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:

Prasco Laboratories

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mupirocin calcium 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. Mupirocin calcium nasal ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of Mupirocin calcium nasal ointment. Pregnancy Category B. There are no adequate and well-controlled studies of Mupirocin calcium nasal ointment (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 ra

Product summary:

Mupirocin calcium nasal ointment, 2% is supplied in single-use 1‑gram tubes. Mupirocin calcium nasal ointment is a white to off-white ointment that contains mupirocin calcium (equivalent to 2% mupirocin free acid). NDC 66993-943-11 Single-use 1‑gram tube in Package of 10: NDC 66993-943-75. 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 Authorized Generic

Summary of Product characteristics

MUPIROCIN CALCIUM- MUPIROCIN CALCIUM OINTMENT
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MUPIROCIN CALCIUM NASAL
OINTMENT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MUPIROCIN CALCIUM
NASAL OINTMENT.
MUPIROCIN CALCIUM NASAL OINTMENT
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Mupirocin calcium nasal ointment is an antibacterial drug 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
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
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 Mupirocin
calcium nasal ointment for
general prophylaxis of any infection in any patient population.
For Intranasal Use Only. (2)
Apply approximately one-half of the ointment from the single-use tube
into 1 nostril and the other half
into the other nostril twice daily (morning and evening) for 5 days.
(2)
After application, close the nostrils by pressing together and
releasing the sides of the nose
repetitively for approximately 1 minute to spread the ointment
throughout the nares. (2)
Discard tube after usage. Do not re-use. (2)
Do not apply Mupirocin