Expiration date: 08/2025

Trade name: Mycozoral®

International nonproprietary name: ketoconazole

Dosage Form: shampoo

Composition: Active ingredient: 0.02g ketoconazole 1 g of shampoo.

Other ingredients: propylene glycol, hydroxypropyl methylcellulose, sodium laureth sulfate, sodium metabisulfite, makrogolglitserol cocoate, imidomochevina, dye yellow-orange, hydrochloric acid diluted, purified water.

Description: Transparent viscous liquid from yellow-orange to orange color with a weak specific smell.

Pharmacotherapeutic group: anti-fungal agent

ATC code: D01AC08

Pharmachologic effect:

pharmacodynamics

Ketoconazole, a synthetic derivative of imidazole-dioxolane having a strong antifungal activity against dermatophytes (Trichophyton sp., Epidermophyton sp., Microsporum sp.), Yeast-like fungi (Candida sp., Malassezia furfur (Pityrosporum ovale), dimorphic fungi (Blastomyces dermatidis, Coccidioides immitis, Sporotrichum schenckii), as well as against staphylococci and streptococci.

Shampoo Mycozoral® quickly reduces flaking and itching of the scalp, which is commonly associated with dandruff, seborrheic dermatitis and pityriasis versicolor.

Pharmacokinetics

Ketoconazole absorption through the skin when applied topically significantly. With prolonged use of ketoconazole in the blood is not determined.

testimony

Treatment and prevention of dandruff, seborrheic dermatitis and tinea versicolor.

Contraindications:

Hypersensitivity to any component of the drug.

Pregnancy and lactation:

Since the local application of ketoconazole practically not absorbed, it is possible to use a shampoo Mycozoral during pregnancy and lactation.

Dosing and Administration

Outwardly. Apply shampoo Mycozoral to the affected areas of the skin or scalp for 3-5 minutes, then rinse with water.

Treatment:

• Different types of dandruff and seborrheic dermatitis of the scalp 2 times a week for 3-4 weeks,
  
• Pityriasis versicolor daily for 5 days, with no effect extension rate of up to 7 days.
  

Prevention:

• Different types of dandruff and seborrheic dermatitis of the scalp: 1 weekly or once every two weeks,
  
• Chromophytosis daily for 3-5 days (single rate) in the spring before the onset of summer.
  

Side effects

Mycozoral shampoo is generally well tolerated. Occasionally there may be a local irritation and itching. Hair can become dry or fatty.

Special instructions:

When using the shampoo should avoid getting it in your eyes. If you get shampoo in the eyes should be rinsed with water.

If the treatment of seborrheic dermatitis long-term steroids applied topically, in order to prevent withdrawal symptoms it is recommended to continue the topical application of glucocorticosteroids in combination with Mycozoral shampoo followed by gradual withdrawal of corticosteroids within 2-3 weeks.

release Form

Shampoo in bottles of polyethylene, polypropylene or orange glass 25 g, 60 g and 100 g bottle together with instructions for use placed in a pile of cardboard.

Storage conditions

At a temperature of 15 to 25 ° C in the dark, out of reach of children.

Shelf life

2 years. Do not use the drug after the expiry date.