Amorolfine 5%

Amorolfine 5% – Medicated nail lacquer

Amorolfine 5% medicated nail lacquer is a topical antimycotic (antifungal) agent. It is licensed as a P medication, indicated for the treatment of mild cases of fungal infections, affecting the nail, for adults over 18 years of age.

NOTE: Treatment is limited to a maximum of 2 infected nails at one time.

Pharmacists are responsible for the supply of amorolfine P medicine over the counter to patients as a treatment for mild cases of fungal nail infections beneath the tips and sides of nails (distal and lateral subungual onychomycoses) caused by; dermatophytes, yeasts and moulds.

Referral

It is recommended that pharmacists review the treatment at intervals of approximately three months. If symptoms worsen or have not improved by then, referral to doctor/prescriber is recommended.

  • Patients with underlying conditions predisposing to fungal nail infections should be referred to a doctor. Such conditions include peripheral circulatory disorders, diabetes mellitus, and immunosuppression
  • Patients with nail dystrophy and destroyed nail plate should be referred to their doctor
  • Patients who have more than 2 infected nails at the one time

When should it be supplied:

  • Due to the lack of clinical experience available, OTC amorolfine nail lacquer is not recommended for patients below the age of 18 years
  • It should be avoided during pregnancy and lactation
  • It must not be re-used by patients who have shown hypersensitivity to the active substance or to any of the excipients.

Selling/ supply to third party

  • Amorolfine nail lacquer can be supplied to a third party.
  • However, it is important that appropriate measures are taken to ensure that it is being supplied in line with the product’s marketing authorisation.
  • Amorolfine nail should only be considered for patients over 18 years of age who are suffering from the symptoms of subungual onychomycoses caused by dermatophytes, yeasts and moulds.

Differential diagnoses

  • Psoriasis (appears as fine pitting on the nail surface, usually present at other skin sites
  • Liichen planus (itchy, flat-topped papules most commonly seen on wrists and lower legs)
  • Contact dermatitis (previous contact with irritants likely)
  • Nail trauma (nail bed appears normal)
  • Yellow nail syndrome (commonly associated with lung disorders, all nails are affected).