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Drug Details
Daktarin Gold 2% Cream
- Drug Class Description
Imidazole and triazole derivatives - ATC code: D01AC08 - Generic Name
ketoconazole - Presentation
Cream White cream - Description
Ketoconazole 2% w/w. Excipients: Propylene glycol; Cetyl alcohol; Stearyl alcohol - Indications
For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo.
- 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.
- Contra Indications
Daktarin Gold 2 % cream is contra-indicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself.
- 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.
- Interactions
None known.
- Adverse Drug 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 (
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
(
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)
Not Known
(cannot be estimated form the available clinical trial data).
System Organ Class
Adverse Drug Reactions
Frequency Category
Common
(
1/100 to <1/10)Uncommon
(
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