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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: Ezetimibe (ezetimibe) is indicated as an adjunct to lifestyle changes, including diet, when the response to diet and other non-pharmacological measures alone has been inadequate. Primary Hypercholesterolemia Ezetimibe, administered alone or with an HMG-CoA reductase inhibitor (statin), is indicated for: • the…
Verbatim from this product's HC label. Tap a section to expand.
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 Ezetimibe, and should continue on this diet during treatment with Ezetimibe.
If appropriate, a program of weight control and physical exercise should be implemented. Ezetimibe Page 6 of 40 • Prior to initiating therapy with 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 Ezetimibe is 10 mg once daily orally, alone, with a statin, or with fenofibrate. 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 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). 4 Drug-Drug Interactions, Cholestyramine). 4 Administration Ezetimibe tablet is for oral administration. Ezetimibe can be taken with or without food at any time of the day but preferably at the same time each day.
5 Missed Dose The recommended dosing regimen is one tablet, once daily. If a dose is missed, the patient should be counselled to resume the usual schedule of one tablet daily.
5 Post-Market Adverse Reactions). 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 Ezetimibe, and should continue on this diet during treatment with Ezetimibe.
If appropriate, a program of weight control and physical exercise should be implemented. Ezetimibe Page 6 of 40 • Prior to initiating therapy with 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 Ezetimibe is 10 mg once daily orally, alone, with a statin, or with fenofibrate. 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 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:
Ezetimibe should be administered either 2 hours or longer before or 4 hours or longer after administration of a bile acid sequestrant (see
09/2024 7 WARNINGS AND PRECAUTIONS, Immune 09/2024 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 09/2024 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 ............................................................................................................. 6 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.
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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 Ezetimibe Page 3 of 40 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 ..............................................................................................................
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 ........................................................................ 29 15 MICROBIOLOGY ........................................................................................................
29 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 30 17 SUPPORTING PRODUCT MONOGRAPHS […]