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IPG-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: IPG-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 IPG-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 IPG-EZETIMIBE, and should continue on this diet during treatment with IPG-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with IPG-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 IPG-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. IPG-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 IPG-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 IPG-EZETIMIBE tablet is for oral administration. IPG-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 IPG-EZETIMIBE, and should continue on this diet during treatment with IPG-EZETIMIBE.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with IPG-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 IPG-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. IPG-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 IPG-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:
IPG-EZETIMIBE should be administered either 2 hours IPG-EZETIMIBE (Ezetimibe Tablets) Page 6 of 34 or longer before or 4 hours or longer after administration of a bile acid sequestrant (see
09/2024 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 ........................................................................................................................ 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 .......................................................................................................................
• IPG-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 IPG-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 IPG-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.
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................................ 6 7 WARNINGS AND PRECAUTIONS ........................................................................................... 1 Special Populations..........................................................................................................
1 Pregnant Women ............................................................................................................ 2 Breast-feeding .................................................................................................................
3 Pediatrics ......................................................................................................................... 4 Geriatrics .........................................................................................................................
9 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 .............................................................................................................................
5 Post-Market Adverse Reactions .................................................................................... 13 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................................................................................
16 10 CLINICAL PHARMACOLOGY................................................................................................. 1 Mechanism of Action ....................................................................................................
2 Pharmacodynamics ........................................................................................................ 3 Pharmacokinetics...........................................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ................................................................................. 18 12 SPECIAL HANDLING INSTRUCTIONS ....................................................................................
18 PART II: SCIENTIFIC INFORMATION ................................................................................................ 19 13 PHARMACEUTICAL INFORMATION .....................................................................................
19 14 CLINICAL TRIALS ................................................................................................................. 1 Clinical Trials by Indication ............................................................................................
2 Comparative Bioavailability Studies […]