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VYTORIN
Overview
What is VYTORIN?
VYTORIN contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, an HMG-CoA reductase inhibitor.
The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is CHFNO and its molecular weight is 409.4.
Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is:
Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1-[1α,3α,7β,8β(2,4),-8aβ]]. The empirical formula of simvastatin is CHO and its molecular weight is 418.57.
Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is:
VYTORIN is available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (VYTORIN 10/10), 20 mg of simvastatin (VYTORIN 10/20), 40 mg of simvastatin (VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.
What does VYTORIN look like?
What are the available doses of VYTORIN?
What should I talk to my health care provider before I take VYTORIN?
How should I use VYTORIN?
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.
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. VYTORIN 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). After initiation or titration of VYTORIN, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed.
What interacts with VYTORIN?
Sorry No Records found
What are the warnings of VYTORIN?
Sorry No Records found
What are the precautions of VYTORIN?
Sorry No Records found
What are the side effects of VYTORIN?
Sorry No records found
What should I look out for while using VYTORIN?
VYTORIN is contraindicated in the following conditions:
What might happen if I take too much VYTORIN?
VYTORIN
No specific treatment of overdosage with VYTORIN can be recommended. In the event of an overdose, symptomatic and supportive measures should be employed.
Ezetimibe
In clinical studies, administration of ezetimibe, 50 mg/day to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hyperlipidemia for up to 56 days, was generally well tolerated.
A few cases of overdosage have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious.
Simvastatin
Significant lethality was observed in mice after a single oral dose of 9 g/m. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools.
A few cases of overdosage with simvastatin have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae.
The dialyzability of simvastatin and its metabolites in man is not known at present.
How should I store and handle VYTORIN?
Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.No. 3873 — Tablets VYTORIN 10/10 are white to off-white capsule-shaped tablets with code "311" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3874 — Tablets VYTORIN 10/20 are white to off-white capsule-shaped tablets with code "312" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3875 — Tablets VYTORIN 10/40 are white to off-white capsule-shaped tablets with code "313" on one side.They are supplied as follows: NDCNDCNDCNDCNo. 3876 — Tablets VYTORIN 10/80 are white to off-white capsule-shaped tablets with code "315" on one side.They are supplied as follows: NDCNDCNDCNDCStorageStore at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Keep container tightly closed.Storage of 10,000, 5000, and 2500 count bottlesStore bottle of 10,000 VYTORIN 10/10 and 10/20, 5000 VYTORIN 10/40, and 2500 VYTORIN 10/80 capsule-shaped tablets at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Store in original container until time of use. When product container is subdivided, repackage into a tightly-closed, light-resistant container. Entire contents must be repackaged immediately upon opening.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
VYTORIN
Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. VYTORIN contains ezetimibe and simvastatin, two lipid-lowering compounds with complementary mechanisms of action. VYTORIN reduces elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and increases HDL-C through dual inhibition of cholesterol absorption and synthesis.
Ezetimibe
Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. In a 2-week clinical study in 18 hypercholesterolemic patients, ezetimibe inhibited intestinal cholesterol absorption by 54%, compared with placebo. Ezetimibe had no clinically meaningful effect on the plasma concentrations of the fat-soluble vitamins A, D, and E and did not impair adrenocortical steroid hormone production.
Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of hepatic cholesterol stores and an increase in clearance of cholesterol from the blood; this distinct mechanism is complementary to that of statins .
Simvastatin
Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin is a specific inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol. In addition, simvastatin reduces very-low-density lipoproteins (VLDL) and TG and increases HDL-C.
Non-Clinical Toxicology
VYTORIN is contraindicated in the following conditions:Large doses of naloxone are required to antagonize buprenorphine since the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression. The barbiturate methohexital appears to block the acute onset of withdrawal symptoms induced by naloxone in opiate addicts.
Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by elevated plasma levels of simvastatin and simvastatin acid. Predisposing factors for myopathy include advanced age (≥65 years), female gender, uncontrolled hypothyroidism, and renal impairment.
The risk of myopathy, including rhabdomyolysis, is dose related.
