Professional Information
Mupirocin (Topical)
VA CLASSIFICATION
Primary: DE101
Commonly used brand name(s): Bactroban.
Other commonly used names are
pseudomonic acid and pseudomonic acid A.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antibacterial (topical)—
Indications
Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.
Accepted
Impetigo (treatment)—Mupirocin ointment is indicated [alone as a primary agent] {07} in the topical treatment of [localized] {07} impetigo caused by Staphylococcus aureus and beta-hemolytic streptococci, including Streptococcus pyogenes . {01} {02} {03} {04} {05}{14}
—[However, some USP medical experts prefer systemic antibacterials in the treatment of most cases of impetigo.] {07}
[Eczema, infected (treatment)] or
[Folliculitis (treatment)]1—Mupirocin is used as a primary agent {07} in the topical treatment of localized {07} infected eczema {02} {03} and folliculitis {02} {03} caused by S. aureus . {02} {03} {05}
[Skin infections, bacterial, minor (prophylaxis) ]—Mupirocin is used in the topical prophylaxis of minor bacterial skin infections. {02} {05}
Skin lesions, secondarily infected, traumatic (treatment)—Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2in area) due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.{12}{13}
—Not all species or strains of a particular organism may be susceptible to mupirocin.
Unaccepted
Mupirocin is not effective against Enterobacteriaceae , Pseudomonas aeruginosa , or fungi. {04}
1 Not included in Canadian product labeling.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Source—
Produced by fermentation of Pseudomonas fluorescens {01} {02} {03} {04}.
Chemical group—
Structurally unrelated to other systemic or topical antibacterials {02} {03}.
Molecular weight—
500.63
Mechanism of action/Effect:
The mechanism of action is not completely understood. Mupirocin is bacteriostatic at low concentrations and bactericidal at high concentrations. This agent reversibly and specifically binds to bacterial isoleucyl transfer RNA synthetase, thereby inhibiting bacterial protein and RNA synthesis. DNA synthesis and cell wall formation are affected to a lesser extent. {01} {02} {03} {04} {05}
Absorption:
Virtually no systemic absorption (< 1.1 nanograms per mL of whole blood) following application to lower arm of normal males with occlusion for 24 hours. {01}
Precautions to Consider
Pregnancy/Reproduction
Fertility—
Adequate and well-controlled studies in humans have not been done.
Studies in rats and rabbits given oral, subcutaneous, and intramuscular doses of up to 100 times the human topical dose, have not shown that mupirocin causes impaired fertility. {01}
Pregnancy—
Adequate and well-controlled studies in humans have not been done.
Studies in rats and rabbits given oral, subcutaneous, and intramuscular doses of up to 100 times the human topical dose, have not shown that mupirocin causes adverse effects in the fetus. {01}
FDA Pregnancy Category B.
Breast-feeding
It is not known whether mupirocin is distributed into breast milk. However, problems in humans have not been documented. Mupirocin is unlikely to be distributed into breast milk in significant amounts since virtually no systemic absorption occurs following topical administration. {01}
Pediatrics
The safety and effectiveness of Bactroban Cream have not been established in children up to 3 months of age. .{12}{13}
The safety and effectiveness of Bactroban Ointment have not been established in children up to 2 months of age.{14}
Geriatrics
In two studies, 30 patients over 65 years old were treated with Bactroban Cream and no overall difference in the efficacy or safety was observed.{12}
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problem exists
Sensitivity to mupirocin
Side/Adverse Effects
Note: The polyethylene glycol vehicle in mupirocin ointment may irritate broken skin or mucous membranes. {04}
When mupirocin ointment is applied to extensive open wounds or burns, the possibility of absorption of the polyethylene glycol vehicle, resulting in serious renal toxicity, should be considered. {04}
Mupirocin ointment has not been reported to cause contact sensitization or photosensitivity reactions. {02} {03} {04}
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
Dry skin {01} {02} {05}
skin burning, itching, pain, rash, redness, stinging, or swelling {01} {02} {03} {04} {05}
headache {12}
nausea {12}{12}
Incidence rare
Abdominal pain {12}
dizziness {12}
secondary wound infection {12}
ulcerative stomatitis (sores in mouth or on lips ){12}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Mupirocin (Topical) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Proper use of this medication
» Not for ophthalmic use
To use
Before applying, washing affected area(s) with soap and water and drying thoroughly; applying small amount and rubbing in gently
After applying, covering treated area(s) with gauze dressing if desired
» Compliance with full course of therapy
» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose
» Proper storage
Precautions while using this medication
Checking with physician or pharmacist if no improvement within 3 to 5 days
General Dosing Information
Topical mupirocin is not for ophthalmic use. {01} {05}
The treated area(s) may be covered with a gauze dressing if desired. {01} {05}
When mupirocin ointment is applied to extensive open wounds or burns, the possibility of absorption of the polyethylene glycol vehicle, resulting in serious renal toxicity, should be considered. {04}
If skin irritation or hypersensitivity develops, treatment with mupirocin ointment should be discontinued. {01}
Patients not showing a clinical response within 3 to 5 days of treatment should be re-evaluated. {13}{14}
Topical Dosage Forms
Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.
