Drug Catalog - Product Detail
EZETIMIBE/SIMVASTATIN 10MG/20MG TB 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 67877-0508-90 | ASCEND LABORATORIES | 90 | 10-20MG | TABLET |
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Description
11 DESCRIPTION Ezetimibe and Simvastatin Tablets contains ezetimibe, USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, USP, an HMG-CoA reductase inhibitor. 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 and its molecular weight is 409.43. Ezetimibe, USP is a white to off white, crystalline powder, hygroscopic that is soluble in methanol. Its structural formula is: Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2, 2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S- [1α,3α,7β,8β(2 S* ,4 S* ),-8aβ]]. The empirical formula of simvastatin, USP is C 25 H 38 O 5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white powder that is freely soluble in chloroform, methanol and alcohol. Sparingly soluble in Propylene glycol, very slightly soluble in Hexane. Practically insoluble in water. Its structural formula is: Ezetimibe and Simvastatin Tablets is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (Ezetimibe and Simvastatin Tablets 10/10), 20 mg of simvastatin, USP (Ezetimibe and Simvastatin Tablets 10/20), 40 mg of simvastatin, USP (Ezetimibe and Simvastatin Tablets 10/40), or 80 mg of simvastatin, USP (Ezetimibe and Simvastatin Tablets 10/80). Each tablet contains the following inactive ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Croscarmellose Sodium, Sodium Lauryl Sulfate, Hypromellose, Citric Acid Monohydrate, Propyl Gallate, Butylated Hydroxy Anisole and Magnesium Stearate. ES-Str1.jpg ES-Str2.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ezetimibe and Simvastatin Tablets 10/10, (ezetimibe, USP 10 mg/simvastatin, USP 10 mg tablets) are white to off-white, capsule shaped tablets debossed with “A029” on one side and plain on other side. They are supplied as follows: NDC 67877-507-30 bottles of 30 NDC 67877-507-90 bottles of 90 NDC 67877-507-01 bottles of 1000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.) NDC 67877-507-38 carton of 100 (10 x 10) unit-dose tablets Ezetimibe and Simvastatin Tablets 10/20, (ezetimibe, USP 10 mg/simvastatin, USP 20 mg tablets) are white to off-white, capsule shaped tablets debossed with “A028” on one side and plain on other side. They are supplied as follows: NDC 67877-508-30 bottles of 30 NDC 67877-508-90 bottles of 90 NDC 67877-508-01 bottles of 1000 (If repackaged in blisters, then opaque or light-resistant blisters should be used.) NDC 67877-508-38 carton of 100 (10 x 10) unit-dose tablets Ezetimibe and Simvastatin Tablets 10/40, (ezetimibe, USP 10 mg/simvastatin, USP 40 mg tablets) are white to off-white, capsule shaped tablets debossed with “A027” on one side and plain on other side. They are supplied as follows: NDC 67877-509-30 bottles of 30 NDC 67877-509-90 bottles of 90 NDC 67877-509-05 bottles of 500 (If repackaged in blisters, then opaque or light-resistant blisters should be used.) NDC 67877-509-37 carton of 50 (5 x 10) unit-dose tablets Ezetimibe and Simvastatin Tablets 10/80, (ezetimibe, USP 10 mg/simvastatin, USP 80 mg tablets) are white to off-white, capsule shaped tablets debossed with “A026” on one side and plain on other side. They are supplied as follows: NDC 67877-510-30 bottles of 30 NDC 67877-510-90 bottles of 90 NDC 67877-510-05 bottles of 500 (If repackaged in blisters, then opaque or light-resistant blisters should be used.) NDC 67877-510-37 carton of 50 (5 x 10) unit-dose tablets Storage: Store at 20 to 25 o C (68 to 77 o F). [See USP Controlled Room Temperature.] Keep container tightly closed.
Indications & Usage
1 INDICATIONS & 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 and Simvastatin Tablets, which contains 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 has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. 1.1 Primary Hyperlipidemia 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. 1.2 Homozygous Familial Hypercholesterolemia (HoFH) 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 (e.g., LDL apheresis) or if such treatments are unavailable. 1.3 Limitations of Use 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 has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.
