APO-QUINAPRIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-07-2019
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Active ingredient:
QUINAPRIL (QUINAPRIL HYDROCHLORIDE)
Available from:
APOTEX INC
ATC code:
C09AA06
INN (International Name):
QUINAPRIL
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
QUINAPRIL (QUINAPRIL HYDROCHLORIDE) 5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0123206001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-07-02
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
APO-QUINAPRIL
QUINAPRIL TABLETS
APOTEX STANDARD
5 MG, 10 MG, 20 MG AND 40 MG
QUINAPRIL (AS QUINAPRIL HYDROCHLORIDE)
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JULY 10, 2019
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 207079
Page 2 of 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.............................................................
3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................
3
CONTRAINDICATIONS
.................................................................................................
4
WARNINGS AND PRECAUTIONS
................................................................................
5
ADVERSE REACTIONS
................................................................................................
12
DRUG INTERACTIONS
................................................................................................
16
DOSAGE AND ADMINISTRATION
............................................................................
21
OVERDOSAGE
..............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 23
STORAGE AND STABILITY
........................................................................................
26
DOSAGE FORMS, COMPOSTION AND
PACKAGING............................................. 26
PART II: SCIENTIFIC INFORMATION
..................................................................................
27
PHARMACEUTICAL INFORMATION
........................................................................
27
CLINICAL TRIALS
........................................................................................................
29
DETAILED PHARMACOLOGY
...............................................................
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