KETODIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KETODIN (KETODIN)

Composition:

Active substance: ketoconazole;

1 g of cream contains ketoconazole 20 mg;

Excipients: propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan stearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white cream of homogeneous consistency, odorless.

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

ATC code D01A C08.

Pharmacological properties.

Pharmacodynamics.

Ketoconazole is a synthetic derivative of imidazolodioxolane that exhibits antifungal activity against dermatophytes Trichophyton spр., Epidermophyton floccosum, and Microsporum spр., as well as against yeasts, including Malassezia spp. and Candida spp. The effect against Malassezia spp. is particularly pronounced.

Ketoconazole inhibits ergosterol biosynthesis in fungi and alters the composition of other lipid components in the membrane.

Ketoconazole cream rapidly relieves itching commonly associated with infections caused by dermatophytes and yeasts, as well as in skin conditions induced by the presence of Malassezia spp. Symptomatic improvement occurs before the first signs of recovery appear.

Pharmacokinetics.

After topical application of the original ketoconazole cream, its blood levels in adults were not detectable. In one study, approximately 40 g of the original 2% ketoconazole cream was applied daily to 40% of the body surface area in infants with seborrheic dermatitis: ketoconazole was detected in plasma of 5 infants at concentrations ranging from 32 to 133 ng/mL.

Clinical characteristics.

Indications.

For topical use in the treatment of skin infections caused by dermatophytes: tinea corporis, tinea of the hands, feet, tinea pedis, tinea cruris, caused by Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis, and Epidermophyton floccosum, as well as for the treatment of cutaneous candidiasis and pityriasis versicolor.

Ketodin should also be prescribed for the treatment of seborrheic dermatitis—a skin condition associated with the presence of Malassezia furfur.

Contraindications.

Hypersensitivity to ketoconazole and/or to other components of the drug.

Interaction with other medicinal products and other forms of interaction.

No interactions with other medicinal products have been identified.

Special precautions for use.

To prevent withdrawal syndrome after discontinuation of prolonged treatment with topical corticosteroids, it is recommended to continue applying topical corticosteroids to the affected area in the morning, and Ketedin in the evening, then gradually discontinue corticosteroid therapy over a period of 2–3 weeks.

Ketedin cream must not be used in ophthalmological practice.

Propylene glycol may cause skin irritation. Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding.

There are no adequate and well-controlled studies on the use of ketoconazole in pregnant or breastfeeding women. The risks associated with using the drug during pregnancy and breastfeeding are unknown.

Ability to affect reaction rate while driving or operating machinery.

No effect.

Dosage and Administration.

Skin candidiasis, tinea corporis, tinea of hands, feet, tinea cruris, and pityriasis versicolor: it is recommended to apply Kетodin to affected skin areas and surrounding regions once daily.

Seborrheic dermatitis: it is recommended to apply Kетodin to affected skin once or twice daily depending on the severity of the infection.

Treatment should continue for a sufficient duration, at least several more days after all symptoms have disappeared. If symptoms persist after 4 weeks of treatment, the diagnosis should be reconsidered. General hygiene measures must be followed to control sources of infection and reinfection.

The usual duration of treatment is: pityriasis versicolor – 2–3 weeks; yeast infections – 2–3 weeks; tinea cruris – 2–4 weeks; tinea corporis – 3–4 weeks; tinea pedis – 4–6 weeks.

The usual duration of treatment for seborrheic dermatitis is 2–4 weeks. For maintenance therapy in seborrheic dermatitis, the cream should be applied once or twice weekly.

Children.

Experience with the use of Kетodin cream in children is lacking.

Overdose.

Topical application.

In case of accidental application of a large amount of cream to the skin, erythema, swelling, or a burning sensation of the skin may occur, which rapidly resolve after discontinuation of therapy.

Accidental ingestion.

In case of accidental ingestion, supportive and symptomatic therapeutic measures should be taken.

Side effects

During safety studies of the original ketoconazole cream, the following adverse reactions were observed in ≥ 1 % of patients:

General disorders and application site reactions: erythema, pruritus.

Skin and subcutaneous tissue disorders: burning sensation.

Adverse reactions observed in < 1 % of patients:

General disorders and application site reactions: bleeding, discomfort, dryness, inflammation, irritation, paraesthesia, application site reactions.

Immune system disorders: hypersensitivity reactions.

Skin and subcutaneous tissue disorders: bullous rash, contact dermatitis, desquamation or stickiness of the skin.

During post-marketing surveillance of the original ketoconazole cream, the following adverse reactions have been reported.

Skin and subcutaneous tissue disorders: very rare (< 1/10,000, including isolated reports) – rash, urticaria.

Shelf life.

2 years. Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

15 g in an aluminum tube with a membrane and cap, packed in a cardboard box.

Pharmaceutical supply category.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and place of business.

25, 600-richchia St., Vinnytsia, 21027, Ukraine.

Tel.: + 38(0432)52-30-36. E-mail: [email protected]

www.sperco.com.ua