Description

Compound

active ingredient: ketoconazole;

1 g of shampoo contains 20 mg of ketoconazole;

excipients: sodium lauryl ether sulfate, disodium monolauryl ether sulfosuccinate, fatty coconut acid diethanolamide, hydrolyzed animal collagen lauridimonium, macrogol 120-methylglucose dioleate, sodium chloride, concentrated hydrochloric acid, imidourea, perfume bouquet, sodium hydroxide, sodium erythrosin (E 127) , purified water.

Shampoo.

Basic physical and chemical properties: viscous transparent liquid of pink color with a herbal smell.

Pharmacological group

Antifungal agents for topical use. Derivatives of imidazole and triazole.
Pharmacological properties

Pharmacodynamics.

Ketoconazole is a synthetic imidazoledioxolane derivative showing fungicidal and fungistatic activity against dermatophytes such as Trichophyton sp., Epidermophyton sp., Microsporum sp., and yeasts such as Candida sp. and Malassezia furfur (Pityrosporum ovale). Ketoconazole Shampoo quickly reduces flaking and itching often associated with dandruff, seborrheic eczema, and pityriasis versicolor.

Pharmacokinetics.

After topical application of Nizoral® shampoo, the content of ketoconazole in blood plasma is not determined. Plasma levels after topical application of Nizoral® Shampoo were determined after application to the entire body surface.

Indications

Treatment and prevention of skin and hair lesions caused by yeast microorganisms Malassezia (previous name Pityrosporum), such as dandruff, pityriasis versicolor (local), seborrheic dermatitis.

Contraindications

Nizoral shampoo is contraindicated in the presence of hypersensitivity to ketoconazole or any excipient.

Application Features

To avoid any rebound effect, it is recommended to gradually withdraw steroid therapy for a period of 2-3 weeks during the use of Nizoral Shampoo in patients who have received long-term topical corticosteroid treatment.

Avoid contact with eyes. If the shampoo gets into your eyes, rinse them with water.

Use during pregnancy or lactation.

Appropriate and well-controlled studies involving pregnant and lactating women have not been conducted. Data from studies involving a limited number of pregnant women who used the drug indicate that there are no side effects of ketoconazole on pregnancy or the health of the fetus / newborn child when it is applied topically.
After topical application on the scalp of Nizoral shampoo in non-pregnant women, the concentration of ketoconazole in the blood plasma was not determined. Plasma levels after topical application of Nizoral® Shampoo were determined after application to the entire body surface. There are no known risk factors for the use of the drug during pregnancy or lactation.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

Nizoral Shampoo does not affect the ability to drive or use machines.

Dosage and administration

For local use.

Shampoo Nizoral is used for adults and adolescents.

Apply Nizoral® shampoo to the affected areas for 3-5 minutes, then rinse with water. Usually, for one procedure, the amount of shampoo placed in the palm of your hand is enough.

Treatment:

dandruff and seborrheic dermatitis: wash hair 2 times a week for 2-4 weeks;
pityriasis versicolor: daily for 1-5 days.

Prevention:

dandruff and seborrheic dermatitis: every week or once every two weeks.

Children.

Safety and efficacy in neonates and children under 12 years of age have not been established.