Amorolfine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 17, 2026🚩 Report this page

Amorolfine

Overview

Amorolfine is an active pharmaceutical ingredient in the Other Antifungals For Topical Use group (D01AE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	14	April 17, 2026

GBUnited Kingdom· MHRA

14 products

Uses

GBOfficial regulatory label[1]

Treatment of onychomycosis without matrix involvement caused by dermatophytes, yeasts or moulds.

How to take

GBOfficial regulatory label

Sources & citations

[1]MHRA (UK) · PL361430001

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Amorolfine 5% w/v Medicated Nail Lacquer should be applied to the affected finger nails once or twice weekly or toe nails once weekly.
The patient should apply the nail lacquer as follows:
Before the first application of Amorolfine 5% w/v Medicated Nail Lacquer, it is essential that the affected areas of nail (particularly the nail surfaces) should be filed down as thoroughly as possible using the nail file supplied.
The surface of the nail should then be cleansed and degreased using a cleaning swab (as supplied). Before repeat application of Amorolfine 5% w/v Medicated Nail Lacquer, the affected nails should be filed down again as required, following cleansing with a cleaning swab to remove any remaining lacquer.
Caution:
Nail files used for affected nails must not be used for healthy nails. With one of the reusable spatulas supplied, apply the nail lacquer to the entire surface of the affected nails and allow it to dry. After use, clean the spatula with the same cleaning swab used before for nail cleaning.
Keep the bottle tightly closed. For each nail to be treated, dip the spatula into the nail lacquer without wiping off any of the lacquer on the bottle neck. ) wear impermeable gloves in order to protect the Amorolfine lacquer on the nails.
Amorolfine 5% w/v Medicated Nail Lacquer is effective in moderately extensive onychomycosis. Treatment should be continued without interruption until the nail is regenerated and the affected areas are finally cured. The required frequency and duration of treatment depends essentially on intensity and localisation of the infection.
In general, it is six months (finger nails) and nine to twelvemonths (toe nails). A review of the treatment is recommended at intervals of approximately three months. Co-existent tinea pedis should be treated with an appropriate antimycotic cream.
Elderly There are no specific dosage recommendations for use in elderly patients. Paediatric population There are no specific dosage recommendations for children owing to the lack of clinical experience available to date.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

Drugs in the same class

Sources & citations