Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 31 December 2017

Indication(s)

1 INDICATIONS AND USAGE CENTANY® ointment is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes. CENTANY® ointment is an antibacterial drug indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes. (1)

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Psoriasis

Psoriasis

See information on psoriasis pathophysiology, signs and symptoms, comorbidities, treatment options, and more.

+ 2 more

Atopic Dermatitis

Atopic Dermatitis

The Atopic Dermatitis Knowledge Centre is an educational resource, intended for healthcare professionals, that provides credible medical information on the epidemiology, pathophysiology and burden of atopic dermatitis, as well as diagnostic techniques, treatment regimens and guideline recommendations.

Psoriasis Academy

Psoriasis Academy

Learn about the burden of psoriasis, unmet needs, the tools used to assess severity and treatment response, what we know about the pathophysiology behind the condition and what the current guidelines say.

+ 1 more

Load more

Related Content

Advisory information

contraindications
4 CONTRAINDICATIONS CENTANY® ointment is contraindicated in patients with a history of sensitivity reactions to any of its components. CENTANY® ointment is contraindicated in patients with a history of sensitivity reactions to any of its components. (4)
Adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Systemic Allergic Reactions [see Warnings and Precautions (5.1)] Eye and Nose Irritation [see Warnings and Precautions (5.2)] Local Irritation [see Warnings and Precautions (5.3)] Clostridium difficile-associated Diarrhea [see Warnings and Precautions (5.4)] Most common adverse reactions (≥0.3%) are application site reactions, pruritus, contact dermatitis, furunculosis, exfoliative dermatitis and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. 6.2 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 [see Warnings and Precautions (5.1)].

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION 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. A small amount of CENTANY® ointment should be applied to the affected area three times daily or as directed by a physician. (2) The area treated may be covered with a gauze dressing if desired. (2) Patients not showing a clinical response within 3 to 5 days should be re-evaluated. (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 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. 8.3 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. 8.4 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 [see Clinical Studies (14) ].
Pregnancy and lactation
8.3 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.

Interactions

7 DRUG INTERACTIONS The effect of the concurrent application of CENTANY® ointment and other drug products is unknown. The effect of concurrent application of CENTANY® ointment and other drug products is unknown. (7)

More information

Category Value
Authorisation number NDA050788
Agency product number D0GX863OA5
Orphan designation No
Product NDC 43538-310
Date Last Revised 29-11-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 106346
Storage and handling Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Marketing authorisation holder Medimetriks Pharmaceuticals, Inc.