Instructions for Dermazol Plus shampoo bottle 100 ml
Composition
active ingredients: ketoconazole, zinc pyrithione;
1 ml of shampoo contains ketoconazole 20 mg, 48% suspension of zinc pyrithione in water, calculated as zinc pyrithione 10 mg;
excipients: cocodiethanolamide, sodium lauryl ether sulfate, disodium monolauryl sulfosuccinate, macrogol 120 methylglucose dioleate, propylene glycol, hydrochloric acid, sodium chloride, sodium hydroxide, butylhydroxytoluene (E 321), imidourea, Ponceau 4R (E 124), Aloe vera powder, flavoring AL012514, purified water.
Dosage form
Shampoo.
Main physicochemical properties: viscous pink liquid with a specific odor.
Pharmacotherapeutic group
Antifungal drugs for topical use.
ATX code D01A C.
Pharmacological properties
Pharmacodynamics
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 is a synthetic derivative of imidazoledioxalane that has fungicidal, fungistatic activity against dermatophytes (Epidermophyton spp., Microsporum spp., Trichophyton spp.), yeast and yeast-like fungi of various strains (Candida spp., Malassezia furfur – Pitysporum ovale).
Zinc pyrithione, when applied externally, has an antimicrobial and antifungal effect; it is effective against streptococci, staphylococci, fungi and other pathogenic microorganisms. Zinc pyrithione causes the antiseborrheic effect of the drug and has therapeutic efficacy against seborrheic dermatitis and dandruff. Ketoconazole shampoo reduces flaking and itching, which is often associated with dandruff, seborrheic dermatitis, and lichen planus.
Aloe vera powder helps moisturize hair, enriching it with vitamins and trace elements.
Pharmacokinetics
Special studies of the pharmacokinetics of the shampoo have not been conducted, but it is known that ketoconazole and zinc pyrithione are practically not absorbed into the systemic bloodstream when applied externally and do not cause systemic effects.
Indication
Treatment and prevention of fungal diseases of the scalp, accompanied by peeling and itching of the skin, such as:
– dandruff;
– seborrheic dermatitis;
– local tinea versicolor of the scalp.
Contraindication
Hypersensitivity to ketoconazole, zinc pyrithione or any other component of the drug.
Interaction with other medicinal products and other types of interactions
When prescribing Dermazol Plus to patients who have been treated with topical glucocorticosteroids for a long time, treatment with the latter should be continued and discontinued gradually over 2-3 weeks (to avoid withdrawal syndrome).
Given the lack of significant systemic absorption, interactions with other drugs are unlikely.
It is not recommended to use simultaneously with dermatological preparations containing glucocorticosteroids.
Application features
The drug is intended for external use only.
When using the drug, avoid contact with eyes and mucous membranes.
If the drug gets into your eyes, rinse them thoroughly with water.
Seborrheic dermatitis and dandruff are often accompanied by increased hair loss, which can in some cases continue for some time even at the beginning of shampoo use.
The product contains butylhydroxytoluene (E 321), which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the drug can be used only in cases where the expected benefit to the mother outweighs the potential risk to the fetus/child.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The shampoo should be shaken well before use.
Shampoo should be applied to wet hair and scalp for 3-5 minutes, then rinse with water.
Recommended dosage regimens for adults:
| Indication | Treatment | Prevention |
| Dandruff | 2 times a week for 2-4 weeks; | Once a week or once every 2 weeks |
| Seborrheic dermatitis |
| Tinea versicolor | daily for 5 days | daily for 3 days (one-time course of treatment) before the start of the summer season |
Children
There is no experience with the use of the drug in children.
Overdose
Since the shampoo is intended for external use only and ketoconazole is practically not absorbed into the systemic bloodstream, the development of overdose symptoms is unlikely. In case of accidental ingestion of shampoo, only supportive and symptomatic measures should be used. It is forbidden to induce vomiting and perform gastric lavage to prevent aspiration.
Adverse reactions
Skin and subcutaneous tissue disorders: erythema, burning sensation, itching, acne, contact dermatitis, skin irritation, rash, pustular rash at the application site, urticaria, dry skin, increased skin peeling, discomfort, hypersensitivity, skin changes.
On the part of the skin appendages: change in hair structure, increased dryness or oiliness of hair, hair loss (alopecia), change in hair color (generally in patients with chemically damaged or gray hair), discoloration of nails. There are known cases of straightening of naturally curly hair.
From the nervous system: taste disturbance (dysgeusia), paresthesia, hypersensitivity.
Immune system disorders: hypersensitivity reactions, including anaphylactoid reactions, angioedema.
From the organs of vision: eye irritation, eyelid swelling, increased lacrimation,
Infections and infestations: folliculitis.
Expiration date
3 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 with a film-coated cap.
1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
KUSUM HEALTHCARE PVT LTD/KUSUM HEALTHCARE PVT LTD.
Location of the manufacturer and its business 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.
