"June 9, 2011 -- The FDA today tightened its rules on who should take the highest approved dose of the statin drug simvastatin.
Simvastatin, which lowers LDL "bad" cholesterol, is sold under the brand name Zocor and as a generic drug. "...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
NIACIN EXTENDED-RELEASE/SIMVASTATIN - ORAL
COMMON BRAND NAME(S): Simcor
USES: This combination medication is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. Niacin is also known as vitamin B3 (nicotinic acid), one of the B vitamins. It works by reducing the amount of cholesterol made by the liver and by helping the body remove fats from the blood. Simvastatin belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver.
Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. Lowering triglycerides may also help decrease the risk of pancreas problems (pancreatitis) in people at risk.
In addition to eating a proper diet (such as a low cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Talk with your doctor for more details.
HOW TO USE: Take this medication by mouth with a low-fat snack as directed by your doctor, usually once daily at bedtime. Taking this drug with food will help reduce side effects (such as flushing, upset stomach).
Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
To reduce the risk of flushing, avoid alcohol, hot beverages, and spicy foods near the time you take niacin. You may be able to reduce or prevent flushing by taking a plain aspirin (non-enteric coated, 325 milligrams) or a nonsteroidal anti-inflammatory drug (such as 200 milligrams of ibuprofen) 30 minutes before taking niacin. Ask your doctor if this treatment is right for you, especially if you are also taking a "blood thinner" such as warfarin.
The niacin in this product is an extended-release form. Your doctor may instruct you to first take the individual extended-release niacin until you reach the right dose and then switch you over to this combination product. Niacin is also available in other forms (for example, immediate- and sustained-release). If you have not taken niacin before, or if you have been using one of the other forms, your doctor should direct you to start at the lowest dose of this medication. Consult your doctor or pharmacist for more details.
Dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Chinese patients taking this product may require lower doses of simvastatin. Ask your doctor for more details.
The usual maximum dose for the simvastatin in this medication is 40 milligrams a day. If you have been instructed by your doctor to take more than 40 milligrams of simvastatin, continue on that same dose. However, promptly talk with him or her about the risks and benefits of your higher dose.
Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.
If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 4 to 6 hours before or after taking these medications.
Take this medication regularly to get the most benefit from it. Remember to take it at the same time each day. It may take up to 4 weeks before you get the full benefit of this drug.
It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.
Do not stop taking this medicine unless directed by your doctor. If you stop taking this product, you may need to start back at a lower dose and slowly increase the dose again. If you have not taken this medication for an extended period (more than 7 days), consult your doctor or pharmacist for instructions on starting it again.
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