Kraj: Kanada
Język: angielski
Źródło: Health Canada
ETHACRYNIC ACID (ETHACRYNATE SODIUM)
BAUSCH HEALTH, CANADA INC.
C03CC01
ETACRYNIC ACID
50MG
POWDER FOR SOLUTION
ETHACRYNIC ACID (ETHACRYNATE SODIUM) 50MG
INTRAVENOUS
50ML
Prescription
LOOP DIURETICS
Active ingredient group (AIG) number: 0101703001; AHFS:
APPROVED
2020-12-22
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 Przeczytaj cały dokument