Loading…
AURO-EZETIMIBE is a brand name for Ezetimibe, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics, 1.2 Geriatrics 08/2024
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 08/2024 7 WARNINGS AND PRECAUTIONS 08/2024 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 .........................................................................................................
5 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 ..............................................................................................................
6 5 OVERDOSAGE ..................................................................................................................... 7
1 Dosing Considerations • Patients should be placed on a standard cholesterol-lowering diet at least equivalent to the NCEP Adult Treatment Panel III (ATP III) TLC diet before receiving Auro-Ezetimibe, and should continue on this diet during treatment with Auro-Ezetimibe.
If appropriate, a Auro-Ezetimibe Product Monograph Page 6 of 39 program of weight control and physical exercise should be implemented. • Prior to initiating therapy with Auro-Ezetimibe, secondary causes for elevations in plasma lipid levels should be excluded.
A lipid profile should also be performed. 2 Recommended Dose and Dosage Adjustment The recommended dose of Auro-Ezetimibe is 10 mg once daily orally, alone, with a statin, or with fenofibrate. Auro-Ezetimibe can be taken with or without food at any time of the day but preferably at the same time each day.
4 Geriatrics). 3 Pediatrics).
Use in Patients with Hepatic Impairment:
No dosage adjustment is required in patients with mild hepatic insufficiency (Child-Pugh score 5 to 6). Treatment with Auro-Ezetimibe is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score >9) liver dysfunction (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Patients with Liver Impairment).
Use in Patients with Renal Impairment:
No dosage adjustment is required for patients with renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal).
Co-administration with Bile Acid Sequestrants:
Auro-Ezetimibe should be administered either 2 hours or longer before or 4 hours or longer after administration of a bile acid sequestrant (see
08/2024 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 .........................................................................................................
5 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 ..............................................................................................................
6 5 OVERDOSAGE ..................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................................ 7 7 WARNINGS AND PRECAUTIONS ..........................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ezetimibe 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.
1 Special Populations ................................................................................................. 1 Pregnant Women .................................................................................................
2 Breast-feeding ...................................................................................................... 3 Pediatrics .............................................................................................................
4 Geriatrics .............................................................................................................. 10 8 ADVERSE REACTIONS........................................................................................................
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................... 3 Less Common Clinical Trial Adverse Reactions ........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings ........................................................................ 5 Post-Market Adverse Reactions ..............................................................................
15 9 DRUG INTERACTIONS ....................................................................................................... 1 Serious Drug Interactions ........................................................................................
2 Drug Interactions Overview .................................................................................... 4 Drug-Drug Interactions............................................................................................ 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions .......................................................................... 19 10 CLINICAL PHARMACOLOGY .............................................................................................
1 Mechanism of Action ............................................................................................ 2 Pharmacodynamics ............................................................................................... 3 Pharmacokinetics ..................................................................................................
20 11 STORAGE, STABILITY AND DISPOSAL............................................................................... 21 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................
21 PART II: SCIENTIFIC INFORMATION ...................................................................................... 22 13 PHARMACEUTICAL INFORMATION .................................................................................
22 14 CLINICAL TRIALS ............................................................................................................. 1 Clinical Trials by Indication ....................................................................................
2 Comparative Bioavailability Studies ...................................................................... 28 15 MICROBIOLOGY ..............................................................................................................
29 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 29 17 SUPPORTING PRODUCT MONOGRAPHS […]