Fenticonazole

Registered South African indications:

• Vulvovaginal candidiasis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to the imidazole derivatives 

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Concomitant use of barrier contraceptives

Forms avail. in SA and in this monograph: cre, ovule

Vulvovaginal candidiasis

• Topical (cre): 5g, applied intravaginally, morning and night; Treatment duration: 3 days
• Topical (ovule): 200mg, intravaginally, dly at night; Treatment duration: 3 days
  OR
• Topical (ovule) 600mg, as single dose, at night

Sexual partner should also be treated

Not established for use in children

Pregnancy

• Caution
• Oral administration of fenticonazole in rats has been reported to produce prolonged gestation and embryotoxic effects after doses above 40mg/kg/day. Fenticonazole does not interfere with the function of male and female gonads and does not modify the first phases of reproduction
• Fenticonazole has shown no teratogenic effects in rats and rabbits. Fenticonazole or its metabolites cross the placental barrier in pregnant rats and rabbits after vaginal application
• Since there is no experience of use during pregnancy, fenticonazole should not be used unless considered essential to the welfare of the patient
• Pregnant women should not use an applicator without medical instruction

Breastfeeding

• Caution
• Since there is no experience of use during breastfeeding, fenticonazole should not be used by breastfeeding mothers unless it is considered essential to the welfare of the patient

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Genitourinary Disorders

• Transient vaginal burning

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

No information available

None routine

Fenticonazole is a potent broad spectrum antimycotic agent. The mechanism of action of fenticonazole is thought to be the blocking of oxidant enzymes with accumulation of peroxides and necrosis of the fungal cell; direct action on the membrane.

Vaginal cream (per 5g) 100mg

• Lomexin (Litha Pharma) originator

Vaginal ovules 200mg

• Lomexin (Litha Pharma) originator

Vaginal ovules 600mg

• Lomexin (Litha Pharma) originator