Drugs List

Therapeutic Indications

Uses

Dermatophyte infection of the skin and nails: treatment
Onychomycosis
Ringworm (tinea cruris, tinea corporis, and tinea pedis): treatment

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

Treatment of ringworm (tinea cruris, tinea corporis and tinea pedis) where oral therapy is considered appropriate due to site, severity or extent of the infection.

Treatment of onychomycosis.

Contraindications

Children under 1 year
Breastfeeding
Hepatic impairment

Precautions and Warnings

Autoimmune disease
Children aged 1 to 18 years
Pregnancy
Psoriasis
Renal impairment - glomerular filtration rate below 50ml/minute

Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Monitor hepatic function before treatment and regularly during treatment
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
May exacerbate psoriasis
Discontinue if blood dyscrasia develops
Discontinue if jaundice or other evidence of hepatic impairment occurs
Discontinue if liver function tests become abnormal
Discontinue treatment if progressive skin rash occurs

Pregnancy and Lactation

Pregnancy

Use terbinafine with caution during pregnancy.

The manufacturer advises that unless the potential benefits outweigh any potential risks, terbinafine should not be administered during pregnancy. Schaefer notes that due to the lack of data on pregnancy outcome, and given that nail mycosis is not a condition requiring urgent treatment, terbinafine should not be used during pregnancy, but inadvertent exposure does not require termination of pregnancy. Consider detailed foetal ultrasonography after first trimester exposure.

At the time of writing, there is little clinical experience with terbinafine in pregnant women, although data collected so far appear to suggest no increased risk for major malformations. Foetal toxicity and fertility studies in animals do not suggest any adverse effects. No evidence of impaired fertility or foetal harm was seen in pregnant rats and rabbits with oral doses up to 12 and 9 times the maximum recommended human dose respectively. The molecular weight is low enough that transfer to the embryo should be expected, but no studies evaluating the placental transfer of terbinafine in humans have been located.

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

Terbinafine is contraindicated in breastfeeding.

The manufacturer advises that mothers should not receive this treatment whilst breastfeeding. Briggs suggests due to the prolonged nature of the therapy, the potential for serious toxicity in a nursing infant may be increased.

Terbinafine is excreted in breast milk with a milk:plasma ratio of 7:1 and the effect of this exposure on a nursing infant is unknown.

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

Abdominal distension
Abdominal pain
Acute generalised exanthematous pustulosis
Agranulocytosis
Allergic skin reactions
Alopecia
Anaemia
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Angioneurotic oedema
Anorexia
Anxiety
Arthralgia
Cholestasis
Creatine phosphokinase increased
Cutaneous lupus erythematosus
Decreased appetite
Depression
Diarrhoea
Dizziness
Dyspepsia
Erythema multiforme
Exacerbation of psoriasis
Fatigue
Gastro-intestinal symptoms
Haematological disorders
Headache
Hearing disturbances
Hepatic failure
Hepatic impairment
Hepatitis
Hypersensitivity reactions
Hypoacusis
Hypoaesthesia
Increases in hepatic enzymes
Influenza-like symptoms
Jaundice
Malaise
Myalgia
Nausea
Neutropenia
Pancreatitis
Pancytopenia
Paraesthesia
Photosensitivity
Psychiatric disorders
Pyrexia
Rash
Rhabdomyolysis
Sensation of fullness
Serum sickness
Smelling disturbances
Stevens-Johnson syndrome
Systemic lupus erythematosus
Taste disturbances
Taste loss
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vasculitis
Vertigo
Weight loss

Presentation

Tablets containing terbinafine as terbinafine hydrochloride.

Drugs List

Therapeutic Indications

Uses

Dermatophyte infection of the skin and nails: treatment
Onychomycosis
Ringworm (tinea cruris, tinea corporis, and tinea pedis): treatment

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

Treatment of ringworm (tinea cruris, tinea corporis and tinea pedis) where oral therapy is considered appropriate due to site, severity or extent of the infection.

Treatment of onychomycosis.

Dosage

Duration of treatment varies according to the indication and the severity of the infection.

Likely duration of treatment for skin infections
Tinea pedis - 2 to 6 weeks
Tinea cruris - 2 to 4 weeks
Tinea corporis - 4 weeks
Tinea capitis - 4 weeks

Likely duration of treatment for Onychomycosis
The duration of treatment for most patients is between 6 weeks and 3 months. For fingernail infections, toenail infections (except the big toe) and younger aged patients, treatment periods of less than 3 months can be anticipated. For toenail infection, 3 months is usually sufficient although longer therapy duration of up to 6 months may be required. Poor nail outgrowth in the first weeks of treatment may indicate those patients requiring longer treatment.

Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.

Adults

Children

Patients with Renal Impairment

Contraindications

Children under 1 year
Breastfeeding
Hepatic impairment

Precautions and Warnings

Autoimmune disease
Children aged 1 to 18 years
Pregnancy
Psoriasis
Renal impairment - glomerular filtration rate below 50ml/minute

Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Monitor hepatic function before treatment and regularly during treatment
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
May exacerbate psoriasis
Discontinue if blood dyscrasia develops
Discontinue if jaundice or other evidence of hepatic impairment occurs
Discontinue if liver function tests become abnormal
Discontinue treatment if progressive skin rash occurs

Pregnancy and Lactation

Pregnancy

Use terbinafine with caution during pregnancy.

The manufacturer advises that unless the potential benefits outweigh any potential risks, terbinafine should not be administered during pregnancy. Schaefer notes that due to the lack of data on pregnancy outcome, and given that nail mycosis is not a condition requiring urgent treatment, terbinafine should not be used during pregnancy, but inadvertent exposure does not require termination of pregnancy. Consider detailed foetal ultrasonography after first trimester exposure.

At the time of writing, there is little clinical experience with terbinafine in pregnant women, although data collected so far appear to suggest no increased risk for major malformations. Foetal toxicity and fertility studies in animals do not suggest any adverse effects. No evidence of impaired fertility or foetal harm was seen in pregnant rats and rabbits with oral doses up to 12 and 9 times the maximum recommended human dose respectively. The molecular weight is low enough that transfer to the embryo should be expected, but no studies evaluating the placental transfer of terbinafine in humans have been located.

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

Terbinafine is contraindicated in breastfeeding.

The manufacturer advises that mothers should not receive this treatment whilst breastfeeding. Briggs suggests due to the prolonged nature of the therapy, the potential for serious toxicity in a nursing infant may be increased.

Terbinafine is excreted in breast milk with a milk:plasma ratio of 7:1 and the effect of this exposure on a nursing infant is unknown.

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, tablets should preferably be taken at the same time each day and can be taken on an empty stomach or after a meal.

Advise patients to report any signs or symptoms of unexplained persistent nausea, decreased appetite, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale faeces.

Side Effects

Abdominal distension
Abdominal pain
Acute generalised exanthematous pustulosis
Agranulocytosis
Allergic skin reactions
Alopecia
Anaemia
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Angioneurotic oedema
Anorexia
Anxiety
Arthralgia
Cholestasis
Creatine phosphokinase increased
Cutaneous lupus erythematosus
Decreased appetite
Depression
Diarrhoea
Dizziness
Dyspepsia
Erythema multiforme
Exacerbation of psoriasis
Fatigue
Gastro-intestinal symptoms
Haematological disorders
Headache
Hearing disturbances
Hepatic failure
Hepatic impairment
Hepatitis
Hypersensitivity reactions
Hypoacusis
Hypoaesthesia
Increases in hepatic enzymes
Influenza-like symptoms
Jaundice
Malaise
Myalgia
Nausea
Neutropenia
Pancreatitis
Pancytopenia
Paraesthesia
Photosensitivity
Psychiatric disorders
Pyrexia
Rash
Rhabdomyolysis
Sensation of fullness
Serum sickness
Smelling disturbances
Stevens-Johnson syndrome
Systemic lupus erythematosus
Taste disturbances
Taste loss
Thrombocytopenia
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vasculitis
Vertigo
Weight loss

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: November 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.

Summary of Product Characteristics: Lamisil 250 mg tablets. Novartis Pharmaceuticals UK Ltd. Revised January 2017.
Summary of Product Characteristics: Terbinafine 250 mg tablets. Kent Pharmaceuticals UK Ltd. Revised March 2016.
Summary of Product Characteristics: Terbinafine 250 mg tablets. Dr Reddy's laboratory UK Ltd. Revised March 2017.
Summary of Product Characteristics: Terbinafine 250 mg tablets. Aurobindo pharma. Revised November 2017
Summary of Product Characteristics: Terbinafine 250 mg tablets. Accord UK Ltd. August 2016.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

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