Bifonazole

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: 

• Mycoses of the skin and mucocutaneous parts due to dermatophytes, Candida species, Malassezia furfur, Corynebacterium minutissimum and Aspergillus species

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Nappy rash
• Nail and scalp infections

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment 
• Elderly
• Application to large surface area
• Application to broken or damaged skin

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

Infections caused by: Yeasts (including Candida; Malassezia furfur); Corynebacterium minutissimum; Aspergillus spp; Dermatophytes (including Trichophyton spp) 

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
Skin mycoses 

• Topical (cre, sol): Apply small quantity to the affected area(s), dly at night; Treatment duration: 2-3 weeks
• Topical (spo): Apply 1-2 sprays to the affected area(s), dly at night; Treatment duration: 2-3 weeks

Wash and dry skin thoroughly prior to application

No information available

Pregnancy

• Caution
• There are no clinical data from the use of bifonazole in pregnant women. Studies in animals have shown reproductive toxicity at high oral doses however these effects should not be anticipated at the low systemic exposures observed following topical bifonazole administration 
• Bifonazole should only be used during pregnancy after an evaluation by a doctor of the benefit to the patient and the risk to the foetus

Breastfeeding

• Caution
• It is unknown whether bifonazole is excreted in human breast milk after topical application
• Bifonazole is excreted in milk after intravenous administration in animals
• A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue bifonazole therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman
• During the breastfeeding period bifonazole should not be applied to the chest area

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Administration site pain
• Peripheral oedema 
• Contact dermatitis
• Allergic dermatitis
• Erythema
• Pruritus
• Rash
• Urticaria
• Blister
• Skin exfoliation
• Eczema
• Dry skin
• Skin irritation
• Skin maceration
• Skin burning sensation

Immune, Blood and Lymphatic System Disorders

• Systemic hypersensitivity reactions 

Warfarin

None routine

Bifonazole is a broad-spectrum antifungal, which suppresses cell wall synthesis. Its in vitro activity against dermatophytes is primarily fungicidal whereas that against yeasts is primarily fungistatic.

Spectrum of activity: Yeasts (including Candida, Malassezia furfur);Corynebacterium minutissimum; Aspergillus spp; Dermatophytes (including Trichophyton spp)

Cream (per g) 10mg

• Canespor (Bayer) originator
• Mycospor (Bayer) originator

Solution (per ml) 10mg

• Canespor (Bayer) originator
• Mycospor (Bayer) originator

Spray (per ml) 10mg

• Canespor (Bayer) originator
• Mycospor (Bayer) originator