MUPIROCIN ointment

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

MUPIROCIN (UNII: D0GX863OA5) (MUPIROCIN - UNII:D0GX863OA5)

から入手可能:

Teva Pharmaceuticals USA, Inc.

INN（国際名）:

MUPIROCIN

構図:

MUPIROCIN 20 mg in 1 g

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Mupirocin ointment 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. Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment [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 and miscarriages for the indicated population is unknown. The esti

製品概要:

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied in 22 gram tubes (NDC 0093-1010-42). Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

MUPIROCIN- MUPIROCIN OINTMENT
TEVA PHARMACEUTICALS USA, INC.
----------
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 up to 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 22-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 quantities of polyethylene glyco