SPORANOX Itraconazole 10 mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

itraconazole, Quantity: 10 mg/mL

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: propylene glycol; hydroxypropylbetadex; saccharin sodium; purified water; caramel; sorbitol solution (70 per cent) (non-crystallising); sodium hydroxide; hydrochloric acid; Flavour

Administration route:

Oral

Units in package:

150mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sporanox oral solution is indicated for: * the treatment of oral and/or oesophageal candidiasis in HIV-positive or other immunocompromised patients. * prophylaxis of fungal infections in neutropenic patients.

Product summary:

Visual Identification: Clear, slightly amber to yellow solution, with a cherry odour.; Container Type: Bottle; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1998-02-06

Patient Information leaflet

SPORANOX® ORAL SOLUTION (220211)CMI
1
SPORANOX
® ORAL
SOLUTION
_Itraconazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SPORANOX Oral
Solution. 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 SPORANOX
Oral Solution against the benefits this
medicine is expected to have for you.
If you have any concerns about
taking SPORANOX Oral Solution,
ask your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT SPORANOX ORAL
SOLUTION IS USED FOR
SPORANOX Oral Solution is a
medicine used for:
•
the treatment of candida (yeast)
infections of the mouth, throat
and/or gullet in patients who have
a lowered resistance to disease.
•
the prevention of fungal
infections in certain patients who
may have a lowered resistance.
SPORANOX works by killing or
stopping the growth of the fungus
that causes the infection.
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.
BEFORE YOU TAKE
SPORANOX ORAL
SOLUTION
_WHEN YOU MUST NOT TAKE IT _
Do not take SPORANOX Oral
Solution if:
•
you are pregnant or may become
pregnant;
•
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 at
night.
•
you have an allergy to
SPORANOX Oral Solution or
any of the ingredients. See
Product Description at the end of
this leaflet.
SPORANOX ORAL SOLUTION MUST
NOT BE TAKEN WITH CERTAIN
MEDICINES. PLEASE REFER TO THE
SECTION 'BEFORE YOU START TO TAKE IT,
TAKING OTHER MEDICINES.' FOR

Summary of Product characteristics

15.220321
Page 1 of 28
SPORANOXoralsoln(220617)API
AUSTRALIAN PRODUCT INFORMATION
SPORANOX

(ITRACONAZOLE)
ORAL SOLUTION
1. NAME OF THE MEDICINE
Itraconazole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SPORANOX oral solution contains itraconazole 10 mg/mL.
Excipients with known effect: saccharin; sorbitol (7.92 g in 40 mL of
solution). Products
containing sorbitol may have a laxative effect or cause diarrhoea.
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Oral liquid, solution.
SPORANOX oral solution is clear, slightly amber to yellow solution,
with a cherry odour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SPORANOX oral solution is indicated for:
•
the
treatment
of
oral
and/or
oesophageal
candidiasis
in
HIV-positive
or
other
immunocompromised patients.
•
prophylaxis of fungal infections in neutropenic patients.
4.2 DOSE AND METHOD OF ADMINISTRATION
SPORANOX oral solution should be taken on an empty stomach at least 1
hour before food.
TREATMENT OF ORAL CANDIDIASIS:
200 mg (2 measuring cups or 20 mL) once a day or 100 mg (1 measuring
cup or 10 mL) twice
a day for 1 week. If there is no response after 1 week, treatment
should be continued for
another week.
TREATMENT OF OESOPHAGEAL CANDIDIASIS
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 OESOPHAGEAL
CANDIDIASIS:
200 mg (2 measuring cups, 20 mL) daily in one or two intakes for 2
weeks. If there is no
response after 2 weeks the dose should be increased to 400 mg/day for
a further 2 weeks.
15.220321
Page 2 of 28
SPORANOXoralsoln(220617)API
PROPHYLAXIS OF FUNGAL INFECTIONS:
5 mg/kg per day administered as a twice daily dose until recovery of
neutrophils for up to
8 weeks (see section 5.1 – PHARMACODYNAMICS – CLINICAL TRIALS –
ANTIFUNGA