Econazole

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications: 

• Dermatomycoses caused by Dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum) ; Yeasts (Candida albicans, Candida guilliermondii, Torulopsis, Rhodotorula, Pityrosporum orbiculare (ovale) ); Gram-positive bacteria and Moulds

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Contact with eyes or mouth
• Eczematous dermatitis 
• Children < 16 years

Forms avail. in SA and covered in this monograph: cre, pdr, spo

Infections caused by: Dermatophytes; Yeasts (including Candida spp., Rhodotorula, Pityrosporon ovale); Moulds

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Tinea pedis
Tinea cruris
Tinea corporis
Cutaneous candidiasis
Pityriasis versicolor

• Topical (cre, pdr, spo): Apply to affected area(s), 12hrly; Treatment duration: 2-4 weeks

Not established for use in children below 16 years

Pregnancy

• Caution
• Systemic absorption of econazole is low (< 10%) after topical application to the intact skin in humans. There are no adequate and well-controlled studies on adverse effects from the use of topical econazole in pregnant women, and no other relevant epidemiological data are available
• Animal studies have shown reproductive toxicity. Because there is systemic absorption, use of topical econazole is not recommended during pregnancy

Breastfeeding

• Caution; not recommended
• It is not known whether cutaneous administration of topical econazole results in sufficient systemic absorption of econazole nitrate to produce detectable quantities in breast milk in humans
• A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from topical econazole therapy taking into account the benefit of breastfeeding for the child and benefit of therapy for the woman
• If topical econazole is used while breastfeeding, care should be taken to ensure the cream is not applied to the nipple or surrounding area

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Burning sensation of skin
• Rash
• Erythema
• Angioedema
• Urticaria
• Contact dermatitis
• Skin exfoliation
• Blister
• Application site pain
• Application site irritation
• Application site swelling

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

• CYP3A4 substrates
• CYP2C9 substrates
• Oral anticoagulants

None routine

Econazole inhibits the synthesis of the fungal cell membrane, which results in increased cellular permeability and leakage of cellular contents.

Spectrum of activity: Dermatophytes; Yeasts (including Candida spp., Rhodotorula, Pityrosporon ovale); Moulds

Cream (per 100g) 1g

• Pevaryl (Janssen) originator

Powder (per 100g) 1g

• Pevaryl  (Janssen) originator

Spray solution (per 100g) 1g

• Pevaryl (Janssen) originator

Also available in the following forms: Vaginal cream and ovule.

COMBINATION PREPARARTION

Econazole/ Triamcinolone

Cream (per g) 10mg/1mg

• Pevisone (Janssen) originator