FLUCONAZOLE ALPHAPHARM fluconazole 100 mg/50 mL solution for infusion bag

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

fluconazole

Disponibbli minn:

Alphapharm Pty Ltd

INN (Isem Internazzjonali):

Fluconazole

L-istatus ta 'awtorizzazzjoni:

Registered

Karatteristiċi tal-prodott

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