A generic version of the cholesterol-lowering medication Vytorin has been launched by Teva Pharmaceutical Industries, bringing another cheaper statin medication to US pharmacies. Vytorin is an HMG-COA reductase inhibitor/statin with a lipid modifying agent developed by Merck.
IMS data from February 2017 reveals annual sales of Vytorin in the US alone were $678 million. The launch of a generic Vytorin product is good news for many patients across the US, as generic medications are significantly cheaper than their branded counterparts. Almost one in three American adults have high levels of LDL, yet less than a third have the condition under control, according to figures from the Centers for Disease Control and Prevention. Teva has one of the largest portfolios of generic products, with more than 600 products bearing its name.
Vytorin and the new generic tablets contain two active ingredients: ezetimibe and simvastatin. Ezetimibe is a plasma cholesterol-lowering medication; simvastatin is a commonly used lipid-lowering statin often prescribed to treat patients with high cholesterol. Simvastatin is also available without ezetimibe in the form of Zocor. Teva's generic Vytorin tablets are used to lower levels of "bad cholesterol" (low density lipoprotein cholesterol or LDL), increase "good" cholesterol (high density lipoprotein cholesterol or HDL), and lower the levels of triglycerides (fat) in the blood.
Teva's generic ezetimibe and simvastatin tablets are prescribed to reduce cholesterol in patients with a significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Dietary changes are used alongside drug therapy, with doctors advising patients to restrict saturated fat intake and improve nutrition. The FDA has approved four different dosages of the generic Vytorin tablets: 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg.
Nearly nine out of ten prescriptions filled in the US are for generic medications, which usually become available once the patent protection period on the original medication has passed. FDA guidelines for generic drugs require the same quality, strength, purity and stability as the brand-name innovator drugs. Consequently, they provide millions of patients across the country with a cheaper alternative to branded medication, which is often significantly more expensive.
Contraindications of ezetimibe and simvastatin are:
- Concomitant administration of strong CYP3A4 inhibitors.
- Concomitant administration of gemfibrozil, cyclosporine, or danazol.
- Hypersensitivity to any component of this medication.
- Active liver disease or unexplained persistent elevations in hepatic transaminase levels.
- Women who are pregnant or may become pregnant. Ezetimibe and simvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive.
- Nursing mothers.
For more information on possible side effects, details of indication and contraindications of ezetimibe and simvastatin, click here.