MUPIROCIN cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BIOMES PHARMACEUTICALS LLC

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. Click here to enter Use in Specific Populations Pregnancy Category B. There are no adequate and well-controlled studies of mupirocin cream (contains equivalent of 2% mupirocin free acid) 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 su

Product summary:

Mupirocin cream USP, 2% is supplied in 15-gram and 30-gram tubes. Mupirocin cream USP is a white cream that contains 2.15% w/w mupirocin calcium USP (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion. NDC 69150-225-01 15-gram tube (1 tube per carton) NDC 69150-225-03 30-gram tube (1 tube per carton) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MUPIROCIN- MUPIROCIN CREAM
BIOMES PHARMACEUTICALS LLC
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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 USP, 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most frequent adverse reactions (at least 1%) were headache, rash,
and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIOMES PHARMACEUTICALS
LLC., USA AT 1-517-507-5222
O R
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
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)
Cream: 2.15% w/w mupirocin calcium USP (equivalent to 2% mupirocin
free acid) in 15-gram and 30-gram tubes. (3)
Known hypersensitivity to mupirocin or any of the excipients of
mupirocin cream. (4)
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 Di