in the formulation.1 74 78 91 92 93 94 95

Warnings/Precautions

Warnings

Administration Precautions

Mupirocin ointment for dermatologic use and mupirocin cream for dermatologic use are for external use only.1 78 91 92 93 94 95 Use only for topical application to skin;1 78 91 92 93 94 95 do not use on mucous membranes (including intranasal mucous membranes).1 78 91 92 93 94 95

Mupirocin ointment for dermatologic use, mupirocin cream for dermatologic use, and mupirocin ointment for intranasal use should not be applied to eyes.1 74 78 91 92 93 94 95

When mupirocin ointment for intranasal use was applied to the eye under testing condition, severe symptoms such as burning and tearing occurred; symptoms resolved within days to weeks after the drug was discontinued.74

Sensitivity Reactions

Minimal potential for inducing allergic contact sensitization following topical application.7 9 56 57 Unlikely to cause phototoxicity or photoallergic dermatitis.2 3 4 5 9 16

Although causal relationship not established,26 43 45 46 78 contact dermatitis reported in some patients receiving topical mupirocin.1 26 43 45 46 78 91 92 93 94 95

If manifestations suggesting sensitivity or severe local or chemical irritation occur (e.g., irritation, severe pruritus, rash), discontinue mupirocin and substitute an appropriate alternative anti-infective.1 74 78 91 92 93 94 95

General Precautions

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.1 74 78 91 92 93 94 95

Precautions Related to Polyethylene Glycol (PEG) Vehicle

Some preparations of mupirocin ointment for dermatologic use contain mupirocin in a PEG vehicle (Bactroban, various generic preparations).1 92 93 94 95

Some adverse local effects reported with topical mupirocin may be related to the PEG vehicle rather than the drug itself.3 4 26 39 43 45 46

Prolonged or repeated application of a PEG-containing ointment to large areas of damaged skin (e.g., burns) may result in systemic absorption1 66 67 68 71 92 93 94 95 of potentially toxic amounts of PEG.66 67 68 71 Rarely, renal failure and death have been associated with topical application of PEG-containing ointments in burn patients and in animal burn models.66 67 68 71

The manufacturers state that preparations of mupirocin ointment for dermatologic use containing the drug in a PEG vehicle should not be used in conditions where absorption of large quantities of PEG is possible, especially if there is evidence the patient has moderate or severe renal impairment.1 92 93 94 95

Although mupirocin ointment for dermatologic use has been used intranasally,3 16 18 51 52 the manufacturers and some clinicians state that the ointment for dermatologic use (with or without a PEG) should not be used intranasally.1 3 16 18 51 52 66 70 92 93 94 95

Specific Populations

Pregnancy

Category B.1 74 78 91 92 93 94 95

Lactation

Not known whether mupirocin is distributed into milk,1 74 78 91 92 93 94 95 but clinically important concentrations are unlikely in breast milk following topical application of usual dosages to the skin.70 Use with caution.1 74 78 91 92 93 94 95

Pediatric Use

Safety and efficacy of mupirocin ointment for dermatologic use not established in children <2 months of age.1 91 92 93 94 95

Safety and efficacy of mupirocin cream for dermatologic use not established in children <3 months of age.78

Safety and efficacy of mupirocin ointment for intranasal use not established in children <12 years of age.74

Geriatric Use

When mupirocin cream for dermatologic use was used in geriatric patients >65 years of age, no overall differences in efficacy and safety relative to younger adults.78

Renal Impairment

Use preparations of mupirocin ointment for dermatologic use formulated in a PEG vehicle with caution in patients with moderate or severe renal impairment.1 92 93 94 95 (See Precautions Related to Polyethylene Glycol Vehicle under Cautions.)

Common Adverse Effects

Topical administration to skin: Local effects (burning,1 3 7 20 30 35 36 39 46 54 56 78 92 93 94 95 stinging,1 3 4 35 36 52 92 93 94 95 pain,1 3 4 7 52 56 92 93 94 95 pruritus,1 3 4 7 20 36 39 41 52 54 56 78 91 92 93 94 95 rash),1 3 4 20 57 78 92 93 94 95 nausea,1 38 56 78 92 93 94 95 headache.78

Intranasal administration: Headache,74 rhinitis,74 respiratory disorder (including upper respiratory tract congestion),74 pharyngitis,74 taste perversion,74 cough,74 local effects (burning/stinging, pruritus).74

Interactions for Mupirocin

Specific Drugs

Drug

Interaction

Comments

Chloramphenicol

Potential interference with antibacterial action of mupirocin3 19 23

Clinical importance unknown3 19 23

Intranasal preparations

Mupirocin ointment for intranasal use: Concurrent use with other intranasal preparations not studied to date74

Mupirocin ointment for intranasal use: Pending further accumulation of data, do not use concurrently with any other intranasal preparation74

