Methuracol (Sponge) Instructions for Use

Marketing Authorization Holder

Belkozin – Luzhsky Plant, JSC (Russia)

ATC Code

D11AX (Other drugs used in dermatology)

Active Substances

Collagen (BP British Pharmacopoeia)

Dioxomethyltetrahydropyrimidine (Grouping Name)

Dosage Form

Methuracol

Sponge 50×50 mm or 90×90 mm: 1 and 10 pcs.

Dosage Form, Packaging, and Composition

Sponge 50×50 mm or 90×90 mm.

1 pc. – containers (1) made of “Poliform” film and laminated paper – sponge 5 x 5 x 1 cm – cardboard packs.
1 pc. – containers (1) made of “Poliform” film and laminated paper – sponge 9 x 9 x 1 cm – cardboard packs.
1 pc. – two-layer polyethylene bags (1) sponge 9 x 9 x 1 cm – cardboard packs.
1 pc. – PVC containers (1) sponge 9 x 9 x 1 cm – cardboard packs.
1 pc. – PVC containers (1) sponge 5 x 5 x 1 cm – cardboard packs.
1 pc. – two-layer polyethylene bags (1) sponge 5 x 5 x 1 cm – cardboard packs.
1 pc. – containers (1) made of “Poliform” film – sponge 5 x 5 x 1 cm – cardboard packs.
1 pc. – containers (1) made of “Poliform” film – sponge 9 x 9 x 1 cm – cardboard packs.

Clinical-Pharmacological Group

A drug improving trophism and tissue regeneration, for external use

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

It normalizes nucleic acid metabolism and, due to this, accelerates the processes of cellular regeneration in wounds, the growth and granulation tissue maturation, epithelialization, and has an anti-inflammatory effect.

Collagen accelerates the growth, maturation, and structuring of granulation tissue and stimulates epithelialization.

It reduces the risk of hypertrophic scar formation.

Collagen undergoes gradual biodegradation in the wound – lysis and resorption.

Indications

Apply the sponge topically for the management of the following wound types to stimulate tissue regeneration and epithelialization.

• Trophic ulcers resulting from chronic venous insufficiency, diabetes mellitus, or other conditions causing impaired tissue nutrition.
• Bedsores (decubitus ulcers) of various stages to promote granulation and wound cleansing.
• Deep and long-term non-healing wounds including postoperative wounds, infected wounds after debridement, and other wounds with delayed healing processes.
• Superficial skin burns to create a favorable environment for re-epithelialization and to reduce the risk of scar formation.

ICD codes

Dosage Regimen

Determine the dosage regimen individually based on the wound’s area, depth, and severity of the purulent-necrotic process.

Use externally only. Perform surgical treatment of the wound before application. Apply the sponge to the entire wound surface or cut it to the required size and shape, ensuring tight contact with the wound bed.

Change the dressing as needed, typically every 1-3 days, or more frequently if the sponge becomes saturated with wound exudate. Continue treatment until granulation tissue appears and epithelialization begins.

Adverse Reactions

Monitor the wound site for potential adverse reactions, which are generally local and transient in nature.

Allergic reactions may occur, manifesting as localized itching, skin hyperemia, or a short-term burning sensation at the application site. Pain in the wound area is also possible, particularly upon initial application.

Discontinue use immediately if signs of a significant hypersensitivity reaction develop.

Contraindications

Do not use the sponge under the following conditions due to the risk of lack of efficacy or adverse events.

• Hypersensitivity to dioxomethyltetrahydropyrimidine, collagen, or any other component of the product. A history of allergic reactions to collagen-based products is a specific contraindication.
• Presence of excessive granulations (“proud flesh”) in the wound, as the sponge is intended to stimulate granulation and may exacerbate this condition.

Use in Pregnancy and Lactation

Use with caution during pregnancy and breastfeeding.

Pediatric Use

Use with caution in children under 3 years of age.

Drug Interactions

Apply the sponge in combination with other topical agents as part of a comprehensive wound management strategy.

Combined use with topical applications of antibacterial drugs, antiseptic solutions, and local anesthetics is possible and does not typically result in clinically significant interactions.

Ensure the wound is clean and free of residual incompatible substances before applying the sponge to maintain its adhesive properties and therapeutic effect.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.