Amorolfine

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:

• Onychomycoses caused by dermatophytes, yeasts and moulds

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 

Cautions 

• Pregnancy
• Breastfeeding
• Renal impairment 
• Hepatic impairment 
• Contact with eyes, ears and mucous membranes

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

Onychomycoses cause by: Fungi (including dermatophytes, yeasts, moulds, dermateaceae)

• Topical (sol): Apply to affected nail, 1-2 times/week; Treatment duration: 6 months (finger nails), 9-12 months (toe nails)

A review of the treatment is recommended at intervals of three months

Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured

Co-existent tinea pedis should be treated with an appropriate antimycotic cream

When working with organic solvents the patient should wear impermeable gloves in order to protect the nail lacquer on the nails

See additional prescribing points for administration directions

Not established for use in children

Pregnancy

• Caution
• Experience with amorolfine use during pregnancy is limited. Only a few cases of exposure to topical amorolfine use in pregnant women have been reported in the post-authorisation setting, therefore the potential risk is unknown. Studies in animals have shown reproductive toxicity at high oral doses
• Amorolfine should not be used during pregnancy unless clearly necessary

Breastfeeding

• Caution; not recommended
• Experience with amorolfine use during breastfeeding is limited
• It is unknown whether amorolfine is excreted in human milk
• Amorolfine should not be used during breastfeeding unless clearly necessary

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Nail disorder
• Nail discoloration
• Onychoclasis
• Skin burning sensation
• Contact dermatitis
• Erythema
• Pruritus
• Contact dermatitis
• Urticaria
• Blister

Nail varnish 

None routine 

Administration directions

• The affected areas of nail should be filed down as thoroughly as possible prior to application
• The surface of the nail should then be cleansed and degreased using an alcohol cleaning pad
• Apply the nail lacquer to the entire surface of the affected nails and allow it to dry
• For each nail to be treated, dip the applicator into the nail lacquer without wiping off any of the lacquer on the bottle neck
• After use, clean the applicator with an alcohol cleaning pad 

Special warnings

• Amorolfine 5% Nail Lacquer should not be applied to the skin around the nail
• Before repeat application of amorolfine 5% nail lacquer, the cosmetic nail lacquer should be removed carefully
• After applying amorolfine 5% nail lacquer, an interval of at least 10 min should be respected before application of any cosmetic nail lacquer

Amorolfine is a topical antimycotic. Amorolfine belongs to a new chemical class, and its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. The ergosterol content is reduced, and at the same time unusual sterically nonplanar sterols accumulate.

Paint (per ml) 50mg

• Loceryl (Galderma) originator