Ezetimibe + Simvastatin
Find more information about this combination medication at the webpages for Simvastatin and Ezetimibe
Hypercholesterolemia
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Advisory
- This medicine contains a combination of 2 drugs Ezetimibe and Simvastatin.
- Ezetimibe and Simvastatin are both used to treat the same disease or symptom but work in different ways in the body.
- Most doctors will advise making sure that each individual medicine is safe and effective before using a combination form.
Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
None
Controlled Drug Substance
NO
Summary
Ezetimibe and Simvastatin are used to treat high cholesterol levels, specifically low-density lipoprotein (LDL) or 'bad' cholesterol. They help prevent heart disease, strokes and heart attacks by reducing cholesterol buildup in the arteries. They are also used in adults and children over 10 years old with familial hypercholesterolemia, a genetic condition that causes high cholesterol. These medications can also reduce the risk of heart attacks, strokes, and the need for heart surgery in individuals with heart disease or at high risk of developing it.
Ezetimibe works by reducing the absorption of cholesterol in the intestines, while Simvastatin decreases cholesterol production in the liver. This combination helps to lower cholesterol levels in the body, which helps prevent the buildup of cholesterol in the arteries and reduces the risk of cardiovascular diseases.
Ezetimibe is typically taken at a dose of 10 mg once a day. Simvastatin's dose can vary, but it typically ranges from 10 mg to 40 mg per day. When combined in a single tablet, the doses are often 10 mg of Ezetimibe with 10 mg, 20 mg, or 40 mg of Simvastatin. This combination is taken once daily in the evening, with or without food.
Common side effects of Ezetimibe and Simvastatin include headache, increased liver enzyme levels, muscle pain, upper respiratory infections, and diarrhea. Serious side effects can include muscle problems such as myopathy and rhabdomyolysis which can lead to kidney damage, and liver problems including elevated liver enzymes and liver failure.
Ezetimibe and Simvastatin can cause muscle and liver problems. Patients with active liver disease or unexplained persistent elevations in liver enzymes should not use this medication. It is also contraindicated in individuals taking strong CYP3A4 inhibitors, cyclosporine, danazol, or gemfibrozil. Pregnant or breastfeeding women should avoid this medication due to potential harm to the fetus or infant.
Indications and Purpose
How does combination of Ezetimibe and Simvastatin work?
Ezetimibe and Simvastatin work together to lower cholesterol levels in the body through complementary mechanisms. Ezetimibe acts by inhibiting the absorption of cholesterol in the small intestine, reducing the amount of cholesterol that enters the bloodstream. Simvastatin, on the other hand, is a statin that inhibits the enzyme HMG-CoA reductase in the liver, which is responsible for cholesterol synthesis. By reducing both the absorption and production of cholesterol, this combination effectively lowers LDL cholesterol levels, helping to prevent the buildup of cholesterol in the arteries and reducing the risk of cardiovascular diseases.
How effective is combination of Ezetimibe and Simvastatin?
Clinical trials have demonstrated the effectiveness of Ezetimibe and Simvastatin in lowering LDL cholesterol levels and reducing the risk of cardiovascular events. Ezetimibe has been shown to inhibit intestinal cholesterol absorption by 54%, while Simvastatin reduces cholesterol synthesis in the liver. Together, they provide a significant reduction in LDL cholesterol, total cholesterol, and triglycerides, while increasing HDL cholesterol. Studies have also shown that this combination reduces the incidence of heart attacks, strokes, and the need for revascularization procedures, proving its efficacy in managing hyperlipidemia and preventing cardiovascular diseases.
Directions for Use
What is the usual dose of combination of Ezetimibe and Simvastatin?
The usual adult daily dose for Ezetimibe is 10 mg, taken once a day. For Simvastatin, the dose can vary depending on the patient's condition and response to treatment, but it typically ranges from 10 mg to 40 mg per day. When combined in a single tablet, the doses are often 10 mg of Ezetimibe with 10 mg, 20 mg, or 40 mg of Simvastatin. This combination is taken once daily in the evening, with or without food, to maximize the cholesterol-lowering effects of both medications.
How does one take combination of Ezetimibe and Simvastatin?
