AMILORIDE HYDROCHLORIDE TABLETS, USP

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

AMILORIDE HYDROCHLORIDE

MAH:

ORBUS PHARMA INC

ATC_code:

C03DB01

INN:

AMILORIDE

dosage:

5MG

pharmaceutical_form:

TABLET

composition:

AMILORIDE HYDROCHLORIDE 5MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

POTASSIUM-SPARING DIURETICS

leaflet_short:

Active ingredient group (AIG) number: 0113867001; AHFS:

authorization_status:

CANCELLED (UNRETURNED ANNUAL)

authorization_date:

2018-04-04

SPC

PRODUCT MONOGRAPH
AMILORIDE HYDROCHLORIDE TABLETS, USP
(amiloride hydrochloride tablets, USP)
Tablets 5 mg
Antikaliuretic Agent with Diuretic Properties
ORBUS PHARMA INC.
Date of Preparation:
20 Konrad Crescent
August 09, 2004
MARKHAM, ONTARIO
L6S 8T4
Date of Revision:
Control #: 093182
1
PRODUCT MONOGRAPH
NAME OF DRUG
AMILORIDE HYDROCHLORIDE TABLETS, USP
(amiloride hydrochloride tablets, USP)
Tablets 5 mg
THERAPEUTIC CLASSIFICATION
Antikaliuretic Agent with Diuretic Properties
ACTION AND CLINICAL PHARMACOLOGY
Amiloride Hydrochloride Tablets, USP is an antikaliuretic drug with
mild natriuretic
diuretic and antihypertensive activity. These activities may be
additive to the effects
of thiazides or other saluretic-diuretic agents. The principal use of
Amiloride
Hydrochloride Tablets, USP is to conserve potassium in selected
patients receiving
kaliuretic-diuretic agents. Amiloride Hydrochloride Tablets, USP
interferes with the
mechanism involved in the exchange of sodium for potassium in the
distal
convoluted tubule and collecting duct of the nephron. An increase in
sodium and
a decrease in potassium and hydrogen ion excretion are induced in the
presence
or absence of aldosterone, thereby suggesting a direct tubular action
of the drug.
Chloride excretion may remain unchanged or increase slowly with
continued
therapy.
Amiloride Hydrochloride Tablets, USP when administered with
hydrochlorothiazide
has been shown to result in less excretion of magnesium than thiazide
or loop
diuretics used alone.
2
Approximately 50% of an oral dose is absorbed. Amiloride Hydrochloride
Tablets,
USP usually begins to act within 2 hours after an oral dose. Its
effect on electrolyte
excretion reaches a peak between 6 and 10 hours and lasts about 24
hours. Peak
plasma levels are obtained in 3 to 4 hours and plasma half-life varies
from 6 to 9
hours.
Amiloride hydrochloride is not metabolized by the liver. About 50% of
a 20 mg dose
of Amiloride Hydrochloride Tablets, USP is excreted unchanged in the
urine and
40% is excreted in the stool with