Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Adults

250mg once daily.

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

Skin infections

Likely durations of treatment are as follows:

Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks

Tinea corporis: 4 weeks

Tinea cruris: 2 to 4 weeks

Onychomycosis

The duration of treatment for most patients is between 6 weeks and 3 months. Treatment periods of less than 3 months can be anticipated in patients with fingernail infection, toenail infection other than of the big toe, or patients of younger age. In the treatment of toenail infections, 3 months is usually sufficient although a few patients may require treatment of 6 months or longer. Poor nail outgrowth during the first weeks of treatment may enable identification of those patients in whom longer therapy is required.

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

Additional information on special population

Liver impairment

Lamisil tablets are not recommended for patients with chronic or active liver disease.

Renal impairment

The use of Lamisil tablets has not been adequately studied in patients with renal impairment and is therefore not recommended in this population

Children

A review of safety experience with oral LAMISIL in children, which includes 314 patients involved in the UK LAMISIL Post Marketing Surveillance study, has shown that the adverse event profile in children is similar to that seen in adults. No evidence of any new, unusual or more severe reactions to those seen in the adult population have been noted. However, as data is still limited its use is not recommended.

Elderly

There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients. The possibility of impairment of liver or kidney function should be considered in this age group (see Precautions).

Method of administration

Via the oral route.

.

Child Dosage

Contra Indications

Hypersensitivity to Lamisil

Special Precautions

Liver Function

Lamisil tablets are not recommended for patients with chronic or active liver disease. Before prescribing Lamisil tablets, any pre-existing liver disease should be assessed.

Hepatotoxicity may occur in patients with and without pre-existing liver disease.

Very rare cases of serious liver failure (some with a fatal outcome, or requiring liver transplant) have been reported in patients treated with Lamisil tablets. In the majority of liver failure cases the patients had serious underlying systemic conditions and a causal association with the intake of Lamisil tablets was uncertain.

Patients prescribed Lamisil tablets should be instructed to report immediately any signs or symptoms suggestive of liver dysfunction such as pruritus, unexplained persistent nausea, anorexia or tiredness, or jaundice, vomiting, fatigue, abdominal pain or dark urine, or pale stools. Patients with these symptoms should discontinue taking oral terbinafine and the patient's liver function should be immediately evaluated.

Dermatological effects

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

Haematological effects

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

Single dose pharmacokinetic studies in patients with pre-existing liver disease have shown that the clearance of Lamisil may be reduced by about 50%.

Lamisil should be used with caution in patients with psoriasis, as very rare cases of exacerbation of psoriasis have been reported.

Renal function

In patients with renal impairment (creatinine clearance less than 50 mL/min or serum creatinine of more than 300 micro mol/L) the use of Lamisil tablets has not been adequately studied, and therefore, is not recommended.

Interactions

Effect of other medicinal products on terbinafine

The plasma clearance of terbinafine may be accelerated by drugs which induce metabolism and may be inhibited by drugs which inhibit cytochrome P450. Where co-administration of such agents is necessary, the dosage of Lamisil may need to be adjusted accordingly.

The following medicinal products may increase the effect or plasma concentration of terbinafine:

Cimetidine decreased the clearance of terbinafine by 30%.

The following medicinal products may decrease the effect or plasma concentration of terbinafine:

Rifampicin increased the clearance of terbinafine by 100%.

Effect of terbinafine on other medicinal products

Studies undertaken in vitro and in healthy volunteers suggest that terbinafine shows negligible potential to inhibit or induce the clearance of drugs that are metabolised via other cytochrome P450 enzymes (e.g. tolbutamine, terfenadine, triazolam, oral contraceptives) with exception of those metabolised through CYP2D6 (see below).

Terbinafine does not interfere with the clearance of antipyrine or digoxin.

Some cases of menstrual disturbance (breakthrough bleeding and irregular cycle) have been reported in patients taking Lamisil concomitantly with oral contraceptives.

Terbinaine may increase the effect or plasma concentration of the following medicinal products:

Caffeine – Terbinafine decreased the clearance of caffeine administered intravenously by 21%.

Compounds predominantly metabolised by CYP2D6 – In vitro and in vivo studies have shown that terbinafine inhibits the CYP2D6-mediated metabolism. This finding may be of clinical relevance for patients receiving compounds predominantly metabolised by CYP2D6, e.g. certain members of the following drug classes, tricyclic antidepressants (TCA's), β-blockers, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics (including class 1A, 1B and 1C) and monoamine oxidase inhibitors (MAO-Is) Type B.

Terbinafine decreased the clearance of desipramine by 82%.

Terbinafine may decrease the effect or plasma concentration of the following medicinal products:

Terbinafine increased the clearance of ciclosporin by 15%.

Rare cases of changes in INR and/or prothrombin time have been reported in patients receiving terbinafine concomitantly with warfarin.

Adverse Reactions

Side effects are generally mild to moderate, and transient. The following adverse reactions have been observed in the clinical trials or during post-marketing experience.

Adverse reactions are ranked under headings of frequency, using the following convention:

Very common ( 1/10); Common ( 1/100, < 1/10); Uncommon ( 1/1,000, <1/100); Rare ( 1/10,000, < 1/1,000); Very rare (< 1/10,000), including isolated reports.

Manufacturer

Drug Availability

Updated