KETOZORAL®-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KETOSORALE-DARNITSA (KETOSORALE-DARNITSA)

Composition:

Active substance: ketoconazole;

1 g of shampoo contains 20 mg of ketoconazole;

Excipients: propylene glycol, hypromellose (hydroxypropylmethylcellulose), sodium lauryl sulfate 70 % aqueous solution, polyethylene glycol (macrogol) glyceryl cocoate, sodium metabisulfite (E 223), imidourea, yellow FCF (E 110), hydrochloric acid diluted, purified water.

Pharmaceutical form. Shampoo.

Main physicochemical properties: transparent viscous liquid ranging from yellow-orange to orange in color with a weak characteristic odor.

Pharmacotherapeutic group. Antifungal agents for topical use. Imidazole and triazole derivatives. ATC code D01AC08.

Pharmacological properties.

Pharmacodynamics.

Ketoconazole is a synthetic imidazolodioxolane derivative that exerts 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 scaling and itching, which are commonly associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Pharmacokinetics.

After topical application of the shampoo, the concentration of ketoconazole in blood plasma is not detectable. Plasma levels following topical application were determined after application of the drug to the entire body surface.

Clinical characteristics.

Indications.

Treatment and prevention of skin and hair disorders caused by yeast-like microorganisms Malassezia (former name Pityrosporum), such as dandruff, pityriasis versicolor (localized), seborrheic dermatitis.

Contraindications.

Individual hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

There are no objective data on the interaction of the medicinal product with other medicinal products.

Special precautions for use.

When using the medicinal product, contact with the eyes should be avoided. If shampoo gets into the eyes, they should be rinsed with water.

To prevent withdrawal syndrome during prolonged local corticosteroid therapy, it is recommended to continue local corticosteroid application in combination with the shampoo, followed by a gradual withdrawal of corticosteroids over 2–3 weeks.

Use during pregnancy or breastfeeding.

Adequate and well-controlled studies on the use of ketoconazole in pregnant women and breastfeeding mothers have not been conducted. After topical application of the shampoo in non-pregnant women, the concentration of ketoconazole in blood plasma was not detectable. Plasma levels following topical application were measured after application of the medicinal product to the entire body surface. Due to the absence of known risk factors, the use of the medicinal product during pregnancy or breastfeeding is not contraindicated.

Ability to influence reaction rate while driving or operating machinery.

The medicinal product does not affect the reaction rate when driving vehicles or operating machinery.

Dosage and Administration.

Apply the medicinal product topically. Apply the shampoo to the affected areas of the skin and hair for 3-5 minutes, then rinse thoroughly with water.

Treatment.

Pityriasis (seborrheic dermatitis, seborrheic eczema): use the shampoo twice a week for 2-4 weeks.

Pityriasis versicolor: use the shampoo once daily for 5 consecutive days.

Prophylaxis.

Pityriasis (seborrheic dermatitis, seborrheic eczema): use the shampoo once every 1-2 weeks.

Pityriasis versicolor: use the shampoo once daily for 3 consecutive days (single treatment course) prior to the start of summer season.

Children.

There is no experience with the use of this medicinal product in children.

Overdose.

Since the medicinal product is intended for external use only, overdose is not expected.

In case of accidental ingestion, supportive and symptomatic therapy should be administered. Induction of vomiting or gastric lavage is contraindicated due to the risk of aspiration.

Side effects.

Eye disorders: eye irritation, increased lacrimation.

Nervous system disorders: dysgeusia.

Immune system disorders: hypersensitivity reactions, including urticaria, angioedema.

Skin and subcutaneous tissue disorders: pruritus, hyperemia, irritation, rash (including pustular rash), burning sensation, discomfort at the application site, dry skin, increased skin desquamation, contact dermatitis, skin changes, hair structure changes, hair color changes (mainly in patients with chemically damaged or gray hair), acne, alopecia, folliculitis.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature between 15 °C and 25 °C.

Packaging.

60 g or 100 g in a bottle; 1 bottle per carton.

Supply category. Over-the-counter.

Manufacturer: JSC "Pharmaceutical company "Darnytsia".

Manufacturer's location and address of operations.

13, Boryspylska Street, Kyiv, 02093, Ukraine.