In an open pilot study, 12 children with tinea capitis were treated for 6 weeks with oral terbinafine (125 mg/day), and followed up 2 weeks later. The study was conducted to evaluate the efficacy, safety and pharmacokinetics of terbinafine. All patients were completely cured at the end of the treatment period, and there was no evidence of relapse at follow-up. Seven had a negative culture after 3 weeks of treatment. The time to obtain culture conversion from positive to negative did not appear to be related to body weight, but to clinical severity at baseline. Terbinafine is well tolerated and safe over a 56-day period. The kinetic data show a higher clearance of terbinafine in children compared with adults, with shorter alpha- and beta-phase elimination half-lives. However, a longer terminal gamma-phase (at least 6 days) is observed, as in adults, after multiple dose administration, and this is related to elimination from the tissues. The plasma concentrations are comparable between children and adults at a steady state (125 mg/day).
These results show the reliability and reproducibility of this route of dihydroergotamine administration adapted for the treatment of migraine headaches.
The dose-dependency of the pharmacokinetic parameters of terbinafine and its N-demethyl derivative was investigated in a randomized four-way crossover study in healthy volunteers following single oral administrations of 125, 250, 500 and 750 mg of terbinafine. Plasma concentrations of terbinafine and its metabolite were measured by a validated high-performance liquid chromatography (HPLC) method using ultraviolet detection. Concentration data were fitted to a two-compartment model. The relationship between Cmax or the area under the concentration curve (AUC) and the terbinafine dose was analysed by classical linear regression. Terbinafine disposition parameters were dose-independent, with the exception of Tmax and t1/2 alpha, which were prolonged with the 500- and 750-mg doses. The terbinafine Cmax and AUC, however, were linear and dose-proportional over the entire dose range. The N-demethylated metabolite appeared in plasma at the same time as terbinafine and showed similar prolongations in Tmax and t1/2 alpha with the 500- and 750-mg doses. In addition, the Cmax deviated from proportionality at these doses, giving values 22% lower than projected, while the AUC was linear and dose-proportional over the whole range of doses. The slight disproportionality in the dispositions of terbinafine and its N-demethyl metabolite at 500 and 750 mg are not expected to be clinically significant.
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