Bactend Ointment 2% w/w

Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes) . 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 cm 2 in area) due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes . ( 1 )

• For Topical Use Only
• Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 10 days
• Cover the treated area with gauze dressing if desired
• Re-evaluate patients not showing a clinical response within 3 to 5 days
• Mupirocin cream is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions ]
• Do not apply mupirocin cream concurrently with any other lotions, creams or ointments [see Clinical Pharmacology ]
• For Topical Use Only
• Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 10 days
• Re-evaluate patients not showing a clinical response within 3 to 5 days
• Not for intranasal, ophthalmic, or other mucosal use

Mupirocin cream USP, 2% is a white to off white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil-and water-based emulsion, supplied in 15-gram and 30-gram tubes. Cream: 20 mg (2% w/w) of mupirocin per gram in 15-gram and 30-gram tubes. ( 3 )

• The safety and effectiveness of mupirocin cream have been established in the age-groups 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
• Adults with additional data from 93 pediatric subjects studied as part of the pivotal trials
• Adults [see Clinical Studies ]

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.

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Advise the patient to administer mupirocin cream as follows: Use mupirocin cream only as directed by the healthcare provider
• It is for external use only
• Avoid contact of mupirocin cream with the eyes
• If mupirocin cream gets in the eyes, rinse thoroughly with water
• Do not use mupirocin cream in the nose
• Wash your hands before and after applying mupirocin cream
• Use a gauze pad or cotton swab to apply a small amount of mupirocin cream to the affected area
• The treated area may be covered by gauze dressing if desired
• Report to the healthcare provider any signs of local adverse reactions. …

• Mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream
• Known hypersensitivity to mupirocin or any of the excipients of mupirocin cream

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): If diarrhea occurs, evaluate patients for CDAD. ( 5.4 ) Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. ( 5.5 ) Risk Associated with Mucosal Use: Mupirocin cream is not formulated for use on mucosal surfaces. …

The following adverse reactions are discussed in more detail in other sections of the labeling: Severe Allergic Reactions [see Warnings and Precautions ( 5.1 )] Eye Irritation [see Warnings and Precautions ( 5.2 )] Local Irritation [see Warnings and Precautions ( 5.3 )] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most frequent adverse reactions (at least 1%) were headache, rash, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy 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 )] . …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.