MUPIROCIN- mupirocin ointment

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Mupirocin (UNII: D0GX863OA5) (Mupirocin - UNII:D0GX863OA5)

Tersedia dari:

Lake Erie Medical DBA Quality Care Products LLC

Rute administrasi :

TOPICAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. Pregnancy Category B. There are no adequate and well-controlled studies of mupirocin ointment in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day in both species. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. There was no evidence of fetal harm due to mupirocin. It is not known whether this drug is excreted in human milk. Because many drugs a

Ringkasan produk:

Mupirocin Ointment USP, 2% is supplied as follows: 55700-069-22   22g Each gram of mupirocin ointment contains 20 mg mupirocin in a water-miscible ointment base. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

MUPIROCIN- MUPIROCIN OINTMENT
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MUPIROCIN OINTMENT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MUPIROCIN OINTMENT.
MUPIROCIN OINTMENT, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Mupirocin ointment is an RNA synthetase inhibitor antibacterial
indicated for the topical treatment of impetigo 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 ointment, 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
Ointment: Each gram contains 20 mg mupirocin in a water-miscible
ointment base supplied in 15 gram, 22 gram and 30
gram tubes. (3)
CONTRAINDICATIONS
Known hypersensitivity to mupirocin or any of the excipients of
mupirocin ointment. (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 ointment.
(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 ointment is not formulated
for use on mucosal surfaces. A separate
formulation, mupirocin nasal ointment, is available for intranasal
use. (5.6)
Risk of Polyethylene Glycol Absorption: Mupirocin ointment should not
be used where absorption of large