Supirocin^® (Ointment) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

Contact Information

GLENMARK IMPEX LLC (Russia)

ATC Code

D06AX09 (Mupirocin)

Active Substance

Mupirocin (Rec.INN registered by WHO)

Dosage Form

Supirocin®

Ointment for topical and external use 2%: tube 15 g

Dosage Form, Packaging, and Composition

Ointment for topical and external use white, homogeneous.

Excipients: macrogol 4000 (polyethylene glycol 4000), macrogol 400 (polyethylene glycol 400).

15 g – lacquered aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic for external use

Pharmacotherapeutic Group

Antibiotic

Pharmacological Action

Mechanism of action

Mupirocin is a new antibiotic obtained by fermentation of Pseudomonas fluorescens. Mupirocin inhibits isoleucyl-transfer-RNA synthetase, blocking protein synthesis in the bacterial cell.

Due to the specific mechanism of action and unique chemical structure, Mupirocin is not characterized by cross-resistance with other antibiotics used in clinical practice.

When applied topically at minimum inhibitory concentrations (MIC), Mupirocin has bacteriostatic properties, and at higher concentrations, it has bactericidal properties.

Pharmacodynamic effects

Activity. Mupirocin is an antibacterial substance for topical use, demonstrating in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and beta-hemolytic strains of Streptococcus species.

The in vitro activity spectrum includes the following bacteria

• Staphylococcus aureus^1,2;
• Staphylococcus epidermidis^1,2;
• Coagulase-negative staphylococci^1,2;
• Streptococcus species¹;
• Haemophilus influenzae;
• Neisseria gonorrhoeae;
• Neisseria meningitidis;
• Moraxella catarrhalis;
• Pasteurella multocida.

¹Clinical efficacy has been demonstrated for isolates of susceptible bacteria for the registered clinical indications for use.

²Including beta-lactamase-producing strains and methicillin-resistant strains.

Susceptible: less than or equal to 1 µg/ml.

Intermediate: from 2 to 256 µg/ml.

Resistant: greater than 256 µg/ml.

Pharmacokinetics

Absorption

Mupirocin is poorly absorbed through intact human skin.

Metabolism

Mupirocin is intended for external use only. If absorbed through damaged skin, Mupirocin is rapidly metabolized to inactive monic acid.

Excretion

Mupirocin is rapidly eliminated from the body by metabolic conversion to an inactive metabolite, monic acid, which is rapidly excreted by the kidneys.

Indications

Treatment of primary and secondary infectious skin lesions caused by microorganisms susceptible to mupirocin, including

• primary skin infections impetigo, folliculitis, furunculosis (including furuncles of the external auditory canal and auricle) and ecthyma;
• secondary infections: infected eczema; infected injuries (abrasions, insect bites), minor wounds and burns (not requiring hospitalization).

Prevention of bacterial infections in minor wounds, cuts, abrasions and other uncontaminated skin lesions.

ICD codes

Dosage Regimen

Externally.

A small amount of ointment is applied to the affected skin surface 2-3 times/day using a cotton or gauze swab. A simple gauze or occlusive dressing may then be applied to the area where the ointment was applied. The frequency of application and duration of treatment depend on the dynamics of the clinical picture. The drug should not be used for more than 10 days.

If there is no effect after 5 days of treatment, it is recommended to review further treatment tactics taking into account the dynamics of clinical indicators.

Hands should be washed before and after applying the drug.

There are no restrictions on use in children.

Elderly patients see the “Special Precautions” section.

Patients with renal impairment see the “Special Precautions” section.

Adverse Reactions

The adverse reactions listed below are presented according to the affected organs and organ systems and frequency of occurrence. Frequency is defined as follows: very common (≥1/10), common (≥ 1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), including isolated cases.

Immune system disorders: very rare – systemic allergic reactions (including anaphylaxis, generalized rash, urticaria and angioedema).

Skin and subcutaneous tissue disorders: common – burning at the application site; uncommon – itching, erythema, tingling, dryness at the application site. Skin allergic reactions to Mupirocin or the ointment base.

Contraindications

• Hypersensitivity to mupirocin or any other component of the drug in the history.

With caution

Moderate and severe renal failure, old age.

Use in Pregnancy and Lactation

There is no data on the use of the drug during pregnancy and breastfeeding.

Animal studies have not revealed signs of reproductive toxicity.

However, as with the use of other drugs, the use of Supirocin^® during pregnancy and breastfeeding is possible only if the intended benefit to the mother outweighs any potential risk to the fetus.

Breastfeeding should be discontinued during the use of the drug for the prevention of bacterial infection of nipple fissures.

Use in Renal Impairment

With caution: moderate and severe renal failure.

Pediatric Use

There are no restrictions on use in children.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Avoid getting the ointment into the eyes. If it gets into the eyes, rinse with plenty of water until the ointment residue is completely removed.

In rare cases, the use of the drug may cause a hypersensitivity reaction or severe local irritation. In this case, it is necessary to stop treatment, remove the drug from the treated surface if possible, and prescribe alternative therapy for the infection.

As with other antibacterial drugs, with prolonged use of mupirocin there is a risk of overgrowth of non-susceptible microorganisms.

Cases of pseudomembranous colitis have been reported with the use of antibiotics, the severity of which can range from mild to life-threatening. Thus, it is important to consider the possibility of such a diagnosis in patients who develop diarrhea during or after antibiotic use. Although the likelihood of this phenomenon with topical use of mupirocin is lower, if prolonged or severe diarrhea or abdominal cramps develop, treatment should be stopped immediately and the patient should be further examined.

The drug should not be used in ophthalmology, intranasally, in combination with the use of catheters, or at the site of central venous catheter insertion.

Polyethylene glycol (macrogol) can be absorbed through an open wound surface or other skin lesions and excreted by the kidneys.

Like other macrogol-based ointments, Supirocin^® ointment should not be used in conditions where large amounts of macrogol may be absorbed, especially in moderate or severe renal failure.

The drug should not be mixed with other drugs to avoid dilution of the ointment and, consequently, a decrease in antibacterial activity or possible changes in the stability of mupirocin.

Do not use the ointment remaining in the tube at the end of treatment for the next course of treatment.

Elderly patients

There are no restrictions (in the absence of symptoms of moderate or severe renal failure).

Effect on ability to drive vehicles and machinery

Not studied.

Overdose

Symptoms: Currently, there is limited data on mupirocin overdose.

Treatment: There is no specific treatment for mupirocin overdose. In case of overdose, supportive therapy and appropriate patient monitoring are indicated if necessary.

Drug Interactions

No interaction with other drugs has been noted.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F). Do not freeze.

Shelf Life

Shelf life – 2 years. Do not use the drug after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.