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Nu-Simvastatin

Common Name

simvastatin

How does this medication work? What will it do for me?

Simvastatin belongs to the group of medications known as HMG CoA reductase inhibitors ("statins"). It is used in addition to diet and exercise to lower cholesterol levels.

It is also used to decrease the risk of heart attack, stroke, or death regardless of whether cholesterol levels are high or not for people who have coronary heart disease (CHD) or have other arteries in the body that are blocked, or for those who have diabetes and are over the age of 40.

It works by blocking an enzyme that helps create cholesterol in the body. Therefore, less cholesterol is made and levels of cholesterol in the blood decrease. Simvastatin lowers the level of total cholesterol and low density lipoprotein (LDL, or "bad" cholesterol) and raises high density lipoprotein (HDL, or "good" cholesterol) levels.

The medication usually takes about 2 to 4 weeks to have a significant effect on the cholesterol level in your blood. After this time, your doctor will likely send you for a blood test to check for changes in your cholesterol levels.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

5 mg
Each light yellow, shield-shaped, biconvex, straight-edged, film-coated tablet, engraved "NU" on one side and "5" on the other, contains simvastatin 5 mg. Nonmedicinal ingredients: butylated hydroxyanisole, croscarmellose sodium, hydroxyethyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and yellow ferric oxide.

10 mg
Each light pink, shield-shaped, biconvex, straight-edged, film-coated tablet, engraved "NU" on one side and "10" on the other, contains simvastatin 10 mg. Nonmedicinal ingredients: butylated hydroxyanisole, croscarmellose sodium, hydroxyethyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and red ferric oxide.

20 mg
Each peach, shield-shaped, biconvex, straight-edged, film-coated tablet, engraved "NU" on one side and "20" on the other, contains simvastatin 20 mg. Nonmedicinal ingredients: butylated hydroxyanisole, croscarmellose sodium, hydroxyethyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, red ferric acid, and yellow ferric oxide.

40 mg
Each dusty rose, shield-shaped, biconvex, straight-edged, film-coated tablet, engraved "NU" on one side and "40" on the other, contains simvastatin 40 mg. Nonmedicinal ingredients: butylated hydroxyanisole, croscarmellose sodium, hydroxyethyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and red ferric acid.

80 mg
Each dusty rose, shield-shaped, biconvex, straight-edged, film-coated tablet, engraved "NU" on one side and "80" on the other, contains simvastatin 80 mg. Nonmedicinal ingredients: butylated hydroxyanisole, croscarmellose sodium, hydroxyethyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and red ferric acid.

How should I use this medication?

Before or when starting simvastatin, you should be placed on a cholesterol-lowering diet. If appropriate, a health care professional will discuss an individualized program of weight control and physical exercise with you.

The starting dose of this medication depends on your medical conditions and other medications you are taking, and can range from 5 mg to 40 mg taken once daily in the evening. The maximum recommended daily dose is 80 mg, which may be required for some people who are unable to achieve a desired cholesterol level using lower doses. The maximum daily dose may be lower for people taking certain medications.

The maximum dose for children and adolescents 10 to 17 years of age is 40 mg.

For best results in lowering your cholesterol, it is very important that you closely follow the diet suggested by your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

This medication is available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms listed here. The forms available for the specific brand you have searched are listed under "What form(s) does this medication come in?"

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Simvastatin should not be taken by anyone who:

• is allergic to simvastatin or to any of the ingredients of the medication
• is breast-feeding
• is pregnant or plans to become pregnant
• has active liver disease or unexplained increases in liver function tests

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• constipation
• diarrhea
• gas
• headache
• nausea
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision
• depression
• memory loss
• skin rash
• symptoms of liver damage (e.g., yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
• symptoms of muscle damage (e.g., unexplained muscle pain, tenderness, or weakness, or brown or discoloured urine - especially if you also have a fever or a general feeling of being unwell)
• symptoms of nerve damage (e.g., muscle weakness, decreased sensation in the hands and feet, numbness, or tingling or prickling sensations)

Stop taking the medication and seek medical attention immediately if any of the following occur:

• severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
• symptoms of a serious allergic reaction (e.g., swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.

Grapefruit juice: Drinking large quantities (more than 1 litre daily) of grapefruit juice should be avoided while taking this medication as it can increase the amount of simvastatin in the blood and increase the risk of serious side effects. Drinking small quantities (one 250 mL glass daily) does not appear to increase the risk of side effects significantly.

Kidney problems: People with decreased kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Laboratory tests show signs of harmful effects to the liver that may occur for a small percentage of people who take simvastatin. When this medication is stopped, liver function usually slowly returns to normal. Your doctor will perform regular tests to check your liver function.

This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. People with a history of liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Muscle effects: In rare cases, serious muscle pain, cramps, and weakness have been associated with the use of statin medications (i.e., cholesterol-lowering medications whose names end in "statin," such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

• are 65 years of age or older
• are female
• are taking other cholesterol-lowering medications such as fibrates (e.g., gemfibrozil, fenofibrate) or niacin
• do excessive physical exercise
• have a family history of muscular disorders
• have diabetes
• have had any past problems with the muscles (pain, tenderness) after taking a statin medication
• have hypothyroidism (low thyroid) that is not controlled with medication
• have kidney or liver problems
• have undergone surgery or other tissue injury
• regularly drink 3 or more alcoholic drinks daily

Report any unexplained muscle pain, tenderness, weakness, or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: Simvastatin should not be taken during pregnancy. If you become pregnant, stop taking this medication and contact your doctor immediately.

Breast-feeding: It is not known if simvastatin passes into breast milk. Women taking simvastatin should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children under 10 years of age or in girls who have not started menstruating.

Seniors: If you are 65 years of age or older, you may experience more side effects. Your doctor will monitor you closely while you are taking this medication.

What other drugs could interact with this medication?

There may be an interaction between simvastatin and any of the following:

amiodarone amlodipine cholestyramine clarithromycin colchicine colestipol cyclosporine danazol daptomycin digoxin diltiazem dronedarone erythromycin fusidic acid

gemfibrozil itraconazole ketoconazole nefazodone niacin (nicotinic acid) phenytoin protease inhibitors (e.g., ritonavir, saquinavir) quinine rifampin rifabutin sildenafil telithromycin verapamil warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material © 1996-2013 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.