SPORANOX

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Itraconazole

Available from:

Janssen-Cilag Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

 
CPPI100928 
Page 1 of 5 
SPORANOX(110113)ACI.doc 
SPORANOX
®
 CAPSULES 
_Itraconazole _
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions 
about SPORANOX 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 
SPORANOX capsules against the benefits this 
medicine is expected to have for you. 
If you have any concerns about taking 
SPORANOX capsules, ask your doctor or 
pharmacist.   
Keep this leaflet with your medicine.  You may 
need to read it again. 

WHAT SPORANOX CAPSULES ARE 
USED FOR 
SPORANOX 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. 
SPORANOX works by killing or stopping the 
growth of the fungus that causes the infection. 
Your doctor may have prescribed SPORANOX 
capsules for another reason.  Ask your doctor if 
you have any questions about why this medicine 
has been prescribed for you. 

BEFORE YOU TAKE SPORANOX 
CAPSULES 
WHEN YOU MUST NOT TAKE IT_ _
Do not take SPORANOX capsules 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

Summary of Product characteristics

CCDS121018 
SPORANOXoralsoln(130131)API.doc 
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SPORANOX
®
 ORAL SOLUTION 
PRODUCT INFORMATION 
NAME OF THE DRUG 
Itraconazole 
DESCRIPTION 
Itraconazole is a synthetic triazole antifungal agent. It has
three chiral centres and is a 1:1:1:1 
racemic mixture of four diastereomers (two enantiomeric pairs). 

 CAS-84625-61-6 
 C
35
H
38
Cl
2
N
8
O
4

  MW: 
705.64 

(
±)-cis-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-
yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2,4-dihydro-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one. 
It is a white to slightly yellowish powder, insoluble in water
at pH 1-12, very slightly soluble in 
alcohols and freely soluble in dichloromethane. 
SPORANOX oral solution contains itraconazole 10 mg/mL,
hydroxypropyl-beta-cyclodextrin, 
sorbitol, propylene glycol, hydrochloric acid, cherry flavour 1,
cherry flavour 2, caramel flavour, 
saccharin sodium, sodium hydroxide and purified water. 
PHARMACOLOGY 
_In vitro_
 studies have demonstrated that itraconazole inhibits the cytochrome
P450-dependent 
synthesis of ergosterol, which is a vital component of fungal cell
membranes. 
PHARMACOKINETICS_ _
The oral bioavailability of SPORANOX oral solution is maximal when
it is taken without food.  
During chronic administration, steady state is reached after 1-2
weeks.  Peak plasma levels 
are observed 2 hours (fasting) to 5 hours (with food)
following oral solution administration.  
After repeated administration of SPORANOX oral solution, at a
dosage of 200 mg once a day 
in fasting condition, steady state plasma concentrations of
itraconazole fluctuate between 1 
and 2 micrograms/mL (trough to peak).  When SPORANOX oral
solution is taken with food, 
steady state plasma concentrations of itraconazole are about 25%
lower. 
The bioavailability of SPORANOX oral solution taken in a fasting
condition is approximately 
60% higher than the bioa