Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1690
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BACTROBAN (Ointment)
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| dailymed-instance:dosage |
A small amount of BACTROBAN OINTMENT should be applied to
the affected area 3 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.
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| dailymed-instance:descripti... |
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-��-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic
acid. The molecular formula of mupirocin is CHOand
the molecular weight is 500.63. The chemical structure is:
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| dailymed-instance:clinicalP... |
Application ofC-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 7 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.<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 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 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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This drug is contraindicated in individuals with a history
of sensitivity reactions to any of its components.
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| dailymed-instance:supply |
BACTROBAN OINTMENT 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). GlaxoSmithKline ResearchTriangle Park, NC 27709 BACTROBAN OINTMENT and BACTROBAN
NASAL are registered trademarks of GlaxoSmithKline. ��2005,
GlaxoSmithKline. All rights reserved. MAY 2005BC:L13C
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| dailymed-instance:precautio... |
If a reaction suggesting sensitivity or chemical irritation
should occur with the use of BACTROBAN OINTMENT, 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.<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 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.<br/>Drug Interactions: The effect of the concurrent application of BACTROBAN OINTMENT
and other drug products has not been studied.<br/>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/mbasis and revealed no
evidence of impaired fertility and reproductive performance from mupirocin.<br/>Pregnancy:<br/>Teratogenic Effects: 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/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
studies are not always predictive of human response, this drug should be used
during pregnancy only if clearly needed. 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.<br/>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).
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| dailymed-instance:genericMe... |
mupirocin
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| dailymed-instance:fullName |
BACTROBAN (Ointment)
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| dailymed-instance:adverseRe... |
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 OINTMENThave occurred rarely.
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| dailymed-instance:warning |
BACTROBAN OINTMENT
is not for ophthalmic use.
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| dailymed-instance:indicatio... |
BACTROBAN OINTMENT is indicated for the topical treatment
of impetigo due to: S. aureus and S. pyogenes.
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| dailymed-instance:name |
BACTROBAN
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