Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24)
direct rx
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. 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 die
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: 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.
Abbreviated New Drug Application
EZETIMIBE- EZETIMIBE TABLET direct rx ---------- Ezetimibe Tablets, USP 10 mg Patient Information about Ezetimibe (ĕ-zĕt´-ĕ-mīb) Tablets, USP Read this information carefully before you start taking Ezetimibe Tablets and each time you get more Ezetimibe Tablets. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about Ezetimibe Tablets, ask your doctor. Only your doctor can determine if Ezetimibe Tablets is right for you. What is Ezetimibe Tablets? Ezetimibe Tablet is a medicine used to lower levels of total cholesterol and LDL (bad) cholesterol in the blood. Ezetimibe Tablet is for patients who cannot control their cholesterol levels by diet and exercise alone. It can be used by itself or with other medicines to treat high cholesterol. You should stay on a cholesterol- lowering diet while taking this medicine. Ezetimibe Tablets works to reduce the amount of cholesterol your body absorbs. Ezetimibe Tablets does not help you lose weight. Ezetimibe Tablets has not been shown to prevent heart disease or heart attacks. For more information about cholesterol, see the “What should I know about high cholesterol?” section that follows. Who should not take Ezetimibe Tablets? • Do not take Ezetimibe Tablets if you are allergic to ezetimibe, the active ingredient in Ezetimibe Tablets, or to the inactive ingredients. For a list of inactive ingredients, see the “Inactive ingredients” section that follows. • If you have active liver disease, do not take Ezetimibe Tablets while taking cholesterol-lowering medicines called statins. • If you are pregnant or breast-feeding, do not take Ezetimibe Tablets while taking a statin. • If you are a woman of childbearing age, you should use an effective method of birth control to prevent pregnancy while using Ezetimibe Tablets added to statin therapy. Ezetimibe Tablets has not been studied in children under age 10. What should I tell my doctor before Կարդացեք ամբողջական փաստաթուղթը
EZETIMIBE- EZETIMIBE TABLET DIRECT RX ---------- EZETIMIBE 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. 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 Կարդացեք ամբողջական փաստաթուղթը