The efficacy and safety of terbinafine in children

Journal of the European Academy of Dermatology and Venereology

Volumn 17, Issue 6, 2003, Pages 627-640

  Gupta, A K ^a,b,c   Adamiak, A ^b   Cooper, E A ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b Mediprobe Laboratories Inc   (Canada)

^c NONE   (Canada)

Author keywords

Children; Mycoses; Omychomycosis; Terbinafine; Tinea capitis

Indexed keywords

AMPHOTERICIN B; ANTIFUNGAL AGENT; ANTIHISTAMINIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CAFFEINE; CIMETIDINE; CYCLOSPORIN; DIGOXIN; FLUCONAZOLE; FLUCYTOSINE; GRISEOFULVIN; ITRACONAZOLE; KETOCONAZOLE; MONOAMINE OXIDASE INHIBITOR; NAPHTHALENE DERIVATIVE; PHENAZONE; RIFAMPICIN; SEROTONIN UPTAKE INHIBITOR; TERBINAFINE; TRICYCLIC ANTIDEPRESSANT AGENT;

ABDOMINAL PAIN; ADOLESCENT; AGE; ANOREXIA; BIOAVAILABILITY; CHILD; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DERMATOMYCOSIS; DIARRHEA; DOSE RESPONSE; DRUG ABSORPTION; DRUG ADMINISTRATION; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG MECHANISM; DRUG POTENTIATION; DRUG SAFETY; DRUG USE; EOSINOPHILIA; FEMALE; FEVER; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GRANULOCYTOPENIA; HEADACHE; HUMAN; HYPERESTHESIA; HYPERTRIGLYCERIDEMIA; LEUKOPENIA; LIVER TOXICITY; MALE; MYCOSIS; NAUSEA; ONYCHOMYCOSIS; ORAL DRUG ADMINISTRATION; PATIENT COMPLIANCE; PRESCHOOL CHILD; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; REVIEW; RISK FACTOR; SIDE EFFECT; SKIN MANIFESTATION; SOMNOLENCE; STOMACH DISEASE; TASTE DISORDER; TINEA CAPITIS; TREATMENT OUTCOME; TRICHOPHYTON; URTICARIA; VERTIGO; VOMITING; WEIGHT REDUCTION;

ADMINISTRATION, ORAL; ADOLESCENT; AGE FACTORS; ANTIFUNGAL AGENTS; BIOLOGICAL AVAILABILITY; CHILD; CHILD, PRESCHOOL; DERMATOMYCOSES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; NAPHTHALENES; RANDOMIZED CONTROLLED TRIALS; RISK FACTORS; TREATMENT OUTCOME;

EID: 0242624571     PISSN: 09269959     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1468-3083.2003.00691.x     Document Type: Review

References (79)

