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Author: Admin | 2025-04-28
Is supported by evidence from adequate andwell-controlled trials of BACTROBAN ointment in impetigo in pediatric subjectsstudied as a part of the pivotal clinical trials [see Clinical Studies]. Overdose Information for Bactroban OintmentNo information provided.Contraindications for Bactroban OintmentBACTROBAN ointment is contraindicated in patients withknown hypersensitivity to mupirocin or any of the excipients of BACTROBANointment. Clinical Pharmacology for Bactroban OintmentMechanism Of ActionMupirocin is an RNA synthetase inhibitor antibacterial [seeMicrobiology].PharmacokineticsAbsorptionApplication of 14C-labeled mupirocin ointmentto the lower arm of normal male subjects followed by occlusion for 24 hoursshowed no measurable systemic absorption (less than 1.1 nanogram mupirocin permilliliter of whole blood). Measurable radioactivity was present in the stratumcorneum of these subjects 72 hours after application.The effect of the concurrent application of BACTROBANointment with other topical products has not been studied [see DOSAGE ANDADMINISTRATION].EliminationIn a trial conducted in 7 healthy adult male subjects,the elimination half-life after intravenous administration of mupirocin was 20to 40 minutes for mupirocin and 30 to 80 minutes for monic acid.Metabolism: Following intravenous or oraladministration, mupirocin is rapidly metabolized. The principal metabolite,monic acid, demonstrates no antibacterial activity.Excretion: Monic acid is predominantly eliminatedby renal excretion.MicrobiologyMupirocin is an RNA synthetase inhibitor antibacterialproduced by fermentation using the organism Pseudomonas fluorescens.Mechanism Of ActionMupirocin inhibits bacterial protein synthesis by reversiblyand specifically binding to bacterial isoleucyl-transfer RNA (tRNA) synthetase.Mupirocin is bactericidal at concentrations achieved bytopical administration. Mupirocin is highly protein bound (greater than 97%)and the effect of wound secretions on the minimum inhibitory concentrations(MICs) of mupirocin has not been determined.ResistanceWhen mupirocin resistance occurs, it results from theproduction of a modified isoleucyl-tRNA synthetase, or the acquisition of, bygenetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase.High-level plasmid-mediated resistance (MIC ≥ 512 mcg/mL) has beenreported in increasing numbers of isolates of S. aureus and with higherfrequency in coagulase-negative staphylococci. Mupirocin resistance occurs withgreater frequency in methicillin-resistant than methicillin-susceptiblestaphylococci.Cross ResistanceDue to its mode of action, mupirocin does not demonstratecross resistance with other classes of antimicrobial agents.Antimicrobial ActivityMupirocin has been shown to be active against susceptibleisolates of S. aureus and S. pyogenes, both in vitro and in clinical trials [seeINDICATIONS AND USAGE]. The following in vitro data are available, buttheir clinical significance is unknown. Mupirocin is active against mostisolates of Staphylococcus epidermidis.Susceptibility Test MethodsHigh-level mupirocin resistance ( ≥ 512 mcg/mL) maybe determined using standard disk diffusion or broth microdilution tests.1,2Because of the occurrence of mupirocin resistance in methicillin-resistant S.aureus (MRSA), it is appropriate to test MRSA populations for mupirocinsusceptibility prior to the use of mupirocin using a standardized method.3,4,5Clinical StudiesThe efficacy of topical BACTROBAN ointment in impetigowas tested in 2 trials. In the first, subjects with impetigo were randomized toreceive either BACTROBAN ointment or vehicle placebo 3 times daily for 8 to 12days. Clinical efficacy rates at end of therapy in the evaluable populations(adults and pediatric subjects included) were 71% for BACTROBAN ointment (n =49) and 35% for vehicle placebo (n = 51). Pathogen eradication rates in theevaluable populations were 94% for BACTROBAN ointment and 62% for vehicleplacebo.In the second trial, subjects with impetigo wererandomized to receive either BACTROBAN ointment 3 times
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