MUPIROCIN cream

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Welgo, Llc

SNN (starptautisko nepatentēto nosaukumu):

MUPIROCIN CALCIUM

Kompozīcija:

MUPIROCIN 2 g in 100 g

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

MUPIROCIN- MUPIROCIN CREAM
WELGO, LLC
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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
Mupirocincream 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 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 heada