Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24), SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)
Actavis Pharma, Inc.
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. Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments
Ezetimibe and Simvastatin Tablets are supplied as follows: 10 mg/10 mg – Each light tan, slightly speckled, round, unscored, biconvex tablet debossed with 511 on one side and on opposite side contains 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP. Tablets are supplied in bottles of 30 (NDC 45963-565-30), and 90 (NDC 45963-565-08). 10 mg/20 mg – Each light tan, slightly speckled, round, unscored, biconvex tablet debossed with 512 on one side and on opposite side contains 10 mg of ezetimibe, USP and 20 mg of simvastatin, USP. Tablets are supplied in bottles of 30 (NDC 45963-566-30), and 90 (NDC 45963-566-08). 10 mg/40 mg – Each light tan, slightly speckled, round, unscored, biconvex tablet debossed with 513 on one side and on opposite side contains 10 mg of ezetimibe, USP and 40 mg of simvastatin, USP. Tablets are supplied in bottles of 30 (NDC 45963-567-30), and 90 (NDC 45963-567-08). 10 mg/80 mg – Each light tan, slightly speckled, capsule shaped, unscored, biconvex tablet debossed with 515 on one side and on opposite side contains 10 mg of ezetimibe, USP and 80 mg of simvastatin, USP. Tablets are supplied in bottles of 30 (NDC 45963-568-30), and 90 (NDC 45963-568-08). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep container tightly closed. Dispense in a tight, light-resistant container as defined in the USP.
Abbreviated New Drug Application
EZETIMIBE AND SIMVASTATIN- EZETIMIBE AND SIMVASTATIN TABLET ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EZETIMIBE AND SIMVASTATIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE AND SIMVASTATIN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE Ezetimibe and simvastatin tablets, which contain a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to: reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. (1.1) reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. (1.2) Limitations of Use (1.3) No incremental benefit of ezetimibe and simvastatin tablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. Ezetimibe and simvastatin tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. DOSAGE AND ADMINISTRATION Dose range is 10 mg/10 mg/day to 10 mg/40 mg/day. (2.1) Recommended usual starting dose is 10 mg/10 mg or 10 mg/20 mg/day. (2.1) Due to the increased risk of myopathy, including rhabdomyolysis, use of the 10 mg/80-mg dose of ezetimibe and simvastatin should be restricted to patients who have been taking ezetimibe and simvastatin 10 mg/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. (2.2) Patients who are currently tolerating the 10 mg/80-mg dose of ezetimibe and simvastatin who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction. (2.2) Due t Preberite celoten dokument