What is niacin and simvastatin?
Simvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a
type of fat) in the body.
Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and
animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many
multiple vitamins and nutritional supplements.
The combination of niacin and simvastatin is used to lower cholesterol and triglycerides (types
of fat) in the blood. Lowering your cholesterol and triglycerides can help prevent heart disease and
coronary artery disease (also called atherosclerosis), conditions that can lead to heart attack, stroke,
and vascular disease.
Niacin 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 niacin and simvastatin?
You should not take this medication if you are allergic to simvastatin or niacin, or if you
have:
Before taking niacin and simvastatin, tell your doctor if you are allergic to
any drugs, or if you have:
-
diabetes;
-
underactive thyroid;
-
gout;
-
kidney disease; or
-
if you are also taking amiodarone (Cordarone, Pacerone)
or verapamil (Calan, Covera, Isoptin, Verelan).
If you have any of these conditions, you may need a dose adjustment or
special tests to safely take niacin and 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.
FDA pregnancy category X. This medication can cause birth defects.
Do not use
niacin and simvastatin if you are pregnant. Tell your doctor right away if you become
pregnant during treatment. Use effective birth control while you are using this medication.
It is not known whether niacin 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.
How should I take niacin and simvastatin?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or
for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this
medication.
Take each dose with a full glass of water.
Niacin and simvastatin is usually taken at bedtime with a low-fat snack. Follow your
doctor's instructions.
Do not crush, chew, or break a niacin and simvastatin tablet. Swallow the pill whole. The
niacin ingredient in this pill is an extended-release form. Breaking or crushing the pill may cause too
much of the drug to be released at one time.
Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling
under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after
you take niacin and simvastatin. These effects should disappear over time as you keep taking the
medication.
Niacin and simvastatin can cause you to have unusual results with certain medical tests. You
may need to stop taking this medication for a short time if you have surgery or a major illness. Tell any
doctor or surgeon who treats you that you are taking niacin and simvastatin.
If you stop taking niacin and simvastatin for longer than 7 days in a row, talk with your doctor
before restarting the medication. You may need to start with a lower dose.
To be sure this medication is not causing harmful effects, your liver function will need to be
tested on a regular basis. Do not miss any scheduled appointments.
Niacin 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 this medication at room temperature away from moisture and heat.
What happens if I miss a dose of niacin and simvastatin?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait
until then to take the medicine and skip the missed dose.
Do not
take extra medicine
to make up the missed dose.
Where can I get more information about niacin and simvastatin?
Your pharmacist has information about niacin and simvastatin written for health professionals that you may read.
What are the possible side effects of niacin 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 this medication 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;
-
feeling like you might pass out;
-
fast or pounding heartbeats; or
-
feeling short of breath.
Less serious side effects may include:
-
warmth, redness, or tingly feeling under your skin;
-
dizziness;
-
sweating or chills;
-
swelling;
-
headache;
-
stomach or back pain;
-
runny nose or other cold symptoms;
-
nausea, diarrhea, constipation; or
-
itching or rash.
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.
What is the most important information I should know about niacin and simvastatin?
You should not take this medication if you are allergic to simvastatin or niacin, if you are
pregnant or breast-feeding, or if you have liver disease, a stomach ulcer, or active bleeding.
Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling
under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after
you take niacin and simvastatin. These effects should disappear over time as you keep taking the
medication.
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.
To be sure this medication is not causing harmful effects, your liver function will need to be
tested on a regular basis. Do not miss any scheduled appointments.
If you stop taking niacin and simvastatin for longer than 7 days in a row, talk with your doctor
before restarting the medication. You may need to start with a lower dose.
What should I avoid while taking niacin and simvastatin?
Avoid taking cholestyramine (Questran) or colestipol (Colestid) within 4 hours before or
after you take niacin and simvastatin.
Avoid drinking hot beverages shortly after taking niacin and simvastatin. Hot drinks can worsen
niacin's flushing effect (warmth, itching, redness, or tingly feeling under your skin).
Avoid drinking alcohol while taking niacin and simvastatin. Alcohol may increase your risk
of liver damage, and can also worsen the flushing effects of niacin.
Avoid eating foods that are high in fat or cholesterol. Niacin and simvastatin will not be as
effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
Grapefruit and grapefruit juice may interact with niacin 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 getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly
and steady yourself to prevent a fall.
What other drugs will affect niacin and simvastatin?
Before taking niacin and simvastatin, tell your doctor if you are using any of the following
medicines:
-
amiodarone (Cordarone, Pacerone);
-
cyclosporine (Gengraf, Sandimmune, Neoral);
-
danazol (Danocrine);
-
digoxin (digitalis, Lanoxin);
-
fenofibrate (Tricor);
-
gemfibrozil (Lopid);
-
a blood thinner such as warfarin (Coumadin);
-
niacin, nicotinic acid, or nicotinamide (or vitamin
supplements that contain niacin);
-
verapamil (Calan, Covera, Isoptin);
-
an antibiotic such as clarithromycin (Biaxin), erythromycin
(E.E.S., E-Mycin, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);
-
an antifungal medication such as clotrimazole (Mycelex
Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or
voriconazole (Vfend); or
-
HIV /AIDS medicine such as amprenavir (Agenerase),
atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), lopinavir (Kaletra),
nelfinavir (Viracept), ritonavir (Kaletra, Norvir), or saquinavir (Invirase, Fortovase).
This list is not complete and there may be other drugs that can interact with
niacin and simvastatin. Tell your doctor about all your prescription and over-the-counter medications,
vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new
medication without telling your doctor.
What happens if I have an overdose of niacin and simvastatin?