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PMS-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: pms-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 pms-EZETIMIBE, administered alone or with an HMG-CoA reductase inhibitor (statin), is indicated…
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 pms-EZETIMIBE, and should continue on this diet during treatment with pms-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. pms-EZETIMIBE (ezetimibe) Page 6 of 41 • Prior to initiating therapy with pms-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 pms-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. pms-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 pms-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 pms-EZETIMIBE tablet is for oral administration. pms-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. pms-EZETIMIBE (ezetimibe) Page 7 of 41
5 Post-Market Adverse Reactions 07/2024 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....................................................................................
• pms-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 pms-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 pms-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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1 Special Populations ................................................................................................ 1 Pregnant Women ................................................................................................
2 Breast-feeding .................................................................................................... 3 Pediatrics ............................................................................................................
4 Geriatrics ............................................................................................................ 11 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 ....................................................................... 31 15 MICROBIOLOGY ..........................................................................................................
31 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 32 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 35 PATIENT MEDICATION […]