DOM-ENALAPRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ENALAPRIL SODIUM

Available from:

DOMINION PHARMACAL

ATC code:

C09AA02

INN (International Name):

ENALAPRIL

Dosage:

8MG

Pharmaceutical form:

TABLET

Composition:

ENALAPRIL SODIUM 8MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152325002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2017-05-03

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
DOM-ENALAPRIL
Enalapril Tablets
2.5 mg, 5 mg, 10 mg and 20 mg
Each tablet is made with 2.5 mg, 5 mg, 10 mg or 20 mg of enalapril
maleate that appears as
2 mg, 4 mg, 8 mg or 16 mg of enalapril sodium in the tablets
Angiotensin Converting Enzyme Inhibitor
DOMINIUM PHARMACAL.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
April 12, 2011
Montreal, Quebec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO. 145478
_ _
_Dom-ENALAPRIL Product Monograph _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY
PRODUCT
INFORMATION
.........................................................................3
INDICATIONS
AND
CLINICAL
USE...............................................................................3
CONTRAINDICATIONS....................................................................................................4
ADVERSE
REACTIONS
....................................................................................................9
DRUG
INTERACTIONS...................................................................................................13
DOSAGE
AND
ADMINISTRATION...............................................................................14
OVERDOSAGE.................................................................................................................17
ACTION
AND
CLINICAL
PHARMACOLOGY
.............................................................17
STORAGE
AND
STABILITY...........................................................................................19
PART II: SCIENTIFIC
INFORMATION.................................................................................21
PHARMACEUTICAL
INFORMATION
..........................................................................21
CLINICAL
TRIALS...........................................................................................................22
DETAILED
PHARMACOLOGY...........................................................