Pharmacokinetics of terbinafine and five known metabolites in children, after oral administration

Biopharmaceutics and Drug Disposition

Volumn 19, Issue 7, 1998, Pages 417-423

  Humbert, H ^a   Denouel J ^a   Cabiac, M D ^a   Lakhdar, H ^b   Sioufi, A ^a  

^a NOVARTIS PHARMA K K   (Japan)

^b IBN ROCHD UNIVERSITY HOSPITAL   (Morocco)

Author keywords

Children; Kinetics; Metabolism; Oral; Terbinafine

Indexed keywords

CARBOXYTERBINAFINE; DRUG METABOLITE; GLUCURONIDE; N DESMETHYLTERBINAFINE; TERBINAFINE; UNCLASSIFIED DRUG;

ARTICLE; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CONJUGATION; DRUG HYDROXYLATION; HUMAN; ORAL DRUG ADMINISTRATION; STEADY STATE;

ADMINISTRATION, ORAL; ANTIFUNGAL AGENTS; AREA UNDER CURVE; BIOTRANSFORMATION; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; MALE; NAPHTHALENES;

EID: 0031715232     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1099-081X(199810)19:7<417::AID-BDD111>3.0.CO;2-T     Document Type: Article

References (19)

1. G. Petranyi, N.S. Ryder and A. Stuetz, Allylamine derivatives: new class of synthetic antifungal agents inhibiting fungal squalene epoxidase. Science, 224, 1239-1241 (1984).
2. G. Petranyi, J.G. Meingassner and H. Mieth, Antifungal activity of the allylamine derivative terbinafine in vitro. Antimicrob. Agents Chemother., 31, 1365-1368 (1987).
3. H. Mieth, The early development of allylamine antimycotics. J. Dermatol. Treat., 1 (Suppl 2), 5-6 (1990).
4. J.C. Jensen, Clinical pharmacokinetics of terbinafine (Lamisil). Clin. Exp. Dermatol., 14, 110-113 (1989).
5. H. Humbert, M.D. Cabiac, J. Denouël and S. Kirkesseli, Pharmacokinetics of terbinafine and of its five main metabolites in plasma and urine, following a single oral dose in healthy subjects. Biopharm. Drug Dispos., 16, 685-694 (1995).
6. F. Nejjam, M. Zagula, M.D. Cabiac, N. Guessous, H. Humbert and H. Lakhdar, Pilot study of terbinafine in children suffering from tinea capitis: evaluation of efficacy, safety and pharmacokinetics. Br. J. Dermatol., 132, 98-105 (1995).
7. J. Denouël, H.P. Keller, P. Schaub, C. Delaborde and H. Humbert, Determination of terbinafine and its desmethyl metabolite in human plasma by high performance liquid chromatography, J. Chromatogr., 663, 353-359 (1995).
8. H. Zehender, J. Denouël, M. Roy, L. Le Saux and P, Schaub, Simultaneous determination of terbinafine (Lamisil®) and five metabolites in human plasma and urine by high performance liquid chromatography using on-line solid-phase extraction. J. Chromatogr. B, 664, 347-355 (1995).
9. L.B. Sheine, ELSFIT (version 3.1) - a program for the extended least squares fit to individual pharmacokinetic data, users manual. Technical Report of the Division of Clinical Pharmacology, University of California, San Francisco, 1983.
10. H. Zehender, M.D. Cabiac, J. Denouël, J. Faergemann, P. Donatsch, K. Kutz and H. Humbert, Elimination kinetics of terbinafine from human plasma and tissues following multiple-dose administration, and comparison with 3 main metabolites. Drug Invest., 8, 203-210 (1994).
11. J.M. Kovarik, S. Kirkesseli, H. Humbert, P. Grass and K. Kutz, Dose-proportional pharmacokinetics of terbinafine and its N-demethylated metabolite in healthy volunteers. Br. J. Dermatol., 126 (Suppl 39), 8-13 (1992).
12. RS/1 for Vax and Micro-Vax, Release 4 features, Bolt Beranek and Newman Inc. (BBN) Software Products Corporation, Cambridge MA, USA, 1988.
13. T.S. Haroon, I. Hussain, A. Mahmood, A.H. Nagi, I. Ahmad and M. Zahid, An open clinical pilot sutdy of the efficacy and safety of oral terbinafine in dry non-inflammatory tinea capitis. Br. J. Dermatol., 126 (Suppl 39), 47-50 (1992).
14. T.S. Haroon, I. Hussain, S. Aman, A.H. Nagi, I. Ahmad, M. Zahid, K.H. Alvi, N. Iqbal and K.A. Khan, A randomized, double-blind, comparative study of terbinafine vs. griseofulvin in tinea capitis. J. Dermatol. Treat., 3 (Suppl 1), 25-27 (1992).
15. F.A. Battig, M. Nefzger and G. Schulz, Major biotransformation routes of some allylamine antimycotics. In Recent Trends in the Discovery, Development and Evaluation of Antifungal Agents, R.A. Fromtling (Ed.), J.R. Prous Science Publishers, SA, Barcelona, 1987, pp. 479-495.
16. H. Humbert, G. Guest, M.B. Said, M.D. Cabiac, M.F. Gagnadoux, P. Niaudet and M. Broyer, Steady-state pharmacokinetics of cyclosporine in renal transplant patients: does an influence of age or body weight exist? Transpl. Proc., 26, 2791-2797 (1994).
17. D. Lavène, C. Julien-Larose, M. Guerret, M. Hubert and J.R. Kiechel, Kétotifène: données cinétiques récentes. In Sywposium Zaditen, Montpellier, éditions Sandoz, 1985.
18. J.J. Reilly and P. Workman, Normalisation of anti-cancer drug dosage using body weight and surface area: is it worthwhile? A review of theoretical and practical considerations. Cancer Chemother. Pharmacol., 32, 411-418 (1993).
19. L.B. Grochow, C. Baraldi and D. Noe, Is dose normalization to weight or body surface area useful in adults? J. Natl. Cancer Inst., 82, 323-325 (1990).