A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Sporanox Indications, Dosage, Storage, Stability - Itraconazole Capsules
Sporanox Indications, Dosage, Storage, Stability - Itraconazole Capsules
INDICATIONS
Sporanox (itraconazole capsules) is indicated for the treatment
of the following fungal infections in immunocompromised
and non- immunocompromised patients:
Blastomycosis, pulmonary
and extrapulmonary;
Histoplasmosis, including chronic
cavitary pulmonary
disease and disseminated,
non-meningeal histoplasmosis;
Aspergillosis, pulmonary
and extrapulmonary, in patients who are intolerant of or who are
refractory to amphotericin
B therapy; and
Onychomycosis due to dermatophytes (tinea unguium) of the toenail
with or without fingernail
involvement.
Specimens for fungal cultures and other relevant laboratory
studies (wet mount, histopathology, serology) should be obtained
prior to therapy to isolate
and identify causative organisms. Therapy may be instituted before
the results of the cultures and other laboratory
studies are known; however, once these results become available,
anti-active therapy
should be adjusted accordingly.
Blastomycosis: Analyses were conducted on data from
two open-label, non-currently controlled studies (n=73 combined)
in patients with normal
or abnormal immune
status. The median dose
was 200 mg/day. A response
for most signs and symptoms was observed within the first two weeks,
and all cleared between 3 and 6 months. Results of these two studies
demonstrated substantial evidence
of the effectiveness
of itraconazole, for the treatment
of blastomycosis, compared to the natural
history of untreated
cases.
Histoplasmosis: Analyses were conducted on
data from two open-label, non-currently controlled studies (n=34
combined) in patients with normal
or abnormal immune
status (not including
HIV-infected patients). The median
dose was 200 mg/day. A
response for most signs
and symptoms was observed within the first 2 weeks, and all cleared
between 3 and 12 months. Results of these two studies demonstrated
substantial evidence of the effectiveness
of itraconazole, for the treatment
of histoplasmosis, compared to the natural
history of untreated
cases.
Histoplasmosis in HIV-infected patients: Data from
a small number of HIV-infected patients suggested that the response
rate of histoplasmosis
in HIV-infected patients is similar to non-HIV-infected patients.
The clinical course of histoplasmosis
in HIV-infected patients is more severe and usually requires maintenance
therapy to prevent relapse.
Studies to investigate the efficacy
and safety of itraconazole in HIV-infected patients, including optimal
dosage regimens for treatment
and maintenance therapies, are ongoing.
Aspergillosis: Analyses were conducted on data from
an open-label, "single-patient-use" protocol
designed to make itraconazole available in the U.S. for patients
who either failed or were intolerant to amphotericin B therapy
(n=190). The findings were corroborated by two smaller open-label
studies (n=31 combined) in the same patient
population. Most adult
patients were treated with a daily dose
of 200 to 400 mg with a median
duration of 3 months.
Results of these studies demonstrated substantial evidence of effectiveness
of itraconazole, as a second-line therapy
for the treatment
of aspergillosis, compared to the natural
history of the disease
in patients who either failed or were intolerant to amphotericin
B therapy.
Onychomycosis: Analyses were conducted on data from
three double-blind, placebo-controlled studies (n=214 total) in
which patients with onychomycosis
of the toenails received 200 mg
once daily for 12 consecutive weeks. Results of these studies demonstrated
mycological cure in 54%
of patients, defined as simultaneous occurrence of negative
KOH plus negative culture.
Thirty-five (35) percent
of patients were considered an overall success (mycological cure
plus clear or minimal
nail involvement with significantly
decreased signs); 14% of patients demonstrated mycological cure
plus clinical cure (clearance of all signs, with or without residual
nail deformity). The mean
time to overall success
was approximately 10 months. Twenty-one (21) percent
of the overall success group
had a relapse (worsening
of the global score or
conversion of KOH
or culture from negative
to positive).
DOSAGE AND ADMINISTRATION
Sporanox (itraconazole capsules) should be taken with a full meal
to ensure maximal absorption.
Treatment of blastomycosis
and histoplasmosis: The recommended dose is 200 mg
once daily (2 capsules). If there is no
obvious improvement or there is evidence
of progressive fungal
disease, the dose
should be increased in 100 mg
increments to a maximum
of 400 mg daily. Doses above
200 mg per
day should be given in two divided doses.Treatment of aspergillosis:
A daily dose of 200 to
400 mg of itraconazole is
recommended.
In life-threatening situations: Although these studies did
not provide for a loading
dose, it is recommended, based on pharmacokinetic data, that a loading
dose of 200 mg
(2 capsules) t.i.d. (600
mg/day) be given for the first three days.
Treatment should be continued for a minimum
of three months and until clinical parameters and laboratory
tests indicate that the active fungal infection has subsided. An
inadequate period of
treatment may lead
to recurrence of active infection. The above recommendations for
the treatment of blastomycosis
and histoplasmosis
are based on the results of two open-label studies of patients with
blastomycosis
(n=73) and histoplasmosis
(n=34) where results were compared to the expected outcome
for untreated patients from historical controls. The recommendation
for the treatment
of aspergillosis
is based primarily on the results of an open-label, single-patient
use protocol designed to make itraconazole available in the U.S.
for patients who either failed or were intolerant to amphotericin
B therapy (n=190), and
is supported by two smaller open- label
studies (n=31 combined) in the same patient population.
Onychomycosis: The recommended dose
is 200 mg once daily for
12 consecutive weeks.
HOW SUPPLIED
Sporanox (itraconazole capsules) is available as capsules containing
100 mg of itraconazole, with
a blue opaque
cap and pink transparent
body, imprinted with "Janssen" and "Sporanox 100".
They are supplied in unit-dose
blister packs of 3 x
10 capsules and bottles of 30 capsules.
Store at room temperature
(59°-86°F/15°- 30°C). Protect from light
and moisture.
top
