Instructions for Ketozoral-Darnitsa shampoo 2% bottle 60 g
Composition
active ingredient: ketoconazole;
1 g of shampoo contains 20 mg of ketoconazole;
excipients: propylene glycol, hypromellose (hydroxypropylmethylcellulose), sodium laureth sulfate 70% aqueous solution, polyethylene glycol (macrogol) glyceryl cocoate, sodium metabisulfite (E 223), imidourea, sunset yellow FCF (E 110), diluted hydrochloric acid, purified water.
Dosage form
Shampoo.
Main physicochemical properties: transparent viscous liquid from yellow-orange to orange color with a faint specific odor.
Pharmacotherapeutic group
Antifungal agents for topical use. Imidazole and triazole derivatives. ATX code D01A C08.
Pharmacological properties
Pharmacodynamics.
Ketoconazole is a synthetic imidazoledioxolane derivative that has 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). The drug rapidly reduces the scaling and itching often associated with dandruff, seborrheic eczema, and lichen planus.
Pharmacokinetics.
Plasma levels of ketoconazole were not detectable after topical application of the shampoo. Plasma levels after topical application were determined after application of the drug to the entire body surface.
Indication
Treatment and prevention of skin and hair lesions caused by yeast microorganisms Malassezia (previous name Pityrosporum), such as dandruff, lichen planus (topical), seborrheic dermatitis.
Contraindication
Individual hypersensitivity to the active substance or to other components of the medicinal product.
Interaction with other medicinal products and other types of interactions
There is no objective information about the interaction of the drug with other drugs.
Application features
When using the medicine, avoid contact with eyes. If the shampoo gets into your eyes, rinse them with water.
To prevent withdrawal syndrome during long-term topical treatment with corticosteroids, it is recommended to continue their topical application in combination with shampoo, followed by gradual withdrawal of corticosteroids over 2-3 weeks.
Use during pregnancy or breastfeeding
Adequate and well-controlled studies of the use of ketoconazole in pregnant women and nursing mothers have not been conducted. After topical application of the shampoo in non-pregnant women, the concentration of ketoconazole in the blood plasma was not determined. Plasma levels after topical application were determined after applying the drug to the entire body surface. Due to the absence of known risk factors, the use of the drug during pregnancy or breastfeeding is not contraindicated.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving or working with other mechanisms.
Method of administration and doses
The medicine should be applied topically. Apply the shampoo to the affected areas of the skin and hair for 3-5 minutes, then rinse with water.
Treatment
Dandruff, seborrheic dermatitis (seborrheic eczema): use shampoo 2 times a week for 2-4 weeks.
Tinea versicolor: use shampoo once a day for 5 days.
Prevention.
Dandruff, seborrheic dermatitis (seborrheic eczema): use shampoo once every 1-2 weeks.
Tinea versicolor: apply shampoo once a day for 3 days (one-time course of treatment) before the start of the summer season.
Children.
There is no experience with the use of the drug in children.
Overdose
Since the drug is intended for external use only, the development of an overdose is not expected.
In case of overdose, supportive and symptomatic therapy should be provided. To prevent aspiration, vomiting or gastric lavage should not be induced.
Side effects
On the part of the organs of vision: eye irritation, increased lacrimation.
Nervous system disorders: dysgeusia.
Immune system disorders: hypersensitivity reactions, including urticaria, angioedema.
Skin and subcutaneous tissue: itching, hyperemia, irritation, rashes (including pustular), burning sensation, discomfort at the site of application, dry skin, increased skin peeling, contact dermatitis, skin changes, change in hair structure, change in hair color (mainly in patients with chemically damaged or gray hair), acne, alopecia, folliculitis.
Expiration date
2 years.
Storage conditions
Store out of the reach of children in the original packaging at a temperature of 15 °C to 25 °C.
Packaging
60 g or 100 g in a bottle; 1 bottle in a pack.
Leave category. Without a prescription.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
