TARKA TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VERAPAMIL HYDROCHLORIDE; TRANDOLAPRIL

Available from:

ABBOTT LABORATORIES, LIMITED

ATC code:

C09BB10

INN (International Name):

TRANDOLAPRIL AND VERAPAMIL

Dosage:

240MG; 1MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

VERAPAMIL HYDROCHLORIDE 240MG; TRANDOLAPRIL 1MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0233661004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-11-12

Summary of Product characteristics

_TARKA® Product Monograph_
_Page 1 of 45_
PRODUCT MONOGRAPH
PR
TARKA
®
Sustained-Release Tablets
trandolapril/verapamil hydrochloride
1/180 mg, 2/180 mg, 1/240 mg, 2/240 mg, 4/240 mg
Antihypertensive Agent
Abbott Laboratories, Limited
8401 Trans Canada Highway
Saint-Laurent (QC) CANADA
H4S 1Z1
Date of Preparation:
June 22, 2001
Date of Revision:
February 13, 2007
Submission Control No.: 109661
_TARKA® Product Monograph_
_Page 2 of 45_
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 . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 11
DRUG INTERACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 15
DOSAGE AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . 23
OVERDOSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 26
ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 27
STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 30
DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . .
. . . . . . . 30
PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . 32
PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 32
DETAILED PHARMACOLOGY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . .