HYDROMORPH CONTIN-CONTROLLED RELEASE CAP - 6MG CAPSULE (SUSTAINED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROMORPHONE HYDROCHLORIDE

Available from:

PURDUE PHARMA

ATC code:

N02AA03

INN (International Name):

HYDROMORPHONE

Dosage:

6MG

Pharmaceutical form:

CAPSULE (SUSTAINED-RELEASE)

Composition:

HYDROMORPHONE HYDROCHLORIDE 6MG

Administration route:

ORAL

Units in package:

50

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0108698010; AHFS:

Authorization status:

MARKETED

Authorization date:

1995-12-31

Summary of Product characteristics

_ _
_HYDROMORPH CONTIN_
_® _
_(HYDROmorphone hydrochloride controlled release capsules) _
_ _
_ _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
HYDROMORPH CONTIN
®
HYDROmorphone* hydrochloride Controlled Release Capsules
Capsules, 3 mg, 4.5 mg, 6 mg, 9 mg, 10 mg, 12 mg, 18 mg, 20 mg, 24 mg
and 30 mg, Oral
Purdue Pharma Standard
Opioid Analgesic
ATC code:
N02AA03
Purdue Pharma
3381 Steeles Avenue East Suite 310
Toronto, ON
M2H 3S7
Date of Initial Approval:
August 9, 1994
Date of Revision:
August 25, 2023
Submission Control No: 273931
HYDROMORPH CONTIN
®
is a registered trademark of Purdue Pharma
DILAUDID
®
is a registered trademark of Purdue Pharma
*HYDROmorphone is the name of the active chemical ingredient
(hydromorphone) and is not a
brandname/tradename.
_ _
_HYDROMORPH CONTIN_
_® _
_(HYDROmorphone hydrochloride controlled release capsules) _
_ _
_ _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION
08/2023
7 WARNINGS AND PRECAUTIONS
08/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
...............................