Simvastatin

Simvastatin is a prescription medication used to treat high cholesterol, high triglycerides, and disease of the heart and blood vessels. Simvastatin belongs to a group of drugs called HMG-CoA reductase inhibitors, also known as statins. It works by blocking the production of cholesterol in the body.

This medication comes in tablet form and is usually taken once daily at bedtime, with or without food.

Common side effects of simvastatin include muscle and joint soreness, nausea, and constipation.

Simvastatin is a prescription medication used to treat high cholesterol, high triglycerides, and to prevent cardiovascular disease (heart or blood vessel disease).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Simvastatin may be found in some form under the following brand names:

• Juvisync

• Simcor

• Vytorin

• Zocor

Serious side effects have been reported with simvastatin. See the “Simvastatin Precautions” section.

Common side effects of simvastatin include the following:

• muscle and joint aches
• constipation
• stomach pain
• nausea
• headache
• upper airway infections

This is not a complete list of simvastatin side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• warfarin (Coumadin, Jantoven)
• cyclosporine (Neoral, Sandimmune)
• danazol (Danocrine)
• amiodarone (Cordarone, Pacerone)
• ranolazine (Ranexa)
• colchicine (Colcrys)
• digoxin (Lanoxin)
• calcium channel blockers such as nifedipine (Adalat, Nifedical, Procardia), amlodipine (Norvasc), verapamil (Calan, Isoptin, Covera, Verelan), and diltiazem (Cardizem)
• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• medications that block the enzyme CYP2D6 such as quinidine (Qualaquin), fluoxetine (Prozac,Sarafem), amitriptyline (Elavil, Amitril), and paroxetine (Paxil)
• fibrates such as gemfibrozil (Lopid) or fenofibrate (TriCor)
• nicotinic acid medications such as niacin (Niacor, Niaspan, Slo-Niacin) and vitamin B3

This is not a complete list of simvastatin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with simvastatin including the following:

• myopathy/rhabdomyolysis. This is a condition in which muscle tissue breaks down, releasing proteins into the blood that can damage other organs, especially the kidney. The risk increases with higher doses and is highest for patients taking simvastatin 80 mg. Tell your healthcare provider right away about any unexplained muscle pain, tenderness, or weakness.
• changes in liver enzymes.  Your doctor will probably order a blood test to measure liver function before you start taking simvastatin. 

Do not take simvastatin if you:

• are allergic to simvastatin or any of its ingredients

• are taking strong CYP3A4 inhibitors (such as itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone)
• are taking gemfibrozil, cyclosporine, or danazol
• have active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• are pregnant
• are breastfeeding

Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects, including muscle injury. Discuss the use of grapefruit products with your doctor.

Before taking simvastatin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to simvastatin or to any of its ingredients
• have liver disease
• drink large amounts of alcohol
• are pregnant or plan to become pregnant
• are breastfeeding
• are of Chinese descent
• have severe kidney disease
• have seizures, diabetes, or underactive thyroid gland
• will be undergoing surgery

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Simvastatin falls into category X. It has been shown that women taking simvastatin during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Many statins have been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from simvastatin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take simvastatin exactly as prescribed.

Simvastatin comes in tablet form and is given once a day at bedtime, with or without food.

Your doctor may start you on a low dose of simvastatin and gradually increase your dose. Do not increase or decrease your dose or stop taking it without first talking to your doctor.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of simvastatin at the same time.

Take simvastatin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The simvastatin dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of simvastatin for the treatment of high cholesterol is 5 mg to 40 mg daily.

If you take too much simvastatin, call your local Poison Control Center or seek emergency medical attention right away.

• Store simvastatin at room temperature between 41°F to 86°F (5°C to 30°C).
• Protect from moisture and light.
• Keep simvastatin and all medicines out of the reach of children.