CLORAZEPATE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLORAZEPATE DIPOTASSIUM

Available from:

AA PHARMA INC

ATC code:

N05BA05

INN (International Name):

CLORAZEPATE POTASSIUM

Dosage:

15MG

Pharmaceutical form:

CAPSULE

Composition:

CLORAZEPATE DIPOTASSIUM 15MG

Administration route:

ORAL

Units in package:

100/500/1000

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0108895003; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-06-02

Summary of Product characteristics

_CLORAZEPATE (Clorazepate dipotassium) _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CLORAZEPATE
Clorazepate dipotassium
Capsules, 3.75 mg, 7.5 mg and 15 mg, oral
ATC Code: N05BA05
Anxiolytic-Sedative
AA PHARMA INC.
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
DEC 31, 1990
Date of Revision:
DEC 16, 2021
Submission Control Number: 253157
_ _
_CLORAZEPATE (Clorazepate dipotassium) _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
12/2021
3 Serious Warnings and Precautions Box
12/2021
4 Dosage and Administration, 4.1 Dosing considerations
12/2021
7 Warnings and Precautions
12/2021
7 Warnings and Precautions, 7.1.4 Geriatrics
12/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
R