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Simvastatin

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(CAS: 79902-63-9)

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CAS: 79902-63-9

Chemical Name: 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]- 4(S)-(4-hydroxy-phenyl)-2-azetidinone

Formula: C24H21F2NO3

Structure:

What is the most important information I should know about simvastatin?

# Rare cases of muscle problems and liver problems have been associated with the use of simvastatin and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by a fever or flulike symptoms or yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark colored urine or pale colored stools. These may be early symptoms of muscle or liver problems.
# Do not take simvastatin without first talking to your doctor if you have liver disease.
# Alcohol and simvastatin can both be damaging to the liver. Alcohol should be used only in moderation. Discuss the use of alcohol with your doctor so that the potential for liver problems can be determined.
# Do not take simvastatin if you are pregnant, could become pregnant during treatment, or if you are breast-feeding a baby.

What is simvastatin?

# Simvastatin is an HMG CoA reductase inhibitor. Simvastatin blocks the production of cholesterol (a type of fat) in the body.
# Simvastatin is used to reduce the total amounts of cholesterol, LDL (bad) cholesterol, triglycerides (another type of fat), and apolipoprotein B (a protein needed to make cholesterol) in your blood. Simvastatin (Zocor) is also used to increase the level of HDL (good) cholesterol in your blood. These actions may reduce the risk of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral vascular disease.
# Simvastatin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking simvastatin?

# Do not take simvastatin without first talking to your doctor if you have liver disease.
# Before taking simvastatin, tell your doctor if you
, have kidney disease,
, drink alcoholic beverages,
, have a chronic muscular disease, or
, have a blood disorder.
# You may not be able to take simvastatin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
# Simvastatin is in the FDA pregnancy category X. This means that simvastatin is known to cause birth defects if it is taken during pregnancy. Do not take simvastatin if you are pregnant or could become pregnant during treatment.
# It is not known whether simvastatin passes into breast milk. Do not take simvastatin without first talking to your doctor if you are breast-feeding a baby.

How should I take simvastatin?

# Take simvastatin exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
# Take each dose with a full glass of water.
# For the greatest effect, simvastatin is usually taken at bedtime or with an evening meal. Follow your doctor's instructions.
# Your doctor may want to monitor your liver function with blood tests before starting treatment with simvastatin and every six months after both the start of your treatment and any increase in dose. Depending on the results of these tests, your doctor can determine how much monitoring you will require.
# Grapefruit and grapefruit juice may interact with simvastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
# Eat a low-fat, low-cholesterol diet. To realize beneficial effects from simvastatin, avoid fatty, high-cholesterol foods.
# It is important to take simvastatin regularly to get the most benefit.
# Do not stop taking simvastatin without first talking to your doctor. Simvastatin may need to be taken on a long-term basis for the treatment of high cholesterol.
# Your doctor may want you to have blood tests or other medical evaluations during treatment with simvastatin to monitor progress and side effects.
# Store simvastatin at room temperature away from moisture and heat.

What happens if I miss a dose of simvastatin?

# Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose simvastatin?

# Seek emergency medical attention if an overdose is suspected.
# Symptoms of a simvastatin overdose include nausea, diarrhea, stomach distress, and indigestion.

What should I avoid while taking simvastatin?

# Grapefruit and grapefruit juice may interact with simvastatin. The interaction could lead to potentially dangerous effects. Discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
# Alcohol and simvastatin can both be damaging to the liver. Alcohol should be used only in moderation. Discuss the use of alcohol with your doctor so that the potential for liver problems can be determined.

What are the possible side effects of simvastatin?

# Rare cases of muscle problems and liver problems have been associated with the use of simvastatin and other similar medicines. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by a fever or flulike symptoms or yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark colored urine or pale colored stools. These may be early symptoms of muscle or liver problems.
# If you experience any of the following serious side effects, stop taking simvastatin and seek emergency medical attention or contact your doctor immediately:
, an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
, decreased urine or rust-colored urine; or
, blurred vision.
# Other, less serious side effects may be more likely to occur. Continue to take simvastatin and talk to your doctor if you experience
, gas, bloating, nausea, stomach upset, heartburn, abdominal pain, constipation, or diarrhea;
, cough;
, headache; or
, insomnia.
# Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect simvastatin?

# Do not take simvastatin without first talking to your doctor if you are taking any of the following medicines:
, cyclosporine (Sandimmune, Neoral);
, gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor);
, niacin (Nicolar, Nicobid, Slo-Niacin, others);
, erythromycin (E-Mycin, E.E.S., Ery-Tab, others) or clarithromycin (Biaxin);
, cholestyramine (Questran) or colestipol (Colestid);
, an antifungal medication such as itraconazole (Sporanox), fluconazole (Diflucan), or ketoconazole (Nizoral);
, nefazodone (Serzone);
, digoxin (Lanoxin, Lanoxicaps);
, warfarin (Coumadin);
, a protease inhibitor such as amprenavir (Agenerase), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), lopinavir-ritonavir (Kaletra), or saquinavir (Invirase, Fortovase);
, amiodarone (Cordarone, Pacer one); or
, verapamil (Calan, Covera-HS, Isoptin, Verelan).
# You may not be able to take simvastatin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
# Drugs other than those listed here may also interact with simvastatin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

What is the simvastatin recommend dosage?

#For oral dosage form (tablets):

Where can I get more information about simvastatin?

# Your pharmacist has additional information about simvastatin written for health professionals that you may read.