Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
FUROSEMIDE
AVANSTRA INC
C03CA01
FUROSEMIDE
40MG
TABLET
FUROSEMIDE 40MG
ORAL
100
Prescription
LOOP DIURETICS
Active ingredient group (AIG) number: 0101944001; AHFS:
CANCELLED POST MARKET
2014-08-21
0 PRODUCT MONOGRAPH AVA-FUROSEMIDE FUROSEMIDE TABLETS USP 20, 40 AND 80 MG DIURETIC AVANSTRA INC. DATE OF PREPARATION: 10761 – 25 TH NE, SUITE 110, BUILDING “B” March 2, 2011 CALGARY, ALBERTA T2C 3C2 CONTROL NO.: 145249 1 PRODUCT MONOGRAPH AVA-FUROSEMIDE Furosemide Tablets USP 20, 40 and 80 mg THERAPEUTIC CLASSIFICATION Diuretic ACTIONS AND CLINICAL PHARMACOLOGY Animal experiments using stop-flow and micropuncture techniques have demonstrated that furosemide inhibits sodium reabsorption in the ascending limb of Henle's loop as well as in both proximal and distal tubules. The action of furosemide on the distal tubule is independent of any inhibitory effect on carbonic anhydrase or aldosterone. Furosemide may promote diuresis in cases which have previously proved resistant to other diuretics. Furosemide has no significant pharmacological effects other than on renal function. Absorption, Metabolism and Excretion: In man, furosemide is rapidly absorbed from the gastrointestinal tract. The diuretic effect of furosemide is apparent within 1 hour following oral administration and the peak effect occurs in the first or second hour. The duration of action is 4 to 6 hours but may continue up to 8 hours. Following i.v. administration of the drug, the diuresis occurs within 30 minutes and the duration of action is about 2 hours. 2 Urinary excretion is accomplished both by glomerular filtration and proximal tubular secretion, together this accounts for roughly only 2/3 of the ingested dose, the remainder being excreted in the feces. A small fraction is metabolized by cleavage of the side chain. Table 1 summarizes the elimination kinetics of furosemide. TABLE 1 - FUROSEMIDE ELIMINATION KINETICS SUBJECTS ROUTE OF ADMINISTRATION DOSE (MG) RATE OF ADMINISTRATION BILLIARY EXCRETION MAX. SERUM CONCENTRATION T 1/2 (H) Normal Oral 40 - 10 to 15% <1 µg/mL 4.0 Normal I.V. 40 Bolus 10 to 15% 2.5 µg/mL 4.5 Renal insufficiency I.V. 1000 25 mg/min 60% 53 μ g/mL 13.5 Renal insufficiency I.V. 1000 4 mg/min - 29 μ g/mL - INDICATIONS Přečtěte si celý dokument