Diazon

Diazon

ketoconazole

Manufacturer:

Unison

Distributor:

Medispec
Full Prescribing Info
Contents
Ketoconazole.
Action
Pharmacotherapeutic group: Antifungal (Topical).
Pharmacology: Fungistatic; may be fungicidal, depending on concentration; azole antifungals interfere with cytochrome P450 enzyme activity, which is necessary for the demethylation of 14-alpha-methylsterols to ergosterol. Ergosterol, the principal sterol in the fungal cell membrane, becomes depleted. This damages the cell membrane, producing alterations in membrane functions and permeability. In candida albicans, azole antifungals inhibit transformation of blastospores into invasive mycelial form.
High dose Ketoconazole therapy can interfere with conversion of lanosterol to cholesterol, a major precursor of several hormones. It has been shown to suppress corticosteroid secretion and lower serum testosterone concentrations, which return to baseline values when Ketoconazole is discontinued.
Pharmacokinetics: Absorption: After a single topical application of Ketoconazole cream to the chest, back, and arms of normal volunteers, systemic absorption of Ketoconazole was not detected during the following 72 hour period, using a minimum detection level of 5 nanograms per ml in blood.
Indications/Uses
Tinea corporis; Tinea cruris (treatment): Ketoconazole cream is indicated as a primary agent in the topical treatment of Tinea corporis (ringworm of the body) and Tinea cruris (ringworm of the groin; jock itch) caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum (Acrothesium floccosum).
Tinea pedis (treatment): Ketoconazole cream is indicated as primary agent in the topical treatment of Tinea pedis (athlete's foot).
Pityriasis versicolor (treatment): Ketoconazole cream is indicated as primary agents in the topical treatment of Pityriasis versicolor (Tinea versicolor; "sun fungus") caused by Malassezia furfur (Pityrosporon orbiculare).
Candidiasis cutaneous (treatment): Ketoconazole cream is indicated as a primary agent in the topical treatment of cutaneous candidiasis caused by Candida species.
Dermatitis seborrheic (treatment or prophvlaxis): Ketoconazole cream is indicated in the treatment of seborrheic dermatitis.
Dosage/Direction for Use
Topical.
Usual adult and adolescent dose: Tinea corporis; Tinea cruris; Tinea pedis; Pityriasis versicolor : To the affected skin and surrounding areas, once a day.
Candidiasis, cutaneous: To the affected skin and surrounding areas, once a day. More resistant cases may require twice a day treatment.
Seborrheic dermatitis: To the affected skin and surrounding areas, two or three times a day.
Usual pediatric dose: Safety and efficacy have not been established.
Overdosage
If accidental ingestion of Ketoconazole cream occurs, an appropriate method of gastric emptying may be used if considered appropriate.
Contraindications
Risk-benefit should be considered when the following medical problems exist: Sensitivity to topical Ketoconazole.
Sensitivity to sulfites present in Ketoconazole cream.
Special Precautions
Not for ophthalmic use.
Use In Pregnancy & Lactation
After topical application, Ketoconazole cream is not systematically absorbed and does not produce detectable plasma concentrations. However, as with any medication, Ketoconazole cream should only be used in pregnant women if its use is considered essential by a doctor. Since no Ketoconazole is detected in plasma following topical administration, use of Ketoconazole cream is not contraindicated for breast feeding women.
Side Effects
A few instances of irritation, dermatitis and burning sensation have been observed during treatment with Ketoconazole cream.
Storage
Store at temperature of not more than 30°C.
MIMS Class
Topical Antifungals & Antiparasites
ATC Classification
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Presentation/Packing
Form
Diazon cream 2 %
Packing/Price
15 g x 1's
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