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SPC-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: SPC-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 SPC-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 SPC-EZETIMIBE, and should continue on this diet during treatment with SPC-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with SPC-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 SPC-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. SPC-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 SPC-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 SPC-EZETIMIBE is for oral administration. SPC-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 SPC-EZETIMIBE, and should continue on this diet during treatment with SPC-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with SPC-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 SPC-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. SPC-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 SPC-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:
SPC-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. 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 .................................................................................................................
6 5 OVERDOSAGE ....................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..........................................
• SPC-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 SPC-EZETIMIBE with a statin is contraindicated in patients with active PrSPC-EZETIMIBE (Ezetimibe Tablets) Product Monograph Page 5 of 36 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 SPC-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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6 7 WARNINGS AND PRECAUTIONS ............................................................................................ 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 ................................................................................. 14 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 .............................................................................
17 10 CLINICAL PHARMACOLOGY ............................................................................................... 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics .....................................................................................................
19 11 STORAGE, STABILITY AND DISPOSAL ................................................................................. 19 12 SPECIAL HANDLING INSTRUCTIONS...................................................................................
19 PART II: SCIENTIFIC INFORMATION ........................................................................................ 20 13 PHARMACEUTICAL INFORMATION....................................................................................
20 14 CLINICAL TRIALS ................................................................................................................ 1 Clinical Trials by Indication .......................................................................................
2 Comparative Bioavailability Studies ........................................................................ 26 15 MICROBIOLOGY ................................................................................................................
27 16 NON-CLINICAL TOXICOLOGY […]