Dermazole® plus

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

Composition:

Active substances: ketoconazole, zinc pyrithione;

1 ml of shampoo contains ketoconazole 20 mg, 48% suspension of zinc pyrithione in water, equivalent to 10 mg of zinc pyrithione;

Excipients: cocodiethanolamide, sodium lauryl ether sulfate, disodium monolauryl sulfosuccinate, polyglycol 120 methyl glucose dioleate, propylene glycol, hydrochloric acid, sodium chloride, sodium hydroxide, butylhydroxytoluene (E 321), imidourea, Ponceau 4R (E 124), Aloe vera powder, flavor AL012514, purified water.

Pharmaceutical form. Shampoo.

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

Pharmacotherapeutic group. Antifungal agents for topical use.

ATC code D01A C.

Pharmacological properties.

Pharmacodynamics.

The pharmacological properties of the shampoo are determined by the properties of the active ingredients it contains: ketoconazole and zinc pyrithione.

Ketoconazole is a synthetic derivative of imidazolodioxolane, which has fungicidal and fungistatic activity against dermatophytes (Epidermophyton spp., Microsporum spp., Trichophyton spp.), yeast and yeast-like fungi of various strains (Candida spp., Malassezia furfur – Pityrosporum ovale).

Zinc pyrithione, when applied topically, exerts antimicrobial and antifungal effects; it is effective against streptococci, staphylococci, fungi, and other pathogenic microorganisms. Zinc pyrithione provides the anti-seborrheic action of the preparation and has therapeutic efficacy against seborrheic dermatitis and dandruff. The ketoconazole shampoo reduces scaling and itching, which are commonly associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Aloe vera powder promotes hair hydration and enriches it with vitamins and trace elements.

Pharmacokinetics.

Specific pharmacokinetic studies of the shampoo have not been conducted. However, it is known that ketoconazole and zinc pyrithione, when applied topically, are practically not absorbed into the systemic circulation and do not cause systemic effects.

Clinical characteristics.

Indications.

Treatment and prevention of fungal diseases of the scalp skin accompanied by skin scaling and itching, such as:

• dandruff;
• seborrheic dermatitis;
• localized pityriasis versicolor of the scalp.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

When prescribing Dermazol Plus to patients who have been treated for a prolonged period with topical glucocorticosteroids, treatment with the latter should be continued and gradually discontinued over 2–3 weeks (to avoid withdrawal syndrome).

Given the lack of significant systemic absorption, interaction with other medicinal products is unlikely.

Concomitant use with dermatological preparations containing glucocorticosteroids is not recommended.

Special precautions for use.

The medicine is intended for external use only.

When using the medicine, care should be taken to avoid contact with eyes and mucous membranes.

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

Seborrhoeic dermatitis and dandruff are often accompanied by increased hair loss, which may persist for some time at the beginning of the use of the shampoo.

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

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the medicine should be used only if the expected benefit to the mother outweighs the potential risk to the fetus/child.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of administration and dosage.

Before use, the shampoo should be shaken well.

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

Recommended regimens for adults:

Children.

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

Overdose.

Since the shampoo is intended for topical 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 the shampoo, only supportive and symptomatic measures should be administered. Inducing vomiting and gastric lavage are contraindicated to prevent the risk of aspiration.

Adverse reactions.

Skin and subcutaneous tissue disorders: erythema, skin burning sensation, pruritus, acne, contact dermatitis, skin irritation, rash, pustular eruptions at the application site, urticaria, dry skin, increased skin desquamation, discomfort, hypersensitivity, skin changes.

Disorders of skin appendages: altered hair structure, increased dryness or oiliness of hair, hair loss (alopecia), hair color changes (mainly in patients with chemically damaged or gray hair), nail discoloration. Cases of straightening of naturally curly hair have been reported.

Nervous system disorders: taste disturbances (dysgeusia), paresthesia, hypersensitivity.

Immune system disorders: hypersensitivity reactions, including anaphylactoid reactions, angioneurotic edema.

Eye disorders: eye irritation, eyelid edema, increased lacrimation.

Infections and infestations: folliculitis.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach and sight of children.

Packaging.

50 ml or 100 ml in a bottle, the cap of which is covered with a foil membrane.

1 bottle per cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

KUSUM HEALTHCARE PVT LTD.

Manufacturer's address and place of business.

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