EMCIN® – Mupirocin USP

Chemical Name:
Chemical Name: 9-[(E)-4-[(2S,3R,4R,5S)-3,4-dihydroxy-5-[[(2S,3S)-3-[(2S,3S)-3-hydroxybutan-2-yl]oxiran-2-yl]methyl]oxan-2-yl]-3-methylbut-2-enoyl]oxynonanoic acid

Description:EMCIN CREAM® formerly termed pseudomonic acid A, is a novel antibacterial agent with a unique chemical structure and mode of action apart from other antibiotic agents. Produced by fermentation using the organism Pseudomonas fluorescens, EMCIN CREAM® is a naturally-occurring antibiotic that displays a broad-specturm activity against many gram-positive bacteria and certain gram-negative bacteria in vitro. EMCIN CREAM® primarily works by inhibiting bacterial protein synthesis. Due to its unique mode of action of inhibiting the activity of bacterial isoleucyl-tRNA synthetase, EMCIN CREAM® does not demonstrate cross-resistance with other classes of antimicrobial agents, giving it a therapeutic advantage. EMCIN CREAM® is available in topical formulations only due to extensive systemic metabolism and is used in the treatment of impetigo caused by Staphylococcus aureus and Streptococcus pyogenes and traumatic skin lesions due to secondary skin infections caused by S. aureus and S. pyogenes.

— 10 gm Tube

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EMCIN® – Mupirocin USP

COMPOSITION
EMCIN® 2% ointment: Each gram of ointment contains Mupirocin USP 20 mg.

PHARMACOLOGY
EMCIN® is a naturally occurring antibiotic. It is an antibacterial agent produced by fermentation of Pseudomonas fluorescens. It is active against a wide range of bacteria which are responsible for the majority of skin infections, e.g. Staphylococcus aureus including methicillin-resistant Staphylococcus aureus (MRSA) other Staphylococci and Streptococci. It is also active against certain gram-negative pathogens like, E.coli and H. influenzae. EMCIN® inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, EMCIN® demonstrates no in vitro cross-resistance with other classes of antimicrobial agents. Mupirocin is bactericidal at concentrations achieved by topical administration. However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally eight-fold to thirty-fold higher than the minimum inhibitory concentration (MIC).

INDICATION
EMCIN® ointment is indicated for the topical treatment of impetigo due to Staphylococcus aureus and Streptococcus Pyogenes. It is also indicated in folliculitis and furunculosis.

DOSAGE AND ADMINISTRATION
A small amount of EMCIN® ointment should be applied to the affected area three times daily. The treated area may be covered with dressing gauze if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

SIDE EFFECT
The following local adverse reactions have been reported in connection with the use of EMCIN® 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 exudates in less than 1% of patients.

PRECAUTION
If chemical irritations occur with the use of EMCIN® ointment, treatment should be discontinued and appropriate alternative therapy for the infection should be maintained. As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. In common with other polyethylene glycol-based ointments, EMCIN® should not be used; if there is evidence of moderate or severe renal impairment.

CONTRAINDICATION
This drug is contraindicated in individuals with a history of sensitivity reactions to EMCIN® or any of the components of the preparation.

DRUG INTERACTION
The effect of the concurrent application of EMCIN® and other drug products has not been studied.

USE IN PREGNANCY AND LACTATION
Use In Pregnancy: EMCIN® is classified in Pregnancy Category “B”. This drug can be used in pregnancy only if clearly needed.

Use in lactation: 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 EMCIN® ointment is administered to a nursing mother.

Pediatric Use: The safety and effectiveness of EMCIN® ointment have been established in the age range of 2 months to 16 years. Use of the ointment in these age groups is supported by evidence from adequate and well-controlled studies of EMCIN® in impetigo in pediatric patients.

STORAGE
Store at or below 30° C. Do not freeze. Keep out of the reach of children.

PACKING
EMCIN® 2% ointment: Each tube contains 10gm ointment.

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