ITRANOX itraconazole 100 mg capsule blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

itraconazole, Quantity: 100 mg

متاح من:

Arrotex Pharmaceuticals Pty Ltd

INN (الاسم الدولي):

Itraconazole

الشكل الصيدلاني:

Capsule

تركيب:

Excipient Ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; Gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

طريقة التعاطي:

Oral

الوحدات في الحزمة:

6 capsules, 15 capsules, 28 capsules, 60 capsules, 4 capsules

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

ITRANOX is indicated for use in adults for the treatment of: ? Superficial dermatomycoses not responding to topical treatment. ? Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? Pityriasis versicolor not responding to any other treatment. ? Vulvovaginal candidiasis not responding to topical treatment. ? Oral candidiasis in immunocompromised patients. ? Onychomycosis caused by dermatophytes. ? Systemic mycoses: - Systemic aspergillosis, histoplasmosis, sporotrichosis. - Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. - Treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

ملخص المنتج:

Visual Identification: Size 0el hard gelatin white opaque capsules filled with off-white to cream colored pellets and imprinting with ITR on cap and 100 on body; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

الوضع إذن:

Licence status A

تاريخ الترخيص:

2016-08-09

نشرة المعلومات

ITRANOX
CAPSULES
1
ITRANOX
CAPSULES
_itraconazole _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ITRANOX
capsules. 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
ITRANOX capsules against the
benefits this medicine is
expected to have for you. If you
have any concerns about taking
ITRANOX capsules, ask your
doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT ITRANOX
CAPSULES ARE USED FOR
ITRANOX capsules are 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 in patients with
lower resistance to disease;
•
generalised infections.
ITRANOX works by killing or
stopping the growth of the
fungus that causes the infection.
Your doctor may have prescribed
ITRANOX capsules for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
ITRANOX CAPSULES
_WHEN YOU MUST NOT TAKE IT _
Do not take ITRANOX capsules if:
•
YOU ARE PREGNANT OR MAY
BECOME PREGNANT.
If there is any chance of you
becoming pregnant, talk to your
doctor about the need for highly
effective contraception. Once you
have finished taking ITRANOX,
you should continue using highly
effective contraception until you
have had your next period. Tell
your doctor immediately if you do
become pregnant while taking
ITRANOX.
•
YOU HAVE A CONDITION CALLED
HEART FAILURE (ALSO CALLED
CONGESTIVE HEART FAILURE OR
CHF)
ITRANOX could make it worse.
If your doctor decides that you
need to take ITRANOX even if
you have this condition, be sure to
get immediate me

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION
ITRANOX (ITRACONAZOLE) CAPSULES
1
NAME OF THE MEDICINE
Itraconazole
.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ITRANOX capsules contain itraconazole 100 mg.
Itraconazole is a synthetic triazole antifungal agent.
EXCIPIENTS WITH KNOWN EFFECT: sugars and sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ITRANOX is available as Size 0el hard gelatin white opaque capsules
filled with off-white to
cream colored pellets and imprinting with ITR on cap and 100 on body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ITRANOX is indicated for use in adults for the treatment of:
•
Superficial dermatomycoses not responding to topical treatment.
•
Fungal keratitis which has failed to respond to topical treatment or
where the disease
is either progressing rapidly or is immediately sight threatening.
•
Pityriasis versicolor not responding to any other treatment.
•
Vulvovaginal candidiasis not responding to topical treatment.
•
Oral candidiasis in immunocompromised patients.
•
Onychomycosis caused by dermatophytes.
•
Systemic mycoses, only in the following fungal infections:
-
Systemic
aspergillosis,
histoplasmosis,
lymphocutaneous/cutaneous
sporotrichosis.
-
Treatment and maintenance therapy in AIDS patients with disseminated
or
chronic pulmonary histoplasmosis infection.
-
Treatment of oropharyngeal and/or oesophageal candidiasis when first
line
systemic antifungal therapy is inappropriate or has proven
ineffective.
-
Treatment of non-invasive candidiasis in non-neutropenic patients when
first-line
2
systemic antifungal therapy is inappropriate or has proven
ineffective. This may
be due to underlying pathology, insensitivity of the pathogen or drug
toxicity.
4.2
D
OSE AND METHOD OF ADMINISTRATION
It is essential that ITRANOX capsules are taken immediately after a
meal for maximal
absorption. The capsules must be swallowed whole. Treatment schedules
are as follows:
SUPERFICIAL DERMATOMYCOSES:
•
Tinea corporis, tinea cruris: