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Pharmacological properties

The pharmacological properties of the shampoo are due to the properties of the active substances that make up its composition: ketoconazole and zinc pyrithione.

Ketoconazole, a synthetic derivative of imidazoldioxalan, has a fungicidal, fungistatic effect against dermatophytes (Epidermophyton spp., Microsporum spp., Trichophyton spp.), Yeast and yeast-like fungi of different strains (Candida spp., Malassezia furfurvpsp.

Zinc pyrithione, when applied externally, has an antimicrobial and antifungal effect; effective against streptococci, staphylococci, fungi and a number of other pathogenic microorganisms. Zinc pyrithione causes the antiseborrheic effect of the drug and acts against dandruff. Ketoconazole shampoo reduces flaking and itching, which are often associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Aloe vera powder helps moisturize the hair, enrich it with vitamins and minerals.

Pharmacokinetics Special studies of the pharmacokinetics of shampoo have not been conducted, but it is known that ketoconazole and zinc pyrithione, when applied topically, are practically not absorbed into the systemic circulation and do not cause a systemic effect.

Indications

Treatment and prevention of fungal diseases of the skin of the scalp, accompanied by desquamation and itching, such as dandruff, seborrheic dermatitis, local pityriasis versicolor of the scalp.

Application

Shampoo well before use.

Apply shampoo to wet hair and scalp for 3-5 minutes, then rinse with water.

Recommended regimens for adults:

Indications Treatment Prevention
Dandruff 2 times a week for 2-4 weeks Once a week or once every 2 weeks
Seborrheic dermatitis
Pityriasis versicolor Daily for 5 days Daily for 3 days (single course of treatment) before the start of the summer season

Contraindications

Hypersensitivity to ketoconazole, zinc pyrithione or any other component of the drug.

Side effects

On the part of the skin and subcutaneous tissue: erythema, burning sensation of the skin, itching, acne, contact dermatitis, skin irritation, rash, pustular rash at the site of application, urticaria, dry skin, increased peeling of the skin, discomfort, hypersensitivity, changes in the skin.

On the part of the skin appendages: a change in the structure of the hair, increased dryness or oily hair, hair loss (alopecia), a change in hair color (in particular in patients with chemically damaged or gray hair), discoloration of the nails. There are known cases of straightening curly hair by nature.

From the nervous system: taste disturbance (dysgeusia), paresthesia, hypersensitivity.

On the part of the immune system: hypersensitivity reactions, including anaphylactoid reactions; angioedema.

From the side of the organ of vision: eye irritation, swelling of the eyelids, increased lacrimation.

Infections and infestations: folliculitis.

special instructions

The drug is intended for external use only.

When using the drug, avoid contact with eyes and mucous membranes.

In case of contact with eyes, rinse thoroughly with water.

Seborrheic dermatitis and dandruff are often accompanied by increased hair loss, which in some cases may continue for some time at the beginning of the use of shampoo.

The drug contains butylhydroxytoluene (E321), which can cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

Use during pregnancy and lactation. During pregnancy and lactation, the drug can be used only in cases where the expected benefit to the mother outweighs the potential risk to the fetus / baby.

Children. There is no experience with the use of the drug in children.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Does not affect.

Interactions

When prescribing dermazole plus to patients who have been treated for a long time with topical corticosteroids, the treatment should be continued last and canceled gradually over 2–3 weeks (to avoid withdrawal syndrome).

Given the absence of significant systemic absorption, interaction with other drugs is unlikely.

It is not recommended to use simultaneously with dermatological preparations containing corticosteroids.

Overdose

Since the shampoo is intended for external use only, and ketoconazole is practically not absorbed into the systemic circulation, the development of overdose symptoms is unlikely. in case of accidental ingestion of shampoo, only supportive and symptomatic measures are used. do not induce vomiting and gastric lavage to prevent aspiration.

Storage conditions

At a temperature not exceeding 25 ° C.

Tags: Ketoconazole, Zinc Pyrithione