MUPIROCIN- mupirocin calcium cream

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Taro Pharmaceuticals U.S.A., Inc.

Manustamisviis:

TOPICAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

Mupirocin cream is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- and water-based emulsion. Mupirocin Cream USP, 2% is supplied in 15-gram (NDC 51672-1370-1) and 30-gram (NDC 51672-1370-2) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

MUPIROCIN- MUPIROCIN CALCIUM CREAM
TARO PHARMACEUTICALS U.S.A., 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 cm2 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 SUS