Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
Ezetimibe (UNII: EOR26LQQ24) (Ezetimibe - UNII:EOR26LQQ24)
Major Pharmaceuticals
Ezetimibe
Ezetimibe 10 mg
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, 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, 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 to
Ezetimibe tablets, USP 10 mg are white to off-white, flat-face, beveled edge, capsule shaped tablets; engraved "APO" on one side and "EZ 10" on the other side. They are supplied as follows: Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6664-04 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
EZETIMIBE- EZETIMIBE TABLET MAJOR PHARMACEUTICALS ---------- 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 RECENT MAJOR CHANGES Indications and Usage Addition of non-HDL lipid parameter to Monotherapy and Combination therapy (1.1) 07/2011 Dosage and Administration Patients with Renal Impairment (2.5) 01/2012 INDICATIONS AND USAGE Ezetimibe tablets are an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to: 5. 6. 7. 8. Limitations of Use (1.4) 3. 4. DOSAGE AND ADMINISTRATION 3. 4. DOSAGE FORMS AND STRENGTHS Tablets: 10 mg (3) CONTRAINDICATIONS 3. 4. WARNINGS AND PRECAUTIONS 4. 5. 6. 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) 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. 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) Statin contraindications apply when ezetimibe is used with a statin: 4. 5. 6. 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 Izlasiet visu dokumentu