Emcin

Mupirocin Ointment 2%
Topical Preparations

Emcin

Mupirocin 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. 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. 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).

Description

Composition:

Emcin 2% ointment: Each gram of ointment contains Mupirocin USP 20 mg.

Pharmacology:

Mupirocin 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. 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. 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).

Indications:

Mupirocin 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 & Administration:

A small amount of Mupirocin 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.

Contraindications:

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

Warning & Precautions:

If chemical irritations occur with the use of Mupirocin 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, Mupirocin should not be used; if there is evidence of moderate or severe renal impairment.

Side Effects:

The following local adverse reactions have been reported in connection with the use of Mupirocin 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.

Use in Pregnancy:

The drug 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 Mupirocin ointment is administered to a nursing mother.

Pediatric Use:

The safety and effectiveness of Mupirocin 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 Mupirocin in impetigo in pediatric patients.

Drug Interaction:

The effect of the concurrent application of Mupirocin and other drug products has not been studied.

Over dosage:

There is currently limited experience with over dosage of mupirocin ointment.

Storage:

Store at or below 25° C. Do not freeze. Keep out of the reach of children.

Packing: Emcin 2% ointment: Each tube contains 10 gm ointment.