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Drug Notebook

FDA Alerts

Special Alerts:

[Posted 08/21/2008] FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of ezetimibe with simvastatin (Vytorin) and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.

FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2 and http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm.

[Posted 08/08/2008] FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin (Zocor) is used with amiodarone (Cordarone, Pacerone ). This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin, http://www.fda.gov/cder/drug/infopage/simvastatin_amiodarone/default.htm, http://www.fda.gov/cder/drug/InfoSheets/HCP/simvastatin_amiodaroneHCP.htm, http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=simvastatin and http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=amiodarone&x=10&y=11.

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simvastatin
(SIM va stat in)

What is this medicine?
SIMVASTATIN (SIM va stat in) is known as a HMG-CoA reductase inhibitor or 'statin'. It lowers the level of cholesterol and triglycerides in the blood. This drug may also reduce the risk of heart attack, stroke, or other health problems in patients with risk factors for heart or blood vessel disease. Diet and lifestyle changes are often used with this drug.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Simvastatin 10MG Tablets TEVA PHARMACEUTICALS USA30/$19.99 or 90/$49.97
Simvastatin 20MG Tablets TEVA PHARMACEUTICALS USA30/$27.99 or 90/$73.97
Simvastatin 40MG Tablets TEVA PHARMACEUTICALS USA30/$27.99 or 90/$75.97
Simvastatin 5MG Tablets TEVA PHARMACEUTICALS USA30/$17.99 or 90/$42.98
Simvastatin 80MG Tablets TEVA PHARMACEUTICALS USA30/$32.99 or 90/$89.97
Vytorin 10-10MG Tablets MERCK/SCHERING-PLOUGH PHARM30/$117.95 or 90/$335.68
Vytorin 10-20MG Tablets MERCK/SCHERING-PLOUGH PHARM30/$115.68 or 90/$328.88
Vytorin 10-40MG Tablets MERCK/SCHERING-PLOUGH PHARM30/$114.54 or 90/$336.83
Vytorin 10-80MG Tablets MERCK/SCHERING-PLOUGH PHARM30/$115.68 or 90/$328.88
Zocor 10MG Tablets MERCK HUMAN HEALTH90/$240.98 or 180/$481.95
Zocor 20MG Tablets MERCK HUMAN HEALTH30/$149.97 or 90/$425.98
Zocor 40MG Tablets MERCK HUMAN HEALTH90/$425.99 or 180/$839.97
Zocor 5MG Tablets MERCK HUMAN HEALTH30/$71.61 or 90/$192.38
Zocor 80MG Tablets MERCK HUMAN HEALTH30/$146.98 or 90/$405.02

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • dark urine
  • fever
  • joint pain
  • muscle cramps, pain
  • redness, blistering, peeling or loosening of the skin, including inside the mouth
  • trouble passing urine or change in the amount of urine
  • unusually weak or tired
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation
  • heartburn
  • stomach gas, pain, upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • medicines for fungal infections like itraconazole, ketoconazole
  • nefazodone
  • other medicines for high cholesterol
  • red yeast rice
  • some antibiotics like clarithromycin, erythromycin, telithromycin
  • some medicines for HIV infection like amprenavir, indinavir, ritonavir

This medicine may also interact with the following medications:

  • alcohol
  • amiodarone
  • cyclosporine
  • danazol
  • diltiazem
  • grapefruit juice
  • fluconazole
  • verapamil
  • voriconazole
  • warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Active liver disease or unexplained, persistent elevations of serum aminotransferases.
  • Pregnancy or lactation. Administer to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.
  • Known hypersensitivity to simvastatin or any ingredient in the formulation.

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What should I watch for while using this medicine?
Visit your doctor or health care professional for regular check-ups. You may need regular tests to make sure your liver is working properly.

Tell you doctor or health care professional right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.

This drug is only part of a total heart-health program. Your doctor or a dietician can suggest a low-cholesterol and low-fat diet to help. Avoid alcohol and smoking, and keep a proper exercise schedule.

Do not use this drug if you are pregnant or breast-feeding. Serious side effects to an unborn child or to an infant are possible. Talk to your doctor or pharmacist for more information.

If you are going to have surgery tell your health care professional that you are taking this drug.

Some drugs may increase the risk of side effects from simvastatin. If you are given certain antibiotics or antifungals, your doctor or health care professional may stop simvastatin for a short time. Check with your doctor or pharmacist for advice.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • frequently drink alcoholic beverages
  • kidney disease
  • liver disease
  • muscle aches or weakness
  • other medical condition
  • an unusual or allergic reaction to simvastatin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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