Drugs List

Therapeutic Indications

Uses

Mild onychomycosis due to dermatophytes, yeasts and moulds: maximum 2 nails
Onychomycosis caused by dermatophytes, yeasts and moulds

POM pack
Onychomycoses caused by dermatophytes, yeasts and moulds.
First line treatment of onychomycoses without matrix affection.

P pack
Mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds limited up to 2 nails.

Contraindications

None known

Precautions and Warnings

Children under 12 years
Breastfeeding
Pregnancy

Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Avoid contact with ears
Avoid contact with eyes
Avoid contact with mucous membranes
Discontinue if allergic reaction occurs
Advise patient to wear protective gloves when working with organic solvents
Avoid use of nail polish and artificial nails during treatment

Co-existent tinea pedis infection should be treated with an appropriate antifungal cream.

Pregnancy and Lactation

Pregnancy

Use amorolfine with caution in pregnancy.

At the time of writing, safety has not been established in humans.

Animal studies do no indicate any teratogenic effects, however embryotoxicity has been observed in laboratory animals at high oral doses.

The systemic absorption of topical amorolfine is very low and therefore the risk to humans is considered to be negligible.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use amorolfine with caution in breastfeeding.

At the time of writing, safety has not been established in humans and it is unknown if amorolfine is excreted into breast milk.

The systemic absorption of topical amorolfine is very low and therefore the risk to humans is considered to be negligible.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Blisters (application site)
Brittle nails
Burning sensation (local)
Contact dermatitis
Discolouration of nails (temporary)
Erythema
Nail disorders
Onychoclasis
Pruritus
Urticaria

Presentation

Nail lacquer containing amorolfine.

Drugs List

Therapeutic Indications

Uses

Mild onychomycosis due to dermatophytes, yeasts and moulds: maximum 2 nails
Onychomycosis caused by dermatophytes, yeasts and moulds

POM pack
Onychomycoses caused by dermatophytes, yeasts and moulds.
First line treatment of onychomycoses without matrix affection.

P pack
Mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds limited up to 2 nails.

Dosage

Adults

Children

Contraindications

None known

Precautions and Warnings

Children under 12 years
Breastfeeding
Pregnancy

Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Avoid contact with ears
Avoid contact with eyes
Avoid contact with mucous membranes
Discontinue if allergic reaction occurs
Advise patient to wear protective gloves when working with organic solvents
Avoid use of nail polish and artificial nails during treatment

Co-existent tinea pedis infection should be treated with an appropriate antifungal cream.

Pregnancy and Lactation

Pregnancy

Use amorolfine with caution in pregnancy.

At the time of writing, safety has not been established in humans.

Animal studies do no indicate any teratogenic effects, however embryotoxicity has been observed in laboratory animals at high oral doses.

The systemic absorption of topical amorolfine is very low and therefore the risk to humans is considered to be negligible.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use amorolfine with caution in breastfeeding.

At the time of writing, safety has not been established in humans and it is unknown if amorolfine is excreted into breast milk.

The systemic absorption of topical amorolfine is very low and therefore the risk to humans is considered to be negligible.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Administration advice:
Before the first application, the affected nail(s) should be filed down as thoroughly as possible using a nail file. The nail surface should then be cleansed and degreased using either the cleansing pad supplied by the manufacturer or a cleansing pad or swab impregnated with a nail varnish remover.

The lacquer should be applied to the entire surface of the affected nail(s) with one of the re-usable applicators supplied and allowed to dry. The applicator should be dipped into the nail lacquer and applied fully laden to the affected nail(s) without wiping any off on the bottle neck. The applicator should be cleaned between each nail treated to avoid infecting the lacquer. Care should be taken not to apply the lacquer to the skin around the nail.

Before repeat applications, nail(s) should be similarly filed and cleansed, and any remaining lacquer removed with a cleansing pad or cleansing swab provided, or a cleansing pad or swab impregnated with a nail varnish remover.

After use applicators should be cleaned with the cleansing pad or cleansing swab used for the nails.

Manufacturers of some amorolfine products advise that cosmetic nail lacquer can be used alongside amorolfine treatment. For compatible products, cosmetic nail lacquer should be applied at least 10 minutes after amorolfine nail lacquer. Where cosmetic nail lacquer has been used, it should be carefully removed (using the cosmetic pads provided or nail varnish remover) prior to any repeat applications of amorolfine.

Additional counselling points:
Advise the patient that protective gloves should be worn if products containing organic solvents (such as paint thinners or white spirit) are used.

Advise patient to avoid using the same nail file for affected and healthy nails.

Advise patient artificial nails should not be used during treatment with amorolfine nail lacquer.

Advise patient to discontinue treatment and seek medical advice if any systemic or local allergic reactions occur after using amorolfine nail lacquer.

Side Effects

Blisters (application site)
Brittle nails
Burning sensation (local)
Contact dermatitis
Discolouration of nails (temporary)
Erythema
Nail disorders
Onychoclasis
Pruritus
Urticaria

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: August 2014

Reference Sources

Summary of Product Characteristics: Amorolfine 5% w/v medicated nail lacquer. Apsire Pharma Ltd. Revised July 2018.

Summary of Product Characteristics: Clavusimyl 5% Medicated Nail Lacquer UK. Mylan. Revised June 2013.

Summary of Product Characteristics: Curanail 5% Medicated Nail Lacquer. Galderma UK Ltd. Revised August 2018.

Summary of Product Characteristics: Loceryl 5% Medicated Nail Lacquer. Galderma UK Ltd. Revised July 2017.

Summary of Product Characteristics: Omicur 5% Medicated Nail Lacquer. Morningside Healthcare Ltd. Revised December 2011.

Summary of Product Characteristics: Schollmed Once Weekly Fungal Nail Treatment 5%w/v Medicated Nail Lacquer. Reckitt Benckiser Healthcare (UK) Ltd. Revised July 2017.

NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 18 August 2014.