DILAUDID TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROMORPHONE HYDROCHLORIDE

Available from:

PURDUE PHARMA

ATC code:

N02AA03

INN (International Name):

HYDROMORPHONE

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

HYDROMORPHONE HYDROCHLORIDE 1MG

Administration route:

ORAL

Units in package:

25/100

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0108698004; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-08-07

Summary of Product characteristics

_ _
_DILAUDID_
_®_
_ (HYDROmorphone hydrochloride) Page 1 of 37 _
_ _
_ _
PRODUCT MONOGRAPH
_ _
INCLUDING PATIENT MEDICATION INFORMATION
N
DILAUDID
®
HYDROmorphone* hydrochloride
Tablets, 1 mg, 2 mg, 4 mg and 8 mg, Oral
Sterile Solution for Injection, 2 mg/mL, Intramuscular, Intravenous,
Subcutaneous
USP Standard
Opioid Analgesic
ATC code:
N02AA03
Purdue Pharma
3381 Steeles Avenue East Suite 310
Toronto, ON
M2H 3S7
Date of Initial Approval:
August 8, 2008
_ _
Date of Revision:
August 29, 2023
Submission Control No: 273917
DILAUDID
® is a registered trademark of Purdue Pharma
*HYDROmorphone is the name of the active chemical ingredient
(hydromorphone) and is not a
brandname/tradename.
_ _
_DILAUDID_
_®_
_ (HYDROmorphone hydrochloride) Page 2 of 37 _
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RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION
08/2023
7 WARNINGS AND PRECAUTIONS
08/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
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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
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4
DOSAGE AND ADMINISTRATION
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6
4.1 Dosing Considerations
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6
4.2 Recommended Dose and Dosage Adjustment
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