Itrazole

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Itraconazole 100mg;  

Tersedia dari:

Viatris Limited

INN (Nama Internasional):

Itraconazole 100 mg

Dosis:

100 mg

Bentuk farmasi:

Capsule

Komposisi:

Active: Itraconazole 100mg   Excipient: Capsugel red G60CSA00150 Colloidal silicon dioxide Ethanol Gelatin Hypromellose Iron oxide red Methylene chloride Opacode white S-1-7078 Purified water Sorbitan stearate Sugar spheres Titanium dioxide

Unit dalam paket:

Blister pack, PVC/PVDC-aluminium, 4 capsules

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Mylan Laboratories Limited

Indikasi Terapi:

Itraconazole capsules are indicated for the treatment of: · vulvovaginal candidiasis. · pityriasis versicolor, · dermatomycosis - including highly keratinised regions as in plantar tinea pedis and palmer tinea manus, · fungal keratitis, · oral candidiasis, · onychomycosis caused by dermatophytes and/or yeasts. · systemic mycoses, only in the following fungal infections: - systemic aspergillosis - histoplasmosis, - histoplasmosis, maintenance therapy only in AIDS patients - sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous) - paraconccidioidomycosis, - chromomycosis, - blastomycosis

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC-aluminium - 4 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 6 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 7 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 8 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 14 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 15 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 18 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 30 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 50 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 60 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 84 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 100 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 140 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 150 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 280 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC-aluminium - 300 capsules - 36 months from date of manufacture stored at or below 25°C

Tanggal Otorisasi:

2004-06-04

Selebaran informasi

Page 1 of 6
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ITRAZOLE
_ITRACONAZOLE CAPSULE 100 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Itrazole.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Itrazole
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT ITRAZOLE IS USED
FOR
Itrazole is used to treat certain
fungal infections which include the
following:
•
persistent infections of the
nails, skin, hands, feet or
groin;
•
persistent candida (yeast)
infections of the vagina;
•
eye infections which have
not responded to other
treatment or which may be
affecting vision;
•
candida (yeast) infections of
the mouth or throat;
•
generalised infections.
Itrazole contains the active
ingredient itraconazole_._ It belongs to
a group of medicines called azoles.
It works by killing or stopping the
growth of the fungus that causes
the infection. Patches of skin may
take a few weeks to completely
clear up after you have finished
your treatment with Itrazole. Finger
and toenails may take several
months to completely clear up. This
is because your skin or nail will only
look normal after new skin or nail
has grown, even though the
medicine has killed the fungus that
caused the infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
ITRAZOLE
WHEN YOU MUST NOT TAKE IT:
DO NOT TAKE ITRAZOLE IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
itraconazole
•
any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezi

Karakteristik produk

Page 1 of 29
NEW ZEALAND DATA SHEET
ITRAZOLE
1. PRODUCT NAME
Itrazole 100 mg capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of itraconazole.
Excipient with known effect: Sugar
Allergen Declaration: Sugar
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule: Size 00, hard gelatin capsule with a red opaque cap and red
opaque body printed axially
with “MYLAN” over “IE 100” in white ink on cap and body, and
containing white to off-white coloured
pellets.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Itrazole capsule is indicated for the treatment of:
•
vulvovaginal candidiasis.
•
pityriasis versicolor,
•
dermatomycosis – including highly keratinised regions as in plantar
tinea pedis and palmer
tinea manus,
•
fungal keratitis,
•
oral candidiasis,
•
onychomycosis caused by dermatophytes and/or yeasts,
•
systemic mycoses, only in the following fungal infections:
o
systemic aspergillosis and candidiasis,
o
histoplasmosis,
o
histoplasmosis, maintenance therapy only in AIDS patients
o
sporotrichosis (including lymphocutaneous/cutaneous and
extracutaneous),
o
paracoccidioidomycosis,
o
chromomycosis,
o
blastomycosis.
Page 2 of 29
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
Treatment schedules are as follows:
INDICATION
DOSE
DURATION
Vulvovaginal candidiasis
200 mg twice daily
or 200 mg once daily
1 day
3 days
Pityriasis versicolor
100 mg twice daily
200 mg once daily
5-7 days
Dermatomycosis
100 mg once daily
or 200 mg once daily
15 days
or 7 days
Dermatomycosis in highly
keratinised regions as in
plantar tinea pedis and
palmar tinea manus
200 mg twice daily
or 100 mg once daily
7 days
or 30 days
Oral candidiasis
100 mg once daily
15 days
Fungal keratitis
200 mg once daily
21 days
The duration of treatment
should be adjusted to clinical
response.
ONYCHOMYCOSIS
_Pulse treatment (see table below): _
A pulse treatment consists of two capsules (200 mg) twice daily for
one week. Two pulse treatments
are recommended for fingernail infect