Drugs List

Therapeutic Indications

Uses

Fungal infection of skin

Cream
Treatment of fungal infections of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

Cutaneous yeast infections, principally those caused by the genus Candida (e.g. C. albicans ).

Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur ).

Not all preparations are licensed for all indications.

Spray
Treatment of tinea pedis and tinea cruris caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

Gel
Treatment of tinea pedis and tinea cruris and tinea corporis caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

Contraindications

None known

Precautions and Warnings

Children under 16 years
Breastfeeding
Pregnancy

Not all available brands are licensed for all indications
Some formulations contain butylated hydroxy toluene (E321)
Some formulations contain propylene glycol
Avoid broken or inflamed skin
Avoid contact with eyes
Do not apply to broken or denuded skin
Do not inhale the spray
If accidental contact with the eyes occurs, rinse thoroughly with water
May cause irritation when applied to sensitive skin
Risk of recurrence with irregular use/premature discontinuation of therapy
Discontinue treatment if severe irritation or contact allergy occurs
Refer to doctor if symptoms persist after 2 weeks treatment

Pregnancy and Lactation

Pregnancy

Topical terbinafine is contraindicated in pregnancy.

Manufacturer states that, unless the potential benefits outweigh any potential risks, topical terbinafine should not be administered during pregnancy.

Animal studies have not revealed any teratogenic or embryofoetotoxic potential of terbinafine.
No cases of malformations in humans have been reported with terbinafine to date, however, clinical experience of the use of terbinafine in pregnant women is limited.
It is unknown whether terbinafine crosses the placenta. The molecular weight is low enough that transfer to the foetus should be expected.
Schaefer states that the use of terbinafine should be avoided during pregnancy. However, if used during pregnancy this is not an indication either for a termination of pregnancy or for invasive diagnostic procedures. Nystatin, clotrimazole and miconazole are the preferred local antimycotics of choice during pregnancy.

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

Topical terbinafine is contraindicated in breastfeeding.

Manufacturer advises that terbinafine is excreted in human breast milk, therefore nursing mothers should not use topical terbinafine. And infants should not be allowed to come into contact with any treated skin.

Less than 5% of the dose is absorbed after topical application therefore systemic exposure is very slight. However, topical terbinafine has not been studied during breastfeeding.
Schaefer suggests nystatin, clotrimazole and miconazole as local antimycotics of choice during breastfeeding.

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

Allergic reaction
Bullous eruption
Burning sensation (local)
Contact dermatitis
Dry skin
Eczema
Erythema at application site
Eye irritation
Hypersensitivity reactions
Irritation at application site
Itching at application site
Pain
Pain at application site
Pruritus
Rash
Skin depigmentation
Skin disorder
Skin exfoliation
Skin lesions
Stinging
Urticaria

Presentation

Topical preparations containing terbinafine

Drugs List

Therapeutic Indications

Uses

Fungal infection of skin

Cream
Treatment of fungal infections of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

Cutaneous yeast infections, principally those caused by the genus Candida (e.g. C. albicans ).

Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur ).

Not all preparations are licensed for all indications.

Spray
Treatment of tinea pedis and tinea cruris caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

Gel
Treatment of tinea pedis and tinea cruris and tinea corporis caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

Dosage

The likely duration of treatments are as follows;
1 to 2 weeks for tinea corporis and tinea cruris;
1 week for tinea pedis;
2 weeks for cutaneous candidiasis;
2 weeks for pityriasis versicolor.

Relief of clinical symptoms usually occurs within a few days.

Adults

Children

Contraindications

None known

Precautions and Warnings

Children under 16 years
Breastfeeding
Pregnancy

Not all available brands are licensed for all indications
Some formulations contain butylated hydroxy toluene (E321)
Some formulations contain propylene glycol
Avoid broken or inflamed skin
Avoid contact with eyes
Do not apply to broken or denuded skin
Do not inhale the spray
If accidental contact with the eyes occurs, rinse thoroughly with water
May cause irritation when applied to sensitive skin
Risk of recurrence with irregular use/premature discontinuation of therapy
Discontinue treatment if severe irritation or contact allergy occurs
Refer to doctor if symptoms persist after 2 weeks treatment

Pregnancy and Lactation

Pregnancy

Topical terbinafine is contraindicated in pregnancy.

Manufacturer states that, unless the potential benefits outweigh any potential risks, topical terbinafine should not be administered during pregnancy.

Animal studies have not revealed any teratogenic or embryofoetotoxic potential of terbinafine.
No cases of malformations in humans have been reported with terbinafine to date, however, clinical experience of the use of terbinafine in pregnant women is limited.
It is unknown whether terbinafine crosses the placenta. The molecular weight is low enough that transfer to the foetus should be expected.
Schaefer states that the use of terbinafine should be avoided during pregnancy. However, if used during pregnancy this is not an indication either for a termination of pregnancy or for invasive diagnostic procedures. Nystatin, clotrimazole and miconazole are the preferred local antimycotics of choice during pregnancy.

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

Topical terbinafine is contraindicated in breastfeeding.

Manufacturer advises that terbinafine is excreted in human breast milk, therefore nursing mothers should not use topical terbinafine. And infants should not be allowed to come into contact with any treated skin.

Less than 5% of the dose is absorbed after topical application therefore systemic exposure is very slight. However, topical terbinafine has not been studied during breastfeeding.
Schaefer suggests nystatin, clotrimazole and miconazole as local antimycotics of choice during breastfeeding.

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

Advise patients that they should administer this preparation according to the instructions to ensure a positive outcome.

Advise the patients that if there are no signs of improvement after two weeks, the diagnosis should be verified.

Advise patients that treatment should be discontinued if an allergic reaction such as pruritus, rash, bullous eruptions or hives occurs.

Advise patients not to inhale the spray. If accidental inhalation occurs, seek medical advice if symptoms develop or persist.

Side Effects

Allergic reaction
Bullous eruption
Burning sensation (local)
Contact dermatitis
Dry skin
Eczema
Erythema at application site
Eye irritation
Hypersensitivity reactions
Irritation at application site
Itching at application site
Pain
Pain at application site
Pruritus
Rash
Skin depigmentation
Skin disorder
Skin exfoliation
Skin lesions
Stinging
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: April 2013

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Lamisil Cream. Novartis Consumer Health UK Ltd. Revised November 2013.

Summary of Product Characteristics: Lamisil AT 1% Cream. Novartis Consumer Health. Revised November 2013.

Summary of Product Characteristics: Scholl Advance Athlete's Foot Cream. SSL International Plc. Revised March 2010.

Summary of Product Characteristics: Lamisil AT 1% Gel. Novartis Consumer Health UK Ltd. Revised January 2013.

Summary of Product Characteristics: Lamisil AT 1% Spray. Novartis Consumer Health UK Ltd. Revised January 2013.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Terbinafine. Last revised: September 7, 2013
Last accessed: April 11, 2014