PRO-DILTIAZEM CD CAPSULE (CONTROLLED-DELIVERY)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-08-2023
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Active ingredient:
DILTIAZEM HYDROCHLORIDE
Available from:
PRO DOC LIMITEE
ATC code:
C08DB01
INN (International Name):
DILTIAZEM
Dosage:
300MG
Pharmaceutical form:
CAPSULE (CONTROLLED-DELIVERY)
Composition:
DILTIAZEM HYDROCHLORIDE 300MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0115863008; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-08-30
Summary of Product characteristics
_PRO-DILTIAZEM CD (Diltiazem Hydrochloride) Product Monograph _
_page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-DILTIAZEM CD
Diltiazem Hydrochloride Controlled Delivery Capsules
Controlled Delivery Capsules, 120 mg, 180 mg, 240 mg and 300 mg, Oral
Manufacturer’s Standard
Antihypertensive Agent_ _
Antianginal Agent
PRO DOC LTEE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control Number: 277917
Date of Initial Authorization:
AUG 30, 2023
_Pr _
_PRO-DILTIAZEM CD (Diltiazem Hydrochloride) Product Monograph _
_page 2 of 47 _
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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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
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
.................................................................. 5
4.4
Administration
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