MUPIROCIN- mupirocin calcium cream

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Mupirocin Calcium (UNII: RG38I2P540) (Mupirocin - UNII:D0GX863OA5)

可用日期:

NORTHSTAR RX LLC

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin cream [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 a

產品總結:

Mupirocin cream is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- water-based emulsion. Mupirocin Cream USP, 2% is supplied in 15-gram (NDC 16714-055-01) and 30-gram (NDC 16714-055-02) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

授权状态:

Abbreviated New Drug Application

产品特点

MUPIROCIN- MUPIROCIN CALCIUM CREAM
NORTHSTAR RX 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
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: 20 mg (2% w/w) of mupirocin per gram 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, mupirocin nasal ointment, is available for intranasal
use. (5.6)
ADVERSE REACTIONS
The most frequent adverse reactions (at least 1%) were headache, rash,
and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REA