Loading…
TEVA-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: TEVA-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 TEVA-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 TEVA-EZETIMIBE, and should continue on this diet during treatment with TEVA-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. TEVA-EZETIMIBE (Ezetimibe Tablets) Page 6 of 41 • Prior to initiating therapy with TEVA-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 TEVA-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. TEVA-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 TEVA-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 TEVA-EZETIMIBE tablet is for oral administration. TEVA-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 TEVA-EZETIMIBE, and should continue on this diet during treatment with TEVA-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. TEVA-EZETIMIBE (Ezetimibe Tablets) Page 6 of 41 • Prior to initiating therapy with TEVA-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 TEVA-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. TEVA-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 TEVA-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:
TEVA-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 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 ................................................................................................................. 5 2 CONTRAINDICATIONS ...................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 6 5 OVERDOSAGE................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................... 10 8 ADVERSE REACTIONS ..................................................................................................
15 9 DRUG INTERACTIONS .................................................................................................. 19 TEVA-EZETIMIBE (Ezetimibe Tablets) Page 3 of 41 10 CLINICAL PHARMACOLOGY .........................................................................................
21 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 22 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 22 PART II: SCIENTIFIC INFORMATION .........................................................................................
• TEVA-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 TEVA-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).
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.
23 13 PHARMACEUTICAL INFORMATION .............................................................................. 23 14 CLINICAL TRIALS ..........................................................................................................
30 15 MICROBIOLOGY .......................................................................................................... 31 16 NON-CLINICAL TOXICOLOGY .......................................................................................
31 17 SUPPORTING PRODUCT MONOGRAPHS […]