Hello 161tat
You are correct in your assessment of Itraconazole?s safety. This drug
is not FDA approved for use in children because of its toxicity, and
the high incidence of side effects. The drug is not licensed in the UK
either, and probably will never be. Anti-fungals are very toxic drugs,
and with the exception of griseofulvin, are usually reserved for use
in children who are suffering from conditions where a fungal infection
could be life threatening. (Immunodeficiency, AIDS, etc.) Some
physicians do prescribe Itraconazole for children in an ?off-label?
use. Currently, little information is available to guide physicians in
prescribing the appropriate dosage "off-label" use. There is no
pediatric dosage available from the manufacturer. The drug *IS*
approved for use in general, and if the prescriber feels its use is
warranted, may utilize Itraconazole. Many studies have not found
Itraconazole to be very effective.
When a drug is approved by the FDA, the manufacturer submits to them,
all of its research and studies. If tinea capitis was not included in
the manufacturer?s studies, then the FDA will not approve its use. It
is up to the manufacturer to provide evidence against which conditions
the drug is effective. Many drugs which are intended for a specific
treatment, are found, through further testing to be effective against
other conditions. Minoxidil, for high blood pressure is a good
example. A side effect of this BP drug was increased hair growth.
Studies were performed and now Minoxidil, better known as Rogaine, is
used for hair growth in men and women.
Oral Sporonax (itraconazole), manufactured by Janssen Oharmaceuticals
was FDA approved in 1997, for thrush
National Institues of Health
http://ott.od.nih.gov/NewPages/therapeutics.pdf
Reapproved for febrile neutropenic patients with suspected fungal
infections, May, 2001
http://www.fda.gov/cder/da/da0501.htm
Three studies evaluated itraconazole and found it to be less than effective
http://www.aafp.org/afp/991115ap/tips/4.html
Tinea capitis is difficult to treat, as the fungus infects and
nourishes itself on dead keratin in the stratum corneum epidermidis
layer of the scalp. The scalp reacts to the organism, and tries to
protect itself by growing a thicker layer of keratin,leading to
scaling, and making it more difficult to treat. Because of this, some
topical creams are less than effective.
http://www.findarticles.com/cf_dls/m3225/10_65/85615727/p1/article.jhtml
?Itraconazole is currently unlicensed in the U.K. for use in tinea
capitis and for use in children and there are no plans to change
this.?
BAD (This site, in spite of its acronym , is actually a very GOOD, and
informative site, belonging to the British Association of
Dermatologists)
http://www.bad.org.uk/doctors/guidelines/Tinea%20Capitis.htm
?Itraconazole: Of all the oral antifungal agents, itraconazole has the
broadest spectrum of activity. It is effective against dermatophytes,
Candida species, some molds, and P ovale . It is effective in
treatment of tinea corporis, tinea cruris, tinea pedis, tinea manuum,
and onychomycoses . Because of the lipophilic tendencies of
itraconazole, concentration of the drug in keratinous tissues remains
high for months after cessation of therapy.?
Dr Zuber is program director, department of family practice, Saginaw
Cooperative Hospitals, and director of the dermatology clinic, Aleda
E. Lutz Veterans Affairs Medical Center, Saginaw, Michigan, and
associate professor, Michigan State University, East Lansing. Dr
Baddam is a member of the department of family practice, Saginaw
Cooperative Hospitals, and clinical instructor, Michigan State
University. Correspondence: Thomas J. Zuber, MD, Department of Family
Practice, Saginaw Cooperative Hospitals, 1000 Houghton Ave, Saginaw,
MI 48602. E-mail: zuber@pilot.msu.edu.
VOL 109 / NO 1 / JANUARY 2001 / POSTGRADUATE MEDICINE, Thomas J.
Zuber, MD; Kavitha Baddam, MD
http://www.postgradmed.com/issues/2001/01_01/zuber.htm
?The three studies that were cited using itraconazole for tinea
capitis found the response rate to be generally poor. In one of these
three, only a 50 percent cure rate occurred after four weeks of dosing
at 100 mg per day.?
