MUPIROCIN- mupirocin calcium cream

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

REMEDYREPACK INC.

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 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 ris

ملخص المنتج:

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 NDC: 70518-3774-00 PACKAGING: 1 in 1 CARTON, 30 g in 1 TUBE, TYPE 0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MUPIROCIN- MUPIROCIN CALCIUM 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 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 SUSPEC