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Atorvastatin

Generic Name: atorvastatin (a TOR va sta tin)


Brand Names: Lipitor

Atorvastatin is in a group of drugs called HMG CoA reductase inhibitors, or


"statins." Atorvastatin reduces levels of "bad" cholesterol (low-density
lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of
"good" cholesterol (high-density lipoprotein, or HDL).
Atorvastatin is used to treat high cholesterol, and to lower the risk of
stroke, heart attack, or other heart complications in people with type 2
diabetes, coronary heart disease, or other risk factors.
Atorvastatin is used in adults and children who are at least 10 years old.

Important information
You should not take atorvastatin if you are pregnant or breast-feeding, or if
you have liver disease.
Stop taking this medication and tell your doctor right away if you
become pregnant.
Serious drug interactions can occur when certain medicines are used
together with atorvastatin. Tell each of your healthcare providers about all
medicines you use now, and any medicine you start or stop using.
In rare cases, atorvastatin can cause a condition that results in the
breakdown of skeletal muscle tissue, leading to kidney failure. Call your
doctor right away if you have unexplained muscle pain, tenderness, or
weakness especially if you also have fever, unusual tiredness, and dark
colored urine.
Avoid eating foods that are high in fat or cholesterol. Atorvastatin will not be
as effective in lowering your cholesterol if you do not follow a cholesterollowering diet plan.

Atorvastatin 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.

Before taking this medicine


You should not use atorvastatin if you are allergic to it, or if you have:

liver disease; or

if you are pregnant or breast-feeding.

To make sure atorvastatin is safe for you, tell your doctor if you have:

muscle pain or weakness;

history of liver disease;

history of kidney disease;

history of stroke (including TIA or "mini-stroke");

a thyroid disorder; or

if you drink more than 2 alcoholic beverages daily.

Atorvastatin can cause a condition that results in the breakdown of skeletal


muscle tissue, leading to kidney failure. This condition may be more likely to
occur in older adults and in people who have kidney disease or poorly
controlled hypothyroidism (underactive thyroid).
This medicine can harm an unborn baby or cause birth defects. Do not use
if you are pregnant. Stop taking atorvastatin and tell your doctor
right away if you become pregnant Use effective birth control to prevent
pregnancy while you are taking this medicine.
Atorvastatin may pass into breast milk and could harm a nursing baby. Do
not breast-feed while you are taking this medicine.
Atorvastatin is not approved for use by anyone younger than 10 years old.

How should I take atorvastatin?


Take atorvastatin exactly as prescribed by your doctor. Follow all directions
on your prescription label. Your doctor may occasionally change your dose to
make sure you get the best results. Do not use this medicine in larger or
smaller amounts or for longer than recommended.
Atorvastatin is usually taken once a day, with or without food. Take the
medicine at the same time each day.
Do not break or crush a tablet before taking it.
You may need to stop using atorvastatin for a short time if you have:

uncontrolled seizures;
an electrolyte imbalance (such as high or low potassium levels in your
blood);

severely low blood pressure;

a severe infection or illness; or

surgery or a medical emergency.

While using atorvastatin, you may need frequent blood tests.


Atorvastatin is only part of a complete treatment program that may also
include diet, exercise, and weight control. Follow your doctor's instructions
very closely.
Store at room temperature away from moisture, heat, and light.
See also: Dosage Information (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if your
next dose is less than 12 hours away. Do not take extra medicine to make up
the missed dose.

What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-2221222.

What should I avoid while taking atorvastatin?


Avoid eating foods that are high in fat or cholesterol. Atorvastatin will not be
as effective in lowering your cholesterol if you do not follow a cholesterollowering diet plan.
Avoid drinking alcohol. It can raise triglyceride levels and may increase your
risk of liver damage.
Grapefruit and grapefruit juice may interact with atorvastatin and lead to
potentially dangerous effects. Discuss the use of grapefruit products with
your doctor.

Atorvastatin side effects


Get emergency medical help if you have signs of an allergic reaction to
atorvastatin: hives; difficulty breathing; swelling of your face, lips, tongue,
or throat.
In rare cases, atorvastatin can cause a condition that results in the
breakdown of skeletal muscle tissue, leading to kidney failure. Call your
doctor right away if you have unexplained muscle pain, tenderness, or
weakness especially if you also have fever, unusual tiredness, and dark
colored urine.
Also call your doctor at once if you have:

kidney problems - little or no urinating, painful or difficult urination,


swelling in your feet or ankles, feeling tired or short of breath;

liver problems - nausea, upper stomach pain, itching, tired feeling, loss
of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin
or eyes); or

signs of a stroke - sudden numbness or weakness (especially on one


side of the body), sudden severe headache, slurred speech, problems with
vision or balance.

Common atorvastatin side effects may include:

muscle or joint pain;

diarrhea; or

upset stomach.

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.
See also: Side effects (in more detail)

Atorvastatin dosing information


Usual Adult Dose for Prevention of Cardiovascular Disease:
Initial dose: 10 mg to 80 mg orally once a day.
The initial dosage of atorvastatin recommended for this patient in the
prevention of cardiovascular disease is 10 mg to 80 mg orally once a day.
The dose may be administered at any time of the day without regard for
meals.
Dose adjustments should be made at intervals of 2 to 4 weeks.
Studies have demonstrated that treatment with atorvastatin is associated
with significant reductions in the risk of cardiovascular endpoints and stroke
in various patient populations for both primary and secondary prevention.
For primary prevention, atorvastatin treatment was effective in hypertensive
patients with normal or mildly elevated cholesterol levels as well as in
patients with type II diabetes. Patients had relatively low cholesterol levels at
baseline in both trials; however, treatment with this medicine still resulted in
significant reductions in cardiovascular outcomes and stroke.

For secondary prevention, intensive lipid lowering therapy with atorvastatin


80 mg/day was associated with significant incremental clinical benefit
beyond therapy with 10 mg/day in patients with stable coronary heart
disease. It was also shown to significantly reduce the risk of clinical
outcomes in coronary heart disease patients versus usual medical care.
Usual Adult Dose for Hyperlipidemia:
Initial dose: 10, 20 or 40 mg orally once a day. The 40 mg starting dose is
recommended for patients who require a reduction in LDL-cholesterol of
more than 45%.
Dose adjustments should be made at intervals of 2 to 4 weeks.
Maintenance dose: 10 to 80 mg orally once a day.
Usual Pediatric Dose for Heterozygous Familial
Hypercholesterolemia:
10 to 17 years:
10 mg per day (max dose is 20 mg per day). Adjustments should be made at
intervals of 4 weeks or more.

What other drugs will affect atorvastatin?


Certain other drugs can increase your risk of serious muscle problems, and it
is very important that your doctor knows if you are using any of them. Tell
your doctor about all your current medicines and any you start or stop using,
especially:

antibiotic or antifungal medicine;

birth control pills;

cholesterol-lowering medication;

heart medication; or

medicine to treat HIV or AIDS.

This list is not complete. Other drugs may interact with atorvastatin,
including prescription and over-the-counter medicines, vitamins, and herbal
products. Not all possible interactions are listed in this medication guide.

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