Dermazol®

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

Composition:

Active substance: ketoconazole;

1 ml of shampoo contains 20 mg of ketoconazole;

Excipients: cocodiethanolamide, sodium laureth ether sulfate, disodium monolauryl ether sulfosuccinate, polyglycol 120 methylglucose dioleate, propylene glycol, concentrated hydrochloric acid, sodium chloride, sodium hydroxide, butylhydroxytoluene (E 321), imidourea, Ponceau 4R (E 124), flavoring agent SK D00923, purified water.

Pharmaceutical form. Shampoo.

Main physicochemical properties: clear, viscous pink liquid with a characteristic odor.

Pharmacotherapeutic group.
Antifungal agents for topical use. Imidazole and triazole derivatives. ATC code D01A C08.

Pharmacological properties.

Pharmacodynamics.

Ketoconazole is a synthetic imidazoldioxolane 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). Ketoconazole shampoo rapidly reduces scaling and itching commonly associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Pharmacokinetics.

After topical application of Dermazol® shampoo, the content of ketoconazole in blood plasma is not detectable. Plasma levels following topical application of ketoconazole shampoo were measured after its application to the entire body surface.

Clinical characteristics.

Indications.

Treatment and prevention of skin and hair disorders caused by the yeast microorganisms Malassezia (previously named Pityrosporum), such as dandruff, pityriasis versicolor (localized), and seborrheic dermatitis.

Contraindications.

Dermazol® shampoo is contraindicated in individuals with hypersensitivity to any of its components.

Interaction with other medicinal products and other forms of interaction.

Not known.

Special precautions for use

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

Avoid contact of the shampoo with the eyes. If contact occurs, rinse thoroughly with water.

The product contains butylated hydroxytoluene (E 321), which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

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

Use during pregnancy or breastfeeding

Adequate and well-controlled studies in pregnant and breastfeeding women have not been conducted. After topical application of ketoconazole shampoo on the skin of non-pregnant women, plasma concentrations of ketoconazole were undetectable. Plasma levels following topical application of ketoconazole shampoo were measured only after application over the entire body surface. Due to the lack of known risk factors, use of the product during pregnancy or breastfeeding is not contraindicated.

Effect on ability to drive or operate machinery

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

Method of administration and dosage.

Apply Dermazol® shampoo to affected areas for 3–5 minutes, then rinse off with water.

Treatment:

• Dandruff and seborrheic dermatitis (seborrheic eczema): twice weekly for 2–4 weeks;
• Pityriasis versicolor: daily for 5 days.

Prophylaxis:

• Dandruff and seborrheic dermatitis (seborrheic eczema): once weekly or once every 2 weeks;
• Pityriasis versicolor: daily for 3 days (single course of treatment) prior to the start of summer season.

Children.

The safety and efficacy of the medicinal product in children under 12 years of age have not been established.

Overdose.

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

In case of accidental ingestion, treatment consists of supportive and symptomatic measures. Inducing vomiting or gastric lavage is contraindicated to prevent aspiration.

Adverse reactions.

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

Skin and subcutaneous tissue disorders: alopecia, skin dryness, hair texture changes, rash, skin burning sensation, acne, contact dermatitis, skin desquamation, increased oiliness or dryness of hair, hair color changes (mainly in patients with chemically damaged or gray hair).

Eye disorders: increased lacrimation, eye irritation.

Nervous system disorders: dysgeusia (disturbance of taste sensation).

Infections and infestations: folliculitis.

General disorders and administration site conditions: erythema, irritation, pruritus, discomfort, hypersensitivity, pustular rash at the application site.

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.

8 ml in sachets. 20 sachets in a cardboard package.

50 ml or 100 ml in a bottle with a cap lined with a foil lining.

1 bottle in a cardboard package.

Prescription status.

Over-the-counter.

Manufacturer.

Kusum Healthcare Pvt Ltd.

Manufacturer's name and address of the place of business.

