FLUCONAZOLE ALPHAPHARM fluconazole 200 mg/100 mL solution for infusion bag

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

fluconazole

Disponible des:

Alphapharm Pty Ltd

Designació comuna internacional (DCI):

Fluconazole

Estat d'Autorització:

Registered

Informació per a l'usuari

FLUCONAZOLE
ALPHAPHARM
_contains the active ingredient fluconazole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLUCONAZOLE
Alphapharm.
It does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
FLUCONAZOLE Alphapharm
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT FLUCONAZOLE
ALPHAPHARM IS USED
FOR
FLUCONAZOLE Alphapharm is
used to treat certain fungal and yeast
infections.
It belongs to a group of medicines
called azole antibiotics.
It works by preventing the growth of
the fungal and yeast organisms
causing your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
FLUCONAZOLE ALPHAPHARM
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
FLUCONAZOLE Alphapharm is
available only with a doctor's
prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
FLUCONAZOLE
ALPHAPHARM
_WHEN YOU MUST NOT BE GIVEN_
YOU MUST NOT BE GIVEN
FLUCONAZOLE ALPHAPHARM IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
fluconazole
•
any other medicines related to
fluconazole such as miconazole,
ketoconazole or clotrimazole
•
any of the ingredients listed at the
end of this leaflet (see 'Product
Description').
•
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.
YOU MUST NOT BE GIVEN
FLUCONAZOLE ALPHAPHARM IF
YOU ARE TAKING CISAPRIDE (A
MEDICINE USED TO TREAT STOMACH
PROBLEMS).
YOU MUST NOT BE GIVEN THIS
MEDICINE AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YO

Fitxa tècnica

FLUCONAZOLE
ALPHAPHARM
_Fluconazole _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
Fluconazole
Chemical name
:
2-(2,4-difluorophenyl)-1,3-bis-(1H-1,2,4-triazol-1-yl)propan-2-ol
Structural formula
:
Molecular formula
:
C
13
H
12
F
2
N
6
O
Molecular weight
:
306.3
CAS Registry no.
:
86386-73-4
DESCRIPTION
Fluconazole is a white to off white crystalline powder which is
sparingly soluble in water and saline.
FLUCONAZOLE Alphapharm solution for infusion is a clear, odourless and
colourless solution. The solution
contains active ingredient of 2 mg/mL fluconazole. It is available in
either 50 mL, or 100 mL, or 200 mL infusion
bag with each is formulated with 0.9% sodium chloride solution as
isotonising agent.
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 adrenocorticotrophic
hormone (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.
FLUCONAZOLE ALPHAPHARM – Product Information
2
PHARMACOKINETICS
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 term