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CPPI100928
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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
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製品の特徴
CCDS121018
SPORANOXoralsoln(130131)API.doc
Page 1 of 14
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
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