MUPIROCIN OINTMENT {09} USP
Usual adult and adolescent dose
Impetigo or
[Eczema, infected]or
[Folliculitis]1
Topical, to the affected area(s), three times a day. {01} {02} {03} {04} {05} {07}
Usual pediatric dose
Impetigo
Children up to 2 months of age: Safety and efficacy have not been established.{14}
Children 2 months to 16 years of age: See Usual adult and adolescent dose.{14}
Strength(s) usually available
U.S.—
2% (Rx) [Bactroban (polyethylene glycol [PEG] 400) (PEG 3350)]{10}{14}
Canada—
2% (OTC) [Bactroban (polyethylene glycol [PEG] 400) (PEG 3350)]{08}{11}
Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.
Auxiliary labeling:
• For external use only.
• Continue medicine for full time of treatment.
Note: Mupirocin ointment is available in a bland, water-miscible ointment base.
MUPIROCIN CALCIUM CREAM 2%
Usual adult and adolescent dose
Secondarily infected traumatic skin lesion
Topical, the affected area(s), three times a day for 10 days.{12}
Usual pediatric dose
Secondarily infected traumatic skin lesion
Children up to 3 months of age: Safety and efficacy have not been established.{13}
Children 3 months to 16 years of age: See Usual adult and adolescent dose.{13}
Strength(s) usually available
U.S.—
2% (Rx) [Bactroban (benzyl alcohol) ( cetomacrogol 1000) (cetyl alcohol) (mineral oil) (phenoxyethanol) (purified water) (stearyl alcohol) (xanthan gum)]{12}
Packaging and storage:
Store at or below 25° C (77° F). Protect from freezing
Auxiliary labeling:
• For external use only.
• Continue medicine for full time of treatment.
Note: Mupirocin cream is available in an oil and water-based emulsion.
Revised: 06/11/2001
References
- Bactroban package insert (Beecham—US), Rev 2/88, Rec 3/88.
- Rumsfield J. West DP, Aronson IK. Topical mupirocin in the treatment of bacterial skin infections. Drug Intell Clin Pharm 1988 Dec; 20: 943-8.
- Parenti MA, Hartfield SM, Leyden JJ. Mupirocin: a topical antibiotic with a unique structure and mechanism of action. Clin Pharm 1987 Oct; 6: 761-70.
- Mupirocin—A new topical antibiotic. Med Lett 1988 May 20; 30(766): 55-6.
- Bactroban (Beecham). In: Krogh, CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988: 99-100
- Hold
- Panel comments, 1/4/89.
- Manufacturer"s comment, 1/17/89.
- The United States pharmacopeia. The national formulary. USP 22nd revision (January 1, 1990). NF 17th ed (January 1, 1990). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1990: 3071 (Seventh Supplement 1992).
- Bactroban package insert (SmithKline Beecham—US), Rev 5/92 Rec 7/93.
- Bactroban (SmithKline Beecham). In: Krogh, CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 131-2.
- Product Information: Bactroban(R) Cream, mupirocin calcium cream 2%. SmithKline Beecham Pharmaceuticals, Philadelphia, PA, (PI revised 4/98) reviewed 8/2000.
- Product Information: Bactroban® Cream, mupirocin calcium cream 2%. SmithKline Beecham Pharmaceuticals, Philadelphia, PA, (PI revised 07/2000) reviewed 5/2001.
- Product Information: Bactroban® Ointment, mupirocin ointment 2%. SmithKline Beecham Pharmaceuticals, Philadelphia, PA, (PI revised 09/1999) reviewed 5/2001.
| Link to this page |  |
Printable Version |  |
Email Page |
