NOVAMILOR TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

זמין מ:

TEVA CANADA LIMITED

קוד ATC:

C03EA01

INN (שם בינלאומי):

HYDROCHLOROTHIAZIDE AND POTASSIUM-SPARING AGENTS

כמות:

5MG; 50MG

טופס פרצבטיות:

TABLET

הרכב:

AMILORIDE HYDROCHLORIDE 5MG; HYDROCHLOROTHIAZIDE 50MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/500/1000

סוג מרשם:

Prescription

איזור תרפויטי:

POTASSIUM-SPARING DIURETICS

leaflet_short:

Active ingredient group (AIG) number: 0213868001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2021-07-29

מאפייני מוצר

PRODUCT MONOGRAPH
PR
NOVAMILOR
(AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS USP)
EACH TABLET CONTAINS 5 MG OF AMILORIDE HYDROCHLORIDE
AND 50 MG OF HYDROCHLOROTHIAZIDE
DIURETIC -ANTIHYPERTENSIVE
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
May 8, 2014
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control#: 173375
2
PRODUCT MONOGRAPH
NOVAMILOR
(AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS USP)
EACH TABLET CONTAINS 5 MG OF AMILORIDE HYDROCHLORIDE
AND 50 MG OF HYDROCHLOROTHIAZIDE
THERAPEUTIC CLASSIFICATION
DIURETIC - ANTIHYPERTENSIVE
ACTION AND CLINICAL PHARMACOLOGY
NOVAMILOR (amiloride hydrochloride and hydrochlorothiazide) is a
diuretic-antihypertensive
that combines the potent natriuretic action of hydrochlorothiazide
with the potassium-conserving
property of amiloride hydrochloride. Amiloride hydrochloride’s
diuretic and antihypertensive
actions are additive with the natriuretic, diuretic and
antihypertensive activities of the thiazide
while potassium loss is minimized and the possibility of acid-base
imbalance is decreased. The
onset of the diuretic action occurs within 1 to 2 hours of
administration and this action appears to
be sustained for approximately 24 hours.
AMILORIDE HYDROCHLORIDE
Amiloride hydrochloride is an antikaliuretic drug. It has mild
natriuretic, diuretic and
antihypertensive activities which may be additive to the actions of
thiazides or other saluretic-
diuretic agents. The principal use of amiloride hydrochloride is to
conserve potassium in patients
who are receiving kaliuretic-diuretic agents. Amiloride hydrochloride
is not an aldosterone
antagonist and thus its action is not related to the level of
aldosterone excretion. It acts directly
on the distal portion of the nephron resulting in an increase in
sodium excretion and a decrease in
potassium and hydrogen ion excretion. Chloride excretion may remain
unchanged; however,
prolonged therapy may result in a gradual increase in chloride.
Approximately 50% of an oral dose is absorbed. Th