Search The Medical Knowledge Base

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