American Family Physician, Nov 15, 1999, by Jeffrey T. Kirchner
http://www.findarticles.com/cf_dls/m3225/8_60/58267046/p2/article.jhtml?term=
?The use of itraconazole in children is not recommended because its
safety has not been established?
http://www.medicinenet.com/itraconazole/article.htm
?Although this study was small, it does suggest that more than 50
percent of patients might not respond to 100 mg of itraconazole given
daily for 4 weeks? and ?Selenium sulfide is available in a 1 percent
shampoo and 2.5 percent lotion. Some important evidence exists: 54
patients with T tonsurans receiving griseofulvin 15 mg/kg/d were
randomized to receive either the 2.5 percent lotion or 1 percent
selenium sulfide shampoo or a bland nonmedicated shampoo. Patients
were observed at 2-week intervals until they were clinically and
mycologically cured. The selenium sulfide products were statistically
superior to the nonmedicated shampoo for time required to eliminate
shedding and viable spores. When the two different selenium products
were compared, however, no difference was noted.?
http://www.familypractice.com/journal/1999/v12.n03/1203.08/art-1203.08.htm
Side Effects:
Known side effects of itraconazole include:
Headache
Diarrhea
Nausea
Dry skin
Itching (pruritis)
dissiness
congestive heart failure (CHF)
liver failure
death
Recent studies indicate that itraconazole may weaken the force of the
heart's contractions
http://www.postgradmed.com/issues/2001/01_01/zuber.htm
Side effects including congestive heart failure:
http://www.injuryboard.com/view.cfm/Article=187/?ref=ink
?On May 9, the FDA issued a Public Health Advisory to announce
significant safety concerns with Sporanox® (itraconazole) and Lamisil®
(terbinafine hydrochloride).?
Page 3 of this University of Kentucky Medical Center site, May 2001:
http://www.mc.uky.edu/pharmacy/dic/currenttopics/issues/Topics0501.pdf
The above site quotes directly from the FDA warning:
http://www.fda.gov/cder/drug/advisory/sporanox-lamisil/advisory.htm
Treatment:
Because generally speaking, a treatment works for the majority of
patients, some doctors prescribe the same treatment for all.
Determining the exact species on is dealing with can help select a
specific treatment, and avoid taking medication that is ineffective.
Before starting any new therapy, have the infected site examined with
a Wood?s light. This is not a very specific test, but it can rule out
or rule in certain species of fungal infections, as M. canis, M.
rivalieri and M. audouinii will fluoresce. T. tonsurans will not.
All of these fungi can cause T. capitis:
·Microsporum audouinii
·Microsporum canis
·Microsporum distortum
·Microsporum gypseum
·Trichophyton megninii
·Trichophyton mentagrophytes
·Trichophyton rubrum
·Trichophyton schoenleinii
·Trichophyton tonsurans
·Trichophyton verrucosum
·Trichophyton tonsurans
A skin scraping, placed on a slide with 10% KOH (potassium hydroxide
solution) to dissolve tissue, yet leave fungal elements intact, for
easy viewing can help differentiate fungal species.
A fungal culture (Fungal C&S) can be taken to identify the fungal
species is the most precise test, but can take weeks for results.
Don?t use any topical creams and don?t wash the hair with selenium
sulfide and povidone iodine shampoos the day before, or the day of the
culture is taken.
Once the causative agent has been found, effective therapy can begin.
Treatments other than oral anti-fungals are:
Maintaining extreme hygiene can be of great help. Soaking for 10
minutes, followed by a thorough rinsing of hair brushes and combs in a
10% bleach solution can destroy fungus. This will prevent reinfection.
(Mix fresh daily, 1 part bleach to 9 parts water, adding the bleach to
the water, and not water to the bleach. Avoid skin contact.). Washing
towels and bedding in the hottest water possible, and dried in a hot
dryer can kill fungal spores, and prevent reinfection. Spores have
been implicated in recurrence and found in linens and hair brushes and
combs. Use clean towels with each bath/hair washing.
Corticosteroid creams (hyrocortisone), and or oral steroids with a
short term use can help.
Removal of scalp crust before application of topical therapy can help,
by allowing the cream/lotion to get closer to the infected layer of
skin. Soak the scalp with a very damp towel, 20-30 minutes. Part the
hair and using a comb or brush, try to gently remove scales, without
scraping or cutting the scalp. Be very gentle. Comb or brush away the
scales. The hair can then be washed, and the topical cream/lotion can
be applied.
Selenium sulfide and povidone iodine shampoos, 2-3 times a week, will
reduce fungal spores and reduce reinfection.
Check all family members as well. One person can re-infect other
family members, especially if sharing bedding or towels.
Some hair dressings and pomades increase the likelihood of acquiring tinea capitis.
From the British Association of Dermatologists:
Treatment failures
Some individuals are not clear at follow-up. The reasons for this include:
1.Lack of compliance with the long courses of treatment.
2.Suboptimal absorption of the drug.
3.Relative insensitivity of the organism.
4.Reinfection.
