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    Ketoconazole, 2 % shampoo

    Drug formLiquid (for external use)

    ATC categoryAnifungals

    ATC subcategoryAzole antifungals (for external use)

    Brand nameKetoconazole

    Generic nameKetoconazole

    Dosage form

    Shampoo.

    General characteristics

    Main physico-chemical properties

    A red, transparent, viscous liquid with pleasant apple flavor.

    Composition

    Each ml of shampoo contains:

    active ingredient: ketoconazole – 20mg;

    excipients: cocamide DEA, cocamidopropyl betaine, sodium laureth sulfate, diazolidinyl urea, hydrochloric acid(conc), triethanolamine 98 %, sodium chloride, flavor apple,color red E-129, water deionized.

    Pharmacological group and ATC code

    Antifungal, D01AC08.

     

    Pharmacologic action

    Antifungal drug for external use, derivative of imidazole-dioxolane. It has fungicidal and fungistatic effects on dermatophytes, such as Trichophyton rubrum, T. mentagrophytes, T. Tonsurans, Microsporum canis, M. audouini, M gypseum, Epidermophyton floccosum; yeast and yeast-like fungi Candida albicans, C tropicalis, Pityrosporum ovale, pityrosporum orbiculare (M. furfur). Mechanism of action is inhibition of ergosterol biosynthesis and change of lipid composition of fungus cell membrane. Drug quickly decreases exfoliation and itching, which are connected with dandruff, seborrheic eczema and tinea versicolor.

     

    Pharmacokinetics

    When used externally ,Ketoconazol is exposed to systemic absorbtion in insignificant quantity. Even if drug is used for long period  Ketoconazol isn’t detected in blood.

    Uses and Administration

    Treatment and prevention of skin fungal infections, such as.

    – Tinea versicolor

    – dandruff

    – seborrheic dermatitis

     

    Shampoo must be applied on affected areas and mustn’t be washed during 3-5 min, after what, it must be washed with water.

    In case of treting dandruff and seborrheic dermatitis shampoo must be applied on hairy part of head twice a week during 3-4 weeks, in case of tinea versicolor once a day durng 3 days until summer.

     

    Adverse effects

    As in case of use of other shampooslocal irritation, pruritus or contact dermatitis may observedafter application of ketococonazole shampoo (as result of irritation or allergic reactions). Hair may become fatty or dry.However, when using a Ketoconazole as 20 mg/g shampoo these effects are rare.

    In rare cases,primarily in patients with chemically damaged or gray hair,change in hair color observed.

    Adverse reactions identified in clinical studies:Adverse reactions, observed in ≥ 1% of patients after application Ketoconazole shampoo 2% on the hairy parts heads or skin, is not revealed.Adverse reactions, observed in ≤ 1% of patients, after application of Ketoconazole 2% shampoo on the hairy parts heads or skin, are follows:

    Eye disorders: eye irritation, increased lacrimation.

    General disorders and administration site conditions: application site erythema, application site irritation, application site pruritus, application site reaction , hypersensitivity, pruritus, pustules, skin reactions.

    Immune system disorders: hypersensitivity.

    Infections and Infestations: folliculitis.

    Nervous System Disorders: dysgeusia.

    Skin and subcutaneous tissue disorders: acne, alopecia, dermatitis contact, dry skin, hair texture abnormal, skin burning sensation, skin rash, skin exfoliation.

    Adverse effects have been identified during post-marketing studies, listed below according to the following classification:

    Very common (≥1/10);
    Common (≥1/100 to ≤ 1/10);
    Uncommon (≥1/1,000 to ≤ 1/100);
    Rare (≥1/10,000 to ≤ 1/1,000);
    Very rare (<1/10,000) including isolated reports;
    Skin and Subcutaneous Tissue Disturbances.

    Violations of the skin and subcutaneous tissue:
    Very rare: angioedema, urticarial, hair colour changes.

    Contraindications

    Hypersensitivity to Ketoconazole

    – In children under 12 years.

    Pregnancy and lactation

    Use of Ketoconazol shampoo during pregnancy and lactation period is not contraindicated, as in case of external usage Ketoconazol practically doesn’t permeate to systemic blood flow and risk of development systemic adverse reactions is practically absent.

     

    Special precautions

    Avoid contact with eyes. In case of getting into eyes, it’s necessary to wash the shampoo with water. If prescribed to pacients, who take topical glucocorticosteroids during long period of time, you should continue their usage during treatment with Ketoconazol shampoo with the aim of avoiding withdrawal syndrome with subsequent gradual withdrawal of glucocorticosteroids during 2-3 weeks.

    Seborrheic dermatitis and dandruff are often accompanied by increased hair loss. In rare cases increased hair loss may be registered while using Ketoconazol shampoo.

    Overdosage

    There no observed of overdose in using Ketoconazole 2 % shampoo , as the product intended for topical use. In case of accidental ingestion, supportive or symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

     

    Drug interactions

    There is not any case of systemic absorption of Ketoconazole during it’s usage. Any drug interactions are excluded.

    Presentation

    90 ml of shampoo in a plastic bottle (inside package).

    The 1 bottle with leaflet packed in cardboard box (outer package).

     

    Expiry date

    3 years. Do not use after the expiration date.

    Prescription status

    To be dispensed without prescription.

    Storage conditions

    Store at temperature not higher than 25°C in a dry place, out of reach of children, protect from light.