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

INSTRUCTIONS

for medical use of the medicinal product

DERMAZOLE®

(DERMAZOLE®)

Composition:

Active ingredient: ketoconazole;

1 ml of shampoo contains 20 mg of ketoconazole;

Excipients: cocodiethanolamide, sodium laureth sulfate, disodium monolauryl ether sulfosuccinate, polyglycol 120 methyl glucose dioleate, propylene glycol, concentrated hydrochloric acid, sodium chloride, sodium hydroxide, butylhydroxytoluene (E 321), imidourea, Ponceau 4R (E 124), flavoring agent SK D00923, purified water.

Pharmaceutical form. Shampoo.

Main physicochemical properties: clear, viscous, pink-colored liquid with a characteristic odor.

Pharmacotherapeutic group.

Topically applied antifungal agents. Imidazole and triazole derivatives. ATC code D01A C08.

Pharmacological properties.

Pharmacodynamics.

Ketoconazole is a synthetic imidazolodioxolane derivative with 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). Ketoconazole shampoo rapidly reduces scaling and itching commonly associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Pharmacokinetics.

After topical application of Dermazol® shampoo, the concentration of ketoconazole in blood plasma is not detectable. Plasma levels following topical use of ketoconazole shampoo were measured after its application to the entire body surface.

Clinical characteristics.

Indications.

Treatment and prevention of skin and hair disorders caused by the yeast microorganisms Malassezia (previously named Pityrosporum), such as dandruff, pityriasis versicolor (localized), and seborrheic dermatitis.

Contraindications.

Dermazol® shampoo is contraindicated in individuals with known hypersensitivity to any of its components.

Interaction with other medicinal products and other forms of interaction.

Not known.

Special precautions for use.

To prevent withdrawal syndrome after prolonged local treatment with corticosteroids, it is recommended to continue local application of corticosteroids in combination with Dermazol® shampoo, followed by gradual discontinuation of corticosteroids over 2–3 weeks.

Avoid contact of the shampoo with the eyes. If the shampoo gets into the eyes, rinse them thoroughly with water.

The product contains butylated hydroxytoluene (E 321), which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

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

Use during pregnancy or breastfeeding.

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

Ability to affect reaction rate when driving or operating machinery.

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

Method of Administration and Dosage

Apply DermaZol® shampoo to affected areas for 3–5 minutes, then rinse thoroughly with water.

Treatment:

• Dandruff and seborrheic dermatitis (seborrheic eczema): twice weekly for 2–4 weeks;
• Pityriasis versicolor: daily for 5 days.

Prevention:

• Dandruff and seborrheic dermatitis (seborrheic eczema): once weekly or once every 2 weeks;
• Pityriasis versicolor: daily for 3 consecutive days (one treatment course) prior to the start of summer season.

Children.

The safety and efficacy of the medicinal product in children under 12 years of age have not been established.

Overdose.

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

In case of accidental ingestion, treatment consists of supportive and symptomatic measures. Inducing vomiting or gastric lavage is contraindicated to prevent aspiration.

Side effects.

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

Skin and subcutaneous tissue disorders: alopecia, dry skin, changes in hair structure, rash, burning sensation of the skin, acne, contact dermatitis, dryness of the skin, skin changes, increased skin desquamation, increased oiliness or dryness of hair, change in hair color (mainly in patients with chemically damaged or gray hair).

Eye disorders: increased lacrimation, eye irritation.

Nervous system disorders: dysgeusia (disturbance of taste sensation).

Infections and infestations: folliculitis.

General disorders and administration site conditions: erythema, irritation, pruritus, discomfort, hypersensitivity, pustular rash at the application site.

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.

50 ml or 100 ml in a bottle, the cap of which is sealed with a film coating.

1 bottle in a cardboard box.

Availability.

Over-the-counter.

Manufacturer.

LLC "GLEDPHARM LTD"

Manufacturer's address and place of business.

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