MUPIROCIN ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

MUPIROCIN

Composition:

MUPIROCIN 20 mg in 1 g

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 USP, 2% is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of Mupirocin Ointment USP, 2%. 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 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 popula

Product summary:

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied in 15-gram and 22-gram tubes. NDC 45802-112-14 (15-gram tube) NDC 45802-112 -22 (22-gram tube) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN OINTMENT
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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 USP, 2% 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 PADAGIS AT
1-866-634-9120 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2022
For Topical Use Only. (2)
Apply a small amount of Mupirocin Ointment USP, 2%, with a cotton swab
or gauze pad, to the
affected area 3 times daily for up to 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 22-
gram tubes. (3)
Known hypersensitivity to mupirocin or any of the excipients of
Mupirocin Ointment USP, 2%. (4)
Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and
generalized rash have been
reported in patients treated with formulations of mupirocin, including
Mupirocin Ointment USP, 2%.
(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 fungi. (5.5)
Risk Associated with Mucosa