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Canada, USA. Novartis Pharmaceuticals 1, 2 ; has issued a `Dear Healthcare Professional' letter informing them of the revisions in the warnings, precautions and adverse reactions sections of the product monograph for terbinafine Lamis8l ; . The revisions are aimed at providing more detailed information regarding the use of terbinafine tablets in patients with liver disease and are in response to reports of rare cases of hepatic failure, some leading to death or liver transplant subsequent to therapy. Contraindications now include pre-existing liver disease in patients and chronic or active liver disease. The druginteractions section draws attention to the fact that terbinafine is a potent inhibitor of the CYP 2D6 enzyme 2 ; . Physicians are therefore required to exercise great caution while prescribing terbinafine in patients receiving concomitant therapy with drugs metabolised by this enzyme system, especially those with a narrow therapeutic window. Death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system. When given orally, the drug concentrates rapidly in skin, hair and nails at levels associated with fungicidal activity. Pharmacokinetics Oral LAMISIL * Absorption: Following oral administration, terbinafine is well absorbed 70% ; and the absolute bioavailability of terbinafine from LAMISIL * tablets as a result of first-pass metabolism is approximately 50 %. A single 250 mg dose of LAMISIL * tablets resulted in mean a peak plasma concentration of 1.3 g ml within 1.5 hours after administration. At steady-state, in comparison to a single dose, peak concentration of terbinafine was on average 25% higher and plasma AUC increased by a factor of 2.3. From the increase in plasma AUC an effective half-life of ~30 hours can be calculated. The bioavailability of terbinafine is moderately affected by food increase in the AUC of less than 20% ; , but not sufficiently to require dosing adjustments. Distribution: LAMISIL * binds strongly to plasma proteins 99% ; and is lipophilic. LAMISIL * is widely distributed in the body including adipose tissue. It rapidly diffuses through the dermis and concentrates in lipophilic stratum corneum. It is also secreted in sebum, thus achieving high concentrations in hair follicles, hair and sebum-rich skin. There is evidence that LAMISIL * is distributed in the nail plate within the first few weeks of commencing therapy. Metabolism and Excretion: Oral LAMISIL * is excreted mainly in urine 80% ; and in feces 20% ; . Following absorption terbinafine is metabolised rapidly and extensively by the liver. At least seven cytochrome isoenzymes are involved in its metabolism with major contributions from CYP 2C9, CYP 1A2, CYP 3A4, CYP 2C8 and CYP 2C19. Biotransformation results in metabolites with no antifungal activity which are excreted predominantly through the urine. No clinically relevant agedependent changes in steady-state plasma concentrations of terbinafine have been observed. Following a single 250 mg dose in 12 hepatically impaired cirrhotic alcoholic ; patients, total clearance of terbinafine was reduced by about 40%. In a sample of 12 renally impaired patients median creatinine clearance of 17.6 mL min ; , LAMISIL * clearance following a single 250 mg dose was halved resulting in the doubling or more of peak plasma concentrations or AUC. Patients at the highest and lowest ends of the renal impairment spectrum were not represented. There was no direct correlation between creatinine clearance and terbinafine clearance in renally impaired patients, the.
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