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Drug Details

Daktacort Ointment

• Drug Class Description
  Antifungal-antibacterials / mildly potent corticosteroids (topical steroids).
• Generic Name
  hydrocortisone, miconazole nitrate
• Presentation
  White, odourless, fatty ointment.
• Description
  Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.
• Indications
  

  For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, eg intertrigo and infected eczema.

  Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.

  Intertriginous eczema including inframammary intertrigo, perianal and genital dermatitis.

  Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (eg Candida spp.). Also many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.

  The properties of Daktacort indicate it particularly for the initial stages of treatment. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with Daktarin™ Cream or Daktarin™ Powder.

• Adult Dosage
  

  For topical administration.

  Daktacort Ointment should be applied topically two or three times daily.

  The same dosage applies to both adults and children.

  If after about 7 days' application, no improvement has occurred, cultural isolation of the offending organism should be followed by appropriate local or systemic antimicrobial therapy.

• Child Dosage
  

  The same dosage applies to both adults and children.

  In infants, long term continuous topical corticosteroid therapy should be avoided.

• Elderly Dosage
  

  Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time.

• Contra Indications
  

  True hypersensitivity to any of the ingredients. Tubercular or viral infections of the skin or those caused by Gram-negative bacteria.

• Special Precautions
  

  When Daktacort is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored.

  As with any topical corticosteroid, care is advised with infants and children when Daktacort is to be applied to extensive surface areas or under occlusive dressings including baby napkins; similarly, application to the face should be avoided.

  In infants, long term continuous topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion.

• Interactions
  

  Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

  Miconazole is a CYP3A4 inhibitor that can decrease the rate of metabolism of hydrocortisone. Serum concentrations of hydrocortisone may be higher with the use of Daktacort compared with topical preparations containing hydrocortisone alone.

• Adverse Drug Reactions
  

   

  Rarely, local sensitivity may occur requiring discontinuation of treatment.

  Additional adverse drug reactions reported in postmarketing reports with DAKTACORT CREAM but not with DAKTACORT OINTMENT are included in Table 1. The frequencies are based on spontaneous reporting rates, according to the following convention:

  Very common	1/10
  Common	1/100 and < 1/10
  Uncommon	1/1,000 and <1/100
  Rare	1/10,000, <1/1,000
  Very rare	<1/10,000, including isolated reports

  Table 1. Adverse Drug Reactions Identified During Postmarketing Experience with Daktacort Cream by Frequency Category Estimated from Spontaneous Reporting Rates
  Immune system disorders
  Very rare	Anaphylactic reaction
  Skin and Subcutaneous Tissue Disorders
  Very rare	Contact dermatitis, Erythema, Rash

  Review of adverse events reported with Daktacort Ointment did not find sufficient evidence to assess any of the events as adverse drug reactions associated with the use of Daktacort Ointment