Hydrocortisone/ Miconazole

Registered South African indications:

• Fungal infections of the skin with inflammation

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Tuberculous skin infections, herpes simplex, vaccinia or varicella
• Pregnancy

Cautions 

• Breastfeeding
• Renal impairment 
• Hepatic impairment 
• Elderly 
• Children
• Occlusive dressings 
• Contact with latex products
• Contact with synthetic clothing

Forms avail. in SA and covered in this monograph: cre

Infections of the skin caused by dermatophytes or Candida with prominent inflammation
Mycotic infections with bacterial superinfection 

Hydrocortisone/ Miconazole
10/20 (mg/g) 

• Topical (cre): Apply to affected area, 12-24hrly; Max treatment duration: 7 days

Once the inflammatory symptoms have disappeared treatment may be continued with miconazole nitrate topical cream without interruption until the lesion has completely disappeared (usually after 2 to 5 weeks)

Should NOT be used with occlusive dressing 

Paed. forms avail in SA and covered in this monograph: cre

Infections of the skin caused by dermatophytes or Candida with prominent inflammation
Mycotic infections with bacterial superinfection 

Hydrocortisone/ Miconazole
10/20 (mg/g) 

• Younger 10 years: Not established for use
• Older than 10 years: See adult dosage 

Pregnancy

• Contraindicated

Breastfeeding

• Caution
• There are no adequate and well-controlled studies on the topical administration of topical hydrocortisone/miconazole during breastfeeding. It is not known whether concomitant topical administration of hydrocortisone/miconazole cream to the skin could result in sufficient systemic absorption to produce detectable quantities of hydrocortisone and miconazole in breast milk in humans. Caution is recommended during breastfeeding. Treatment of large surfaces and the application under occlusive dressing should be avoided during that time. A risk to the newborn child cannot be excluded

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no dose adjustment recommended
  Use sparingly and for short periods of time

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders 

• Irritability 

Skin and Subcutaneous Tissue Disorders 

• Irritation
• Burning
• Urticaria
• Pruritis
• Angioedema
• Rash 
• Contact dermatitis 
• Erythema
• Inflammation 
• Hypopigmentation 
• Application site reaction

Immune, Blood and Lymphatic System Disorders 

• Anaphylaxis
• Hypersensitivity

• Warfarin
• Systemic hydrocortisone

None routine 

Miconazole
Miconazole acts by increasing the permeability of the fungal cell membrane through damage caused by the inhibition of ergosterol biosynthesis. This results in leakage of nutrients and cellular contents from the fungal cell which ultimately causes cell necrosis.

Hydrocortisone
Hydrocortisone inhibits the release of arachadonic acid from the cell membrane and thus interferes with the initiation of the inflammatory response. It may depress the formation, release and activity of endogenous chemical mediators of inflammation. It has anti-inflammatory, antipruritic, antiallergic and vasoconstrictive effects.

COMBINATION PREPARATIONS

Hydrocortisone/ Miconazole

Cream (per g) 10mg/20mg

• Daktacort (Janssen Pharmaceutica) originator
• Elozart (LeBasi)