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STRAMUCIN is a brand name for Mupirocin, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: STRAMUCINTM (Mupirocin Cream USP 2% w/w as mupirocin calcium) is indicated topically for the treatment of secondarily infected traumatic lesions such as small lacerations, sutured wounds or abrasions. To reduce the development of drug-resistant bacteria and maintain the effectiveness of mupirocin cream and other…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Apply a small amount of STRAMUCINTM, with a cotton swab or gauze pad, to the affected area 3 times daily for up 10 days. Discontinue use and consult a physician if condition worsens or if irritation occurs.
Scabs do not have to be removed. The treated area may be covered by a dressing. Wash your hands before and after applying. No dosage adjustment is necessary for: - Adults/Children/Elderly - Patients with hepatic or renal impairment. Do not mix with other preparations as there is a potential risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the cream.
3 Missed Dose If an application of STRAMUCINTM is missed, apply as soon as you remember or when it is convenient.
1 Adverse Reaction Overview The following local adverse reactions have been reported during therapy with mupirocin cream: itching, burning, erythema, stinging, and dryness. It was usually not necessary to discontinue therapy due to these adverse reactions.
Systemic allergic reactions have been reported with mupirocin cream. Cutaneous sensitization reactions to mupirocin or the cream base have been reported rarely. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In previously conducted clinical studies with other formulations of mupirocin cream, the following adverse reactions were reported in connection with the use of mupirocin cream: headache, rash, and nausea.
Other adverse reactions reported rarely included: abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis. In a multi-center, double-blind, randomized, parallel-group, vehicle-controlled study in patients 18 months of age or older with secondarily infected traumatic skin lesions the safety and efficacy of STRAMUCINTM was compared against a vehicle cream.
7% Vehicle). The only TEAEs that were considered possibly, probably, or definitely related to study medication were application site pruritus and worsening of ingrowing toenail in the Test group and hypersensitivity and wound complication in the Vehicle group, which occurred in only 1 subject each.
Two subjects in the Vehicle group discontinued due to an adverse event. 3%) for topical placebo. 4 Post-Market Adverse Reactions Very rare adverse events consisting of systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin.
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. General In the rare event of a possible sensitization reaction or severe local irritation occurring with the use of the product, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms. Avoid contact with the eyes. Prescribing mupirocin cream in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug- resistant bacteria.
Ear/Nose/Throat STRAMUCINTM is not suitable for intranasal use. Gastrointestinal Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhea during or after antibiotic use.
Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Ophthalmologic STRAMUCINTM is not suitable for ophthalmic use. Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the cream residue has been removed. Sensitivity/Resistance The use of this product may result in overgrowth of non-susceptible organisms.
Also the use of this product may result in localized site irritation. Please see General Warning section above for further information or PART II MICROBIOLOGY for further information. Sexual Health Reproduction There are no data on the effects of mupirocin on human fertility.
STRAMUCINTM is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream (see DOSAGE FORMS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mupirocin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Studies in rats showed no effects on fertility (see PART II TOXICOLOGY).
Product Monograph – STRAMUCINTM (Mupirocin Cream USP, 2% w/w) Date:
November 21, 2018 Page 7 of 20 Skin In the rare event of a possible sensitization reaction or severe local irritation occurring with the use of the product, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy of the infection instituted.
As with other topical antibacterial products, prolonged use may result in overgrowth of non- susceptible organisms. 1 Pregnant Women The safety of STRAMUCINTM in the treatment of infections during pregnancy has not been established.
If administration to pregnant patients is considered necessary, its potential benefits should be weighed against the possible hazards to the fetus. 2 Breast-feeding Caution should be exercised when STRAMUCINTM is administered to nursing mothers.
If a cracked nipple is to be treated, lactation from the affected breast should be maintained by manual expression until the end of treatment. During this time, milk from the affected breast should be discarded. 3 Pediatrics Pediatrics (18 months to 16 years): The safety and effectiveness of mupirocin cream have been established in the age-groups 18 months to 16 years [see ADVERSE REACTIONS].
4 Geriatrics In 2 adequate and well-controlled trials, 30 subjects older than 65 years were treated with other formulations of 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.