Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2226
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BACTROBAN (Cream)
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| dailymed-instance:dosage |
A small amount of BACTROBAN CREAM should be applied to the
affected area 3 times daily for 10 days. The area treated may be covered
with gauze dressing if desired. Patients not showing a clinical response within
3 to 5 days should be re-evaluated.
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| dailymed-instance:descripti... |
BACTROBAN CREAM (mupirocin calcium cream), 2% contains the
dihydrate crystalline calcium hemi-salt of the antibiotic mupirocin. Chemically,
it is (��E,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-��-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic
acid, calcium salt (2:1), dihydrate. The molecular
formula of mupirocin calcium is (CHO)Ca���2HO,
and the molecular weight is 1075.3. The molecular weight of mupirocin free
acid is 500.6. The structural formula of mupirocin calcium is: BACTROBAN
CREAM is a white cream that contains 2.15% w/w mupirocin calcium (equivalent
to 2.0% mupirocin free acid) in an oil and water-based emulsion. The inactive
ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral
oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum.
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| dailymed-instance:clinicalP... |
Pharmacokinetics: Systemic absorption of mupirocin through intact human skin
is minimal. The systemic absorption of mupirocin was studied following application
of BACTROBAN CREAM 3 times daily for 5 days to various skin lesions (���10 cm
in length or 100 cmin area) in 16 adults (aged 29 to
60 years) and 10 children (aged 3 to 12 years). Some systemic
absorption was observed as evidenced by the detection of the metabolite, monic
acid, in urine. Data from this study indicated more frequent occurrence of
percutaneous absorption in children (90% of patients) compared to adults (44%
of patients); however, the observed urinary concentrations in children (0.07
- 1.3 mcg/mL [1 pediatric patient had no detectable level]) are within
the observed range (0.08 - 10.03 mcg/mL [9 adults had no detectable level])
in the adult population. In general, the degree of percutaneous absorption
following multiple dosing appears to be minimal in adults and children. Any
mupirocin reaching the systemic circulation is rapidly metabolized, predominantly
to inactive monic acid, which is eliminated by renal excretion.<br/>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 demonstratesno 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 Staphylococcus aureus and
coagulase-negative staphylococci. Mupirocin is bactericidal
at concentrations achieved by topical application. The minimum bactericidal
concentration (MBC) against relevant pathogens is generally 8-fold to 30-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 S.
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.
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| dailymed-instance:contraind... |
BACTROBAN CREAM is contraindicated in patients with known
hypersensitivity to any of the constituents of the product.
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| dailymed-instance:supply |
BACTROBAN CREAM is supplied in 15-gram and 30-gram tubes. NDC
0029-1527-22 (15-gram tube) NDC 0029-1527-25 (30-gram
tube) Store at or below 25��C (77��F). Do not
freeze. GlaxoSmithKline Research
Triangle Park, NC 27709 BACTROBAN
CREAM is a registered trademark of GlaxoSmithKline. ��2005,
GlaxoSmithKline. All rights reserved. May 2005 BB:L7B
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| dailymed-instance:precautio... |
General: As with other antibacterial products, prolonged use may result
in overgrowth of nonsusceptible microorganisms, including fungi. (See DOSAGE
AND ADMINISTRATION.) BACTROBAN CREAM is not formulated
for use on mucosal surfaces.<br/>Information for Patients: ���Use this medication only as directed by your healthcare
provider. It is for external use only. Avoid contact with the eyes. ���The treated area may be covered by gauze dressing if desired. ���Report to your healthcare provider any signs of local adverse reactions. The
medication should be stopped and your healthcare provider contacted if irritation,
severe itching, or rash occurs. ���If no improvement
is seen in 3 to 5 days, contact your healthcare provider.<br/>Drug Interactions: The effect of the concurrent application of topical mupirocin
calcium cream and other topical products has not been studied.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic potential
of mupirocin calcium 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 mutagenicity: 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 assayin mice. Fertility
studies were performed in rats with mupirocin administered subcutaneously
at doses up to 49 times a human topical dose of 1 gram/day (approximately
20 mg mupirocin per day) on a mg/mbasis and revealed no
evidence of impaired fertility from mupirocin sodium.<br/>Pregnancy: Teratogenic Effects:Pregnancy Category B. Teratology studies have been
performed in rats and rabbits with mupirocin administered subcutaneously at
doses up to 78 and 154 times, respectively, a human topical dose of 1 gram/day
(approximately 20 mg mupirocin per day) on a mg/mbasis 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
reproduction studies are not always predictive of human response, this drug
should be used during pregnancy only if clearly needed.<br/>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 CREAM is administered to a nursing woman.<br/>Pediatric Use: The safety and effectiveness of BACTROBAN CREAM have been
established in the age groups 3 months to 16 years. Use of BACTROBAN
CREAM in these age groups is supported by evidence from adequate and well-controlled
studies of BACTROBAN CREAM in adults with additional data from 93 pediatric
patients studied as part of the pivotal trials in adults. (See CLINICAL STUDIES.)<br/>Geriatric Use: In 2 well-controlled studies, 30 patients older than
65 years were treated with BACTROBAN CREAM. No overall difference in
the efficacy or safety of BACTROBAN CREAM was observed in this patient population
when compared to that observed in younger patients.
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| dailymed-instance:overdosag... |
Intravenous infusions of 252 mg, as well as single
oral doses of 500 mg of mupirocin, have been well tolerated in healthy
adult subjects. There is no information regarding overdose of BACTROBAN CREAM.
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| dailymed-instance:genericMe... |
mupirocin calcium
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| dailymed-instance:fullName |
BACTROBAN (Cream)
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| dailymed-instance:adverseRe... |
In 2 randomized, double-blind, double-dummy trials, 339 patients
were treated with topical BACTROBAN CREAM plus oral placebo. Adverse events
thought to be possibly or probably drug-related occurred in 28 (8.3%) patients.
The incidence of those events that were reported in at least 1% of patients
enrolled in these trials were: Headache (1.7%), rash, and nausea (1.1% each). Other
adverse events thought to be possibly or probably drug-related which occurred
in less than 1% of patients were: Abdominal pain, burning at application site,
cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and
ulcerative stomatitis. In a supportive study in the
treatment of secondarily infected eczema, 82 patients were treated with
BACTROBAN CREAM. The incidence of adverse events thought to be possibly or
probably drug-related was as follows: Nausea (4.9%), headache, and burning
at application site (3.6% each), pruritus (2.4%) and 1 report each of abdominal
pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin,
and rash.
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| dailymed-instance:warning |
Avoid contact with the eyes. In the
event of a sensitization or severe local irritation from BACTROBAN CREAM,
usage should be discontinued, and appropriate alternative therapy for the
infection instituted.
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| dailymed-instance:indicatio... |
BACTROBAN CREAM is indicated for the treatment of secondarily
infected traumatic skin lesions (up to 10 cm in length or 100 cmin
area) due to susceptible strains of S.aureus and S. pyogenes.
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| dailymed-instance:name |
BACTROBAN
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