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| Drug Name |
VYTORIN |
| Active Ingredient(s) |
EZETIMIBE/SIMVASTATIN |
Form(s) and
Strength(s) Available |
TABLET; ORAL:10/10MG ;10/20MG ;10/40MG ;10/80MG |
Product Information / Press Release VYTORIN (Ezetimibe/Simvastatin) - called INEGY in EU Information:
NEW PRODUCT LAUNCH: Vytorin (Ezetimibe & Simvastatin)(INEGY) NOW AVAILABLE Merck/Schering-Plough Pharmaceuticals announced the regulatory approval of Vytorin (Ezetimibe & Simvastatin) on April 2nd 2004 in Germany for the treatment of elevated cholesterol (hypercholesterolemia). Vytorin (Ezetimibe & Simvastatin) is the first product to reduce low-density lipoprotein cholesterol (LDL-C or bad cholesterol), along with diet and exercise, through dual inhibition by inhibiting cholesterol production in the liver and absorption in the intestine. The approval of Vytorin (Ezetimibe & Simvastatin) in Germany represents the first approval in Europe for Vytorin (Ezetimibe & Simvastatin) tablets and the first step in seeking marketing approval throughout the European Union (EU) under the EUs mutual recognition procedure. Vytorin (Ezetimibe & Simvastatin) will be available in several dosing strengths (ezetimibe/simvastatin): 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg. In the United States, a New Drug Application for ezetimibe/simvastatin was submitted on Sept. 24, 2003. The filing was accepted by the U.S. Food and Drug Administration on Nov. 23, 2003 and is currently under standard review. If approved, ezetimibe/simvastatin will be marketed under the name Vytorin (Ezetimibe & Simvastatin).
VYTORIN (Ezetimibe/Simvastatin) - called INEGY in EU Side Effects:
Important information about Vytorin side effects .
In clinical trials of ezetimibe co-administered with simvastatin, there was no increased incidence of Vytorin side effects like myopathy or rhabdomyolysis associated with ezetimibe/simvastatin. However, myopathy and rhabdomyolysis are known Vytorin side effects to statins and other lipid-lowering drugs. All patients starting therapy with ezetimibe/simvastatin or whose dose of ezetimibe/simvastatin is being increased should be advised of the risk of Vytorin side effects like myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness because they could be signs of serious side effects. It is recommended that liver function tests be performed before treatment with ezetimibe/simvastatin begins and thereafter as clinically indicated. Patients titrated to the 10/80 mg dose should receive an additional liver function test prior to titration, three months after titration to the 10/80 mg dose, and periodically thereafter (e.g. semiannually) for the first year of treatment. Due to the unknown Vytorin side effects of the increased exposure to ezetimibe/simvastatin in patients with moderate or severe hepatic insufficiency, ezetimibe/simvastatin is not recommended in these patients. The safety and effectiveness of ezetimibe/simvastatin with fibrates have not been established; therefore, co-administration with fibrates is not recommended. Ezetimibe/simvastatin should not be used in pregnant or nursing women. In clinical trials, ezetimibe/simvastatin was generally well tolerated. The most common Vytorin side effects included headache, dizziness, arthralgia, myalgia and asthenia. Important information about ezetimibe When ezetimibe is used with a statin, liver function tests should be performed at the start of therapy and after that in accordance with the label for that statin. Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate or severe hepatic insufficiency, ezetimibe is not recommended in these patients. In clinical trials, there was no increased incidence of myopathy or rhabdomyolysis associated with ezetimibe. However, myopathy and rhabdomyolysis are known adverse reactions to statins and other lipid-lowering drugs. There are no adequate and well-controlled studies of ezetimibe in pregnant women. Ezetimibe should not be used in pregnant or nursing women unless the benefit outweighs the potential risks. The safety and effectiveness of ezetimibe with fibrates have not been established; therefore, co-administration with fibrates is not recommended. Important information about simvastatin Simvastatin should not be used by anyone allergic to any of its components, with liver disease, or by women who are pregnant, breast-feeding or likely to become pregnant.Vytorin side effects like muscle pain or weakness in people taking simvastatin should be reported to a doctor because these could be signs of a serious side effect. Doctors may perform blood tests before and periodically during treatment with simvastatin to check for liver problems. People taking 80 mg of simvastatin should receive an additional liver function test at three months. To help avoid serious Vytorin side effects, discuss with your doctor medicine or food you should avoid while taking simvastatin. In clinical trials, Vytorin side effects usually have been mild and transient. Most common Vytorin side effects included headache (3.5 percent), abdominal pain (3.2 percent) and constipation (2.3 percent).
Vytorin is the first product to reduce low-density lipoprotein cholesterol (LDL-C or 'bad' cholesterol) through Dual Inhibition of both cholesterol production in the liver and absorption in the intestine. Germany is the first European country to give regulatory approval for INEGY. The approval in Germany represents the first step in seeking marketing approval throughout the European Union (EU) under the EU's mutual recognition procedure. Ezetimibe/simvastatin has also been approved in Mexico. "INEGY is an important treatment that offers more LDL-C-lowering compared to statins alone, and will, therefore, allow significantly more patients in Europe to reach their LDL-C targets," said Professor Heiner Greten, Universitatskrankenhaus, Eppendorf, Medizinische Klinik, Hamburg, Germany. To provide physicians with choices for dosing based on patients' needs, INEGY, which contains both ezetimibe and simvastatin, will be available in several tablet strengths - ezetimibe 10 mg with simvastatin 10, 20, 40 or 80 mg. Ezetimibe with simvastatin more efficacious than atorvastatin as demonstrated in studies presented at ACC The regulatory approval of INEGY is based on extensive clinical data that has shown INEGY provides greater LDL-C-reduction than statin alone. Ezetimibe with simvastatin, the active ingredients in INEGY, have been shown to be significantly more effective at reducing LDL-C than atorvastatin (LIPITOR®) across all dosages. New data released this month at the American College of Cardiology from a 24-week study of ezetimibe 10 mg taken with simvastatin (doses ranging from 10 mg to 80 mg) compared to atorvastatin alone (does ranging from 10 mg to 80 mg) showed greater LDL-C reductions in patients taking ezetimibe/simvastatin compared to patients taking atorvastatin across the dosing ranges. After six weeks of therapy, patients taking ezetimibe 10 mg with simvastatin 10 mg and patients taking ezetimibe 10 mg with simvastatin 20 mg experienced greater LDL-C reductions (46 percent and 50 percent, respectively) compared to atorvastatin 10 mg, which produced a 37 percent reduction. In addition, as each treatment group was titrated through the dosing ranges, ezetimibe with simvastatin provided greater LDL-C reductions than atorvastatin at all points in the treatment period.1 What is Dual Inhibition? Cholesterol in the body originates from two main sources: production by hepatic and extra hepatic tissues and absorption in the intestine. Cholesterol-lowering agents (statins) reduce cholesterol levels by single inhibition, that is, by inhibiting the synthesis (production) of cholesterol in the liver. Ezetimibe, the first cholesterol absorption inhibitor, works by inhibiting intestinal absorption of cholesterol, both dietary and the cholesterol which is a component of bile. INEGY provides Dual Inhibition by targeting both of the main sources of cholesterol in the body, production and absorption, providing significantly more effective reduction of LDL-C plasma levels. About INEGY / VYTORIN INEGY will be marketed by a partnership between Merck & Co., Inc. and Schering-Plough Corporation. Ezetimibe/Simvastatin is also currently under review by the Food and Drug Administration for marketing approval under the brand name VYTROIN in the United States.
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