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AG-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: AG-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 AG-Ezetimibe, administered alone or with an HMG-CoA reductase inhibitor (statin), is indicated for:…
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 AG-Ezetimibe, and should continue on this diet during treatment with AG-Ezetimibe.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with AG-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 AG-Ezetimibe is 10 mg once daily orally, alone, with a statin, or with fenofibrate. AG-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 AG-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 AG-Ezetimibe tablet is for oral administration. AG-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 AG-Ezetimibe, and should continue on this diet during treatment with AG-Ezetimibe.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with AG-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 AG-Ezetimibe is 10 mg once daily orally, alone, with a statin, or with fenofibrate. AG-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 AG-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 AG-Ezetimibe tablet is for oral administration. AG-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. 5 OVERDOSAGE In clinical studies, administration of ezetimibe, 50 mg/day to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolemia for up to 56 days, was generally well tolerated.
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 ..................................................................................
• AG-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 AG-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 AG-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.
A few cases of overdosage with Ezetimibe Tablets have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious. In the event of an overdose, symptomatic and supportive measures should be employed.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Compositi on Non-medicinal Ingredients Oral Tablet 10 mg Colloidal silicon dioxide, Croscarmellose sodium, Hydrogenated castor oil, Hypromellose, Lactose monohydrate, Microcrystalline cellulose, Sodium lauryl sulfate and Sodium stearyl fumarate.
AG-Ezetimibe 10 mg tablets are white to off-white, capsule shaped, flat beveled edged, uncoated tablets debossed with ‘E10’ on one side and plain on other side. AG-Ezetimibe tablets are available in bottles of 100 and 500 tablets, and blister packs of 30 tablets (3x10 tablets).
AG-Ezetimibe (Ezetimibe Tablets) Page 7 of 34 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General When AG-Ezetimibe is to be administered with a statin or with fenofibrate, please refer also to the Product Monograph for that medication.
1 Pregnant Women).
Sex:
Plasma concentrations for total ezetimibe are slightly higher (<20%) in women than in men. LDL-C reduction and safety profile are comparable between men and women treated with ezetimibe. Therefore, no dosage adjustment is necessary on the basis of sex.
Race:
Based on a meta-analysis of pharmacokinetic studies, there were no pharmacokinetic differences between Blacks and Caucasians. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ).
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ). 3%). 4% in patients on a statin alone.
Patients with Liver Impairment:
The pharmacokinetics of ezetimibe were examined in […]
18 PART II: SCIENTIFIC INFORMATION .............................................................................................. 19 13 PHARMACEUTICAL INFORMATION ...................................................................................
19 14 CLINICAL TRIALS ............................................................................................................... 2 Comparative Bioavailability Studies […]