MUPIROCIN ointment

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

BIOMES PHARMACEUTICALS LLC

INN (שם בינלאומי):

MUPIROCIN

הרכב:

MUPIROCIN 20 mg in 1 g

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

MUPIROCIN- MUPIROCIN OINTMENT
BIOMES PHARMACEUTICALS LLC
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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 USP, 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
The most frequent adverse reactions (at least 1%) were burning,
stinging or pain, and itching. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIOMES PHARMACEUTICALS
LLC., AT 1-517-507-5222 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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)
Ointment: Each gram contains 20 mg mupirocin USP in a water-miscible
ointment base supplied in 22-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 f