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    Ketoconazole, 2 % cream

    Drug formSoft

    ATC categoryAnifungals

    ATC subcategoryAzole antifungals (for external use)

    Brand nameKetoconazole

    Generic nameKetoconazole

    Composition

    Each gram of Ketoconazole 2% cream for topical use contains:

    active ingredient: ketoconazole – 20 mg;

    excipients: ceteareth-12, ceteareth-20, cetostearyl alcohol, isopropyl myristate, methylparaben, propylparaben, propylene glycol, color red E-129, deionized water.

    Pharmacological group and ATC code
    Imidazole and triazole derivatives. D01AC08
    Chemical name and CAS number
    (±)-cis-1-Acetyl-4-{4-[2-(2,4-dichlorophenyl)-2-imidazol-1-ylmethyl-1,3-dioxolan-4-ylmethoxy] phenyl} piperazine;
    65277-42-1.
    Pharmacology

    Ketoconazole has a potent antimycotic action against dermatophytes and yeasts. Ketoconazole cream acts rapidly on the pruritus, which is commonly seen in dermatophyte and yeast infections. This symptomatic improvement often occurs before the first signs of healing are observed.

    A study in 250 patients has shown that application twice daily for 7 days of ketoconazole 2% cream vs clotrimazole 1% cream for 4 weeks on both feet demonstrated efficacy in patients with tinea pedis (athlete’s foot) presenting lesions between the toes. The primary efficacy endpoint was negative microscopic KOH examination at 4 weeks. Ketoconazole 2% treatment showed equivalent efficacy to 4 weeks clotrimazole 1% treatment. There was no evidence of relapse following treatment with ketoconazole cream at 8 weeks.

    Pharmacokinetics
    Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral 2% Cream in adults on the skin. In one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of Ketokonazole 2% cream was applied daily on 40% of the body surface area, plasma levels of ketoconazole were detected in 5 infants, ranging from 32 to 133 ng/mL.

    Uses and Administration
    For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Ketokonazole 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

    Administration

    Tinea pedis:

    – Ketokonazole 2% cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.

    For other infections:

    – Ketokonazole 2% cream should be applied to the affected areas once or twice daily, depending on the severity of the infection.

    The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor 2–3 weeks, tinea corporis 3–4 weeks.

    The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection.

    Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.
    Method of administration: Cutaneous administration.

    Contraindications

    Ketoconazole 2% cream is contra-indicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself.

    Adverse effects

    The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin. Based on pooled safety data from these clinical trials, the most commonly reported (1% incidence) ADRs were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%).

    Immune System Disorders
    Uncommon: Hypersensitivity.

    Skin and Subcutaneous Tissue Disorders
    Common: Skin burning sensation.
    Uncommon: Bullous eruption, application site bleeding, application site discomfort, application site dryness.
    Not known: Urticaria.

    General Disorders and Administration Site Conditions
    Common: application site erythema.
    Uncommon: spplication site inflammation, application site irritation, application site paraesthesia, application site reaction

    Pregnancy and Lactation
    There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity following oral administration of ketoconazole. No effects on the breastfed newborn/infant are anticipated.

    Precautions

    Not for ophthalmic use.

    If a potent topical corticosteroid has been used previously in the treatment of seborrhoeic dermatitis, a recovery period of 2 weeks should be allowed before using Nizoral 2% cream, as an increased incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.

    Effects on ability to drive and use machines
    – Ketoconazole 2% cream has no influence on the ability to drive and use machines.

    Overdosage

    Topical Application

    Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.

    Ingestion

    In the event of accidental ingestion, supportive and symptomatic measures should be carried out.

    Drug interactions

    No interaction studies have been performed.

    Identification

    Pink cream.

    Presentation

    15 g and 25 g of cream is filled into aluminum tubes (inside package).
    The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).

    Expiry date

    3 years. Do not use after the expiration date.

    Prescription status

    To be dispensed without prescription.

    Storage conditions

    Store at a room temperature (15-250C), in a dry place, out of the reach of children, protect from light.