Ketoconazole-fitofarm

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KETOCONAZOLE-PHYTOPHARM (KETOCONAZOLUM-PHYTOPHARM)

Composition:

Active substance: ketoconazole;

1 g of cream contains 20 mg of ketoconazole (calculated as 100 % substance);

Excipients: propylene glycol, imidourea, isopropyl myristate, octyldodecanol, cetostearyl alcohol, polyethylene glycol (macrogol) 12 cetostearyl ether, potassium dihydrogen phosphate, sodium hydrogen phosphate dodecahydrate, purified water.

Pharmaceutical form. 2 % cream for external use.

Main physicochemical properties: white or almost white cream.

Pharmacotherapeutic group.

Antifungal agents for topical use. Imidazole and triazole derivatives.

ATC code D01A C08.

Pharmacological Properties.

Pharmacodynamics.

Ketoconazole is a synthetic imidazolodioxolane derivative that exhibits antifungal activity against dermatophytes Trichophyton spp., Epidermophyton floccosum, and Microsporum spp., as well as 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, which commonly accompanies infections caused by dermatophytes and yeasts, as well as skin conditions associated with Malassezia spp. Symptomatic improvement occurs before the first signs of healing become evident.

Pharmacokinetics.

After topical application of the cream, the concentration of ketoconazole in plasma of adults is not detectable. In one study, infants with seborrheic dermatitis (n = 19) were administered approximately 40 g of cream daily over 40% of the body surface area: ketoconazole was detected in plasma of 5 infants, with 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.

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

Contraindications.

Hypersensitivity to ketoconazole or to any of the other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use

Ketoconazole-Phytofarm cream must not be used in ophthalmology. If the cream is applied to affected areas immediately after prolonged treatment with corticosteroid-containing ointments, irritation may occur. In such cases, it is recommended to continue applying mild topical corticosteroids to the affected area in the morning and Ketoconazole-Phytofarm cream in the evening, gradually discontinuing corticosteroid therapy over 2–3 weeks.

Propylene glycol may cause skin irritation. Cetostearyl 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 the drug in pregnant or breastfeeding women. Limited data on use in pregnant women indicate no adverse effects of ketoconazole on pregnancy or fetal/neonatal health. Animal studies have shown reproductive toxicity at doses not achieved with topical application of ketoconazole.

After topical application of the cream, ketoconazole is not detectable in plasma of non-pregnant women. The risks associated with using the drug during pregnancy or breastfeeding are unknown.

Ability to affect reaction speed when driving or operating machinery

Has no effect.

Method of Administration and Dosage

Ketoconazole-Phytofarm cream is applied to the skin in adults.

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

Seborrheic dermatitis: the cream should be applied to affected skin areas 1–2 times daily.

Treatment should continue for a sufficient period, 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 should be followed to control sources of infection and reinfection.

The usual duration of treatment is as follows: pityriasis versicolor – 2–3 weeks; fungal 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 to 4 weeks. For maintenance therapy in seborrheic dermatitis, apply the cream periodically (once weekly).

Seborrheic dermatitis is a chronic condition with a high risk of recurrence.

Children.

Experience with the use of Ketoconazole-Phytofarm cream in children is lacking.

Overdose.

Topical application. Excessive topical application of the cream may cause erythema, swelling, and sensation of skin burning, which rapidly resolve after discontinuation of therapy.

Accidental ingestion. In case of accidental oral intake, supportive and symptomatic therapeutic measures should be implemented.

Adverse reactions.

Based on pooled safety data from clinical studies, the most frequently reported adverse reactions (≥1%) were: pruritus at the application site (2%), sensation of skin burning (1.9%), and erythema at the application site (1%).

Considering the above-mentioned adverse reactions, the table below lists adverse reactions reported during clinical studies and post-marketing use. The frequency of adverse reactions is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency not known (cannot be estimated based on available clinical study data).

Reporting of Adverse Reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions through the national reporting system.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C. Do not freeze.

Keep out of reach and sight of children.

Packaging.

15 g or 25 g in tubes; 1 tube per pack.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

JSC "FITOPHARM".

Manufacturer's address and location of its operations.

2 Sibirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder.

JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

7 Verkhovnoi Rady Avenue, Kyiv, 02100, Ukraine, Floor 3, Room 18.