Itraconazole in candidosis 
Clinical study 
ITRACONAZOLE IN THE THERAPY 
OF CANDIDOSIS OF URO-GENITAL 
SYSTEM AND/OR ORAL CA VITY AND THROAT 
MUCOSA IN A DAIL Y DOSE OF 100 mg 
S. Urbanowski, Z. Gwiezdzifiski and E. Nierebifiska 
ABSTRACT 
The results of a clinical study on the effectiveness and tolerability of itraconazole used in oral therapy of 
candidosis in a single dose of 100 mg daily were presented. 
Investigations were performed in 3 groups: 20 persons with candidosis of the uro-genital system, 18 persons 
with candidosis of the oral cavity and throat mucosa, 10 persons with candidosis of the uro-genital system 
coexisting with candidosis of oral cavity and throat mucosa. Ali strains of yeast-like fungi isolated from 
patients were susceptible to itraconazole. The values of MIC were from 0,01 to 20,0 ug/ml. In three groups 
of patients results and duration of treatment were:lst group - 90%, from 4 to 8 days; 2nd group- 88,9%, from 
4 days to 10 weeks; 3rd group - 90%, from 4 days to 12 weeks. Two weeks after the end of the therapy 
the recurrence of the disease was observed in 4 persons (8,3 % ). In 2 patients ( 4,2% ), transient adverse 
reactions - nausea and stomach ache were observed. No changes in laboratory tests (Aspat, Alat, bilirubin) 
were noticed. It was concluded that itraconazole applied in a single dose of 100 mg daily is effective and 
safe. 
In the authors' opinion therapy should be continued until negative results of clinical and mycological studies 
of ali morbid yeast foci. 
KEY WORDS 
candidosis, uro-genital system, oral cavity, throat, mucosa, Itraconazole 
INTRODUCTION 
Fungi of the genus Candida are frequent causes 
of infections of the skin and mucous membranes. 
The most common of these organisms is C. albicans, 
but other species as C. tropicalis, C. guilliermondii, 
and C. parapsilosis, may also cause infection (1). 
These organisms, especially C. albicans are common 
in the microflora of the mouth, throat, gastrointestinal 
acta dennatovenerologica A.P.A. Vol 6, 97, No 2 
tract, urethra and/or vagina, they appear as pathogen 
only under a variety of circumstances. 
Candida infections of the skin and mucous 
membranes had been exclusively treated topically 
until a period of ten years ago. Indeed, only the 
availability of orally active ketoconazole made it 
possible in the early 1980s to start oral treatment 
for vagina! and oral candidosis (2). Recently, new 
oral therapy with itraconazole and fluconazole have 
55 
ltraconazole in candidosis 
Table I. Candidosis of mucous membranes. Sites of involvement 
urogenital tract, 
oral cavity, throat 
become available. 
M 
F 
4 
6 3 
ltraconazole, a new oral triazole derivative, a 
tbird-generation, bas a broad spectrum of antifungal 
activity. In vitro and in vivo it is active against 
yeasts, dermatopbytes, Aspergillus species and dimor-
pbic fungi (1,4). Extensive clinical testing bas sbown 
that highly lipopbylic itraconazole bas a favourable 
tissue/plasma leve! ratio (5). Tbis affinity for tissue 
results in therapeutically beneficial effects. This antimy-
cotic bas been tested extensively for treatment of 
vagina! and oral candidosis and other mycoses (6,7,8,9). 
MATERIALS AND METHODS 
Forty-eigbt patients (13 males, 35 females) with 
candidosis of tbe uro-genital system and/or candidosis 
of the oral cavity and throat mucosa, divided in 3 
groups were treated with a single daily dose of 100 
mg; 1'1 - with candidosis of urogenital system; 2nd -
with candidosis of oral cavity and throat mucosa; 3"1 
- witb candidosis of tbe urogenital system coexisting 
with candidosis of tbe oral cavity and throat mucosa. 
4 
1 2 
Written consent was obtained from ali patients before 
their enrollment in the study. Patients were included 
wben microscopic examination was positive for mycelial 
elements, cultures were also made on Sabouraud's 
agar. When growth was observed, tbe colonies were 
reinoculated on Nickerson medium far furtber 
identification on tbe Api 20 C AUX test. Then, the 
activity of itraconazole against ali isolated strains 
was determined by plate dilution method ranging 
from 0.02 to 55.0 ug/ml of classic Sabouraud agar 
medium after initial solution in 96% vol. ethanol. 
Media controls without solvent and with solvent at 
various concentrations were used. Tbe inoculum was 
10 cells per 1 ml saline. The minimal inhibitory 
concentration (MIC) was established after 72 hours. 
Patients with serious concurrent diseases, treated 
with systemic and/or topical antifungal agents within 
1 montb, witb mixed infections ( e.g., Candida + 
Trichomonasis + Neisseria gonorrhoea + gonorrhoea 
vaginalis + Bacteria) and those who were pregnant 
or who were not using adequate birth control were 
excluded. 
Table JI. Activity "in vitro" of itraconazole against yeast-like Jungi isolated from patients. 
