MUPIROCIN ointment

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

REMEDYREPACK INC.

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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. 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 mg per kg per day 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 estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data: Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area. Mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose. Risk Summary It is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of mupirocin in humans following topical administration of mupirocin ointment [see Clinical Pharmacology (12.3)] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mupirocin ointment and any potential adverse effects on the breastfed child from mupirocin ointment or from the underlying maternal condition. Clinical Considerations To minimize oral exposure of the drug to children, a breast and/or nipple being treated with mupirocin ointment should be thoroughly washed prior to breastfeeding. The safety and effectiveness of mupirocin ointment have been established in the age range of 2 months to 16 years. Use of mupirocin ointment in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment in impetigo in pediatric subjects studied as a part of the pivotal clinical trials in adults [see Clinical Studies (14)] .

leaflet_short:

Each gram of mupirocin ointment contains 20 mg mupirocin in a water-miscible ointment base. Mupirocin Ointment USP, 2% is supplied as follows: NDC: 70518-2344-00 NDC: 70518-2344-01 PACKAGING: 1 in 1 CARTON, 22 g in 1 TUBE, TYPE 0 PACKAGING: 1 in 1 CARTON, 15 g in 1 TUBE, TYPE 0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

MUPIROCIN- MUPIROCIN OINTMENT
REMEDYREPACK INC.
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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 quantities of poly