Instructions for Dermazol shampoo 20 mg/ml bottle 100 ml
Composition
active ingredient: ketoconazole;
1 ml of shampoo contains 20 mg of ketoconazole;
excipients: cocodiethanolamide, sodium lauryl ether sulfate, disodium monolauryl ether sulfosuccinate, macrogol 120 methylglucose dioleate, propylene glycol, concentrated hydrochloric acid, sodium chloride, sodium hydroxide, butylhydroxytoluene (E 321), imidourea, Ponceau 4R (E 124), flavoring SK D00923, purified water.
Dosage form
Shampoo.
Main physicochemical properties: transparent, viscous pink liquid with a characteristic odor.
Pharmacotherapeutic group
Antifungal agents for topical use. Imidazole and triazole derivatives. ATX code D01A C08.
Pharmacological properties
Pharmacodynamics.
Ketoconazole is a synthetic imidazoledioxolane 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 the flaking and itching often associated with dandruff, seborrheic eczema, and lichen planus.
Pharmacokinetics.
After topical application of Dermazol® shampoo, the content of ketoconazole in blood plasma is not determined. Plasma levels after topical application of ketoconazole shampoo were determined after its application to the entire body surface.
Indication
Treatment and prevention of skin and hair lesions caused by yeast microorganisms Malassezia (previous name Pityrosporum), such as dandruff, lichen planus (local), seborrheic dermatitis.
Contraindication
Dermazol® shampoo is contraindicated in case of hypersensitivity to any of its components.
Interaction with other medicinal products and other types of interactions
Unknown.
Application features
To prevent withdrawal syndrome with prolonged topical corticosteroid treatment, it is recommended to continue topical application of corticosteroids in combination with Dermazol® shampoo, followed by gradual withdrawal of corticosteroids over 2–3 weeks.
Avoid contact of shampoo with eyes. If shampoo gets into eyes, rinse them with water.
The drug contains butylhydroxytoluene (E 321), therefore it may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
The drug contains propylene glycol, so it may cause skin irritation.
Use during pregnancy or breastfeeding
Adequate and well-controlled studies in pregnant women and breastfeeding mothers have not been conducted. Plasma concentrations of ketoconazole have not been determined in non-pregnant women after topical application of ketoconazole shampoo to the skin. Plasma levels after topical application of ketoconazole shampoo were determined after application to the entire body surface. In the absence of known risk factors, the use of the drug during pregnancy or breastfeeding is not contraindicated.
Ability to influence reaction speed when driving vehicles or other mechanisms
Dermazol® shampoo does not affect the ability to drive or operate other machinery.
Method of administration and doses
Apply Dermazol® shampoo to the affected areas for 3–5 minutes, then rinse with water.
Treatment:
dandruff and seborrheic dermatitis (seborrheic eczema): 2 times a week for 2–4 weeks;
lichen planus: daily for 5 days.
Prevention:
dandruff and seborrheic dermatitis (seborrheic eczema): every week or once every 2 weeks;
lichen planus: daily for 3 days (one-time course of treatment) before the start of the summer season.
Children.
The safety and efficacy of the drug in children under 12 years of age have not been established.
Overdose
Since the drug is intended for external use only, the development of an overdose is not expected.
In case of accidental ingestion, treatment consists of supportive and symptomatic measures. To prevent aspiration, do not induce vomiting or perform gastric lavage.
Side effects
Immune system disorders: Hypersensitivity reactions, including angioedema and urticaria.
Skin and subcutaneous tissue disorders: alopecia, dry skin, hair structure changes, rash, burning sensation of the skin, acne, contact dermatitis, dry skin, skin changes, increased skin peeling, increased oiliness or dryness of hair, hair colour changes (mainly in patients with chemically damaged or grey hair).
From the organs of vision: increased lacrimation, eye irritation.
From the nervous system: dysgeusia (impaired taste sensation).
Infections and infestations: folliculitis.
General disorders and administration site conditions: erythema, irritation, itching, discomfort, hypersensitivity, pustular rash at the application site.
Expiration date
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 per sachet. 20 sachets per carton.
50 ml or 100 ml in a bottle with a film-coated cap.
1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
Kusum Healthcare Pvt Ltd.
Address
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India/SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
