Mikoragil (Ointment) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

D01AE54 (Undecylenic acid in combination with other drugs)

Active Substances

Undecylenic acid (USP United States Pharmacopeia)

Zinc undecylenate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Mikoragil

Ointment for external use 5%+20%/100 g: tubes from 10 g to 200 g

Dosage Form, Packaging, and Composition

Ointment for external use from almost white to white with a light yellowish tint, with a characteristic odor.

Excipients: stearic acid – 1.3 g, white beeswax – 2.3 g, hard paraffin – 8 g, liquid paraffin – 34.2 g, methylparaben – 0.2 g, macrogol oleate – 4 g, distilled monoglycerides – 3.3 g, white soft paraffin – 13.7 g, purified water – 8 g.

From 10 g to 200 g – tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agents used in dermatology; external antifungal agents; other external antifungal agents

Pharmacological Action

Undecylenic acid and its salts have a pronounced fungistatic effect against dermatophytes of the genera Trichophyton, Epidermophyton, Microsporum.

Zinc, which is part of this agent, has an astringent effect, thereby reducing the manifestations of skin irritation and promoting faster healing.

Indications

Treatment and prevention of fungal skin diseases caused by fungi sensitive to the drug.

ICD codes

Dosage Regimen

For external use.

Apply to a clean, dry surface of the affected skin 2 times/day. The duration of the treatment course is 4-6 weeks.

After the disappearance of clinical manifestations of the disease, to prevent relapse, it is recommended to apply this agent 1 time/day for a week and then, every other day or 2 times a week for one month; shortening the course of treatment increases the risk of disease recurrence.

Adverse Reactions

Possible hypersensitivity to the components of the combination – redness, itching of the skin, swelling, burning sensation, skin rash.

If signs of hypersensitivity appear, the use of the drug should be discontinued and the doctor should be informed.

Contraindications

Children under 2 years of age; hypersensitivity to the components of this agent.

Use in Pregnancy and Lactation

The possibility of using this agent during pregnancy and breastfeeding is determined by the doctor individually.

Pediatric Use

The drug is contraindicated in children under 2 years of age.

Special Precautions

Do not apply to an open wound surface, damaged skin surface, or the periorbital area; avoid getting this agent into the eyes.

Storage Conditions

Store at 2°C (36°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.