Loading…
PMS-BUPRENORPHINE-NALOXONE is a brand name for Buprenorphine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-BUPRENORPHINE-NALOXONE (buprenorphine and naloxone) is indicated for: • substitution treatment in adults with problematic opioid drug dependence. 1.1 Pediatrics Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of buprenorphine/naloxone in pediatric…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 09/2023 7 WARNINGS AND PRECAUTIONS, Gastro-intestinal 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...............................................................................................
2 TABLE OF CONTENTS ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .........................................................................
4 1 INDICATIONS .................................................................................................................. 1 Pediatrics ...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX................................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................... 4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
11
, Gastro-intestinal 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...............................................................................................
2 TABLE OF CONTENTS ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .........................................................................
4 1 INDICATIONS .................................................................................................................. 1 Pediatrics ...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX................................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................... 4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
1 Special Populations .................................................................................................. 1 Pregnant Women .....................................................................................................
• Patients who are hypersensitive to buprenorphine, naloxone, or to any ingredient in the formulation (For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • Opioid naïve patients. , acute or severe bronchial asthma, chronic obstructive airway, status asthmaticus, acute respiratory depression, and/or cor pulmonale.
• Patients with severe hepatic impairment. • Patients with acute alcoholism or delirium tremens. , ileus of any type). , acute appendicitis or pancreatitis). • Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
• Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy). • Patients with convulsive or seizure disorders. pms-BUPRENORPHINE-NALOXONE Product Monograph Page 5 of 63
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buprenorphine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
2 Breast-feeding ......................................................................................................... 3 Pediatrics .................................................................................................................
4 Geriatrics ................................................................................................................. 1 Adverse Reaction Overview .....................................................................................
2 Clinical Trial Adverse Reactions ................................................................................ 3 Less Common Clinical Trial Adverse Reactions ........................................................ 5 Post-Market Adverse Reactions ...............................................................................
1 Serious Drug Interactions......................................................................................... 2 Drug Interactions Overview ..................................................................................... 3 Drug-Behavioural Interactions .................................................................................
4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food Interactions ............................................................................................
6 Drug-Herb Interactions ............................................................................................ 7 Drug-Laboratory Test Interactions ........................................................................... 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics.....................................................................................................
1 Clinical Trials by Indication....................................................................................... 2 Comparative Bioavailability Studies ......................................................................... 50 17 SUPPORTING PRODUCT MONOGRAPHS […]