Centany

Dosage Forms And Strengths

Ointment: 2%. Each gram of CENTANY® ointment contains 20 mg of mupirocin in a soft white ointment base.

Storage And Handling

CENTANY® ointment, 2% is a white soft ointment and is supplied as follows:

30 g tube (NDC 43538-300-30)

Store at 20-25°C (68-77°F).

Manufactured for: Medimetriks Pharmaceuticals, Inc. 383 Route 46 West, Fairfield, NJ 07004-2402. Manufactured by : PERRIGO Bronx, NY 10457. Revised: Feb 2016

CENTANY® ointment is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.

A small amount of CENTANY® ointment should be applied to the affected area three times daily or as directed by a physician. 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.

CENTANY® ointment is contraindicated in patients with a history of sensitivity reactions to any of its components.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Severe Allergic Reactions

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients with mupirocin formulations..

Eye and Nose Irritation

CENTANY® ointment is not for ophthalmic use or nasal use or on mucosal surfaces. If this product comes in contact with the eyes, rinse thoroughly with water.

Local Irritation

If a reaction suggesting sensitivity or chemical irritation should occur with the use of CENTANY® ointment treatment should be discontinued and appropriate alternative therapy for the infection instituted.

Clostridium Difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, 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 strains 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 2 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.

Potential For Microbial Overgrowth

As with other antibacterial products, prolonged use of CENTANY® ointment may result in overgrowth of nonsusceptible microorganisms, including fungi.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

Reproduction studies were performed with mupirocin administered subcutaneously to male and female rats at doses up to 14 times the human topical dose (approximately 60 mg mupirocin/day) based on body surface area. Neither evidence of impaired fertility nor impaired reproductive performance attributable to mupirocin was observed.

Use In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies of CENTANY® ointment in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. There was no evidence of fetal harm due to mupirocin.

Nursing Mothers

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 CENTANY® ointment is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of CENTANY® ointment have been established in the age range of 2 months to 16 years. Use of CENTANY® ointment in these age groups is supported by evidence from adequate and well-controlled studies of CENTANY® ointment in impetigo in pediatric patients studied as a part of the pivotal clinical trials.

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Systemic Allergic Reactions
• Eye and Nose Irritation
• Local Irritation
• Clostridium difficile-associated Diarrhea

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following local adverse reactions have been reported in connection with the use of CENTANY® ointment, in 300 patients in one clinical trial: 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.

Post Marketing Experience

The following local adverse reactions have been identified during post-approval use of CENTANY® ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash.

DRUG INTERACTIONS

The effect of the concurrent application of CENTANY® ointment and other drug products is unknown.

Pregnancy Category B

There are no adequate and well-controlled studies of CENTANY® ointment in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. There was no evidence of fetal harm due to mupirocin.

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Systemic Allergic Reactions
• Eye and Nose Irritation
• Local Irritation
• Clostridium difficile-associated Diarrhea

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following local adverse reactions have been reported in connection with the use of CENTANY® ointment, in 300 patients in one clinical trial: 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.

Post Marketing Experience

The following local adverse reactions have been identified during post-approval use of CENTANY® ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash.

No information provided.

The pharmacodynamics of CENTANY® ointment are unknown.

Following the application of CENTANY® ointment to a 400cm² 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.

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.