Atorvastatin patient counseling information

Atorvastatin
Lipitor® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] ; Associate Editor(s)-in-Chief: , Pratik Bahekar, MBBS [2]

PATIENT COUNSELING INFORMATION

Patients taking atorvastatin should be advised that cholesterol is a chronic condition and they should adhere to their medication 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 [see Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin.

Muscle Pain

All patients starting therapy with atorvastatin should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing atorvastatin. The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (>1 liter) of grapefruit juice. They should discuss all medication, both prescription and over the counter, with their healthcare professional.

Liver Enzymes

It is recommended that liver enzyme tests be performed before the initiation of atorvastatin and if signs or symptoms of liver injury occur. All patients treated with atorvastatin should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

Pregnancy

Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using atorvastatin. Discuss future pregnancy plans with your patients, and discuss when to stop atorvastatin if they are trying to conceive. Patients should be advised that if they become pregnant, they should stop taking atorvastatin and call their healthcare professional.

Breast-feeding

Women who are breastfeeding should be advised to not use atorvastatin. Patients who have a lipid disorder and are breast-feeding, should be advised to discuss the options with their healthcare professional.

PATIENT INFORMATION

LIPITOR^® atorvastatin calcium tablets

(LIP-ih-tore)

Read the Patient Information that comes with atorvastatin 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 atorvastatin, ask your doctor or pharmacist.

What is atorvastatin?

Atorvastatin 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. atorvastatin is for adults and children over 10 whose cholesterol does not come down enough with exercise and a low-fat diet alone.

Atorvastatin 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.

atorvastatin 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.

Atorvastatin 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 atorvastatin?

Do not take atorvastatin if you:

are pregnant or think you may be pregnant, or are planning to become pregnant. Atorvastatin may harm your unborn baby. If you get pregnant, stop taking atorvastatin and call your doctor right away. are breast feeding. Atorvastatin can pass into your breast milk and may harm your baby. have liver problems. are allergic to atorvastatin or any of its ingredients. The active ingredient is atorvastatin. See the end of this leaflet for a complete list of ingredients in atorvastatin.

Atorvastatin has not been studied in children under 10 years of age.

Before You Start atorvastatin

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 atorvastatin. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. atorvastatin and certain other medicines can interact causing serious side effects. Especially tell your doctor if you take medicines for:

• your immune system
• cholesterol
• infections
• 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 atorvastatin?

Take atorvastatin exactly as prescribed by your doctor. Do not change your dose or stop atorvastatin without talking to your doctor. Your doctor may do blood tests to check your cholesterol levels during your treatment with atorvastatin. Your dose of atorvastatin may be changed based on these blood test results.

Take atorvastatin each day at any time of day at about the same time each day. atorvastatin can be taken with or without food. Don't break atorvastatin tablets before taking. Your doctor should start you on a low-fat diet before giving you atorvastatin. Stay on this low-fat diet when you take atorvastatin. If you miss a dose of atorvastatin, take it as soon as you remember. Do not take atorvastatin 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 atorvastatin at the same time. If you take too much atorvastatin or overdose, call your doctor or Poison Control Center right away. Or go to the nearest emergency room.

What Should I Avoid While Taking atorvastatin?

Talk to your doctor before you start any new medicines. This includes prescription and non-prescription medicines, vitamins, and herbal supplements. atorvastatin and certain other medicines can interact causing serious side effects. Do not get pregnant. If you get pregnant, stop taking atorvastatin right away and call your doctor.

What are the Possible Side Effects of atorvastatin?

Atorvastatin 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 atorvastatin is stopped. These serious side effects include:

Muscle problems

Atorvastatin 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 atorvastatin. Liver problems. Your doctor should do blood tests to check your liver before you start taking atorvastatin and if you have symptoms of liver problems while you take atorvastatin. Call your doctor right away if you have the following symptoms of liver problems:

• feel tired or weak
• loss of appetite
• upper belly pain
• dark amber colored urine
• yellowing of your skin or the whites of your eyes

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. This may be an early sign of a rare muscle problem. muscle problems that do not go away even after your doctor has advised you to stop taking atorvastatin. Your doctor may do further tests to diagnose the cause of your muscle problems. 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 atorvastatin: diarrhea, upset stomach, muscle and joint pain, and alterations in some laboratory blood tests.

The following additional side effects have been reported with atorvastatin:

tiredness, tendon problems, memory loss, and confusion.

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 atorvastatin. Ask your doctor or pharmacist for a complete list.

How do I store atorvastatin

Store atorvastatin 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 atorvastatin 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 atorvastatin

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use atorvastatin for a condition for which it was not prescribed. Do not give atorvastatin to other people, even if they have the same problem you have. It may harm them.

This leaflet summarizes the most important information about atorvastatin. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atorvastatin that is written for health professionals. Or you can go to the atorvastatin website at www.lipitor.com.

What are the Ingredients in atorvastatin?

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.