||Chemical Name: Ezetimibe/Simvastatin
EZETIMIBE/SIMVASTATIN contains two cholesterol-lowering medications, ezetimibe and simvastatin, available as a tablet
in four strengths:
- EZETIMIBE/SIMVASTATIN 10/10 (ezetimibe 10 mg/simvastatin 10 mg)
- EZETIMIBE/SIMVASTATIN 10/20 (ezetimibe 10 mg/simvastatin 20 mg)
- EZETIMIBE/SIMVASTATIN 10/40 (ezetimibe 10 mg/simvastatin 40 mg)
- EZETIMIBE/SIMVASTATIN 10/80 (ezetimibe 10 mg/simvastatin 80 mg)
EZETIMIBE/SIMVASTATIN is a medicine used to lower levels of total cholesterol, LDL (bad) cholesterol, and fatty
substances called triglycerides in the blood. In addition, EZETIMIBE/SIMVASTATIN raises levels of HDL (good) cholesterol.
It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a
cholesterol-lowering diet while taking this medicine.
EZETIMIBE/SIMVASTATIN works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your
Merck/Schering-Plough Pharmaceuticals announced the regulatory approval of Ezetimibe/Simvastatin (Ezetimibe & Simvastatin) on April 2nd 2004 in Germany and on July 26, 2004 in the United States for the treatment of elevated cholesterol (hypercholesterolemia).
Take EZETIMIBE/SIMVASTATIN once a day, in the evening, with or without food.
Cholesterol is a type of fat found in your blood. Cholesterol comes from two sources. It is produced by
your body and it comes from the food you eat. Your total cholesterol is made up of both LDL and HDL
LDL cholesterol is called "bad" cholesterol because it can build up in the wall of your arteries and form
plaque. Over time, plaque build-up can cause a narrowing of the arteries. This narrowing can slow or
block blood flow to your heart, brain, and other organs. High LDL cholesterol is a major cause of heart
disease and stroke.
HDL cholesterol is called "good" cholesterol because it keeps the bad cholesterol from building up in the
Triglycerides also are fats found in your body.
Primary Hypercholesterolemia: EZETIMIBE/SIMVASTATIN is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and nonfamilial)hypercholesterolemia or mixed hyperlipidemia.
Homozygous Familial Hypercholesterolemia (HoFH): EZETIMIBE/SIMVASTATIN is 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.
Therapy with lipid-altering agents should be a component of multiple risk-factor intervention in
individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipidaltering
agents should be used in addition to an appropriate diet (including restriction of saturated fat and
cholesterol) and when the response to diet and other non-pharmacological measures has been
Important information about Ezetimibe/Simvastatin side effects .
In clinical trials of ezetimibe co-administered with simvastatin, there was no increased incidence of Ezetimibe/Simvastatin side effects like myopathy or rhabdomyolysis associated with ezetimibe/simvastatin. However, myopathy and rhabdomyolysis are known Ezetimibe/Simvastatin 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 Ezetimibe/Simvastatin 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 Ezetimibe/Simvastatin 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 Ezetimibe/Simvastatin 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.Ezetimibe/Simvastatin 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 Ezetimibe/Simvastatin side effects, discuss with your doctor medicine or food you should avoid while taking simvastatin. In clinical trials, Ezetimibe/Simvastatin side effects usually have been mild and transient. Most common Ezetimibe/Simvastatin side effects included headache (3.5 percent), abdominal pain (3.2 percent) and constipation (2.3 percent).
The generic alternative is not manufactured by the company that makes the brand product.
All prices are in US dollars.
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