What is simvastatin?
Simvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a
type of fat) in the body.
Simvastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the
blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries,
conditions that can lead to heart attack, stroke, and vascular disease.
Simvastatin may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking simvastatin?
Do not use this medication if you are allergic to simvastatin, if you are pregnant or
breast-feeding, or if you have liver disease.
Before taking simvastatin, tell your doctor if you are allergic to any drugs, or if you have:
-
diabetes;
-
underactive thyroid;
-
kidney disease; or
-
a muscle disorder.
If you have any of these conditions, you may need a dose adjustment or
special tests to safely take simvastatin.
FDA pregnancy category X. This medication can cause birth defects.
Do not use
simvastatin if you are pregnant. Tell your doctor right away if you become pregnant during
treatment. Use an effective form of birth control while you are using this medication.
It is not known whether simvastatin passes into breast milk. Do not take simvastatin without
telling your doctor if you are breast-feeding a baby.
Simvastatin is not for use in children younger than 10 years of age.
How should I take simvastatin?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger
amounts, or take it for longer than recommended by your doctor. Follow the directions on your
prescription label.
Take simvastatin with a full glass of water.
Simvastatin is usually taken at bedtime or with an evening meal. If you take simvastatin
several times daily, take it with meals. Follow your doctor's instructions.
To be sure this medication is helping your condition, your blood will need to be tested on a
regular basis. Your liver function may also need to be tested. Do not miss any scheduled
appointments.
In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal
muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have
unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored
urine.
Simvastatin is only part of a complete program of treatment that also includes diet, exercise, and
weight control. Follow your diet, medication, and exercise routines very closely.
You may need to take simvastatin on a long-term basis for the treatment of high cholesterol.
Store simvastatin at room temperature, protected from moisture, heat, and light.
What happens if I miss a dose of simvastatin?
Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the
missed dose and take only the next regularly scheduled dose.
Do not
take extra
medicine to make up the missed dose.
Where can I get more information about simvastatin?
Your pharmacist has information about simvastatin written for health professionals that you may read.
What are the possible side effects of simvastatin?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using simvastatin and call your doctor at once if you have any of these serious side
effects:
Less serious side effects may include:
-
mild stomach pain, gas, bloating, stomach upset, heartburn;
-
nausea;
-
constipation; or
-
diarrhea.
This is not a complete list of side effects and others may occur. Tell your
doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about simvastatin?
In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal
muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have
unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored
urine.
This medication can cause birth defects in an unborn baby.
Do not use if you are
pregnant.
Use an effective form of birth control, and tell your doctor if you become pregnant
during treatment.
Do not take simvastatin if you have liver disease or if you are breast-feeding.
Before taking simvastatin, tell your doctor if you have diabetes, underactive thyroid, kidney
disease, a muscle disorder, or a blood disorder:
Avoid eating foods that are high in fat or cholesterol. Simvastatin will not be as effective in
lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
Avoid drinking alcohol while taking simvastatin. Alcohol can raise triglyceride levels, and
may also damage your liver while you are taking simvastatin.
There are many other drugs that can interact with simvastatin.
Tell
your doctor about all the prescription and over-the-counter medications you use. This includes
vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new
medication without telling your doctor.
What should I avoid while taking simvastatin?
Avoid eating foods that are high in fat or cholesterol. Simvastatin will not be as effective in
lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
Avoid drinking alcohol while taking simvastatin. Alcohol can raise triglyceride levels, and
may also damage your liver while you are taking simvastatin.
Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous
effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the
amount of grapefruit products in your diet without first talking to your doctor.
What other drugs will affect simvastatin?
Many drugs can interact with simvastatin. Below is just a partial list. Tell your doctor if you are
using:
-
danazol (Danocrine);
-
gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate
(Tricor);
-
niacin (Nicolar, Nicobid, Slo-Niacin, others);
-
nefazodone (Serzone);
-
cholestyramine (Questran) or colestipol (Colestid);
-
warfarin (Coumadin);
-
amiodarone (Cordarone), diltiazem (Cartia, Cardizem,
Dilacor, Tiazac), or verapamil (Verelan, Calan, Isoptin);
-
erythromycin (E-Mycin, Ery-Tab, others), clarithromycin
(Biaxin), or telithromycin (Ketek);
-
an antifungal medication such as itraconazole (Sporanox),
fluconazole (Diflucan), or ketoconazole (Nizoral);
-
drugs that weaken your immune system such as cancer
medicine or steroids, cyclosporine (Neoral, Sandimmune, Gengraf), sirolimus (Rapamune),
tacrolimus (Prograf), and others;
-
HIV or AIDS medication such as amprenavir (Agenerase),
indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), lopinavir-ritonavir (Kaletra), or
saquinavir (Invirase, Fortovase).
This list is not complete and there may be other drugs that can interact with
simvastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This
includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using
a new medication without telling your doctor.
What happens if I have an overdose of simvastatin?