MUPIROCIN ointment

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Unit Dose Services

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Mupirocin ointment 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 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 population is unknown. The esti

產品總結:

Product: 50436-1010 NDC: 50436-1010-1 22 g in a TUBE

授权状态:

Abbreviated New Drug Application

产品特点

MUPIROCIN- MUPIROCIN OINTMENT
UNIT DOSE SERVICES
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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
Ointment: Each gram contains 20 mg mupirocin in a water-miscible
ointment base supplied in 22-gram tubes. (3)
CONTRAINDICATIONS
Known hypersensitivity to mupirocin or any of the excipients of
mupirocin ointment. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
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 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)
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 Microbia