Drug Catalog - Product Detail
EZETIMIBE 10MG TB 90CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 67877-0490-90 | ASCEND LABORATORIES | 90 | 10MG | TABLET |
PACKAGE FILES
Generic Name
EZETIMIBE
Substance Name
EZETIMIBE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA209234
Description
11 DESCRIPTION Ezetimibe, USP is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C 24 H 21 F 2 NO 3 . Its molecular weight is 409.4 and its structural formula is: Ezetimibe, USP is a white to off white, crystalline powder that is soluble in methanol. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablet, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, Hypromellose, sodium lauryl sulfate, crospovidone, microcrystaline cellulose, and magnesium stearate. ezetimibe-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ezetimibe Tablets, USP 10 mg, are white to off white capsule shaped, flat faced, beveled edge tablets, debossed with ‘A25’ on one side and plain on other side. They are supplied as follows: NDC 67877-490-30 bottles of 30 NDC 67877-490-90 bottles of 90 NDC 67877-490-01 bottles of 100 NDC 67877-490-05 bottles of 500 NDC 67877-490-55 bottles of 5000 Storage Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.
Indications & Usage
1 INDICATIONS AND USAGE 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 Tablet is an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to: Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (1.1) Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate (1.1) Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin (1.2) Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) (1.3) Limitations of Use ( 1.4 ) The effect of Ezetimibe Tablets on cardiovascular morbidity and mortality has not been determined. Ezetimibe Tablets has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. 1.1 Primary Hyperlipidemia Monotherapy Ezetimibe Tablets, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins) Ezetimibe Tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with Fenofibrate Ezetimibe Tablets, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia. 1.2 Homozygous Familial Hypercholesterolemia (HoFH) The combination of Ezetimibe Tablets and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. 1.3 Homozygous Sitosterolemia Ezetimibe Tablet is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. 1.4 Limitations of Use The effect of Ezetimibe Tablets on cardiovascular morbidity and mortality has not been determined. Ezetimibe Tablets has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION One 10-mg tablet once daily, with or without food ( 2.1 ) Dosing of Ezetimibe Tablets should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. ( 2.3 , 7.4 ) 2.1 General Dosing Information The recommended dose of Ezetimibe Tablets is 10 mg once daily. Ezetimibe Tablets can be administered with or without food. 2.2 Concomitant Lipid-Lowering Therapy Ezetimibe Tablets may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of Ezetimibe Tablets may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications. 2.3 Co-Administration with Bile Acid Sequestrants Dosing of Ezetimibe Tablets should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions ( 7.4 )] . 2.4 Patients with Hepatic Impairment No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions ( 5.4 )]. 2.5 Patients with Renal Impairment No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology ( 12.3 )]. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m 2 ), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations ( 8.6 )]. 2.6 Geriatric Patients No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology ( 12.3 )].