CODEINE CONTIN 100MG CONTROLLED RELEASE TAB TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CODEINE (CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE)

Available from:

PURDUE PHARMA

ATC code:

R05DA04

INN (International Name):

CODEINE

Dosage:

100MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

CODEINE (CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE) 100MG

Administration route:

ORAL

Units in package:

50

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0153086004; AHFS:

Authorization status:

MARKETED

Authorization date:

1995-12-31

Summary of Product characteristics

_CODEINE CONTIN_
_®_
_ (codeine controlled release tablets) _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
CODEINE CONTIN
®
Codeine Controlled Release Tablets
Tablets, 50 mg, 100 mg, 150 mg and 200 mg, Oral
Purdue Pharma Standard
Opioid Analgesic
Purdue Pharma
575 Granite Court
Pickering, ON
L1W 3W8
Date of Initial Approval:
June 02, 1995
Date of Revision:
August 7, 2020
Submission Control No: 237940
CODEINE CONTIN
®
is a registered trademark of Purdue Pharma
_CODEINE CONTIN_
_®_
_ (codeine controlled release tablets) _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, Sept 2018
1 INDICATIONS, 1.1 Pediatrics, Sept 2018
2 CONTRAINDICATIONS, Sept 2018
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Life-threatening Respiratory
Depression:
OVERDOSE, Sept 2018
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment (Opioid
Rotation), Sept 2018
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment,
Adjustment or Reduction of Dosage, Sept 2018
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment,
Children under 12, Sept 2018
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance, Use in Drug and
Alcohol
Addiction, Sept 2018
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Sept 2018
7 WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome
(NOWS), July
2020
7 WARNINGS AND PRECAUTIONS, Neurologic, Sept 2018
7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity/Serotonin
Syndrome, July
2020
7 WARNINGS AND PRECAUTIONS, Respiratory, Sleep Apnea, July 2020
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women, Sept
2018
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.2
Breast-feeding, Sept 2018
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics,
Sept 2018
9 DRUG INTERACTIONS, 9.2 Overview, Sept 2018
10 ACTION AND CLINICAL PHARMACOLOGY, Special Populations and
Conditions,
Pediatrics, Sept 2018
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..............................................