?T. tonsurans and Microsporum sp. are typical culprits in persistently
positive cases. If fungi can still be isolated at the end of
treatment, but the clinical signs have improved, the authors recommend
continuing the original treatment for a further month. If there has
been no clinical response and signs persist at the end of the
treatment period, then the options include:
Increase the dose or duration of the original drug: both griseofulvin
(in doses up to 25 mg/kg for 8-10 weeks) and terbinafine have been
used successfully and safely at higher doses or for longer courses to
clear resistant infections. Change to an alternative antifungal, e.g.
switch from griseofulvin to terbinafine or itraconazole. ?
http://www.bad.org.uk/doctors/guidelines/Tinea%20Capitis.htm
Topical anti-fungal crèmes can be applied, in conjunction with all of the above.
Here is a nice list of topical anti-fungals. Note those marked with an
asterisk(*) are ineffective against T. capitis. Some may not be
available in the US. (I don?t know where you are located)
DermNet, New Zealand
http://www.dermnetnz.org/pre/dna.fungi/topafm.html
Management of tinea capitis
·Evaluate scalp, local lymph nodes, and skin of patient
·Ascertain if other family members or pets are affected
·Obtain cultures from patient
·Instruct patient to shampoo with a topical sporicidal agent (eg,
selenium sulfide lotion or shampoo [Exsel, Selsun], ketoconazole
shampoo [Nizoral]) twice weekly
·Consider treating all close contacts with the shampoo regimen described above
·Reevaluate and obtain another culture at end of treatment period, and
continue treatment as necessary until patient is clinically clear of
the condition and culture is negative
·At present, griseofulvin, 15 to 20 mg/kg per day, is still generally
considered first-line therapy. The medication should be taken with
fatty foods.
·Alternative agents include terbinafine hydrochloride (Lamisil),
fluconazole (Diflucan), and itraconazole (Sporanox)
VOL 110 / NO 1 / JULY 2001 / POSTGRADUATE MEDICINE
Daniel Dr Berg is a resident physician and Dr Erickson is a faculty
physician, department of family practice, Hennepin County Medical
Center, Minneapolis. Correspondence: Daniel Berg, MD, Department of
Family Practice, Hennepin County Medical Center, 5 W Lake St,
Minneapolis, MN 55408. E-mail: berg0231@mnintern.net.
http://www.postgradmed.com/issues/2001/07_01/berg.htm
Berg, MD; Paul Erickson, MD
?Adjunctive agents used in the treatment of tinea capitis include
corticosteroids and selenium sulfide. Corticosteroids are used to
alter the host immune-mediated responses in patients with complicated
tinea capitis, whereas selenium sulfide is used as a topical
sporicidal agent?
http://www.familypractice.com/journal/1999/v12.n03/1203.08/art-1203.08.htm
Additional Information:
A differential diagnosis chart of common tinea infections:
http://www.aafp.org/afp/980700ap/noble.html
FDS Drug Approval Process:
http://www.fda.gov/cder/handbook/develop.htm
?Terbinafine Offers Advantages in Tinea Capitis?
Family Pratice News, April 1, 2001, by Jennifer M. Wang
http://www.findarticles.com/cf_dls/m0BJI/7_31/74699278/p1/article.jhtml
Pharmokinetics of itraconazole
RXList
http://www.rxlist.com/cgi/generic/itraconazole_cp.htm
Hope this helps you, 161tat! Remember, and I am not suggesting this to
be true in your case, the primary causes of treatment failure are
non-compliance and treating the wrong fungal species. Please seek
reliable medical guidance from your physician before implementing any
treatment. I would like to add an opinion here: If a small family
member of mine needed treatment for T. capitis, I would avoid oral
antifungals, and aggressively follow the hygiene routine as described
above, washing of combs, brushes, clean towels, etc. I would rub off
dead keratin, use the recommended medicated shampoos regularly,
followed by a topical ointment(s) prescribed by my doctor. I?d have
the entire family tested for an exact fungal species identification,
to ensure we are following the correct therapy.
One final thought: If the organism is truly resistant to griseofulvin,
perhaps it is not ringworm. Griseofulvin generally carries a 90%
sucess rate, and must be taken with a fatty food. It usually works
well,as it is taken up and concentrated by skin cells, making it an
effective treatment. Without one or more of the above mentioned
diagnostic tests, one can't know for sure.
If any part of my answer is unclear, or if I have duplicated
information you already had, please ask for an Answer Clarification
before rating. This will allow me to assist you further, if possible.
Sincerely,
crabcakes-ga
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