Topical preparations

Mupirocin cream or ointment for dermatologic use: Information not available regarding concurrent application to skin with other topical preparations1 78 91 92 93 94 95

Mupirocin Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed following topical application to intact skin.3 7 56 78 Application to traumatized or diseased skin may result in penetration into deeper epidermal skin layers and possible systemic circulation.3 7

In a study in healthy adults, <0.3% of a topical dose of radiolabeled mupirocin was absorbed through intact skin after 24 hours under an occlusive dressing; no drug detected in urine or feces collected for 5 days after the dose.3 7 56 In this study, 2–4% of the radioactivity was present in the stratum corneum 24 hours after application7 and remained detectable there for ≥72 hours after application.7

Following topical application of mupirocin 2% ointment in a vehicle without PEG (Centany) to an area 400 cm2 on the back of healthy volunteers once daily for 7 days, some systemic absorption of the drug occurred since 0.2–3% of the administered dose was excreted in urine as monic acid (a metabolite of mupirocin) over 24 hours following the last dose.91

Following topical application of mupirocin calcium cream for dermatologic use (2% mupirocin) to various skin lesions (>10 cm in length or 100 cm2 in total area) 3 times daily for 5 days in adults 29–60 years of age and children 3–12 years of age, monic acid was detected in urine.78 Percutaneous absorption occurred more frequently in children than in adults,78 but appears to be minimal in both groups.78

No evidence of systemic absorption following repeated intranasal application of mupirocin ointment for intranasal use in adults.74 Pharmacokinetics of intranasal mupirocin not adequately characterized in neonates or children <12 years of age,74 but systemic absorption reported following intranasal administration of this ointment in neonates and premature infants.74

Distribution

Extent

Following topical application to the skin, may remain detectable in stratum corneum for at least 72 hours.1 7 92 93 94 95

Crosses the placenta in rats and rabbits following IV administration; not known whether crosses the placenta in humans.2

Not known whether mupirocin distributes into milk.1 74 78 91 92 93 94 95

Plasma Protein Binding

≥95–97%.1 3 12 74 91 92 93 94 95

Elimination

Metabolism

Rapidly metabolized following IV or oral administration.1 74 92 93 94 95 Studies using IV mupirocin sodium indicate the drug is almost completely metabolized, presumably in the liver, by conversion to the inactive metabolite, monic acid.2 3 7 78

Any mupirocin that is absorbed systemically following topical application presumably is inactivated by conversion to monic acid and rapidly eliminated in urine.2 7 56 78

Elimination Route

Mupirocin is excreted in urine mostly as monic acid.1 2 7 56 78 78 92 93 94 95

Half-life

Following IV administration in healthy adults, the elimination half-life of mupirocin is 17–40 minutes1 3 7 56 74 92 93 94 95 and that of monic acid is 30–80 minutes.1 7 56 74 92 93 94 95

Stability

Storage

Topical

Cream for Dermatologic Use

≤25°C; do not freeze.78

Ointment for Dermatologic Use

20–25°C.1 91 92 93 94 95

Intranasal

Ointment for Intranasal Use

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

Actions and Spectrum

  • Structurally unrelated to other currently available anti-infectives.2 5 6 8 15 17 31 40

  • Usually bactericidal at concentrations attained following topical application to skin of ointment or cream for dermatologic use or following intranasal application of ointment for intranasal use.1 3 4 5 8 15 23 74 78 91 92 93 94 95

  • Inhibits protein synthesis in susceptible bacteria by reversibly binding to bacterial isoleucine-tRNA ligase (isoleucyl-tRNA synthetase),1 2 4 5 6 11 17 19 21 23 24 74 78 91 92 93 94 95 preventing the formation of isoleucyl-tRNA from isoleucine and tRNA.2 5 16

  • Spectrum of activity includes some gram-positive aerobic bacteria and gram-negative aerobic bacteria; most active against gram-positives.1 2 3 8 11 12 15 56 78 91 92 93 94 95 Inactive against anaerobic bacteria,2 3 4 8 12 Chlamydia,2 4 8 12 and fungi.2 3 4 8 12

  • Gram-positive aerobes: Active against Staphylococci aureus1 2 3 8 11 12 15 56 78 91 92 93 94 95 (including some methicillin-resistant strains)1 3 4 33 34 52 55 62 78 92 93 94 95 and S. pyogenes (group A β-hemolytic streptococci).1 2 3 4 8 12 13 56 91 92 93 94 Active against S. aureus resistant to some other anti-infectives, including penicillins, aminoglycosides, erythromycin, chloramphenicol, and tetracycline.2 3 4 12

