Dermazol®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DERMAZOLE® (DERMAZOLE®)

Composition:

Active substance: ketoconazole;

1 g of cream contains 20 mg of ketoconazole;

Excipients: propylene glycol, cetyl alcohol, cetomacrogol 1000, white soft paraffin, light liquid paraffin, disodium edetate, anhydrous sodium sulfite (E 221), polysorbate 80, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white cream.

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 spp., Epidermophyton floccosum, and Microsporum spp., 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 fungal membrane.

Ketoconazole cream rapidly relieves itching, which usually accompanies infections caused by dermatophytes, yeasts, and Malassezia spp. Symptomatic improvement occurs before the first signs of clinical recovery become evident.

Pharmacokinetics.

After topical application in adults, ketoconazole levels in the blood are not detectable.

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.

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

Contraindications.

Dermazol® cream is contraindicated in individuals with hypersensitivity to ketoconazole or to any of the ingredients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Not observed.

Special precautions for use.

Dermazol® cream should not be used in ophthalmology.

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

The product contains propylene glycol, which may cause skin irritation.

The product contains cetostearyl alcohol, which 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 cream in pregnant or breastfeeding women. After topical application, ketoconazole is not detectable in the plasma of non-pregnant women. The risks associated with the use of this medicinal product during pregnancy or breastfeeding are unknown.

Ability to affect reaction speed when driving or operating machinery.

Dermazol® cream does not affect the ability to drive or operate machinery.

Method of administration and dosage.

Dermazol® cream is for topical use. Apply the cream to the affected skin area and surrounding skin. General hygiene measures should be followed to control sources of infection and reinfection.

For all patients, the duration of treatment should be based on individual response to therapy.

* Depending on the severity of the infection.

Children.

There is no experience with the use of Dermazol® cream in children.

Overdose.

Topical use.

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

Accidental ingestion.

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

Adverse reactions.

Immune system disorders: hypersensitivity reactions;

General disorders and administration site conditions: erythema, pruritus, bleeding, discomfort, dryness, inflammation, irritation, paresthesia, application site reactions.

Skin and subcutaneous tissue disorders: burning sensation, rash, bullous eruptions, contact dermatitis, skin peeling or stickiness, urticaria.

Shelf life.

4 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

15 g or 30 g in a tube in a cardboard package.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

LLC "GLEDPHARM LTD".

Manufacturer's address and place of business.

54 Davydovskoho Hryhoriia Street, Sumy, Sumy region, 40020, Ukraine.

INSTRUCTIONS

for medical use of the medicinal product

DERMAZOL®

(DERMAZOLE®)

Composition:

Active ingredient: ketoconazole;

1 g of cream contains 20 mg of ketoconazole;

Inactive ingredients: propylene glycol, cetyl stearyl alcohol, cetomacrogol 1000, white soft paraffin, light mineral oil, disodium edetate, anhydrous sodium sulfite (E 221), polysorbate 80, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white cream.

Pharmacotherapeutic group.

Antifungal agents for topical use. Imidazole and triazole derivatives.

ATC code: D01AC08.

Pharmacological properties.

Pharmacodynamics.

Ketoconazole is a synthetic derivative of imidazoldioxolane 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 fungal membrane.

Ketoconazole cream rapidly relieves itching, which commonly accompanies infections caused by dermatophytes, yeasts, and Malassezia spp. Symptomatic improvement occurs before the first signs of clinical recovery become evident.

Pharmacokinetics.

After topical application in adults, ketoconazole levels in the blood are not detectable.

Clinical characteristics.

Indications.

For topical use in the treatment of skin infections caused by dermatophytes: tinea corporis, tinea of the hands and 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.

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

Contraindications.

Dermazol® cream is contraindicated in individuals with hypersensitivity to ketoconazole or to any of the ingredients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Not reported.

Special precautions for use.

Dermazol® cream should not be used in ophthalmology.

To prevent withdrawal syndrome after discontinuation of prolonged topical corticosteroid therapy, it is recommended to continue applying topical corticosteroids to the affected area in the morning, while applying Dermazol® cream in the evening. Then, corticosteroid therapy should be gradually discontinued over a period of 2–3 weeks.

The product contains propylene glycol, which may cause skin irritation.

The product contains cetyl stearyl alcohol, which 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 cream in pregnant or breastfeeding women. After topical application, ketoconazole is not detectable in the plasma of non-pregnant women. The risks associated with the use of this medicinal product during pregnancy or breastfeeding are unknown.

Ability to influence reaction rate when driving or operating machinery.

Dermazol® cream does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

Dermazol® cream is for topical use. Apply the cream to the affected skin areas and surrounding regions. General hygiene measures should be followed to control sources of infection and reinfection.

For all patients, the duration of treatment should be based on individual response to therapy.

* Depending on the severity of the infection.

Children.

There is no experience with the use of Dermazol® cream in children.

Overdose.

Topical application.

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

Accidental oral ingestion.

In case of accidental ingestion, supportive and symptomatic therapy should be administered.

Adverse reactions.

Immune system disorders: hypersensitivity reactions;

General disorders and administration site conditions: erythema, itching, bleeding, discomfort, dryness, inflammation, irritation, paraesthesia, application site reactions.

Skin and subcutaneous tissue disorders: burning sensation, rash, bullous eruptions, contact dermatitis, peeling or stickiness of the skin, urticaria.

Shelf life.

4 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

15 g or 30 g in a tube in a cardboard package.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

Kusum Healthcare Pvt Ltd /
Kusum Healthcare Pvt Ltd.

Address of the manufacturer’s premises.

SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India /
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.