Supirocin^®-B (Ointment) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

Contact Information

GLENMARK IMPEX LLC (Russia)

ATC Code

D07CC01 (Betamethasone in combination with antibiotics)

Active Substances

Betamethasone (Rec.INN WHO registered)

Mupirocin (Rec.INN WHO registered)

Dosage Form

Supirocin®-B

Ointment for external use 0.05 g+2 g/100 g: tubes 5 g or 15 g

Dosage Form, Packaging, and Composition

Ointment for external use white, homogeneous.

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

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

Clinical-Pharmacological Group

A drug with antibacterial and anti-inflammatory action for external use

Pharmacotherapeutic Group

Glucocorticoids in combination with antibiotics

Pharmacological Action

A combined drug for external use, the action of which is due to its constituent components.

Betamethasone is a topical glucocorticosteroid.

It has local anti-inflammatory, anti-allergic, anti-edematous, and anti-proliferative effects.

It has a stronger vasoconstrictor effect than other fluorinated glucocorticosteroids; systemic effects are insignificant due to limited absorption through the skin.

When acting on the skin, it prevents the marginal accumulation of neutrophils, which leads to a reduction in exudation, cytokine production, and inhibition of macrophage migration, ultimately resulting in a reduction in infiltration and granulation processes.

Mupirocin

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 its 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 spectrum of activity 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.

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

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

• Corynebacterium species;
• Enterobacteriaceae;
• Gram-negative non-fermenting rods;
• Micrococcus species;
• Anaerobes.

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

Intermediate: from 2 to 256 µg/ml.

Resistant: greater than 256 µg/ml.

Pharmacokinetics

Betamethasone dipropionate is a lipophilic substance and is easily absorbed through the stratum corneum of the skin without undergoing biotransformation.

Absorption increases when applied to skin in body folds, to skin with damaged epidermis, or to areas of inflammation, with frequent application of the drug, or after application to a large skin surface.

The absorption of betamethasone dipropionate through the skin in children occurs faster than in adults.

Mupirocin is poorly absorbed through intact human skin.

If absorbed through damaged skin, Mupirocin is rapidly metabolized to inactive monic acid.

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

Indications

For the treatment of skin diseases complicated by secondary bacterial infections:

• Atopic dermatitis;
• Diffuse neurodermatitis;
• Contact dermatitis (irritant and allergic);
• Exfoliative dermatitis;
• Urticaria;
• Dermatitis herpetiformis;
• Seborrheic dermatitis;
• Eczema;
• Psoriasis.

ICD codes

Dosage Regimen

Apply a thin layer of ointment to the affected skin area two to three times daily.

Limit the treatment duration to a period of 5 to 14 days.

Apply only to areas not exceeding 10 cm in length or 100 cm² in total area.

Re-evaluate the patient if no clinical improvement is observed within 3 to 5 days of initiating therapy.

Use the drug only for the acute phase of the condition and for a short period.

Avoid application on the face, axillae, and groin unless strictly necessary.

Do not use under occlusive dressings.

Discontinue treatment if severe or prolonged diarrhea occurs.

Adverse Reactions

Local reactions burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, miliaria.

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

Contraindications

• Hypersensitivity to mupirocin, betamethasone dipropionate, or any other component of the drug in the history;
• Cutaneous manifestations of syphilis;
• Skin tuberculosis;
• Bacterial, viral, fungal skin diseases;
• Trophic leg ulcers associated with varicose veins;
• Skin cancer;
• Nevus;
• Atheroma;
• Melanoma;
• Hemangioma;
• Xanthoma;
• Sarcoma;
• Rosacea;
• Acne vulgaris;
• Post-vaccination skin reactions;
• Pregnancy;
• Breastfeeding period;
• Children under 12 years of age.

With caution

Moderate and severe renal failure.

Long-term use of the ointment on large areas of the skin is not recommended for patients with diabetes mellitus, glaucoma, tuberculosis, cataracts.

Should be used with caution in subcutaneous tissue atrophy, especially in elderly persons.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

Ointments based on macrogol should not be applied to extensive surfaces in conditions accompanied by increased absorption of polyethylene glycol, and especially in moderate and severe renal failure.

Pediatric Use

Contraindication: children under 12 years of age.

Geriatric Use

Should be used with caution in subcutaneous tissue atrophy, especially in elderly persons.

Special Precautions

Avoid getting the ointment into the eyes, on mucous membranes, as well as on open wounds and burns.

As with other antibacterial substances, prolonged use of the ointment may lead to excessive growth of non-susceptible microorganisms, including fungi.

Macrogol (polyethylene glycol) can be absorbed through the wound surface or through other skin lesions and excreted by the kidneys.

Ointments based on macrogol should not be applied to extensive surfaces in conditions accompanied by increased absorption of polyethylene glycol, especially in moderate and severe renal failure.

Given the presence of a potent glucocorticosteroid in the drug’s composition, the drug should be used in the acute phase of the disease, for a short period, on a small skin area.

The drug should not be used on the skin of the face due to the possibility of telangiectasias, perioral dermatitis.

On the skin in the axillary and groin areas, the drug should be used only in cases of extreme necessity.

The drug should not be used under an occlusive dressing, as this may lead to epidermal atrophy, striae appearance, and the development of superinfection.

Cases of pseudomembranous colitis have been reported with the use of antibiotics, the severity of which can range from mild to life-threatening.

Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after antibiotic use.

Although the likelihood of this phenomenon occurring with topical use of mupirocin is lower, in case of prolonged or severe diarrhea or abdominal cramps, treatment should be stopped immediately and the patient should be further examined.

The drug must not be used in ophthalmology, intranasally, or in combination with the use of catheters.

Effect on the ability to drive vehicles and operate machinery

Not studied.

Overdose

Symptoms reversible suppression of the hypothalamic-pituitary-adrenal system, manifestations of Cushing’s syndrome, hyperglycemia, glucosuria.

Treatment symptomatic therapy.

Drug Interactions

No interaction with other drugs has been noted.

Storage Conditions

The drug should be stored out of the reach of children 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.