AVA-FUROSEMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FUROSEMIDE

Available from:

AVANSTRA INC

ATC code:

C03CA01

INN (International Name):

FUROSEMIDE

Dosage:

40MG

Pharmaceutical form:

TABLET

Composition:

FUROSEMIDE 40MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

LOOP DIURETICS

Product summary:

Active ingredient group (AIG) number: 0101944001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-08-21

Summary of Product characteristics

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