Pre and Post Sx Pouch

PRE AND POST SX POUCH- mupirocin 2%, dimethicone 5%, chlorhexidine gluconate 4%
Terrain Pharmaceuticals

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

For Dermatologic Use

Rx Only

DESCRIPTION

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is ( E)-(2 S ,3 R ,4 R ,5 S)-5-[(2 S ,3 S ,4 S ,5 S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-╬▓-methyl-2 H -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26 H 44 O 9 and the molecular weight is 500.62.

The chemical structure is:

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CLINICAL PHARMACOLOGY

Application of 14 C-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 trial 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.

Microbiology –

Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA (tRNA) synthetase. Due to this unique mode of action, mupirocin does not demonstrate cross-resistance with other classes of antimicrobial agents.

When mupirocin resistance occurs, it results from the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC >512 mcg/mL) has been reported in increasing numbers of isolates of Staphylococcus aureus and with higher frequency in coagulase-negative staphylococci. Mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci. Because of the occurrence of mupirocin resistance in methicillin-resistant Staphylococcus aureu (MRSA), it is appropriate to test MRSA populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method. 1 ,2,3

Mupirocin is bactericidal at concentrations achieved by topical administration. 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 susceptible strains of S. aureus and Streptococcus pyogenes , both in vitro and in clinical trials (see INDICATIONS AND USAGE). The following in vitro data are available, but their clinical significance is unknown. Mupirocin is active against most isolates of Staphylococcus epidermidis.

INDICATIONS AND USAGE

Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to: S. aureus and S. pyogenes.

CONTRAINDICATIONS

This drug is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

WARNINGS

Avoid contact with the eyes. In case of accidental contact, rinse well with water.

In the event of sensitization or severe local irritation from Mupirocin Ointment USP, 2%, usage should be discontinued.

Clostridium difficile — associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including mupirocin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

Mupirocin Ointment USP, 2% 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, Mupirocin Ointment USP, 2% 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.

Mupirocin Ointment USP, 2% should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance.

Information for Patients —

Use this medication only as directed by the healthcare provider. It is for external use only. Avoid contact with the eyes. If Mupirocin Ointment USP, 2% gets in or near the eyes, rinse thoroughly with water. The medication should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs. If impetigo has not improved in 3 to 5 days, contact the healthcare provider.

Drug Interactions

The effect of the concurrent application of Mupirocin Ointment USP, 2% and other drug products has not been studied.

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