02 Apr 2012

Daktarin Gold (ketoconazole) - United Kingdom

Updated: 02 Apr 2012

Daktarin Gold 2% Cream

For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo.

Daktarin Gold Description, Presentation and Dosage

Daktarin Gold Description

Daktarin Gold Drug Class Description

Imidazole and triazole derivatives - ATC code: D01AC08

Daktarin Gold Drug Description

Ketoconazole 2% w/w. Excipients: Propylene glycol; Cetyl alcohol; Stearyl alcohol

Daktarin Gold Generic Name

ketoconazole

Daktarin Gold Presentation

Daktarin Gold Presentation

Cream White cream

Daktarin Gold Manufacturer

McNeil Products Ltd

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Daktarin Gold Dosage

Daktarin Gold Adult Dosage

For the treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch) and candidal intertrigo (sweat rash).

For tinea pedis, Daktarin Gold 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 for 2–3 days after all signs of infection have disappeared to prevent relapse.

For tinea cruris and candidal intertrigo, apply cream to the affected areas once or twice daily until 2-3 days after all signs of infection have disappeared to prevent relapse. Treatment for up to 6 weeks may be necessary. If no improvement in symptoms is experienced after 4 weeks treatment, a doctor should be consulted.

Method of administration: Cutaneous use.

Daktarin Gold Precautions, Reactions and Contraindications

Daktarin Gold Special Precautions

Daktarin Gold Special Precautions

Daktarin Gold 2% cream is not for ophthalmic use.

To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Daktarin Gold 2% cream in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

Daktarin Gold Adverse Reactions

Daktarin Gold Adverse Reactions

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 (GREATER-THAN OR EQUAL TO (8805)1% incidence) ADRs were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%). Including the above-mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of ketoconazole cream from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:

Very Common

(GREATER-THAN OR EQUAL TO (8805)1/10)

Common

(GREATER-THAN OR EQUAL TO (8805)1/100 to <1/10)

Uncommon

(GREATER-THAN OR EQUAL TO (8805)1/1,000 to <1/100)

Rare

(GREATER-THAN OR EQUAL TO (8805)1/10,000 to <1/1,000)

Very rare

(<1/10,000)

Not Known

(cannot be estimated form the available clinical trial data).

System Organ Class

Adverse Drug Reactions

Frequency Category

Common

(GREATER-THAN OR EQUAL TO (8805)1/100 to <1/10)

Uncommon

(GREATER-THAN OR EQUAL TO (8805)1/1,000 to <1/100)

Not Known

Immune System Disorders

 

Hypersensitivity

 

Skin and Subcutaneous Tissue Disorders

Skin burning sensation

Bullous eruption

Dermatitis contact

Rash

Skin exfoliation

Sticky skin

Urticaria

General Disorders and Administration Site Conditions

Application site erythema

Application site pruritus

Application site bleeding

Application site discomfort

Application site dryness

Application site inflammation

Application site irritation

Application site paraesthesia

Application site reaction

 

Daktarin Gold Contraindications

Daktarin Gold Contraindications

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

Related Drugs - Dermatology

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