Instructions Dermazol cream for external use 20 mg/g tube 15 g
Composition
active ingredient: ketoconazole;
1 g of cream contains ketoconazole 20 mg;
excipients: propylene glycol, cetostearyl alcohol, cetomacrogol 1000, white soft paraffin, light mineral oil, disodium edetate, anhydrous sodium sulfite (E 221), polysorbate 80, purified water.
Dosage form
Cream.
Main physicochemical properties: homogeneous white cream.
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 exhibits antifungal activity against dermatophytes Trichophyton spp., Epidermophyton floccosum and Microsporum spp., as well as yeasts, including Malassezia spp. and Candida spp. The effect is particularly pronounced against Malassezia spp.
Ketoconazole inhibits ergosterol biosynthesis in fungi and changes the composition of other lipid components in the membrane.
Ketoconazole cream very quickly eliminates itching, which usually accompanies infections caused by dermatophytes and yeasts, as well as Malassezia spp. Symptomatic improvement is observed before the first signs of recovery appear.
Pharmacokinetics.
After topical application of the drug in adults, the content of ketoconazole in the blood is not determined.
Indication
For topical use in the treatment of skin infections caused by dermatophytes: athlete's foot, athlete's foot, athlete's foot caused by Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton floccosum - as well as for the treatment of cutaneous candidiasis and tinea versicolor.
Dermazol® cream should also be prescribed for the treatment of seborrheic dermatitis, a skin condition associated with the presence of Malassezia furfur.
Contraindication
Dermazol® cream is contraindicated in individuals with hypersensitivity to ketoconazole or any of the ingredients of the drug.
Interaction with other medicinal products and other types of interactions
Not noted.
Application features
Dermazol® cream should not be used in ophthalmological practice.
To prevent withdrawal syndrome after discontinuing long-term use of topical corticosteroids, it is recommended to continue applying topical corticosteroids to the affected area in the morning and Dermazol® cream in the evening, and then gradually discontinue corticosteroid therapy over 2–3 weeks.
The drug contains propylene glycol, so it may cause skin irritation.
The drug contains cetostearyl alcohol, therefore it may cause local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
There are no adequate and well-controlled studies of the use of ketoconazole cream in pregnant or breastfeeding women. After topical application, ketoconazole is not detectable in the blood plasma of non-pregnant women. The risks associated with the use of the drug during pregnancy or breastfeeding are unknown.
Ability to influence reaction speed when driving vehicles or other mechanisms
Dermazol®, cream, does not affect the ability to drive or operate other mechanisms.
Method of administration and doses
Dermasol® cream is for external use. Apply the cream to the affected skin and surrounding areas. General hygiene rules should be followed to control sources of infection and reinfection.
For all patients, the duration of treatment should be based on the individual response to therapy.
| Indication | Application frequency cream | Duration treatment | Notes |
| Skin candidiasis (yeast infections) | 1 time per day | 2–3 weeks | Treatment should be continued for a sufficient period of time, at least for several days after all symptoms have disappeared. If symptoms persist after 4 weeks of treatment, the diagnosis should be reconsidered. |
| Tinea versicolor | 1 time per day | 2–3 weeks |
| Inguinal epidermophytosis | 1 time per day | 2–4 weeks |
| Epidermophytosis of the body | 1 time per day | 3–4 weeks |
| Epidermophytosis of the hands | 1 time per day | 4–6 weeks |
| Athlete's foot | 1 time per day | 4–6 weeks |
Seborrheic dermatitis (basic therapy) | 1–2 times a day* | 2–4 weeks |
| Seborrheic dermatitis (maintenance therapy) | 1 or 2 times a week | |
* Depending on the severity of the infection.
Children.
There is no experience with the use of Dermazol® cream in children.
Overdose
Local application.
Local application of the cream in excessive amounts may cause erythema, edema, and a burning sensation on the skin, which quickly disappear after discontinuation of therapy.
Accidental internal use.
In case of accidental ingestion, supportive and symptomatic therapeutic measures should be taken.
Side effects
General disorders and administration site reactions – erythema, itching, bleeding, discomfort, dryness, inflammation, irritation, paresthesia, application site reactions.
Skin and subcutaneous tissue disorders: burning sensation, rash, bullous eruptions, contact dermatitis, peeling or stickiness of the skin, urticaria.
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
15 g or 30 g in a tube 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.
