CENTANY^™
(mupirocin ointment),2%

OrthoNeutrogena

Rx only       For Dermatologic Use

Each gram of Centany (mupirocin ointment),2% contains 20 mg mupirocin in a soft white ointment base consisting of castor oil, oleyl alcohol, hard fat (Softisan^® 378) and propylene glycol monostearate. 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-β-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C₂₆H₄₄O₉ and the molecular weight is 500.63. The chemical structure is:

Following the application of Centany (mupirocin ointment),2% to a 400 cm² area on the back of 23 healthy volunteers once daily for 7 days, the mean (range) cumulative urinary excretion of monic acid over 24 hrs following the last administration was 1.25% (0.2% to 3.0%) of the administered dose of mupirocin. The monic acid concentration in urine collected at specified intervals for 24 hrs on Day 7 ranged from <0.050 to 0.637 μg/mL.

Centany (mupirocin ointment),2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.

This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components.

Centany (mupirocin ointment),2% is not for ophthalmic use.

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Centany (mupirocin ointment),2%, 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. Centany (mupirocin ointment),2% is not formulated for use on mucosal surfaces. Centany (mupirocin ointment),2% is not intended for nasal use.

The following local adverse reactions have been reported in connection with the use of Centany (mupirocin ointment),2%; application site reactions and pruritus, each in 1% of patients; contact dermatitis and furunculosis, each in 0.7% of patients; and exfoliative dermatitis and rash, each in 0.3% of patients.

A small amount of Centany (mupirocin ointment),2% should be applied to the affected area three 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.

The efficacy of topical Centany (mupirocin ointment),2% in impetigo was tested in one study. Patients with impetigo were randomized to receive either Centany (mupirocin ointment), 2% or Bactroban^® Ointment (mupirocin ointment, 2%) t.i.d. for 7 days. Clinical efficacy rates at the follow-up visit (one week after end of therapy) in the evaluable populations (adults and pediatric patients included) were 94% for Centany (mupirocin ointment), 2% (n=233) and 95% for Bactroban^® Ointment (mupirocin ointment, 2%) (n=242). Pathogen eradication rates at follow-up for both medications were 98%.

There were 413 pediatric patients aged 2 months to 15 years in the clinical study described above. Clinical efficacy rates at follow-up in the evaluable populations were 93% for Centany (mupirocin ointment), 2% (n=199) and 95% for Bactroban^® Ointment (mupirocin ointment, 2%) (n=214).

Centany (mupirocin ointment),2% is supplied in 15 gram (NDC 0062-1610-01) and 30 gram (NDC 0062-1610-03) tubes.

Store at controlled room temperature 20° to 25°C (68° to 77°F).

OrthoNeutrogena

Distributed by: OrthoNeutrogena, Division of Ortho-McNeil Pharmaceutical, Inc.
Skillman, New Jersey 08558
©OMP 2004
Rev: April 2004
Printed in USA
635-10-686-3
U.S. Patent No. 6,013,657