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Amorolfine

Classification: B

Drug products: Amorolfin ABECE, Amorolfin Apofri, Amorolfin Evolan, Amorolfin Mylan, Amorolfine Teva, Finail, Loceryl, Loceryl Creme, Loceryl®

ATC code: D01AE16

Substances: amorolfine, amorolfine hydrochloride

Summary

Published controlled studies on differences between men and women regarding the effect, safety and pharmacokinetics of amorolfine are lacking.
 
The present evidence concerning differences between men and women is very limited and do not motivate differentiation in dosing or treatment.

Additional information

Amorolfine is approved for topical use in the treatment of fungal infections in toe- and finger nails. It is not marketed in North America.

Pharmacokinetics and dosing

Amorolfine is administered topically as a nail laquer and the systemic uptake is very small [1]. No studies on sex differences in pharmacokinetic properties have been identified.

Effects

No studies with a clinically relevant sex analysis regarding effects of amorolfine have been found.

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of amorolfine have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

In a review of the epidemiology of onychomyosis the sex distribution was found to vary considerably between different studies and populations but the conclusion was that most studies showed male preponderance [2].

Updated: 2019-02-26

Date of litterature search: 2016-12-17

References

  1. Baran R, Gupta AK, Piérard GE. Pharmacotherapy of onychomycosis. Expert Opin Pharmacother. 2005;6:609-24. PubMed
  2. Sigurgeirsson B, Baran R. The prevalence of onychomycosis in the global population: a literature study. J Eur Acad Dermatol Venereol. 2014;28:1480-91. PubMed
  3. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-12-19.] Socialstyrelsens statistikdatabas
  4. Conicse. Stockholm: eHälsomyndigheten. 2015 [cited 2016-03-23.] länk

Authors: Mia von Euler, Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson