Country: Canada
Language: English
Source: Health Canada
HYDROMORPHONE HYDROCHLORIDE
PURDUE PHARMA
N02AA03
HYDROMORPHONE
24MG
CAPSULE (SUSTAINED-RELEASE)
HYDROMORPHONE HYDROCHLORIDE 24MG
ORAL
50
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0108698012; AHFS:
MARKETED
1996-12-31
_ _ _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 ............................... Read the complete document