MUPIROCIN cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

MUPIROCIN CALCIUM

Composition:

MUPIROCIN 2 g in 100 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mupirocin cream 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 and miscarriage 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 cream [see Clinical Pharmacology (12.3)] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mupirocin cream and any potential adverse effects on the breastfed child from mupirocin cream 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 cream should be thoroughly washed prior to breastfeeding. The safety and effectiveness of mupirocin cream have been established in the age-groups of 3 months to 16 years. Use of mupirocin cream in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see Clinical Studies (14)] . In 2 adequate and well-controlled trials, 30 subjects older than 65 years were treated with mupirocin cream. No overall difference in the efficacy or safety of mupirocin cream was observed in this patient population when compared with that observed in younger patients.

Product summary:

Mupirocin Cream USP is a white cream that contains 20 mg (2% w/w) of mupirocin per gram (equivalent to 2.15% w/w mupirocin calcium, USP) in an oil- and water-based emulsion. Mupirocin Cream USP, 2% is supplied in 15-gram and 30-gram tubes. NDC 68462-564-17 15-gram tube (1 tube per carton) NDC 68462-564-35 30-gram tube (1 tube per carton) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN CREAM
GLENMARK PHARMACEUTICALS INC., USA
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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
Mupirocincream is an RNA synthetase inhibitor antibacterial indicated
for the treatment of secondarily infected traumatic
skin lesions (up to 10 cm in length or 100 cm in area) due to
susceptible isolates of _Staphylococcus aureus _and
_Streptococcus pyogenes. _(1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Cream: 20 mg (2% w/w) of mupirocin per gram (equivalent to 21.5 mg
(2.15% w/w) of mupirocin calcium, USP) 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
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK
PHARMACEUTICALS INC., USA AT 1(888)721-
7115 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
2
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)
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