  • Strains of S. aureus naturally resistant to mupirocin reported rarely; mupirocin-resistant S. aureus have emerged during mupirocin therapy.1 3 12 17 33 58 59 63 74 78 91 92 93 94 Resistance also reported in coagulase-negative staphylococci.1 11 12 58 59 74 78 91 92 93 94 High-level plasmid-mediated resistance (MIC >500 mcg/mL) reported in increasing numbers of S. aureus isolates and with higher frequency in coagulase-negative staphylococci.91

  • Low potential for cross-resistance with other anti-infectives.1 2 3 8 12 17 74 78 91 92 93 94 95 Rarely, mupirocin-resistant strains of S. aureus have been found to be resistant to penicillins, erythromycin, and/or tetracycline.58 59

Advice to Patients

  • Advise patients using mupirocin cream for dermatologic use or mupirocin ointment for dermatologic use that these preparations are intended for topical application to the skin only and should not be applied to eyes or mucous membranes (including intranasal mucous membranes).1 78 91 92 93 94 95

  • Advise patients using mupirocin ointment for intranasal use that contact with the eyes should be avoided.74 Importance of distributing the ointment evenly throughout the nostrils by pressing together and releasing the sides of the nose repetitively for approximately 1 minute.74 Importance of discarding single-use tube after application; do not reuse.74

  • Importance of discontinuing mupirocin and consulting clinician if manifestations suggesting sensitivity or severe local or chemical irritation (e.g., irritation, severe itching, rash) occurs.1 74 78 91 92 93 94 95

  • Importance of consulting clinician if no improvement occurs after 3–5 days of topical treatment.1 78 91 92 93 94 95

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 91 92 93 94 95

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 74 78 91 92 93 94 95

  • Importance of informing patients of other important precautionary information.1 74 78 91 92 93 94 95 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Mupirocin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

2%*

Bactroban

GlaxoSmithKline

Centany

Medimetriks

Mupirocin Ointment

Mupirocin Calcium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Ointment

2.15% w/w (equivalent to 2% mupirocin)

Bactroban Nasal

GlaxoSmithKline

Topical

Cream

2.15% w/w (equivalent to 2% of mupirocin)

Bactroban

GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Bactroban 2% Cream (GLAXO SMITH KLINE): 15/$64.99 or 45/$181.96

Bactroban 2% Cream (GLAXO SMITH KLINE): 30/$96.99 or 90/$280.98

Bactroban 2% Ointment (GLAXO SMITH KLINE): 22/$79.99 or 66/$219.98

Bactroban Nasal 2% Ointment (GLAXO SMITH KLINE): 1/$19.99 or 4/$45.98

Mupirocin 2% Ointment (PERRIGO PHARMACEUTICALS): 22/$37.99 or 66/$98.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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2. Leyden JJ. Mupirocin: a new topical antibiotic. Semin Dermatol. 1987; 6:48-54.

3. Parenti MA, Hatfield SM, Leyden JJ. Mupirocin: a topical antibiotic with a unique structure and mechanism of action. Clin Pharm. 1987; 6:761-70. [IDIS 234048] [PubMed 3146455]

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6. Cockburn A, Jackson D, White DJ. The background to the safety and tolerance of mupirocin. In: Dobson RL, ed. Bactroban proceedings of an international symposium. Nassau; 1984:11-8.

7. Jackson D, Tasker TCG, Sutherland R et al. Clinical pharmacology of Bactroban: pharmacokinetics, tolerance and efficacy studies. In: Dobson RL, ed. Bactroban proceedings of an international symposium. Nassau; 1984:54-67.

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9. Leyden JJ. Studies on the safety of Bactroban ointment: potential for contact allergy, contact irritation, phototoxicity and photo-allergy. In: Dobson RL, ed. Bactroban proceedings of an international symposium. Nassau; 1984:68-71.

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26. Daly BM. Bactroban allergy due to polyethylene glycol. Contact Dermatitis. 1987; 17:48-9. [PubMed 2958215]

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35. Carter DM, Caldwell D, Varghese M et al. Effectiveness of Bactroban ointment in chronic skin infection: report of a clinical study. In: Dobson RL, ed. Bactroban proceedings of an international symposium. Nassau; 1984:228-34.

36. Wilkinson JD, Lever LR, Leigh DA. Infected eczema and Bactroban. In: Dobson RL, ed. Bactroban proceedings of an international symposium. Nassau; 1984:177-82.

37. Simpson NB, Fitzsimons CP, MacKenzie J et al. Bactroban ointment in flaring atopic dermatitis. In: Dobson RL, ed. Bactroban proceedings of an international symposium. Nassau; 1984:171-6.

38. Rosenberg EW, Churchwell MA. Treatment of infected dermatoses with Bactroban ointment. In: Dobson RL, ed. Bactroban proceedings of an international symposium. Nassau; 1984:257-9.

39. Leyden JJ. Double-blind vehicle-controlled studies of Bactroban ointment in secondary infections. In: Dobson RL, ed. Bactroban proceedings of an international symposium. Nassau; 1984:183-9.

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