Mikanisal^® (Shampoo) Instructions for Use

Marketing Authorization Holder

Grindeks, JSC (Latvia)

Manufactured By

Tallinna Farmaatsiatehase A.S. (Estonia)

ATC Code

D01AC08 (Ketoconazole)

Active Substance

Ketoconazole (Rec.INN registered by WHO)

Dosage Form

Mikanisal®

Shampoo 20 mg/g: bottle 60 or 100 ml

Dosage Form, Packaging, and Composition

60 ml – plastic bottles (1) – cardboard packs.
100 ml – plastic bottles (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent. It has fungicidal and fungistatic effects.

The mechanism of action consists of inhibiting ergosterol synthesis and altering the lipid composition of the membrane.

It is active against the causative agent of pityriasis versicolor, Malassezia furfur, the causative agents of some dermatomycoses (Trichophyton, Epidermophyton floccosum, Microsporum), the causative agents of candidiasis (Candida), as well as the causative agents of systemic mycoses (Cryptococcus).

It is also active against gram-positive cocci: Staphylococcus spp., Streptococcus spp.

Indications

• For external use: treatment and prevention of fungal infections of the scalp skin.
• Treatment of dermatomycosis of smooth skin, tinea cruris, tinea of the hands and feet, and skin candidiasis.

ICD codes

Dosage Regimen

Apply to wet hair and scalp. Lather and leave for 3 to 5 minutes.

Rinse thoroughly with water. For treatment of seborrheic dermatitis and pityriasis versicolor, use twice weekly for 2 to 4 weeks.

For prevention of dandruff recurrence, use once every 1 to 2 weeks. Avoid contact with eyes.

Adverse Reactions

Local reactions: skin redness and irritation are possible.

Hair discoloration, abnormal hair texture, and severe skin reactions may occur. Discontinue use immediately if signs of allergic reaction or severe irritation appear.

Contraindications

• Hypersensitivity to ketoconazole or any excipient.
• Acute and chronic liver diseases.
• Pregnancy and lactation.
• Children under 12 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe liver function impairment.

Use in Renal Impairment

Contraindicated in severe renal function impairment.

Special Precautions

If corticosteroids have been used to treat skin diseases, then Ketoconazole should be prescribed no earlier than 2 weeks after their discontinuation.

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.