Terbinafine

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Fungal infections of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum
• Ringworm (Tinea corporis, Tinea cruris and Tinea pedis) where oral therapy is considered appropriate due to the site, severity or extent of the infection
• Onychomycosis

If a patient presents with signs or symptoms suggestive of liver dysfunction such as pruritus, unexplained persistent nausea, anorexia, tiredness, jaundice, vomiting, fatigue, abdominal pain, dark urine, or pale stools, hepatic origin should be verified and terbinafine should be discontinued. Single dose pharmacokinetic studies in patients with pre-existing liver disease have shown that the clearance of terbinafine may be reduced by about 50%. The therapeutic use of terbinafine in patients with chronic or active liver disease has not been studied in prospective clinical trials, and therefore cannot be recommended.

 

Contraindications

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Impaired liver function
• Pregnancy
• Lactation

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Chronic or active hepatic disease

Cautions

• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding (Recommendations in other jurisdictions)
• Renal impairment
• Elderly
• Psoriasis
• Lupus erythematous

Forms avail. in SA and covered in this monograph: tab 

Infections caused by dermatophytes, moulds and certain dimorphic fungi: Trichopyton (T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum), Microsporum canis, Epidermophyton floccosum; Tinea corporis, Tinea cruris and Tinea pedis

Specific doses based on individual indications 

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities 

South African registered indications and dosages

Tinea pedis
- Interdigital
- Plantar/mocassin type

• Oral (tab): 250mg, dly; Treatment duration: 2-6 weeks

Tinea corporis

• Oral (tab): 250mg, dly; Treatment duration: 4 weeks

Tinea cruris

• Oral (tab): 250mg, dly; Treatment duration: 2-4 weeks

Onychomycosis

• Oral (tab): 250mg, dly; Treatment duration: 6-12 weeks

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The duration of treatment varies according to the indication and the severity of the infection

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For the indication of Onychomycosis: Most patients require between 6 weeks to 3 months. Treatment durations under 3 months can be expected in cases with fingernail infection, toenail infection excluding the big toe, or younger age patients. For toenail infections, usually, 3 months suffice, although some might need 6 months or longer. Poor nail growth in the initial weeks might help determine patients needing extended therapy. Complete alleviation of infection symptoms might take weeks post achieving a mycological cure

Not recommended for use

Pregnancy

South African recommendations

• Contraindicated

Recommendations in other jurisdictions

• Caution
• Foetal toxicity and fertility studies in animals suggest no adverse effects. Since clinical experience in pregnant women is very limited, terbinafine should not be used during pregnancy unless clinical condition of the woman requires treatment with oral terbinafine and the potential benefits for the mother outweigh any potential risks for the foetus

Breastfeeding 

South African recommendations

• Contraindicated
• Terbinafine is excreted in breast milk and therefore mothers who receive treatment with terbinafine should not breastfeed their infants

Recommendations in other jurisdictions

• Caution; not recommended
• Terbinafine is excreted in breast milk. Mothers should not receive treatment with terbinafine while breastfeeding

Fertility

South African recommendations

• No information available

Recommendations in other jurisdictions

• Foetal toxicity and fertility studies in animals suggest no adverse effects

Renal Impairment

South African recommendations

• CrCl≥50ml/min: Caution; no dose adjustment recommended
• CrCl<50ml/min: Caution; dose adjustment recommended
  Patients with impaired renal function (creatinine clearance less than 50 ml/minute or serum creatinine of more than 300 mmol/l) should receive half the normal dose

Recommendations in other jurisdictions

• Caution; not recommended
  In patients with renal impairment (creatinine clearance less than 50ml/min or serum creatinine of more than 300 micro mol/l) the use of terbinafine tablets has not been adequately studied, and therefore, is not recommended

Hepatic Impairment 

South African recommendations

• Contraindicated
  The therapeutic use of terbinafine in patients with chronic or active liver disease has not been studied in prospective clinical trials, and therefore cannot be recommended

Recommendations in other jurisdictions

• Contraindicated
  Terbinafine is contraindicated in patients with chronic or active hepatic disease

Elderly 

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Paraesthesia
• Hypoaesthesia
• Dizziness
• Anxiety symptoms
• Depressive symptoms
• Fatigue
• Malaise

Cardiovascular Disorders

• Vasculitis

Gastrointestinal Disorders

• Nausea
• Abdominal pain
• Dyspepsia
• Diarrhoea  
• Abdominal distension   
• Feeling of fullness

Hepatobiliary Disorders

• Pancreatitis
• Hepatic failure
• Jaundice
• Cholestasis
• Hepatitis
• Increased hepatic enzymes

Endocrine and Metabolic Disorders

• Decreased appetite
• Decreased weight

Musculoskeletal Disorders

• Arthralgia
• Myalgia  
• Rhabdomyolysis

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Erythema multiforme
• Toxic skin eruption
• Exfoliative dermatitis
• Bullous dermatitis
• Photosensitivity reactions
• Alopecia
• Psoriasiform eruptions
• Exacerbation of psoriasis
• Acute generalized exanthematous pustulosis

Immune, Blood and Lymphatic system disorders

• Neutropenia
• Agranulocytosis
• Thrombocytopenia
• Anaemia  
• Pancytopenia
• Anaphylactoid reactions
• Angioedema
• Cutaneous and systemic lupus erythematosus
• Anaphylactic reaction
• Serum sickness-like reaction
• Drug rash with eosinophilia
• Fever

Sensory Disorders

• Visual impairment
• Reduced visual acuity
• Blurred vision
• Vertigo
• Hypoacusis
• Impaired hearing
• Tinnitus
• Dysgeusia
• Hypogeusia
• Ageusia
• Anosmia
• Hyposmia

Other

• Influenza-like illness
• Increased serum creatine phosphokinase  

• CYP450 inhibitors
• Cimetidine
• Fluconazole
• Ketoconazole
• Amiodarone
• Caffeine
• Despiramine
• Rifampicin
• CYP2D6 substrates  
• Dextromethorphan
• Tricyclic antidepressants (TCAs)
• Beta-blockers
• Selective serotonin reuptake inhibitors (SSRIs)
• Antiarrythmics (includine Class IA, IB and IC)
• Monoamine oxidase inhibitors (MAOIs)
• Cyclosporin
• Warfarin

• Hepatic function

Specific cases may require

• Full blood count

Terbinafine is an allylamine with broad spectrum antifungal activity. It inhibits squalene epoxidase in the fungal cell membrane, leading to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death.

Spectrum of activity: Dermatophytes, moulds and certain dimorphic fungi: Trichopyton (T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum), Microsporum canis, Epidermophyton floccosum; Tinea corporis, Tinea cruris and Tinea pedis

Tablet 125mg

• Lamisil (Novartis) originator

Tablet 250mg

• Adco Terbinafine (Adcock)
• Arrow Terbinafine (Arrow)
• Binacil (Aurobindo)
• Lamisil (Novartis) originator
• Lamispor (Cipla Medpro)
• Mylan Terbinafine (Xixia)
• Nafin (Ranbaxy)
• Terbane (Sandoz) 
• Terbicil (Pharmacare)
• Terbi-Clear (Actavis)
• Terbinafine Unicorn (Sandoz)

Also available in the following forms: Cream, gel, spray and solution.