I remember this thread when I got my PM News today:
RE: Oral Lamisil Use in Children (Bruce N. Block, DPM, Brian, Kashan, DPM)
From: Bryan C. Markinson, DPM, Maurice W. Aiken, DPM
The use of terbinafine is not approved in children. Gupta. et al., established in several large series that use of terbinafine in children is safe. In one study of almost 1000 children, there was a 10% adverse effect incidence, of which only 8 out of 100 such incidences actually led to cessation of the treatment.
See Gupta, et al., Onychomycosis in children: prevalence and treatment strategies. J AM Acad Dermatol. 1997;36:395-402, and Gupta AK, Cooper EA, Lunde CW. The efficacy and safety of terbinafine in children. Dermatol Clin 2003;21:511-20.
The dose is by body weight as follows: Less than 25 kg. - 62.5 mgs per day; 25 - 40 kg. - 125 mgs per day; >40 kg. - 250 mgs per day.
The parents should be informed that the drug is not FDA approved for use in children. I always inform the pediatrician.
Bryan C. Markinson, DPM, NY, NY,
Bryan.Markinson@mountsinai.org
Dr. Kashan urges utmost caution regarding use of terbinafine in children. In fact, he states clearly that he would not do it. He does not say, however, what he would do with a child who clearly is distressed at having onychomycosis. In general, I would not argue that his position is too rigid, as he is being true to his own level of tolerance and experience in this situation. However, I would argue that advancing the position that off-label use of anything in children should absolutely be avoided (which I do not think Dr. Kashan intended) may be the wrong message to take away from his post.
For example, the use of Marcaine is not approved in children, but I welcomed the ENT surgeon's injecting it into my own kids throats post-op when they had their tonsilectomies. When I eventually get my own case of prostate hypertrophy, I may welcome the off-label use of Nizoral to help shrink it. Now, one might point out that the risk severity in using terbinafine in children is much greater than my two examples, but the scientific evidence, in well done large sample size studies, states otherwise.
Bryan C. Markinson, DPM, NY, NY,
Bryan.Markinson@mountsinai.org
I have had several pediatric patients in this age range who I have used oral Lamisil successfully. Prior to its use in this population, I contacted Novartis and obtained several articles on its use in Great Britain. It is extensive and has been used in ped populations for many years.
As usual, you do your pre-treatment liver function studies and a CBC w/diff, and do a monthly repeat of those labs if you are more comfortable then the recommended 6 week repeat. As far as dosing is concerned, I have used the usual 250 mg dose each day as per the articles that I have referred to previously. Call Novartis or ask your rep to inquire about this subject. They have been very responsive in the past.
Maurice W. Aiken, DPM, Baltimore, MD,
mwaiken@comcast.net