CENTANY- mupirocin ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)

Available from:

Medimetriks Pharmaceuticals Inc

INN (International Name):

MUPIROCIN

Composition:

MUPIROCIN 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CENTANY® ointment is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes . CENTANY® ointment is contraindicated in patients with a history of sensitivity reactions to any of its components. 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. 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. The safety and effectiveness o

Product summary:

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) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

CENTANY- MUPIROCIN OINTMENT
MEDIMETRIKS PHARMACEUTICALS INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CENTANY OINTMENT SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CENTANY OINTMENT.
CENTANY (MUPIROCIN) OINTMENT, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
CENTANY ointment is an antibacterial drug indicated for the topical
treatment of impetigo due to: _Staphylococcus_
_aureus _and _Streptococcus pyogenes._ (1)
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. (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)
DOSAGE FORMS AND STRENGTHS
Ointment: 2% (3)
CONTRAINDICATIONS
CENTANY ointment is contraindicated in patients with a history of
sensitivity reactions to any of its components. (4)
WARNINGS AND PRECAUTIONS
Severe Allergic Reactions: Including anaphylaxis, urticaria,
angioedema, and generalized rash have been reported in
patients treated with CENTANY ointment. (5.1)
Eye and Nose Irritation: Not intended for ophthalmic use or nasal use
or on mucosal surfaces. (5.2)
Local Irritation: If signs of sensitivity or irritation should occur,
treatment should be discontinued. (5.3)
_Clostridium difficile_-associated Diarrhea (CDAD): If diarrhea
occurs, evaluate patients for CDAD. (5.4)
Potential for Microbial Overgrowth: Prolonged use may result in
overgrowth of nonsusceptible microorganisms,
including fungi. (5.5)
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
The effect of concurrent application of CENTANY ointment and other
drug products is