SPORANOX ORAL SOLUTION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ITRACONAZOLE

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

ITRACONAZOLE

Unit dalam pakej:

150ml mL

Dikeluarkan oleh:

JANSSEN PHARMACEUTICA N.V.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SPORANOX
® ORAL SOLUTION
Itraconazole 10mg/mL
WHAT IS IN THIS LEAFLET
1.
What SPORANOX
®
is used for
2.
How SPORANOX
®
works
3.
Before you use SPORANOX
®
4.
How to use SPORANOX
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
SPORANOX
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SPORANOX
® IS USED FOR
SPORANOX oral solution is a medicine
used:
•
to treat yeast infections of the
mouth, throat and foodpipe
(esophagus) in people with a
lowered resistance;
•
to prevent certain fungal infections
in people who may have a lowered
resistance due to a major blood
disorder or bone marrow
transplantation.
Your doctor may have prescribed
SPORANOX Oral Solution for another
reason. Ask your doctor if you have any
questions about why this medicine has
been prescribed for you.
HOW SPORANOX
® WORKS
SPORANOX works by killing or
stopping the growth of the fungus that
causes the infection.
BEFORE YOU USE SPORANOX
®
-
_When you must not use it _
Do not take SPORANOX oral
solution:
•
if you know you are hypersensitive
(allergic) to it;
•
if you are pregnant (unless your
doctor knows you are pregnant and
decides you need SPORANOX);
•
if you are of child bearing age and
could become pregnant, you should
take adequate contraceptive
precautions to make sure that you do
not become pregnant while you are
taking your medicine. As
SPORANOX remains in the body
for some time after you stop taking
it, you should continue to use
contraception until your next period
after your treatment with
SPORANOX oral solution is
finished.
•
if you have a condition called heart
failure (also called congestive heart
failure or CHF), SPORANOX could
make it worse. If your doctor
decides that you need to take
SPORANOX even if you have this
condition, be sure to get immediate
medical help if you have shortness
of breath, unexpected weight gain,
swelling of the legs, unusual fatigue,
or begin to wake up

Ciri produk

1
PRODUCT NAME
SPORANOX
®
Oral Solution
SPORANOX Oral Solution contains the bactericidal and fungicidal
broad-spectrum antifungal
agent. It is a yellow to slightly amber, clear solution with cherry
flavor.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL SPORANOX Oral Solution contains 10 mg itraconazole.
For excipients, see
_List of Excipients_
.
PHARMACEUTICAL FORM
Oral solution.
SPORANOX Oral Solution is clear.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
SPORANOX
Oral Solution is indicated:
•
For
the
treatment
of
oral
and/or
esophageal
candidosis
in
HIV-positive
or
other
immunocompromised patients.
•
As prophylaxis of deep fungal infections when standard therapy is
considered in appropriate
in patients with hematological malignancy or undergoing bone marrow
transplant, and who are
expected to become neutropenic (i.e., < 500 cells/µL).
At present there are insufficient data on clinical efficacy in the
prevention of aspergillosis.
DOSAGE AND ADMINISTRATION
For optimal absorption, SPORANOX Oral Solution should be taken without
food (patients are
advised to refrain from eating for at least 1 hour after intake).
For the treatment of oral and/or esophageal candidosis,
_ _
the oral solution should be swished around
the oral cavity (approx. 20 seconds) and swallowed. There should be no
rinsing after swallowing.
TREATMENT OF ORAL CANDIDOSIS
200 mg (2 measuring cups, i.e. 20 mL) per day in two intakes, or
alternatively in one intake, for 1
week. If there is no response after 1 week, treatment should be
continued for another week.
TREATMENT OF ESOPHAGEAL CANDIDOSIS
100 mg (1 measuring cup, i.e. 10 mL) daily for a minimum treatment of
three weeks. Treatment
should continue for 2 weeks following resolution of symptoms. Doses up
to 200 mg (2 measuring
cups, i.e. 20 mL) per day may be used based on the clinical response
of the patient.
TREATMENT OF FLUCONAZOLE RESISTANT ORAL AND/OR ESOPHAGEAL CANDIDOSIS
2
100 to 200 mg (1 - 2 measuring cups) twice daily for 2 weeks. If there
is no response after 2 weeks,
treatment should