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GLN-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: , Primary Hypercholesterolemia 08/2024
Verbatim from this product's HC label. Tap a section to expand.
2 Breast-feeding 08/2024 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 ..................................................................
5 1 INDICATIONS ........................................................................................................................... 1 Pediatrics ....................................................................................................................
2 Geriatrics ..................................................................................................................... 5 2 CONTRAINDICATIONS ............................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 6 4 DOSAGE AND ADMINISTRATION .......................................................................................... 1 Dosing Considerations ............................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 4 Administration .......................................................................................................... 5 Missed Dose ............................................................................................................
7 PrGLN-EZETIMIBE (Ezetimibe Tablets USP 10 mg) Page 3 of 37 5 OVERDOSAGE ......................................................................................................................... 7
2 Recommended Dose and Dosage Adjustment The recommended dose of GLN-EZETIMIBE is 10 mg once daily orally, alone, with a statin, or with fenofibrate. GLN-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 GLN-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:
GLN-EZETIMIBE should be administered either 2 hours or longer before or 4 hours or longer after administration of a bile acid sequestrant (see
2 Breast-feeding 08/2024 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 ..................................................................
5 1 INDICATIONS ........................................................................................................................... 1 Pediatrics ....................................................................................................................
2 Geriatrics ..................................................................................................................... 5 2 CONTRAINDICATIONS ............................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 6 4 DOSAGE AND ADMINISTRATION .......................................................................................... 1 Dosing Considerations ............................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................... 4 Administration .......................................................................................................... 5 Missed Dose ............................................................................................................
7 PrGLN-EZETIMIBE (Ezetimibe Tablets USP 10 mg) Page 3 of 37 5 OVERDOSAGE ......................................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................
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.
8 7 WARNINGS AND PRECAUTIONS ........................................................................................... 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 ............................................................................
18 10 CLINICAL PHARMACOLOGY .............................................................................................. 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics ................................................................................................. 3 Pharmacokinetics ....................................................................................................
19 11 STORAGE, STABILITY AND DISPOSAL ............................................................................ 20 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 20 PART II: SCIENTIFIC INFORMATION .......................................................................................
21 13 PHARMACEUTICAL INFORMATION ................................................................................... 21 14 CLINICAL TRIALS […]