Ezetimibe and Simvastatin should be taken once daily in the evening, with or without food. It is important to take the medication at the same time each day to maintain consistent blood levels. Patients are advised to follow a low-fat, low-cholesterol diet and adhere to any exercise recommendations provided by their healthcare provider. Grapefruit juice should be avoided while taking Simvastatin, as it can increase the risk of side effects. Regular monitoring and communication with a healthcare provider are essential to ensure the medication is working effectively and safely.
For how long is combination of Ezetimibe and Simvastatin taken?
Ezetimibe and Simvastatin are typically used as long-term treatments for managing high cholesterol levels. Patients are advised to continue taking these medications even if they feel well, as they help maintain lower cholesterol levels and reduce the risk of cardiovascular events. The duration of use is often indefinite, as long as the patient tolerates the medication well and it remains effective in managing their cholesterol levels. Regular monitoring by a healthcare provider is essential to assess the ongoing need for these medications.
How long does it take for combination of Ezetimibe and Simvastatin to work?
Ezetimibe and Simvastatin work together to lower cholesterol levels in the body. Ezetimibe starts working by inhibiting the absorption of cholesterol in the intestine, while Simvastatin reduces cholesterol production in the liver. The effects of this combination can be observed within 2 weeks, with maximum cholesterol-lowering effects typically achieved by 4 weeks. Both medicines work synergistically to provide a more comprehensive reduction in cholesterol levels, which is beneficial for preventing heart disease and other related conditions.
Warnings and Precautions
Are there harms and risks from taking combination of Ezetimibe and Simvastatin?
Common side effects of Ezetimibe and Simvastatin include headache, increased liver enzyme levels, muscle pain, upper respiratory infections, and diarrhea. Significant adverse effects can include muscle problems such as myopathy and rhabdomyolysis, which can lead to kidney damage. Liver problems, including elevated liver enzymes and liver failure, are also potential risks. Patients should report any unexplained muscle pain, tenderness, or weakness, as well as symptoms of liver issues like fatigue, loss of appetite, or yellowing of the skin or eyes, to their healthcare provider immediately.
Can I take combination of Ezetimibe and Simvastatin with other prescription drugs?
Ezetimibe and Simvastatin have several significant drug interactions. Strong CYP3A4 inhibitors, such as certain antifungal and antibiotic medications, can increase Simvastatin levels, raising the risk of muscle problems. Other drugs like cyclosporine, danazol, and gemfibrozil can also increase the risk of myopathy and rhabdomyolysis. Patients should avoid grapefruit juice, as it can increase Simvastatin levels. It is crucial to inform healthcare providers of all medications being taken to manage potential interactions effectively and adjust dosages as necessary.
Can I take combination of Ezetimibe and Simvastatin if I am pregnant?
Ezetimibe and Simvastatin are contraindicated during pregnancy due to the potential risk of harm to the developing fetus. Statins, including Simvastatin, can interfere with cholesterol synthesis, which is crucial for fetal development. Although there is limited data on Ezetimibe's effects during pregnancy, the combination with Simvastatin poses significant risks. Women who are pregnant or planning to become pregnant should not use this medication, and those who become pregnant while taking it should discontinue use immediately and consult their healthcare provider for alternative treatments.
Can I take combination of Ezetimibe and Simvastatin while breastfeeding?
Ezetimibe and Simvastatin are not recommended during breastfeeding due to the potential for serious adverse reactions in a breastfed infant. While it is not known if Ezetimibe is excreted in human milk, Simvastatin and other statins are known to pass into breast milk. The mechanism of action of these drugs, which involves reducing cholesterol synthesis, could potentially harm a nursing infant. Therefore, alternative treatments should be considered for breastfeeding mothers, and they should consult their healthcare provider to discuss the best options for managing their cholesterol levels.
Who should avoid taking combination of Ezetimibe and Simvastatin?
Important warnings for Ezetimibe and Simvastatin include the risk of muscle problems, such as myopathy and rhabdomyolysis, and liver issues. Patients with active liver disease or unexplained persistent elevations in liver enzymes should not use this medication. It is contraindicated in individuals taking strong CYP3A4 inhibitors, cyclosporine, danazol, or gemfibrozil. Pregnant or breastfeeding women should avoid this medication due to potential harm to the fetus or infant. Patients should be monitored for any signs of muscle pain, weakness, or liver dysfunction and report these symptoms to their healthcare provider immediately.
