Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
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. 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 elev
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: 70518-2262-00 PACKAGING: 90 in 1 BOTTLE PLASTIC 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
EZETIMIBE- EZETIMIBE TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EZETIMIBE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EZETIMIBE TABLETS. EZETIMIBE TABLETS, FOR ORAL USE. INITIAL U.S. APPROVAL: 2002 INDICATIONS AND USAGE 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. 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) DOSAGE FORMS AND STRENGTHS Tablets: 10 mg ( 3) CONTRAINDICATIONS • Statin contraindications apply when Ezetimibe Tablet is used with a statin: ○ Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4, 5.2) ○ Women who are pregnant or may become pregnant ( 4, 8.1) ○ Nursing mothers ( 4, 8.3) • Known hypersensitivity to product components ( 4, 6.2) WARNINGS AND PRECAUTIONS Ezetimibe Tablet is not recommended in patients with moderate or severe hepatic impairment. ( 5.4, 8.7, 12.3) Liver enzyme abnormalit Lees het volledige document