Ezetimibe
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
Ezetimibe, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Ezetimibe is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
The effect of ezetimibe on cardiovascular morbidity and mortality has not been determined.
Ezetimibe has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
History
There is currently no drug history available for this drug.
Other Information
Ezetimibe is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is:
Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: sodium starch glycolate, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate.
Sources
Ezetimibe Manufacturers
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Glenmark Generics Inc., Usa
![Ezetimibe Tablet [Glenmark Generics Inc., Usa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ezetimibe | Glenmark Generics Inc., Usa
2.1 General Dosing InformationThe recommended dose of ezetimibe tablets is 10 mg once daily.
Ezetimibe tablets can be administered with or without food.
2.2 Co-Administration with Bile Acid SequestrantsDosing of ezetimibe tablets should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].
2.3 Patients with Hepatic ImpairmentNo dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].
2.4 Patients with Renal ImpairmentNo dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)].
2.5 Geriatric PatientsNo dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].
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