Mupirocin

The elimination of nasal carriage of staphylococci, including methicillin resistant Staphylococcus aureus (MRSA).

Posology Adults (including the elderly) and children:

Mupirocin Nasal Ointment should be applied to the anterior nares two to three times a day as follows: A small amount of the ointment about the size of a match head is placed on the little finger and applied to the inside of each nostril.

The nostrils are closed by pressing the sides of the nose together; this will spread the ointment throughout the nares. A cotton bud may be used instead of the little finger for the application in particular to infants or patients who are very ill.

Nasal carriage should normally clear within 5-7 days of commencing treatment. Method of administration Topical.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), including isolated reports.

Uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 422 treated patients encompassing 12 clinical studies. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.

Immune system disorders Very rare:

Cutaneous hypersensitivity reactions. Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema.

Respiratory, thoracic and mediastinal disorders Uncommon:

Nasal mucosa reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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1 INDICATIONS AND USAGE 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 .

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2 DOSAGE AND ADMINISTRATION 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.

6 )]. 3 )]. For Topical Use Only. ( 2 ) Apply a small amount of mupirocin 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 )

4 )] The most frequent adverse reactions (at least 1%) were headache, rash, and nausea. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 randomized, double‑blind, double‑dummy trials, 339 subjects were treated with topical mupirocin cream plus oral placebo. 3%) subjects. 1%). Other adverse reactions which occurred in less than 1% of subjects were: abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis.

In a supportive trial in the treatment of secondarily infected eczema, 82 subjects were treated with mupirocin cream. 4%), and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.

2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin cream. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to mupirocin cream. 1 )] .

4 CONTRAINDICATIONS 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.

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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 antibacterial drugs, mupirocin cream should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

1 Pediatrics Pediatrics (18 months – 16 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of mupirocin 2% cream in pediatric patients have been established; therefore, Health Canada has authorized an indication for pediatric use.

2 Geriatrics Geriatrics (> 65 years of age): No overall difference in the efficacy or safety of mupirocin 2% cream was observed in this patient population when compared with that observed in younger patients.

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.

STRAMUCINTM is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream (see DOSAGE FORMS, COMPOSITION AND PACKAGING).