FRUSEMIDE SANOFI HIGH DOSE furosemide (frusemide) 250mg/25mL injection ampoule

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

furosemide (frusemide)

Dostępny od:

Sanofi-Aventis Australia Pty Ltd

INN (International Nazwa):

furosemide (frusemide)

Charakterystyka produktu

frusemide-sanofi-high-dose-ccdsv12-piv13-15sep17
1
PRODUCT INFORMATION
FRUSEMIDE SANOFI HIGH DOSE
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Furosemide (frusemide)
CHEMICAL STRUCTURE
CAS NUMBER
54-31-9
DESCRIPTION
Frusemide
Sanofi
is
an
anthranilic
acid
derivative.
Chemically
it
is
4-chloro-N-furfuryl-5-
sulphamoylanthranilic acid. Furosemide (frusemide) is a white to
off-white odourless crystalline
powder. It is practically insoluble in water, sparingly soluble in
alcohol, freely soluble in dilute alkali
solutions and insoluble in dilute acids.
Frusemide Sanofi High Dose injection contains 250 mg/25 mL furosemide
(frusemide) in water for
injection (without solubiliser, pH about 9): Inactive ingredients
include mannitol and sodium
hydroxide. Contains 0.03 mmol/mL of sodium.
PHARMACOLOGY
SITE AND MODE OF ACTION
Frusemide Sanofi is a potent diuretic. It inhibits sodium and chloride
absorption in the ascending
limb of Henle's loop and in both the proximal and distal tubules. The
high degree of efficacy is due
to this unique site of action. The action on the distal tubule is
independent of any inhibitory effect
on carbonic anhydrase or aldosterone.
Furosemide (frusemide) may promote diuresis in cases which have
previously proved resistant to
other diuretics.
Furosemide (frusemide) has no significant pharmacological effects
other than on renal function.
PHARMACOKINETICS
Absorption
Furosemide (frusemide) is rapidly absorbed from the GIT. Absorption
rates in healthy subjects have
been reported from 60-69% and from 43-46% in patients with end stage
renal failure.
The onset of diuresis following oral administration is within 1 hour.
The peak effect occurs within
the first or second hour. The duration of diuretic effect is 6 to 8
hours.
The onset of diuresis following intravenous administration is within 5
minutes and somewhat later
after intramuscular administration. The peak effect occurs within the
first half hour. The duration of
diuretic effect is approximately 2 hours.
In fasted normal men, the mean bioavailability of