1. Ryder NS. Terbinafine: mode of action and properties of the squalene epoxidase inhibition. Br J Dermatol 1992; 39:2-7.
2. Clayton YM. In vitro activity of terbinafine. Clin Exp Dermatol 1989;14:101-103.
3. Ryder NS, Favre B. Antifungal activity and mechanism of action of terbinafine. Contemp Pharmacother 1997; 8: 275-287.
4. Birnbaum JE. Pharmacology of the allylamines. J Am Acad Dermatol, 1990; 23 (4 Pt 2): 782-785.
5. Haroon TS, Hussain I, Aman S et al. A randomized double-blind comparative study of terbinafine for 1, 2 and 4 weeks in tinea capitis. Br J Dermatol 1996; 135: 86-88.
6. Jensen JC. Clinical pharmacokinetics of terbinafine (Lamisil). Clin Exp Dermatol 1989; 14: 110-113.
7. Terbinafine (Lamisil) Package Insert. New Jersey: Novartis Pharmaceuticals Corporation, May 2001.
8. Leyden J. Pharmacokinetics and pharmacology of terbinafine and itraconazole. J Am Acad Dermatol 1998; 38: S42-S27.
9. Faergemann J. Pharmacokinetics of terbinafine. Rev Contemp Pharmacother 1997; 8: 289-297.
10. Faergemann J, Zehender H, Jones T, Maibach I. Terbinafine levels in serum, stratum corneum, dermis-epidermis (without stratum corneum), hair, sebum and eccrine sweat. Acta Derm Venereol (Stockh) 1990; 71: 322-326.
11. Lamisil® Package Insert. In: Compendium of Pharmaceuticals and Specialties, 36th edn. Ottawa: Canadian Pharmacists Association, 2001; 803-805.
12. Terbinafine (Systemic). In: USP DI Vol. I - Drug Information for the Health Care Professional, 21st edn. MICROMEDEX Thomson Healthcare 2001, 2001; 2786-2788.
13. Abdel-Rahman SM, Marcucci K, Boge T, Gotschall RR, Kearns GL, Leeder JS. Potent inhibition of cytochrome P-450 2D6-mediated dextromethorphan O-demethylation by terbinafine. Drug Metabolism Disposition 1999; 27: 770-775.
14. Vickers AEM, Sinclair JR, Zollinger M et al. Multiple cytochrome P-450s involved in the metabolism of terbinafine suggest a limited potential for drug-drug interactions. Drug Metabolism Disposition 1999; 27: 1029-1038.
15. Long CC, Hill SA, Thomas RC et al. Effect of terbinafine on the pharmacokinetics of cyclosporin in humans. J Invest Dermatol 1994; 102: 740-743.
16. Lobato MN, Vugia DJ, Frieden IJ. Tinea capitis in California children: a population-based study of a growing epidemic. Pediatrics 1997; 99: 551-554.
17. Gupta AK, Summerbell RC. Increased incidence of Trichophyton tonsurans tinea capitis in Ontario, Canada, between 1985 and 1996. Med Mycol 1998; 36: 55-60.
18. Wilmington M, Aly R, Frieden IJ. Trichophyton tonsurans tinea capitis in the San Francisco Bay area: increased infection demonstrated in a 20-year survey of fungal infections from 1974 -1994. J Med Vet Mycol 1996; 34: 285-287.
19. Hamm H, Schwinn A, Bräutigam M, Weidinger G and the Study Group. Short duration treatment with terbinafine for tinea capitis caused by Trichophyton or Microsporum species. Br J Dermatol 1999; 140: 480-482.
20. Friedlander SF, Aly R, Krafchik B et al. A randomized, double-blind, parallel group duration-finding study of oral terbinafine in children with tinea capitis due to Trichophyton species. Pediatr 2002; 109: 602-607.
21. Schwinn A, Hamm H, Braeutigam M, Weidinger G. What is the best approach to treat tinea capitis with terbinafine? Australas J Dermatol 1997; 38 (Suppl. 2): 70.
22. Elewski BE. Treatment of tinea capitis: should terbinafine replace griseofulvin? J Dermatol Treat 1998; 9 (Suppl. 1): S9-S11.
23. Krafchik B, Pelletier J. An open study of tinea capitis in 50 children treated with a 2-week course of oral terbinafine. J Am Acad Dermatol 1999; 41: 60-63.
24. de Freitas C, Marote J, Faria A et al. Tinea capitis in children of Caniçal, Madeira Island, Portugal: isolation of an endemic focus of Trichophyton violaceum. Treatment with terbinafine. J Dermatol Treat 1998; 9: 247-249.
25. Haroon TS, Hussain I, Mahmood A, Nagi AH, Ahmad I, Zahid M. An open clinical pilot study of the efficacy and safety of oral terbinafine in dry non-inflammatory tinea capitis. Br J Dermatol 1992; 126 (Suppl. 39): 47-50.
26. Bruckbauer HR, Hofmann H. Systemic antifungal treatment of children with terbinafine. Dermatol 1997; 195: 134-136.
27. Nejjam F, Zagula M, Cabiac MD, Guessous N, Humbert H, Lakhdar H. Pilot study of terbinafine in children suffering from tinea capitis: evaluation of efficacy, safety and pharmacokinetics. Br J Dermatol 1995; 132: 98-105.
28. Pierini AM, Soliani A, Hernandez M, Garcia-Diaz R, Gonzalez MT, Santos P. Treatment of tinea capitis due to Microsporum canis with oral terbinafine: 40 cases. Ann Dermatol Venereol 1998; 125: 1S133.
