Terbinafine

Chemical formula: C₂₁H₂₅N  Molecular mass: 291.43 g/mol  PubChem compound: 1549008

Interactions

Terbinafine interacts in the following cases:

CYP2D6 substrates

In vitro and in vivo studies have shown that terbinafine inhibits the CYP2D6-mediated metabolism. This finding may be of clinical relevance for compounds predominantly metabolised by CYP2D6, e.g. certain members of the following drug classes, tricyclic antidepressants (TCAs), beta-blockers, selective serotonine reuptake inhibitors (SSRIs), antiarrhythmics (including class 1A, 1B and 1C) and monoamine oxidase inhibitors (MAO-Is) Type B, especially if they also have a narrow therapeutic window.

Oral contraceptives

Some cases of irregular menstruation have been reported in patients taking terbinafine concomitantly with oral contraceptives, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone.

Caffeine

Terbinafine decreased the clearance of caffeine administered intravenously by 19%.

Ciclosporin

Terbinafine increased the clearance of ciclosporin by 15%.

Cimetidine

Cimetidine decreased the clearance of terbinafine by 33%.

Desipramine

Terbinafine decreased the clearance of desipramine by 82%.

Fluconazole

Fluconazole increased the Cmax and AUC of terbinafine by 52% and 69% respectively, due to inhibition of both CYP2C9 and CYP3A4 enzymes.

Ketoconazole, amiodarone

An increase in exposure may occur when other drugs which inhibit both CYP2C9 and CYP3A4 such as ketoconazole and amiodarone are concomitantly administered with Terbinafine tablets.

Rifampicin

Rifampicin increased the clearance of terbinafine by 100%.

Hepatic disease

Terbinafine are not recommended for patients with chronic or active hepatic disease. Before prescribing terbinafine, liver function test should be performed. Hepatotoxicity may occur in patients with and without pre-existing hepatic disease therefore periodic monitoring (after 4-6 weeks of treatment) of liver function test is recommended. Terbinafine should be immediately discontinued in case of elevation of liver function test. Very rare cases of serious hepatic failure (some with a fatal outcome, or requiring hepatic transplant) have been reported in patients treated with terbinafine. In the majority of hepatic failure cases the patients had serious underlying systemic conditions and a causal association with the intake of terbinafine was uncertain.

Patients prescribed terbinafine should be warned to report immediately any signs and symptoms of unexplained persistent nausea, decreased appetite, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale faeces. Patients with these symptoms should discontinue taking oral terbinafine and the patient’s hepatic function should be immediately evaluated.

Stevens-Johnson syndrome, toxic epidermal necrolysis

Serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis) have been very rarely reported in patients taking terbinafine. If progressive skin rash occurs, terbinafine treatment should be discontinued.

Neutropenia, agranulocytosis, thrombocytopenia, pancytopenia

Very rare cases of blood disorders (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported in patients treated with terbinafine. Aetiology of any blood disorders that occur in patients treated with terbinafine should be evaluated and consideration should be given for a possible change in medication regimen, including discontinuation of treatment with terbinafine.

Psoriasis, lupus erythematosus

Terbinafine should be used with caution in patients with pre-existing psoriasis or lupus erythematosus as very rare cases of lupus erythematosus have been reported.

Pregnancy

Foetal toxicity and fertility studies in animals suggest no adverse effects. Since clinical experience in pregnant women is very limited, terbinafine tablets 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.

Terbinafine cream should not be used during pregnancy unless clearly necessary.

Nursing mothers

Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.

After topical use, only a low systemic exposure is expected. Terbinafine cream should not be used during breast-feeding. In addition, infants must not be allowed to come into contact with any treated skin, including the breast.

Carcinogenesis, mutagenesis and fertility

Fertility

No effects of terbinafine on fertility have been seen in animal studies.

Effects on ability to drive and use machines

No studies on the effects of terbinafine tablets treatment on the ability to drive and use machines have been performed. Patients who experience dizziness as an undesirable effect should avoid driving vehicles or using machines.

Terbinafine cream has no influence on the ability to drive and use machines.

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