MUPIROCIN cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)

Available from:

REMEDYREPACK INC.

INN (International Name):

MUPIROCIN CALCIUM

Composition:

MUPIROCIN 2 g in 100 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN CREAM
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MUPIROCIN CREAM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR MUPIROCIN CREAM.
MUPIROCIN CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Mupirocin cream is an RNA synthetase inhibitor antibacterial indicated
for the treatment of secondarily infected traumatic
skin lesions (up to 10 cm in length or 100 cm
in area) due to susceptible isolates of _Staphylococcus aureus _and
_Streptococcus pyogenes. _( 1)
DOSAGE AND ADMINISTRATION
For Topical Use Only. ( 2)
Apply a small amount of mupirocin cream, 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)
DOSAGE FORMS AND STRENGTHS
Cream: 2.15% w/w mupirocin calcium, USP (equivalent to 2% mupirocin
free acid) in 15-gram and 30-gram tubes. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to mupirocin or any of the excipients of
mupirocin cream. ( 4)
WARNINGS AND PRECAUTIONS
Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and
generalized rash have been reported in patients
treated with formulations of mupirocin, including mupirocin cream. (
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 Mucosal Use: Mupirocin cream is not formulated
for use on mucosal surfaces. A separate
formulation, BACTROBAN nasal ointment, is available for intranasal
use. ( 5.6)
ADVERSE REACTIONS
The most frequent adverse reactions (at least 1%) were headache, rash,
and naus