Mikogal (Cream, Suppositories) Instructions for Use

ATC Code

D01AC13 (Omoconazole)

Active Substance

Omoconazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

The active substance, omoconazole nitrate, is an imidazole derivative and possesses antifungal and antibacterial properties.

The mechanism of action is based on blocking the biosynthesis of ergosterol and altering the lipid composition of fungi.

It acts fungistatically against yeasts ( Candida albicans, Candida glabrata and other Candida species), dermatophytes ( Trichophyton spp., Epidermophyton spp., Microsporum spp.), Pityrosporum orbiculare, Pityrosporum ovale, Aspergilus spp. According to in vitro studies, Omoconazole exerts a bactericidal effect against gram-positive bacteria.

Pharmacokinetics

When applied externally, it is not absorbed or is absorbed to a very small extent.

Indications

• Local treatment of fungal skin diseases;
• Candidiasis;
• Skin and hair diseases caused by dermatophytes: dermatophytosis of the hands and feet, smooth skin, tinea cruris, dermatophytosis of the scalp and beard area;
• Pityriasis versicolor;
• Seborrheic dermatitis caused by Pityrosporum ovale;
• Erythrasma.

ICD codes

Dosage Regimen

Cream

For external use.

The cream is applied to the affected area of the skin 1-2 times/day in a thin layer and rubbed in gently.

Depending on the nature of the fungal disease, the average course of treatment is 2-6 weeks. Treatment should be continued for another week after complete recovery (disappearance of inflammation symptoms, subjective complaints) to prevent relapses of the disease.

Suppositories

Vaginal suppositories 150 mg: for 6 consecutive days in the evening, before going to bed, insert 1 suppository deep into the vagina.

Vaginal suppositories 300 mg: for 3 consecutive days in the evening, before going to bed, insert 1 suppository deep into the vagina.

Vaginal suppositories 900 mg: before going to bed, insert 1 suppository deep into the vagina.

Adverse Reactions

The drug is well tolerated. In some cases, local burning or mild skin irritation may be felt. In most cases, these symptoms are temporary and do not require discontinuation of treatment.

Contraindications

• Hypersensitivity to the components of the drug.

Use with caution during pregnancy and lactation.

Use in Pregnancy and Lactation

Animal studies have shown that in therapeutic doses, Omoconazole does not have an embryotoxic effect.

The use of Mikogal during pregnancy is possible only in cases where the potential benefit to the mother outweighs the possible risk to the fetus. If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be considered.

Special Precautions

Use with caution on large areas of damaged skin, when treating children under 5 years of age. Not recommended for use in patients sensitive to benzoic acid.

Do not apply to mucous membranes and the skin around the eyes.

Neutral or slightly alkaline soap should be used for washing the body. During treatment, underwear, towels, and washcloths should be disinfected and changed daily.

Drug Interactions

Not known.

Storage Conditions

Store in a place inaccessible to children at a temperature between 15°C (59°F) and 25°C (77°F).

Shelf Life

The shelf life is 3 years.

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.