SPORANOX CAPSULE 100 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ITRACONAZOLE

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

J02AC02

Pharmaceutical form:

CAPSULE

Composition:

ITRACONAZOLE 100 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

JANSSEN CILAG SPA

Authorization status:

ACTIVE

Authorization date:

1995-06-10

Summary of Product characteristics

1
PRODUCT NAME
TRADE NAME
SPORANOX
®
CAPSULES
GENERIC NAME/INTERNATIONAL NON-PROPRIETARY NAME
Itraconazole
DOSAGE FORMS AND STRENGTHS
Each capsule, for oral administration, contains 100 mg itraconazole in
a pellet formulation, and is
available as a blue opaque cap and pink transparent body.
For excipients, see
_List of Excipients._
CLINICAL INFORMATION
INDICATIONS
SPORANOX
®
capsules are indicated for the following conditions:
•
Gynecological indications:
-
Treatment of vulvovaginal candidosis.
•
Dermatological / mucosal
/
ophthalmological indications:
-
Treatment of dermatomycosis, including highly keratinized regions as
in plantar tinea
pedis and palmar tinea manus;
-
Treatment of pityriasis versicolor;
-
Treatment of oral candidosis;
-
Treatment of fungal keratitis.
•
Treatment of onychomycosis, caused by dermatophytes and/or yeasts.
•
Systemic mycoses, only in the following fungal infections:
-
Treatment of systemic aspergillosis and candidosis;
-
Treatment
of
cryptococcosis
(including
cryptococcal
meningitis):
in
immunocompromised patients with cryptococcosis and in patients with
cryptococcosis
of the central nervous system, only when first line treatment is
considered inappropriate
or has proven ineffective;
-
Histoplasmosis:
-
Treatment of histoplasmosis;
-
Maintenance therapy of histoplasmosis only in AIDS patients;
-
Treatment of blastomycosis;
-
Treatment of lymphocutaneous/cutaneous sporotrichosis;
-
Treatment of paracoccidioidomycosis;
-
Treatment of chromomycosis.
DOSAGE AND ADMINISTRATION
For optimal absorption, administer SPORANOX
®
capsules immediately after a full meal.
The capsules must be swallowed whole.
2
GYNECOLOGICAL INDICATION
INDICATION
DOSE
TREATMENT DURATION
Treatment of vulvovaginal
candidosis
200 mg twice daily
or
200 mg once daily
1 day
or
3 days
DERMATOLOGICAL / MUCOSAL / OPHTHALMOLOGICAL INDICATIONS
INDICATION
DOSE
TREATMENT DURATION
Treatment of dermatomycosis
200 mg once daily
or
100 mg once daily
7 days
or
15 days
Treatment
of
dermatomycosis
in
highly
keratinized
regi