Dosage and Administration
2 DOSAGE & ADMINISTRATION Dose range is 10/10 mg/day to 10/40 mg/day. (2.1) Recommended usual starting dose is 10/10 or 10/20 mg/day. (2.1) Due to the increased risk of myopathy, including rhabdomyolysis, use of the 10/80-mg dose of Ezetimibe and Simvastatin Tablets should be restricted to patients who have been taking Ezetimibe and Simvastatin Tablets 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. (2.2) Patients who are currently tolerating the 10/80-mg dose of Ezetimibe and Simvastatin Tablets 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 to the increased risk of myopathy, including rhabdomyolysis, associated with the 10/80-mg dose of Ezetimibe and Simvastatin Tablets, patients unable to achieve their LDL-C goal utilizing the 10/40-mg dose of Ezetimibe and Simvastatin Tablets should not be titrated to the 10/80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering. (2.2) Dosing of Ezetimibe and Simvastatin Tablets should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. (2.3 , 7.5) 2.1 Recommended Dosing The usual dosage range is 10/10 mg/day to 10/40 mg/day. The recommended usual starting dose is 10/10 mg/day or 10/20 mg/day. Ezetimibe and Simvastatin Tablets should be taken as a single daily dose in the evening, with or without food. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day in the absence of moderate to severe renal impairment (estimated glomerular filtration rate less than 60 mL/min/1.73 m 2 ). After initiation or titration of Ezetimibe and Simvastatin Tablets, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed. 2.2 Restricted Dosing for 10/80 mg Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 10/80-mg dose of Ezetimibe and Simvastatin Tablets should be restricted to patients who have been taking Ezetimibe and Simvastatin Tablets 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions ( 5.1 )]. Patients who are currently tolerating the 10/80-mg dose of Ezetimibe and Simvastatin Tablets 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. Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 10/80-mg dose of Ezetimibe and Simvastatin Tablets, patients unable to achieve their LDL-C goal utilizing the 10/40-mg dose of Ezetimibe and Simvastatin Tablets should not be titrated to the 10/80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering. 2.3 Coadministration with Other Drugs Patients taking Verapamil, Diltiazem, or Dronedarone • The dose of Ezetimibe and Simvastatin Tablets should not exceed 10/10 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)]. Patients taking Amiodarone, Amlodipine or Ranolazine • The dose of Ezetimibe and Simvastatin Tablets should not exceed 10/20 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)]. Patients taking Bile Acid Sequestrants • Dosing of Ezetimibe and Simvastatin Tablets should occur either greater than or equal to 2 hours before or greater than or equal to 4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.5)] . 2.4 Patients with Homozygous Familial Hypercholesterolemia The recommended dosage for patients with homozygous familial hypercholesterolemia is Ezetimibe and Simvastatin Tablets 10/40 mg/day in the evening [see Dosage and Administration, Restricted Dosing for 10/80 mg ( 2.2 )]. Ezetimibe and Simvastatin Tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of Ezetimibe and Simvastatin Tablets should be reduced by 50% if initiating lomitapide. Ezetimibe and Simvastatin Tablets dosage should not exceed 10/20 mg/day (or 10/40 mg/day for patients who have previously taken simvastatin 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide. 2.5 Patients with Renal Impairment/Chronic Kidney Disease In patients with mild renal impairment (estimated GFR greater than or equal to 60 mL/min/1.73 m 2 ), no dosage adjustment is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate less than 60 mL/min/1.73 m 2 , the dose of Ezetimibe and Simvastatin Tablets are 10/20 mg/day in the evening. In such patients, higher doses should be used with caution and close monitoring [see Warnings and Precautions (5.1); Clinical Pharmacology (12.3)] . 2.6 Geriatric Patients No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)] . 2.7 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing Products Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with Ezetimibe and Simvastatin Tablets doses exceeding 10/20 mg/day coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin- containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive Ezetimibe and Simvastatin Tablets 10/80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See Warnings and Precautions (5.1) .]