DBL FLUCONAZOLE (Fluconazole) 150mg capsule strip packs

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

fluconazole

Disponible depuis:

Pfizer Australia Pty Ltd

DCI (Dénomination commune internationale):

Fluconazole

Statut de autorisation:

Registered

Notice patient

DBL
®
Fluconazole Capsules CMI
Page 1
DBL
®
FLUCONAZOLE CAPSULES
Fluconazole
(
_flu-con-a-zol)_
_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL
®
Fluconazole 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
fluconazole against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT DBL
®
FLUCONAZOLE CAPSULES
ARE USED FOR
This medicine is used to treat
fungal and yeast infections_ _
This medicine belongs to a group
of medicines called azole
antibiotics.
It works by preventing the growth
of the fungal and yeast
organisms._ _
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU
.
Your doctor may have prescribed
it for another reason.
This medicine is not addictive.
It is available only with a doctor’s
prescription.
BEFORE YOU TAKE DBL
®
FLUCONAZOLE CAPSULES
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FLUCONAZOLE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
fluconazole
•
any of the ingredients listed at
the end of this leaflet
•
any other similar medicines
such as miconazole,
ketoconazole or clotrimazole.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
IF YOU ARE RECEIVING DOSES OF
400 MG OR MORE A DAY OF
FLUCONAZOLE, DO NOT TAKE
TERFENADINE, A MEDICINE USED TO
TREAT ALLERGIES.
DO NOT TAKE FLUCONAZOLE IF YOU
ARE TAKING CISAPRIDE, A
MEDICINE USED TO TREAT STOMACH
PROBLEMS.
DO NOT TAKE THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
If it has expired or is damag

Résumé des caractéristiques du produit

Product Information - Australia
Version 2.0
Page 1
DBL
®
FLUCONAZOLE CAPSULES
NAME OF THE MEDICINE
Fluconazole
The chemical structure is shown below:
C
13
H
12
F
2
N
6
O
CAS 86386-73-4
DESCRIPTION
Fluconazole is a bis-triazole,
2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)-2-propanol.
Fluconazole is a white to off-white crystalline powder which is
sparingly soluble in water and saline. It
has a molecular weight of 306.3.
DBL
®
Fluconazole Capsules are available as gelatin capsules containing 50
mg, 100 mg, 150 mg or
200 mg fluconazole. Other ingredients - gelatin, lactose, starch –
pregelatinised maize, silicon dioxide,
magnesium stearate, sodium lauryl sulfate, titanium dioxide, quinoline
yellow and indigo carmine (150
mg and 200 mg capsules only).
PHARMACOLOGY
PHARMACODYNAMICS
Fluconazole is a member of the bis-triazole class of antifungal
agents. Fluconazole is a highly selective
inhibitor of fungal cytochrome P-450 sterol C-14 alpha demethylation.
Mammalian cell demethylation is
much less sensitive to fluconazole inhibition. The subsequent loss of
normal sterols correlates with the
accumulation of 14 alpha-methyl sterols in fungi and may be
responsible for the fungistatic activity of
fluconazole.
Fluconazole 50 mg daily given up to 28 days has been shown not to
affect corticosteroid levels or ACTH
stimulated response in healthy female volunteers. Plasma oestradiol
levels and urinary free cortisol levels
were decreased with little effect on plasma testosterone levels.
Interaction studies with antipyrine indicate
that single or multiple doses of fluconazole 50 mg do not affect its
metabolism.
_ _
PHARMACOKINETICS AND METABOLISM
_Adults: _
The pharmacokinetic properties of fluconazole are similar following
administration by the
intravenous or oral routes. In normal volunteers, the bioavailability
of orally administered fluconazole is
over 90% compared with intravenous administration. In fasted normal
volunteers, peak plasma
concentrations occur between 1 and 2 hours post dose with a terminal
plasma e