SODIUM EDECRIN POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ETHACRYNIC ACID (ETHACRYNATE SODIUM)

Disponible depuis:

BAUSCH HEALTH, CANADA INC.

Code ATC:

C03CC01

DCI (Dénomination commune internationale):

ETACRYNIC ACID

Dosage:

50MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

ETHACRYNIC ACID (ETHACRYNATE SODIUM) 50MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

50ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

LOOP DIURETICS

Descriptif du produit:

Active ingredient group (AIG) number: 0101703001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-12-22

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
EDECRIN
®
Ethacrynic acid tablets, USP
25 mg
PR
SODIUM EDECRIN
®
Ethacrynate sodium for injection, USP
Lyophilized powder for injection, 50 mg equivalent to ethacrynic acid,
intravenous
SALURETIC-DIURETIC AGENT
BAUSCH HEALTH, CANADA INC
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Control #: 246160
EDECRIN
®
is a registered trademark of Bausch Health Companies Inc. or its
affiliates.
December
22, 2020
DATE OF
REVISION:
_Pr_
_EDECRIN & SODIUM EDECRIN_
_®_
_ Product Monograph Page 2 of 15_
PRODUCT MONOGRAPH
PR
EDECRIN
®
Ethacrynic acid tablets, USP
25 mg
PR
SODIUM EDECRIN
®
Ethacrynate sodium for injection, USP
Lyophilized powder for injection, 50 mg equivalent to ethacrynic acid,
intravenous
ACTION AND CLINICAL PHARMACOLOGY
EDECRIN (ethacrynic acid) is a saluretic-diuretic agent with marked
potency and rapid onset of
action. It is chemically unrelated to other diuretics. Patients with
congestive heart failure
(including acute pulmonary edema), renal edema, hepatic cirrhosis with
ascites, and other
conditions involving fluid retention have responded well to ethacrynic
acid.
EDECRIN has the following major characteristics:
(1)
WATER AND ELECTROLYTE EXCRETION
may be increased several times over that observed with
thiazide diuretics. The urinary output is usually dose-dependent and
related to the magnitude of
fluid accumulation.
2)
ELECTROLYTE EXCRETION PATTERN DIFFERS FROM THAT OF THIAZIDES.
Initially, sodium and chloride
excretion is usually substantial, and chloride loss exceeds that of
sodium. With prolonged
therapy, chloride excretion declines, and potassium and hydrogen ion
excretion may increase.
In patients with increased diuresis excessive amounts of potassium may
be excreted. Ethacrynic
acid is effective whether or not there is clinical acidosis or
alkalosis.
(3)
RAPID ONSET OF ACTION
usually is observed within 30 minutes after an oral dose or within 5
minutes after an intravenous injection.
(4)
DURATION OF ACTION IS MODERATE
following oral administration (6 to 8 hours). The pea