In a clinical trial in which 12,064 patients with a history of myocardial infarction were treated with simvastatin (mean follow-up 6.7 years), the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum creatine kinase [CK] >10 times upper limit of normal [ULN]) in patients on 80 mg/day was approximately 0.9% compared with 0.02% for patients on 20 mg/day. The incidence of rhabdomyolysis (defined as myopathy with a CK >40 times ULN) in patients on 80 mg/day was approximately 0.4% compared with 0% for patients on 20 mg/day. The incidence of myopathy, including rhabdomyolysis, was highest during the first year and then notably decreased during the subsequent years of treatment. In this trial, patients were carefully monitored and some interacting medicinal products were excluded.
The risk of myopathy, including rhabdomyolysis, is greater in patients on simvastatin 80 mg compared with other statin therapies with similar or greater LDL-C-lowering efficacy and compared with lower doses of simvastatin. Therefore, the 10/80-mg dose of VYTORIN should be used only in patients who have been taking VYTORIN 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity . If, however, a patient who is currently tolerating the 10/80-mg dose of VYTORIN needs to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin, that patient should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction. Patients should be advised of the increased risk of myopathy, including rhabdomyolysis, and to report promptly any unexplained muscle pain, tenderness or weakness. If symptoms occur, treatment should be discontinued immediately .
In the Study of Heart and Renal Protection (SHARP), 9270 patients with chronic kidney disease were allocated to receive VYTORIN 10/20 mg daily (n=4650) or placebo (n=4620). During a median follow-up period of 4.9 years, the incidence of myopathy (defined as unexplained muscle weakness or pain with a serum creatine kinase [CK] >10 times upper limit of normal [ULN]) was 0.2% for VYTORIN and 0.1% for placebo: the incidence of rhabdomyolysis (defined as myopathy with a CK > 40 times ULN) was 0.09% for VYTORIN and 0.02% for placebo.
In postmarketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin prior to initiating ezetimibe. However, rhabdomyolysis has been reported with ezetimibe monotherapy and with the addition of ezetimibe to agents known to be associated with increased risk of rhabdomyolysis, such as fibric acid derivatives. VYTORIN and a fenofibrate, if taking concomitantly, should both be immediately discontinued if myopathy is diagnosed or suspected.
There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
All patients starting therapy with VYTORIN or whose dose of VYTORIN is being increased should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing VYTORIN. VYTORIN therapy should be discontinued immediately if myopathy is diagnosed or suspected.
Many of the patients who have developed rhabdomyolysis on therapy with simvastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients taking VYTORIN merit closer monitoring.
VYTORIN therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. VYTORIN therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy.
Drug Interactions
The risk of myopathy and rhabdomyolysis is increased by elevated plasma levels of simvastatin and simvastatin acid. Simvastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs that inhibit this metabolic pathway can raise the plasma levels of simvastatin and may increase the risk of myopathy. These include itraconazole, ketoconazole, posaconazole, and voriconazole, the macrolide antibiotics erythromycin and clarithromycin, and the ketolide antibiotic telithromycin, HIV protease inhibitors, boceprevir, telaprevir, the antidepressant nefazodone, cobicistat-containing products, or grapefruit juice.Combination of these drugs with VYTORIN is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is unavoidable, therapy with VYTORIN must be suspended during the course of treatment.
The combined use of VYTORIN with gemfibrozil, cyclosporine, or danazol is contraindicated
Caution should be used when prescribing fenofibrates with VYTORIN, as these agents can cause myopathy when given alone and the risk is increased when they are coadministered
Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be exercised when prescribing VYTORIN with colchicine
The benefits of the combined use of VYTORIN with the following drugs should be carefully weighed against the potential risks of combinations: other lipid-lowering drugs (fenofibrates, ≥1 g/day of niacin, or, for patients with HoFH, lomitapide), amiodarone, dronedarone, verapamil, diltiazem, amlodipine, or ranolazine .
Cases of myopathy, including rhabdomyolysis, have been observed with simvastatin coadministered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products. In an ongoing, double-blind, randomized cardiovascular outcomes trial, an independent safety monitoring committee identified that the incidence of myopathy is higher in Chinese compared with non-Chinese patients taking simvastatin 40 mg or ezetimibe/simvastatin 10/40 mg coadministered with lipid-modifying doses of a niacin-containing product. Caution should be used when treating Chinese patients with VYTORIN in doses exceeding 10/20 mg/day coadministered with lipid-modifying doses of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive VYTORIN 10/80 mg coadministered with lipid-modifying doses of niacin-containing products. 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 .
Prescribing recommendations for interacting agents are summarized in Table 1 .
The following serious adverse reactions are discussed in greater detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).