29. Crespi HG. Efficacy and tolerance of oral terbinafine for the treatment of tinea capitis in children. Australas J Dermatol 1997; 38 (Suppl. 2): 271-272.
30. Del Palacio A, Cuetara S, Valle A. Terbinafine (Lamisil) therapy for Microsporum canis scalp ringworm. Clin Exp Dermatol 1998; 23: 142-143.
31. Dragoš V, Lunder M. Lack of efficacy of 6-week treatment with oral terbinafine for tinea capitis due to Microsporum canis in children. Ped Dermatol, 1997; 14: 46-48.
32. Peharda V, Kastelan M, Cabrijan L, Saftic M, Gruber F. Terbinafine in the treatment of tinea capitis. Acta Dermatovenereol Alpina 1998; 7: 164-166.
33. Talarico Filho S, Arruda LHF et al. Efficacy and tolerability of Lamisil (terbinafine) in the treatment of children with tinea capitis. J Eur Acad Dermatol Venereol 1995; 5: S172.
34. Kullavanijaya P, Reangchainam S, Ungpakorn R. Randomized single-blind study of efficacy and tolerability of terbinafine in the treatment of tinea capitis. J Am Acad Dermatol 1997; 37: 272-273.
35. Talarico Filho S, Cucé LC, Foss NT, Marques SA, Santamaria JR. Efficacy, safety and tolerability of terbinafine for tinea capitis in children. Brazilian multicentric study with daily oral tablets for 1, 2 and 4 weeks. J Eur Acad Dermatol Venereol 1998; 11: 141-146.
36. Gargoom AM, Duweb GA. Terbinafine 'Lamisil' in the treatment of tinea capitis. Australas J Dermatol 1997; 38 (Suppl. 2): 284.
37. Herranz P, de Lucas R, Vidaurrazaga C et al. Tinea capitis in children: treatment with terbinafine. Ann Dermatol Venereol 1998; 125: 1S134-1S135.
38. Alvi KH, Iqbal N, Khan KA et al. A randomized, double-blind trial of the efficacy and tolerability of terbinafine once daily in the treatment of tinea capitis. In: Shuster S, Jafary MH, eds. Terbinafine in the Treatment of Superficial Fungal Infections. London: Royal Society of Medicine Services, 1993: 35-40.
39. Haroon TS, Hussain I, Aman S et al. A randomized, double-blind comparative study of terbinafine (Lamisil) versus griseofulvin in tinea capitis. In: Hay RJ, ed. International Perspective on Lamisil. London: CCT Healthcare Communications, 1994: 67-72.
40. Caceres-Ríos H, Rueda M, Ballona R, Bustamante B. Comparison of terbinafine and griseofulvin in the treatment of tinea capitis. J Am Acad Dermatol 2000; 42: 80-84.
41. Memisoglu HR, Erboz S, Akkaya S et al. Comparative study of the efficacy and tolerability of 4 weeks of terbinafine therapy with 8 weeks of griseofulvin therapy in children with tinea capitis. J Dermatol Treat 1999; 10: 189-193.
42. Jones TC, Gansland J, Williams TG. A clinical review of the efficacy and tolerability of terbinafine (Lamisil) in children with tinea capitis. J Eur Acad Dermatol Venereol 1998; 11: S231.
43. Gupta AK, Adam P, Dlova N et al. Therapeutic options for the treatment of tinea capitis: griseofulvin versus the new oral antifungal agents, terbinafine, itraconazole or fluconazole. Pediatr Dermatol 2001; 18: 433-438.
44. Fuller LC, Smith CH, Cerio R et al. A randomized comparison of 4 weeks of terbinafine versus 8 weeks of griseofulvin for the treatment of tinea capitis. Br J Dermatol, 2001; 144: 321-327.
45. Lipozencic J, Skerlev M, Orofino R et al. A randomized, double-blind, parallel-group duration finding study of oral terbinafine in children with tinea capitis due to Microsporum species. J Eur Acad Derm Venereol 2001; 15 (Suppl. 2): 217.
46. Lipozencic J, Skerlev M, Orofino-Costa R et al. A randomized, double-blind, parallel-group, duration-finding study of oral terbinafine and open-label, high-dose giseofulvin in children with tinea capitis due to Microsporum species. Br J Dermatol 2002; 146: 816-823.
47. Jahangir M, Hussain IUI, Hasan M, Haroon TS. A double-blind, randomized, comparative trial of itraconazole versus terbinafine for 2 weeks in tinea capitis. Br J Dermatol 1998; 139: 672-674.
48. Gupta AK, Adam P. Terbinafine pulse therapy is effective in tinea capitis. Pediatr Dermatol 1998; 15: 66-68.
49. Friedlander SF, Skerlev M, Lipozencic J et al. Terbinafine in tinea capitis: overview of efficacy and safety from randomized double-blind duration-finding trials. J Eur Acad Derm Venereol 2001; 15 (Suppl. 2): 221.
50. Momeni AZ, Shadzi S, Chaedgani M, Aminjavaheri M. Efficacy of oral terbinafine treatment in tinea capitis. Australas J Dermatol 1997; 38 (Suppl. 2): 98.
51. Gruseck E, Splanemann V, Bleck O, Ring J, Abeck D. Oral terbinafine in tinea capitis in children. Mycoses 1996; 39: 237-240.
