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M-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: M-EZETIMIBE (Ezetimibe Tablets) 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 M-EZETIMIBE, administered alone or with an HMG-CoA reductase inhibitor (statin), is indicated for: •…
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 M-EZETIMIBE, and should continue on this diet during treatment with M-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with M-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 M-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. M-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 M-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 M-EZETIMIBE tablet is for oral administration. M-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.
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 M-EZETIMIBE, and should continue on this diet during treatment with M-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with M-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 M-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. M-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 M-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:
M-EZETIMIBE should be administered either 2 hours or longer before or 4 hours or longer after administration of a bile acid sequestrant (see
09/2025 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................................................................................ 1 Special Populations..........................................................................................
• M-EZETIMIBE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• The combination of M-EZETIMIBE with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases. • All statins and fenofibrate are contraindicated in pregnant and nursing women.
1 Pregnant Women). • Due to the presence of lactose in M-EZETIMIBE tables, use in patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption or the Lapp lactase deficiency is also contraindicated (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance)
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 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 ................................................
3 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ................................................................................................................ 5 Post-Market Adverse Reactions.......................................................................
14 9 DRUG INTERACTIONS ............................................................................................. 1 Serious Drug Interactions ................................................................................ 2 Drug Interations Overview...............................................................................
4 Drug-Drug Interactions .................................................................................... 5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions ....................................................................................
7 Drug-Laboratory Test Interactions................................................................... 18 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 ................................................................. 32 PATIENT MEDICATION INFORMATION ........................................................................... 33 M-EZETIMIBE (Ezetimibe Tablets) Page 4 of 39 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS M-EZETIMIBE (Ezetimibe Tablets) is indicated as an […]