FUROSEMIDE INJECTION USP SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

FUROSEMIDE

Tillgänglig från:

STERIMAX INC

ATC-kod:

C03CA01

INN (International namn):

FUROSEMIDE

Dos:

250MG

Läkemedelsform:

SOLUTION

Sammansättning:

FUROSEMIDE 250MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

10X25ML

Receptbelagda typ:

Prescription

Terapiområde:

LOOP DIURETICS

Produktsammanfattning:

Active ingredient group (AIG) number: 0101944003; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2017-08-02

Produktens egenskaper

PRODUCT MONOGRAPH
PR
FUROSEMIDE INJECTION USP
(10 mg/mL)
Sterile
Diuretic
SteriMax Inc.
Date of Preparation: July 31, 2017
2770 Portland Drive
Oakville ON
L6H 6R4
Submission Control No: 199005
_Furosemide Injection USP _
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_Page 2 of 14 _
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FUROSEMIDE INJECTION USP
250 MG/25 ML 10 MG/ML
DIURETIC - PRESERVATIVE FREE
DIURETIC RESTRICTED FOR PATIENTS WITH SEVERELY IMPAIRED RENAL
FUNCTION.
FOR INTRAVENOUS INFUSION (IV INFUSION) ONLY.
CLINICAL PHARMACOLOGY
Furosemide is a potent, rapid-acting, nonthiazide, nonmercurial
diuretic. Animal experiments utilizing
micropuncture and stop flow techniques as well as various clearance
studies in both humans and
experimental animals have demonstrated that furosemide inhibits the
reabsorption of electrolytes in the
ascending limb of the loop of Henle. The drug also decreases
reabsorption of sodium and chloride, and
increases potassium excretion in the distal renal tubule and exerts a
direct effect on electrolyte transport at
the proximal tubule. Furosemide does not inhibit carbonic anhydrase
and is not an aldosterone antagonist.
Its diuretic action is independent of alterations in body acid-base
balance.
After IV administration of furosemide, diuresis occurs within 5
minutes, reaches a maximum within 20–
60 minutes and persists for approximately one to two hours; in
patients with severely impaired renal
function, the diuretic response may be prolonged by as much as eight
hours. Patients exhibit large
variability in diuretic response, with the half-lives ranging between
30-70 minutes (mean of 50 minutes).
Furosemide binds to plasma proteins. The elimination half-life is more
prolonged in patients with
advanced renal failure or concomitant liver disease; in the case of
the former, the half-life was extended to
9.7 hours when 1 g of furosemide was administered IV.
Renal furosemide clearance averages 3.3 mL/minute in patients with
advanced renal failure and is
dependent upon the adequacy of renal function. Nonrenal furosemide
clearance is increased to 35.7
mL/minute in the absen