SECTRAL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE)

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

C07AB04

INN (International Name):

ACEBUTOLOL

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

ACEBUTOLOL (ACEBUTOLOL HYDROCHLORIDE) 200MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0131282003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-08-09

Summary of Product characteristics

_SECTRAL Product Monograph _
_Page 1 of 33 _
PRODUCT MONOGRAPH
P
r
SECTRAL
®
Acebutolol tablets, Mfr. Std.
Tablets 100 mg and 200 mg Acebutolol, as Acebutolol hydrochloride
_ _
_ _
_ _
100 mg and 200 mg Tablets
Antihypertensive and Anti-anginal Agent
ATC Code: C07AB04
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
November 6, 2018
Submission Control No.: 219176
_SECTRAL Product Monograph _
_Page 2 of 33 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS
...........................................................................................................
9
DRUG
INTERACTIONS
.........................................................................................................
12
DOSAGE
AND
ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
15
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
16
STORAGE
AND
STABILITY
.................................................................................................
18
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFORMATION
..............................