Candida albicans 
Candida crusei 
Torulopsis glabrata 
*MIC - Minimal lnhibitory Concentration 
56 
45 
2 
1 
0,01 - 20,0 
0,1 
0,1 
acta dennatovenerologica A.P.A. Vol 6, 97, No 2 
Jtraconazole in candidosis 
Table III. Efficacy of itraconazole used in oral therapy of candidosis of uro-genital system and/or oral cavity and 
throat mucosa in a single daily dose of 100 mg. C linica/ and mycological investigation were evaluated. 
urogenital system 
oral cavity 
urogenital tract, 
oral cavity 
18/20 
16/18 
9/10 
90 
88,9 
90 
Each patient was instructed to apply one capsule 
of 100 mg itraconazole once a day immediately 
after a meal. Ali patients were evaluated clinically 
before starting the treatment as well as 2 week 
after treatment. An additional evaluation was carried 
out in patients with candidosis of the urogenital 
system on days 2,4,6 and at weeks 1 to 12 in 
patients with candidosis of the oral cavity and 
throat mucosa. Symptoms and/or signs were scored 
as: absent - O, mild - 1, moderate - 2, severe - 3. 
The microscopic examinations and cultures were 
made at the start of treatment, at each therapy visit 
and at follow-up visits. 
We also noted predisposing and coexisting factors 
(sexu al partners and members of the family) in 
patients with candidosis. 
The biochemical parameters as bilirubin, aspartate 
aminotransferase and alanine aminotransferase were 
determined in 2-week periods in patients who were 
treated longer than 2 weeks. Adverse reactions and 
acceptability were recorded. 
The Candida infection was considered cured clinically 
and microbiologically if the symptoms had disappeared 
and if no fungi were found by direct microscopy or 
culture. 
RESULTS 
Ali the 48 patients were included in the analysis 
of clinical and mycological efficacy and were evaluated 
17/20 
14/18 
8/10 
85 
77,8 
80 
for adverse reactions. The sites of involvement are 
shown in table I, the activity "in vitro" of itraconazole 
against yeast-like fungi in table II, efficacy of 
itraconazole therapy in table III, and duration of 
treatment with a single dose of 100 mg daily in 
table IV. 
In 11 patients predisposing factors ( oral contraceptive 
- 1, diabetes - 2, antibiotic therapy -7, steroid 
therapy - 1) and in 16 patients coexisting factors 
(sexual partner - 7, member of family - 9) were 
noted. 
Ali of the strains isolated before treatment were 
"in vitro" sensitive to itraconazole. 
Two weeks after the end of the therapy the 
recurrence of the disease was observed in 4 persons 
(8.3 % ). In 2 patients ( 4.2%) with candidosis of the 
oral cavity and throat mucosa transient adverse 
reactions - nausea and stomach ache - have been 
observed. No changes in laboratory tests (Aspat, 
Alat, bilirubine) were noticed. 
DISCUSSION AND CONCLUSIONS 
The results of this study demonstrate that 
itraconazole applied in a single dose of 100 mg 
daily is an effective and safe drug in short treatrnent 
of candidosis of the uro-genital systern and also in 
longer therapy of candidosis of the oral cavity and 
throat mucosa. 
Table IV. Duration of oral itraconazole treatment in candidosis of uro-genital system and/or oral cavity and throat 
mucosa in a single daily dose of 100 mg. 
urogenital system 
oral cavity 
urogenital system and oral cavity 
4 8 days 
4 days - 10 weeks 
4 days 12 weeks 
acta dennatovenerologica A.P.A. Vol 6, 97, No 2 
5,7 
23,75 
19,1 
57 
Itraconazole in candidosis 
Generally, for non immunocompromized patients, 
the main treatment is topical (miconazole, clotrimazole, 
nystatin and amphotericin B). For more persistent 
candidosis and in patients with immunosuppression, 
it is necessary to use oral therapy (ketoconazole, 
fluconazole or itraconazole) because responses to 
topical agents are often poor. Itraconazole is usually 
effective in the treatment of acute vagina! candidosis 
at a tata! dose of 400 mg to 600 mg, given as 200 
mg twice daily for 1 day or 200 mg daily for either 
2 or 3 days; 200 mg for 3 days or 100 mg for 5 
days reportedly give better results in chronic vagina! 
candidosis and oral candidosis in dose of 100 mg 
daily for 1 to 3 weeks. 
In our patients with candidosis of the uro-genital 
system we also found minimal symptoms and/or 
signs and/or only positive results of mycological 
examination in oral cavity and throat. And vice 
versa. In patients with candidosis of the oral cavity 
and throat mucosa we found fungi in the uro-
genital system. The authors suggest that treatment 
should be continued until the lesions are healed 
and mycological tests become negative. 
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AUTHORS' ADDRESSES 
Slawomir Urbanowski MD, PhD, Department of Dermatology, Medica! Academy of Bydgoszcz, ul. 
Kurpiiiskiego 5, 85-096 Bydgoszcz, Poland 
Zenon Gwiezdzinski MD, PhD, Professor and Chairman, same address 
Elzbieta Nierebinska PhD, same address 
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