What is ezetimibe and simvastatin?
Ezetimibe and simvastatin are cholesterol-lowering medicines. They reduce the amount of
cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.
The combination of ezetimibe and simvastatin lowers "bad" cholesterol in the blood, (also called
LDL, or low-density lipoprotein) and raises "good" cholesterol (also called HDL, or high-density
lipoprotein). Lowering your LDL and raising your HDL cholesterol levels may reduce your risk of
hardened arteries, which can lead to heart attacks, stroke, and circulation problems.
Ezetimibe and simvastatin may also be used for other purposes not listed in this medication
guide.
What should I discuss with my healthcare provider before taking ezetimibe and simvastatin?
You should not use this medication if you are allergic to ezetimibe (Zetia) or simvastatin
(Zocor), or if you have:
Before taking ezetimibe and simvastatin, tell your doctor if you are allergic to
any drugs, or if you have:
If you have any of these conditions, you may need a dose adjustment or
special tests to safely take this medication.
In rare cases, ezetimibe and 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.
FDA pregnancy category X. This medication can cause birth defects.
Do not use
ezetimibe and 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 ezetimibe and simvastatin passes into breast milk or if it could harm
a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not give this medication to a child younger than 10 years old.
How should I take ezetimibe and 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.
Ezetimibe and simvastatin is usually taken once daily in the evening with or without food.
Follow your doctor's instructions.
It may take up to 2 weeks of using this medicine before your cholesterol levels improve.
For best results, keep using the medication as directed. Your cholesterol will need to be measured with
blood tests at regular intervals. Do not miss any scheduled visits to your doctor.
Ezetimibe and 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.
Store ezetimibe and simvastatin at room temperature away from moisture and heat.
What happens if I miss a dose of ezetimibe and simvastatin?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the
missed dose and take the medicine at the next regularly scheduled time.
Do not
take
extra medicine to make up the missed dose.
Where can I get more information about ezetimibe and simvastatin?
Your pharmacist has information about ezetimibe and simvastatin written for health professionals that you may read.
What are the possible side effects of ezetimibe and 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 ezetimibe and simvastatin and call your doctor at once if you have any of these
serious side effects:
-
muscle pain, tenderness, or weakness with fever or flu symptoms
and dark colored urine;
-
nausea, stomach pain, loss of appetite, itching, dark urine,
clay-colored stools, and jaundice (yellowing of the skin or eyes);
-
pancreatitis (severe pain in your upper stomach spreading
to your back, nausea and vomiting, fast heart rate);
-
easy bruising or bleeding; or
-
vision problems.
Less serious side effects may include:
-
numbness or tingly feeling;
-
headache, dizziness, memory problems;
-
depressed mood;
-
constipation, diarrhea;
-
cough, sore throat, runny or stuffy nose;
-
joint pain, back pain; or
-
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about ezetimibe and simvastatin?
Ezetimibe and 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.
It may take up to 2 weeks of using this medicine before your cholesterol levels improve.
For best results, keep using the medication as directed. Your cholesterol will need to be measured with
blood tests at regular intervals. Do not miss any scheduled visits to your doctor.
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.
In rare cases, ezetimibe and 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.
What should I avoid while taking ezetimibe and simvastatin?
Avoid eating foods that are high in fat or cholesterol. Ezetimibe and simvastatin will not be as
effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
If you take another cholesterol-lowering medication such as cholestyramine (Locholest,
Prevalite, Questran), colestipol (Colestid), or colesevelam (Welchol), take your ezetimibe and
simvastatin dose at least 2 hours before or 4 hours after the other medication(s).
Grapefruit and grapefruit juice may interact with ezetimibe and 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.
Avoid drinking alcohol while taking ezetimibe and simvastatin. Alcohol may increase your
risk of liver damage.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Ezetimibe and
simvastatin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen
(minimum SPF 15) and wear protective clothing if you must be out in the sun.
What other drugs will affect ezetimibe and simvastatin?
Many drugs can interact with ezetimibe and simvastatin. Below is just a partial list. Tell your
doctor if you are using:
-
amiodarone (Cordarone, Pacerone);
-
cholestyramine (Questran), colestipol (Colestid), or
colesevelam (Welchol);
-
cyclosporine (Sandimmune, Neoral);
-
danazol (Danocrine);
-
digoxin (Lanoxin, Lanoxicaps);
-
gemfibrozil (Lopid), fenofibrate (Tricor) or clofibrate
(Atromid-S);
-
nefazodone (Serzone);
-
niacin (Nicolar, Nicobid, Slo-Niacin, others);
-
verapamil (Calan, Covera-HS, Isoptin, Verelan);
-
a blood thinner such as warfarin (Coumadin);
-
an antibiotic such as clarithromycin (Biaxin), erythromycin
(E-Mycin, E.E.S., Ery-Tab, others), itraconazole (Sporanox), ketoconazole (Nizoral), or
telithromycin (Ketek); or
-
HIV medicines such as amprenavir (Agenerase), atazanavir
(Reyataz), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir
(Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), or tipranavir (Aptivus).
This list is not complete and there may be other drugs not listed that can
affect ezetimibe and 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 ezetimibe and simvastatin?
