Important safety information and consumer warnings you should know about atorvastatin.
The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Lipitor (LIP-ih-tore) (atorvastatin)
Patients taking LIPITOR should be advised that cholesterol is a chronic condition and they should adhere to their medicine along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.
Patients should be advised about substances they should not take concomitantly with atorvastatin. Patients should also be advised to inform other healthcare professionals prescribing a new medicine that they are taking LIPITOR.
All patients starting therapy with LIPITOR should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness. The risk of this occurring is increased when taking certain types of medicine or consuming larger quantities (>1 liter) of grapefruit juice. They should discuss all medicines, both prescription and over the counter, with their healthcare professional.
It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter.
Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using LIPITOR. Discuss future pregnancy plans with your patients, and discuss when to stop LIPITOR if they are trying to conceive. Patients should be advised that if they become pregnant, they should stop taking LIPITOR and call their healthcare professional.
Women who are breastfeeding should be advised to not use LIPITOR. Patients who have a lipid disorder and are breastfeeding, should be advised to discuss the options with their healthcare professional.
Read the Patient Information that comes with LIPITOR before you start taking it and each time you get a refill. • There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.
If you have any questions about LIPITOR, ask your doctor or pharmacist.
What is LIPITOR?
LIPITOR is a prescription medicine that lowers cholesterol in your blood. It lowers the LDL-C ("bad" cholesterol) and triglycerides in your blood. It can raise your HDL-C ("good" cholesterol) as well. LIPITOR is for adults and children over 10 whose cholesterol does not come down enough with exercise and a low-fat diet alone.
LIPITOR can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as:
- age, smoking, high blood pressure, low HDL-C, heart disease in the family.
LIPITOR can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as:
- eye problems, kidney problems, smoking, or high blood pressure.
LIPITOR starts to work in about 2 weeks.
What is Cholesterol?
Cholesterol and triglycerides are fats that are made in your body. They are also found in foods. You need some cholesterol for good health, but too much is not good for you. Cholesterol and triglycerides can clog your blood vessels. It is especially important to lower your cholesterol if you have heart disease, smoke, have diabetes or high blood pressure, are older, or if heart disease starts early in your family.
Who Should Not Take LIPITOR?
Do not take LIPITOR if you:
- are pregnant or think you may be pregnant, or are planning to become pregnant. Lipitor may harm your unborn baby. If you get pregnant, stop taking LIPITOR and call your doctor right away.
- are breast feeding. LIPITOR can pass into your breast milk and may harm your baby.
- have liver problems.
- are allergic to LIPITOR or any of its ingredients. The active ingredient is atorvastatin. See the end of this leaflet for a complete list of ingredients in LIPITOR.
LIPITOR has not been studied in children under 10 years of age.
Before You Start LIPITOR
Tell your doctor if you:
- have muscle aches or weakness
- drink more than 2 glasses of alcohol daily
- have diabetes
- have a thyroid problem
- have kidney problems
Some medicines should not be taken with LIPITOR. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. LIPITOR and certain other medicines can interact, causing serious side effects.
Especially tell your doctor if you take medicines for:
- your immune system
- birth control
- heart failure
- HIV or AIDS
Know all the medicines you take. Keep a list of them with you to show your doctor and pharmacist.
How Should I Take LIPITOR?
- Take LIPITOR exactly as prescribed by your doctor. Do not change your dose or stop LIPITOR without talking to your doctor. Your doctor may do blood tests to check your cholesterol levels during your treatment with LIPITOR. Your dose of LIPITOR may be changed based on these blood test results.
- Take LIPITOR each day at any time of day at about the same time each day. LIPITOR can be taken with or without food.
- Don't break LIPITOR tablets before taking.
- Your doctor should start you on a low-fat diet before giving you LIPITOR. Stay on this low-fat diet when you take LIPITOR.
- If you miss a dose of LIPITOR, take it as soon as you remember. Do not take LIPITOR if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time. Do not take 2 doses of LIPITOR at the same time.
- If you take too much LIPITOR or overdose, call your doctor or Poison Control Center right away. Or go to the nearest emergency room.
What Should I Avoid While Taking LIPITOR?
- Talk to your doctor before you start any new medicines. This includes prescription and non-prescription medicines, vitamins, and herbal supplements. LIPITOR and certain other medicines can interact, causing serious side effects.
- Do not get pregnant. If you get pregnant, stop taking LIPITOR right away and call your doctor.
What are the Possible Side Effects of LIPITOR?
LIPITOR can cause serious side effects. These side effects have happened only to a small number of people. Your doctor can monitor you for them. These side effects usually go away if your dose is lowered or LIPITOR is stopped.
These serious side effects include:
Muscle problems. LIPITOR can cause serious muscle problems that can lead to kidney problems, including kidney failure. You have a higher chance for muscle problems if you are taking certain other medicines with LIPITOR.
- Liver problems. LIPITOR can cause liver problems. Your doctor may do blood tests to check your liver before you start taking LIPITOR, and while you take it.
Call your doctor right away if you have:
- muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual.
- allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing which may require treatment right away.
- nausea and vomiting.
- passing brown or dark- colored urine.
- you feel more tired than usual
- your skin and whites of your eyes get yellow.
- stomach pain.
- allergic skin reactions.
In clinical studies, patients reported the following common side effects while taking LIPITOR: diarrhea, upset stomach, muscle and joint pain, and alterations in some laboratory blood tests.
The following additional side effects have been reported with LIPITOR: tiredness, and tendon problems.
Talk to your doctor or pharmacist if you have side effects that bother you or that will not go away.
These are not all the side effects of LIPITOR. Ask your doctor or pharmacist for a complete list.
How do I store LIPITOR
- Store LIPITOR at room temperature, 68 to 77°F (20 to 25°C).
- Do not keep medicine that is out of date or that you no longer need.
- Keep LIPITOR and all medicines out of the reach of children.
- Be sure that if you throw medicine away, it is out of the reach of children.
General Information About LIPITOR
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use LIPITOR for a condition for which it was not prescribed. Do not give LIPITOR to other people, even if they have the same problem you have. It may harm them.
This leaflet summarizes the most important information about LIPITOR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LIPITOR that is written for health professionals. Or you can go to the LIPITOR website at www.lipitor.com.
What are the Ingredients in LIPITOR?
Active Ingredient: atorvastatin calcium Inactive Ingredients:
- calcium carbonate, USP
- candelilla wax, FCC
- croscarmellose sodium, NF
- hydroxypropyl cellulose, NF
- lactose monohydrate, NF
- magnesium stearate, NF
- microcrystalline cellulose, NF
- Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide)
- polysorbate 80, NF
- simethicone emulsion