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ACH-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: ACH-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 ACH-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 ACH-Ezetimibe, and should continue on this diet during treatment with ACH-Ezetimibe.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with ACH-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 ACH-Ezetimibe is 10 mg once daily orally, alone, with a statin, or with fenofibrate. ACH-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 ACH-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 ACH-Ezetimibe tablet is for oral administration. ACH-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 ACH-Ezetimibe, and should continue on this diet during treatment with ACH-Ezetimibe.
If appropriate, a program of weight control and physical exercise should be implemented. • Prior to initiating therapy with ACH-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 ACH-Ezetimibe is 10 mg once daily orally, alone, with a statin, or with fenofibrate. ACH-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 ACH-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 ACH-Ezetimibe tablet is for oral administration. ACH-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.
09/2024 ACH-Ezetimibe Product Monograph Page 3 of 34 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 ........................................................................ 17 10 CLINICAL PHARMACOLOGY .........................................................................................
1 Mechanism of Action ...................................................................................... 2 Pharmacodynamics......................................................................................... 3 Pharmacokinetics............................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 19 PART II: SCIENTIFIC INFORMATION ........................................................................................
20 13 PHARMACEUTICAL INFORMATION ............................................................................. 20 14 CLINICAL TRIALS .........................................................................................................
• ACH-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 ACH-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 ACH-Ezetimibe tablets, use in patients with hereditary problems of ACH-Ezetimibe Product Monograph Page 5 of 34 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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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/Composition Non-medicinal Ingredients Oral Tablet 10 mg croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 80, povidone K-30 and sodium lauryl sulfate.
ACH-Ezetimibe is available as a 10 mg tablet for oral administration. ACH-Ezetimibe is formulated as white to off-white, capsule shaped, flat faced with beveled edge, uncoated tablets, debossed with “10” on one side and plain on other side.
Each tablet contains 10 mg of active ingredient, ezetimibe. ACH-Ezetimibe is packaged in blister packs of 30 tablets (3 strips containing 10 tablets each). ACH-Ezetimibe is also available in HDPE bottles of 30, 100 & 500 tablets. ACH-Ezetimibe Product Monograph Page 7 of 34 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General When ACH-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 Clinical Trial Findings).
4 Abnormal Laboratory Findings : Hematologic, Clinical Chemistry and Quantitative Data Clinical Trial Findings). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Quantitative Data Clinical Trial Findings). 3%). In controlled co-administration trials in patients receiving ezetimibe tablets with a statin, the incidence of […]
1 Clinical Trials by Indication .............................................................................. 27 15 MICROBIOLOGY .........................................................................................................
27 16 NON-CLINICAL TOXICOLOGY ....................................................................................... …31 PATIENT MEDICATION INFORMATION ...................................................................................
32 ACH-Ezetimibe Product Monograph Page 4 of 34 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ACH-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 ACH-Ezetimibe, administered alone or with an HMG-CoA reductase inhibitor (statin), is indicated for: • the reduction of elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG) and • to increase high density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.
ACH-Ezetimibe, administered in combination with fenofibrate, is indicated for: • the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia. Homozygous Familial Hypercholesterolemia (HoFH) ACH-Ezetimibe, administered with a statin, is indicated for: • the reduction of elevated total-C and LDL-C levels in patients with HoFH as an adjunct to treatments such as LDL apheresis or if such treatments are not possible.
Homozygous Sitosterolemia (Phytosterolemia) ACH-Ezetimibe is indicated for: • the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. 1 Pediatrics Pediatrics (<10 years): Treatment with ACH-Ezetimibe in children (<10 years) is not recommended.
2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggests that LDL-C reduction and safety profile are comparable between elderly and young subjects treated with ezetimibe tablets. 2 CONTRAINDICATIONS • ACH-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 ACH-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 ACH-Ezetimibe tablets, use in patients with hereditary problems of ACH-Ezetimibe Product Monograph Page 5 of 34 galactose intolerance, glucose-galactose malabsorption or the Lapp lactase deficiency is also contraindicated (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Drug induced liver injury including hepatitis, • Pancreatitis, • Myopathy/rhabdomyolysis, • Myalgia, • Anaphylaxis, • Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), drug reaction with eosinophilic and systemic symptoms (DRESS), (see 7 WARNINGS AND PRECAUTIONS;