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Drug monograph for the active ingredient in Simvastatin

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

HMG-COA REDUCTASE INHIBITORS (Systemic)

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Some commonly used brand names are:

In the U.S.�

• Altoprev ⁴
• Lescol ³
• Lipitor ¹
• Mevacor ⁴
• Pravachol ⁵
• Zocor ⁶

• Note:

  Baycol was removed from the U.S. market by Bayer in August 2001.

In Canada�

• Lescol ³
• Mevacor ⁴
• Pravachol ⁵
• Zocor ⁶

Other commonly used names are:

• Epistatin
• Eptastatin
• Mevinolin
• Synvinolin

Note:

For quick reference, the following HMG-CoA reductase inhibitors are numbered to match the corresponding brand names.

This information applies to the following medicines:
1.	Atorvastatin (a-TOR-va-sta-tin)
2.	Cerivastatin# (se-RIV-a-sta-tin)*�
3.	Fluvastatin (FLOO-va-sta-tin)
4.	Lovastatin (LOE-va-sta-tin)
5.	Pravastatin (PRA-va-stat-in)
6.	Simvastatin (SIM-va-stat-in)
* Not commercially available in the U.S.
� Not commercially available in Canada

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Category

• Antihyperlipidemic�Atorvastatin; Cerivastatin#; Fluvastatin; Lovastatin; Pravastatin; Simvastatin
• HMG-CoA reductase inhibitor�Atorvastatin; Cerivastatin#; Fluvastatin; Lovastatin; Pravastatin; Simvastatin

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Description

Atorvastatin, cerivastatin# , fluvastatin, lovastatin, pravastatin, and simvastatin are used to lower levels of cholesterol and other fats in the blood. This may help prevent medical problems caused by cholesterol clogging the blood vessels.

These medicines belong to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. They work by blocking an enzyme that is needed by the body to make cholesterol. Thus, less cholesterol is made.

HMG-CoA reductase inhibitors are available only with your doctor's prescription, in the following dosage forms:

• Oral
• Atorvastatin
  • Tablets (U.S. and Canada)
• Cerivastatin
  • Tablets#
• Fluvastatin
  • Capsules (U.S. and Canada)
• Lovastatin
  • Extended-Release Tablets (U.S.)
  • Tablets (U.S. and Canada)
• Pravastatin
  • Tablets (U.S. and Canada)
• Simvastatin
  • Tablets (U.S. and Canada)

# Removed from the market by Bayer in August 2001.

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Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For HMG-CoA reductase inhibitors, the following should be considered:

Allergies�Tell your doctor if you have ever had any unusual or allergic reaction to HMG-CoA reductase inhibitors. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet�Before prescribing medicines to lower your cholesterol, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet will be lower in total fat, particularly saturated fat, and dietary cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.

Pregnancy�HMG-CoA reductase inhibitors should not be used during pregnancy or by women who plan to become pregnant in the near future. These medicines block formation of cholesterol, which is necessary for the fetus to develop properly. HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy. An effective form of birth control should be used during treatment with these medicines. Check with your doctor immediately if you think you have become pregnant while taking this medicine . Be sure you have discussed this with your doctor.

Breast-feeding�These medicines are not recommended for use during breast-feeding because they may cause unwanted effects in nursing babies.

Children�Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of HMG-CoA reductase inhibitors in children with use in other age groups. However, atorvastatin, lovastatin, and simvastatin have been used in a limited number of children under 18 years of age. Early information seems to show that these medicines may be effective in children, but their long-term safety has not been studied.

Older adults�This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines�Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking HMG-CoA reductase inhibitors, it is especially important that your health care professional know if you are taking any of the following:

• Cyclosporine (e.g., Sandimmune) or
• Gemfibrozil (e.g., Lopid) or
• Clofibrate (e.g., Atromid-S) or
• Fenofibrate (e.g., Tricor) or
• Niacin�Use of these medicines with an HMG-CoA reductase inhibitor may increase the risk of developing muscle problems and kidney failure

• Digoxin (e.g., Lanoxin)�Use with atorvastatin, fluvastatin, or simvastatin may increase blood levels of digoxin, increasing the risk of side effects

• Oral contraceptives, (birth control tablets)�Atorvastatin may increase the blood levels of the birth control hormones, increasing the risk of side effects

• HIV protease inhibitors (Amprenavir [e.g., Agenerase], Indinavir [e.g., Crixivan], Nelfinavir [e.g., Viracept], Ritonavir [e.g., Norvir], Saquinavir [e.g., Fortovase, Invirase]) or
• Nefazodone (e.g. Serzone)�Use with simvastatin may increase the risk of developing muscle problems and kidney failure

• Verapamil (e.g. Calan, Isoptin)�Use with simvastatin may increase the risk of muscle problems

Other medical problems�The presence of other medical problems may affect the use of HMG-CoA reductase inhibitors. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Liver disease�Use of this medicine may make liver problems worse

• Convulsions (seizures), not well-controlled, or
• Organ transplant with therapy to prevent transplant rejection or
• If you have recently had major surgery�Patients with these conditions may be at risk of developing problems that may lead to kidney failure

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Proper Use of This Medicine

Use this medicine only as directed by your doctor . Do not use more or less of it, and do not use it more often or for a longer time than your doctor ordered.

Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.

Follow carefully the special diet your doctor gave you . This is the most important part of controlling your condition, and is necessary if the medicine is to work properly.

For patients taking atorvastatin and simvastatin :

• Do not take these medicines with large amounts of grapefruit juice

For patients taking lovastatin :

• For extended-release tablets: This medicine works better when it is taken at bedtime. The extended-release tablets should be swallowed whole. They should not be chewed, crushed, or cut.
• For tablets: This medicine works better when it is taken with food. If you are taking this medicine once a day, take it with the evening meal. If you are taking more than one dose a day, take each dose with a meal or snack.

Dosing�The dose of these medicines will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets that you take depends on the strength of the medicine.

• For atorvastatin
• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults�10 to 80 milligrams (mg) once a day.
    • Children 10 to 17 years of age�10 to 20 milligrams (mg) once a day.
    • Childrenyounger than 10 years of age�Use and dose must be determined by your doctor.

• For cerivastatin
• For oral dosage form :

  Note:

  Removed from the market by Bayer in August 2001

• For fluvastatin
• For oral dosage form (capsules):
  • For high cholesterol:
    • Adults�20 to 40 milligrams (mg) once a day in the evening.
    • Children�Use and dose must be determined by your doctor.

• For lovastatin
• For oral dosage form (extended-release tablets):
  • For high cholesterol:
    • Adults�10 to 60 milligrams (mg) once a day at bedtime.
    • Children�Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults� 20 to 80 milligrams (mg) a day taken as a single dose or divided into smaller doses. Take with evening meals.
    • Children�Use and dose must be determined by your doctor.

• For pravastatin
• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults�10 to 40 mg once a day at bedtime.
    • Children�Use and dose must be determined by your doctor.

• For simvastatin
• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults�5 to 80 mg a day.
    • Children�Use and dose must be determined by your doctor.

Missed dose�If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage�To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits . This will allow your doctor to see if the medicine is working properly to lower your cholesterol levels and that it does not cause unwanted effects.

Check with your doctor immediately if you think that you may be pregnant . HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy. Your doctor may recommend an appropriate method of birth control to prevent adolescent girls and women of child bearing potential from getting pregnant.

Do not stop taking this medicine without first checking with your doctor . When you stop taking this medicine, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine .

Check with your doctor immediately if you have unexplained muscle pain, tenderness, or weakness .

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Side Effects of This Medicine

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

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Revised: 11/15/2004

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