BACTROBAN- mupirocin calcium cream

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 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) . BACTROBAN cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of BACTROBAN cream. Risk Summary There are insufficient human data to establish whether there is a drug-associated risk with BACTROBAN cream in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of BACROBAN 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 miscar

Product summary:

BACTROBAN cream is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- and water-based emulsion. BACTROBAN cream, 2% is supplied in 15‑gram and 30‑gram tubes. NDC 0029-1527-22 (15-gram tube) NDC 0029-1527-25 (30-gram tube) Store at or below 25°C (77°F). Do not freeze.

Authorization status:

New Drug Application

Summary of Product characteristics

BACTROBAN- MUPIROCIN CALCIUM CREAM
GLAXOSMITHKLINE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BACTROBAN CREAM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR BACTROBAN CREAM.
BACTROBAN (MUPIROCIN) CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
BACTROBAN 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 cm in area) due
to susceptible isolates of _Staphylococcus aureus_ and
_Streptococcus pyogenes._ (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Cream: 20 mg (2% w/w) of mupirocin per gram in 15-gram and 30-gram
tubes. (3)
CONTRAINDICATIONS
Known hypersensitivity to mupirocin or any of the excipients of
BACTROBAN cream. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
The most frequent adverse reactions (at least 1%) were headache, rash,
and nausea. (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
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Severe Allergic Reactions
5.2 Eye Irritation
2
For Topical Use Only. (2)
Apply a small amount of BACTROBAN 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 BACTROBAN, including BACTROBAN cream.
(5.1)
Eye Irritation: Avoid contact with eyes. (5.2)
Local Irritation: Discontinue in the event of sens