BACTROBAN- mupirocin calcium ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

GlaxoSmithKline LLC

INN (International Name):

MUPIROCIN CALCIUM

Composition:

MUPIROCIN 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BACTROBAN nasal ointment is indicated for the eradication of nasal colonization with methicillin‑resistant Staphylococcus aureus (MRSA) in adult and pediatric patients (aged 12 years and older) and healthcare workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections with this microorganism. BACTROBAN nasal ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of BACTROBAN nasal ointment. Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with BACTROBAN nasal ointment in pregnant women. Mupirocin absorption was negligible following repeated intranasal administration of BACTROBAN nasal ointment [see Clinical Pharmacology 12.3)] , but the dose regimen used in this study did not mimic recommended clinical use. No developmental toxicity was observed in rats or rabbits treated with mupirocin

Product summary:

BACTROBAN nasal ointment is a white to off-white ointment that contains 20 mg (2% w/w) of mupirocin. BACTROBAN nasal ointment, 2% is supplied in single-use 1‑gram tubes. NDC 0029-1526-03 Single-use 1‑gram tube in Package of 10: NDC 0029-1526-11. Store between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not refrigerate.

Authorization status:

New Drug Application

Summary of Product characteristics

BACTROBAN- MUPIROCIN CALCIUM OINTMENT
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BACTROBAN NASAL OINTMENT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BACTROBAN NASAL
OINTMENT.
BACTROBAN (MUPIROCIN) NASAL OINTMENT
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
BACTROBAN nasal ointment is an RNA synthetase inhibitor antibacterial
indicated for the eradication of nasal colonization
with methicillin-resistant _Staphylococcus aureus_ (MRSA) in adult and
pediatric patients (aged 12 years and older) and
healthcare workers as part of a comprehensive infection control
program to reduce the risk of infection among patients at
high risk of MRSA infection during institutional outbreaks of
infections with this microorganism_._ (1)
Limitations of Use (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Nasal ointment: 20 mg (2% w/w) of mupirocin in single-use 1-gram
tubes. (3)
CONTRAINDICATIONS
Known hypersensitivity to mupirocin or any of the excipients of
BACTROBAN nasal ointment. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most frequent adverse reactions (at least 1% in U.S. trials) were
headache, rhinitis, respiratory disorders, pharyngitis,
taste perversion, burning/stinging, cough, and pruritus. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2020
There are insufficient data at this time to establish that this
product is safe and effective as part of an intervention
program to prevent autoinfection of high-risk patients from their own
nasal colonization with _Staphylococcus aureus_
_(S. aureus)_.
There are insufficient data at this time to recommend use of BACTROBAN
nasal ointment for general prophylaxis of
any infection in any patient population.
For Intranasal Use Only. (2)
Ap