KETO PLUS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KETO PLUS (KETOPLUS)

Composition:

Active substances: ketoconazole, zinc pyrithione;

100 ml of shampoo contains 2 g of ketoconazole and 1 g of zinc pyrithione (in the form of a 48% suspension);

Excipients: aluminum-magnesium silicate, propylene glycol, hydroxypropylmethylcellulose, colloidal anhydrous silicon dioxide, imidourea, concentrated hydrochloric acid, fragrance "Swiss bouquet" P3043, carmoisine dye (E 122), purified water, pearlescent homogeneous shampoo base.

Pharmaceutical form. Shampoo.

Main physicochemical properties: viscous pink-colored shampoo with a pleasant odor.

Pharmacotherapeutic group.

Antifungal agents for topical use. ATC code D01AC.

Pharmacological properties.

Pharmacodynamics.

The pharmacological properties of the shampoo are determined by the characteristics of its active ingredients: ketoconazole and zinc pyrithione. Ketoconazole is an antifungal agent belonging to the imidazole derivatives group. It exerts fungistatic and fungicidal effects by inhibiting the biosynthesis of ergosterol, an essential component of fungal cell membranes, leading to alterations in membrane lipid composition and subsequent cell destruction. It is active against dermatophytes of the genera Trichophyton, Microsporum, Epidermophyton floccosum; as well as against yeast and yeast-like fungi of the genera Candida, Malassezia furfur, and Pityrosporum ovale. Zinc pyrithione inhibits the growth of various gram-positive and gram-negative bacteria and certain fungal species. Zinc pyrithione provides the shampoo's anti-seborrheic effect and acts against dandruff. The ketoconazole shampoo reduces scaling and itching commonly associated with dandruff, seborrheic dermatitis, and pityriasis versicolor.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Treatment and prevention of fungal skin diseases of the scalp accompanied by skin flaking 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 medicinal product.

Interaction with other medicinal products and other forms of interaction.

When prescribing the shampoo 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).

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

Concomitant use with dermatological products containing glucocorticosteroids is not recommended.

Special precautions for use.

The product is intended for external use only.

When using the product, care should be taken to 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 may persist for some time at the beginning of treatment with the shampoo.

The product contains propylene glycol, which may cause skin reactions, and the colouring agent carmoisine (E 122), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the product 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. For the treatment of dandruff and seborrheic dermatitis, use the shampoo twice a week for 2–4 weeks; for the treatment of pityriasis versicolor, use daily for 5 consecutive days.

For prevention of dandruff and seborrheic dermatitis, use the shampoo once a week or once every two weeks. For prevention of pityriasis versicolor, use once daily for 3 consecutive days prior to the beginning of summer season (one course of treatment).

Children.

Experience with use of the product in children is lacking.

Overdose.

Since the shampoo is intended for external use only and ketoconazole is hardly absorbed into the systemic circulation, overdose symptoms are unlikely to occur. In case of accidental ingestion, only supportive and symptomatic treatment should be administered. Inducing vomiting and gastric lavage are contraindicated due to the risk of aspiration.

Side effects.

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

Disorders of skin appendages: folliculitis, 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), nail discoloration. Cases of straightening of naturally curly hair have been reported.

Nervous system and sensory organ disorders: eye irritation, eyelid edema, increased lacrimation, taste disturbances (dysgeusia), paresthesia, peripheral neuritis.

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

Infections and infestations: folliculitis.

Shelf life.

2 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

60 ml or 150 ml of shampoo in a bottle; 1 bottle per cardboard box.

Supply category.

Over-the-counter (without prescription).

Manufacturer.

Glenmark Pharmaceuticals Ltd./Glenmark Pharmaceuticals Ltd.

Manufacturer's address and location of operations.

Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India /
Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India.