52. Baudraz-Rosselet F, Monod M, Jaccoud S, Frenk E. Efficacy of terbinafine treatment of tinea capitis in children varies according to the dermatophyte species. Br J Dermatol 1996; 135: 1003-1017.
53. del Carmen Padilla Desgarennes, Godoy MR, Palencia AB. Therapeutic efficacy of terbinafine in the treatment of three children with tinea tonsurans. J Am Acad Dermatol 1996; 35: 114-116.
54. Ravenscroft J, Goodfield MJD, Evans EGV. Trichophyton tonsurans tinea capitis and tinea corporis treatment and follow-up of four affected family members. Ped Dermatol 2000; 17: 407-409.
55. Wilmer A, Wollina U. Oral terbinafine in the treatment of griseofulvin-resistant tinea capitis et faciei et corporis in a 10-month-old girl. Acta Derm Venereol (Stockh) 1998; 78: 314.
56. Romero G, Garrido JA, Cortina P, Garcia-Bracamonte B, Romero MD. Efficacy of oral terbinafine in children with tinea capitis caused by Microsporum canis. J Eur Acad Dermatol Venereol 1998; 11: S236.
57. Koumantaki E, Kakourou T, Rallis E, Riga P, Georgalla S. Doubled dose of oral terbinafine is required for Microsporum canis tinea capitis. Pediatr Dermatol 2001; 18: 339-342.
58. Gupta AK, Sibbald RG, Lynde CW etal. Onychomycosis in children: prevalence and treatment strategies. J Am Acad Dermatol 1997; 36: 395-402.
59. Suarez S, Friedlander SF. Antifungal therapy in children: an update. Pediatr Ann 1998; 27: 177-184.
60. Ungpakorn R, Reangchainam S, Kullavanijaya P. Onychomycosis in a 2-year-old child successfully treated with oral terbinafine. J Am Acad Dermatol 1998; 39: 654-655.
61. Goulden V, Goodfield MJD. Treatment of childhood dermatophyte infections with oral terbinafine. Ped Dermatol, 1995; 12: 53-54.
62. Gupta AK, Del Rosso JQ. Management of onychomycosis in children. Postgraduate Medicine 1999; (Suppl.): 31-37.
63. Cox NH, Irving B. Cutaneous 'ringworm' lesions of Scopulariopsis brevicaulis. Br J Dermatol 1993; 129: 726-728.
64. Bruynzeel I, Starink TM. Granulomatous skin infection caused by Scopulariopsis brevicaulis. J Am Acad Dermatol 1998; 39: 365-367.
65. Villars VV, Jones TC. Special features of the clinical use of oral terbinafine in the treatment of fungal diseases. Br J Dermatol 1992; 126 (Suppl. 39): 61-69.
66. Shenep JL, English BK, Kaufman L et al. Successful medical therapy for deeply invasive facial infection due to Pythium insidiosum in a child. Clin Inf Dis 1998; 27: 1388-1393.
67. Bahamdan KA, Tallab TM, Johargi H et al. Terbinafine in the treatment of cutaneous leishmaniasis: a pilot study. Int J Dermatol 1997; 36: 59-60.
68. Hall M, Monka C, Krupp P, O'Sullivan D. Safety of oral terbinafine. Results of a postmarketing surveillance study in 25 884 patients. Arch Dermatol 1997; 133: 1213-1219.
69. Diflucan™ Package Insert. In: Compendium of Pharmaceuticals and Specialties, 36th edn. Ottawa: Canadian Pharmacists Association, 2001: 452-455.
70. Committee on Infectious Diseases. Tinea capitis. In: Peter G, ed. 1997 Red Book: Report of the Committee on Infectious Diseases, 24th edn. Chicago: American Academy of Pediatrics, 1997:523-525.
71. Friedlander SF, Skerlev M, Lipozencic J et al. Relationship between terbinafine dose and complete cure rate in tinea capitis: analysis of phase II randomized trials. J Eur Acad Derm Venereol 2001; 15 (Suppl. 2): 221.
72. Friedlander SF, Skerlev M, Lipozencic J et al. Relationship between terbinafine dose and complete cure rate in tinea capits. Ann Dermatol Venereol 2002: 129: 1S608 (Abstract).
73. Williams JV, Honig PJ, McGinley KJ, Leyden JJ. Semiquantitative study of tinea capitis and the asymptomatic carrier state in inner-city school children. Pediatrics 1995; 96 (2 Pt 1): 265-267.
74. Babel DE, Rogers AL, Beneke ES. Dermtophytosis of the scalp: incidence, immune response, and epidemiology. Mycopathologia, 1990; 109: 69-73.
75. Frieden IJ. Tinea capitis: asymptomatic carriage of infection. Pediatr Infect Dis 11999; 18: 186-190.
76. Greer DL. Treatment of symptom-free carriers in management of tinea capitis. Lancet 1996; 348: 350.
77. Neil G, Hanslo D, Buccimazza S, Kibel M. Control of the carrier state of scalp dermatophytes. Pediatr Infect Dis 11990; 9: 57-58.
78. Pomeranz AJ, Sabnis SS, McGrath GJ, Esterly NB. Asymptomatic dermatophyte carriers in the households of children with tinea capitis. Arch Pediatr Adolesc Med 1999; 153: 483-486.
79. Red Book Update Top Volume Rx Products. In: Cardindale V, ed. Drug Topics Red Book Pharmacy's Fundamental Reference. Montvale, NJ: Medical Economics Company, April 2001: 40, 45.