MUPIROCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Mupirocin (UNII: D0GX863OA5) (Mupirocin - UNII:D0GX863OA5)

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [see Clinical Pharmacology (12.3)] . No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 mg per kg per day or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). The estimated background risk of major birth defects and miscarriages for the indicated popu

Product summary:

Each gram of mupirocin ointment contains 20 mg mupirocin in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied as follows: 22-g tube NDC 68788-7993-2 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN OINTMENT
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MUPIROCIN OINTMENT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MUPIROCIN
OINTMENT.
MUPIROCIN OINTMENT, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Mupirocin ointment is an RNA synthetase inhibitor antibacterial
indicated for the topical treatment of
impetigo due to susceptible isolates of _Staphylococcus aureus_ and
_Streptococcus pyogenes_. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO PHARMACEUTICALS
U.S.A., INC., AT 1-
866-923-4914 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2023
For Topical Use Only. (2)
Apply a small amount of mupirocin ointment, with a cotton swab or
gauze pad, to the affected area 3
times daily for 10 days. (2)
Re-evaluate patients not showing a clinical response within 3 to 5
days. (2)
Not for intranasal, ophthalmic, or other mucosal use. (2)
Ointment: Each gram contains 20 mg mupirocin in a water-miscible
ointment base supplied in 15-
gram, 22-gram and 30-gram tubes. (3)
Known hypersensitivity to mupirocin or any of the excipients of
mupirocin ointment. (4)
Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and
generalized rash have been
reported in patients treated with formulations of mupirocin, including
mupirocin ointment. (5.1)
Eye Irritation: Avoid contact with eyes. (5.2)
Local Irritation: Discontinue in the event of sensitization or severe
local irritation. (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