TARGIN TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Available from:

PURDUE PHARMA

ATC code:

N02AA55

INN (International Name):

OXYCODONE AND NALOXONE

Dosage:

40MG; 20MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

OXYCODONE HYDROCHLORIDE 40MG; NALOXONE HYDROCHLORIDE 20MG

Administration route:

ORAL

Units in package:

50/60/100/250/10/14/20/28/30/50/56/60/98

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0252684003; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-12-16

Summary of Product characteristics

_TARGIN_
_® _
_(Oxycodone Hydrochloride/Naloxone Hydrochloride Controlled Release) _
_Page 1 of 63 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
TARGIN
®
Oxycodone Hydrochloride/Naloxone Hydrochloride Controlled Release
Tablets
Tablets, 5/2.5 mg, 10/5 mg, 20/10 mg and 40/20 mg, Oral
Purdue Pharma Standard
Opioid Analgesic
Purdue Pharma
3381 Steeles Avenue East Suite 310
Toronto, ON
M2H 3S7
Date of Initial Authorization:
December 16, 2009
Date of Revision:
January 08, 2024
Submission Control Number: 273393
TARGIN
®
is a trademark of Purdue Pharma
_TARGIN_
_® _
_(Oxycodone Hydrochloride/Naloxone Hydrochloride Controlled Release) _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
10/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dose Adjustment
10/ 2023
7 WARNING AND PRECAUTIONS, Addiction, Abuse and Misuse
10/2023
7 WARNING AND PRECAUTIONS, Dependence/Tolerance
10/ 2023
7 WARNING AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
10/ 2023
7 WARNING AND PRECAUTIONS, Neurologic
10/ 2023
7 WARNING AND PRECAUTIONS, Reproductive Health: Female
and Male Potential
10/ 2023
7 WARNINGS AND PRECAUTIONS, Respiratory
10/2023
7 WARNING AND PRECAUTIONS, 7.1 Special Populations,
Patients with Hepatic and Renal Impairment
10/ 2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
.....................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
...........................................................................................................
4
1.2
Geriatrics...........................................................................................................