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NRA-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: NRA-EZETIMIBE TABLETS (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 NRA-EZETIMIBE TABLETS, administered alone or with an HMG-CoA reductase inhibitor (statin),…
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 NRA-EZETIMIBE TABLETS, and should continue on this diet during treatment with NRA-EZETIMIBE TABLETS.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with NRA-EZETIMIBE TABLETS, 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 NRA-EZETIMIBE TABLETS is 10 mg once daily orally, alone, with a statin, or with fenofibrate. NRA-EZETIMIBE TABLETS 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 NRA-EZETIMIBE TABLETS 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 NRA-EZETIMIBE TABLETS tablet is for oral administration. NRA-EZETIMIBE TABLETS 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 NRA-EZETIMIBE TABLETS, and should continue on this diet during treatment with NRA-EZETIMIBE TABLETS.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with NRA-EZETIMIBE TABLETS, 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 NRA-EZETIMIBE TABLETS is 10 mg once daily orally, alone, with a statin, or with fenofibrate. NRA-EZETIMIBE TABLETS 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 NRA-EZETIMIBE TABLETS 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). NRA-EZETIMIBE TABLETS (Ezetimibe Tablets) Page 6 of 34 Co-administration with Bile Acid Sequestrants: NRA-EZETIMIBE TABLETS should be administered either 2 hours or longer before or 4 hours or longer after administration of a bile acid sequestrant (see
02/2025 02/2025 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 ...................................................................................................................... 4 2 CONTRAINDICATIONS .........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................... 5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 6 5 OVERDOSAGE .....................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................................ 6 7 WARNINGS AND PRECAUTIONS.......................................................................................... 9 8 ADVERSE REACTIONS .........................................................................................................
13 9 DRUG INTERACTIONS........................................................................................................ 16 10 CLINICAL PHARMACOLOGY ...............................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ................................................................................ 18 12 SPECIAL HANDLING INSTRUCTIONS ..................................................................................
• NRA-EZETIMIBE TABLETS 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 NRA-EZETIMIBE TABLETS with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases. NRA-EZETIMIBE TABLETS (Ezetimibe Tablets) Page 5 of 34 • All statins and fenofibrate are contraindicated in pregnant and nursing women.
1 Pregnant Women). • Due to the presence of lactose in NRA-EZETIMIBE TABLETS 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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18 PART II: SCIENTIFIC INFORMATION .............................................................................................. 19 13 PHARMACEUTICAL INFORMATION ...................................................................................
19 14 CLINICAL TRIALS ............................................................................................................... 2 Comparative Bioavailability Studies […]