Atorvastatin

Name: Atorvastatin

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.
  • 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: the common cold (known as nasopharyngitis), joint pain, diarrhea, pain in extremeties, and urinary tract infections.

The following additional side effects have been reported with atorvastatin:

  • general feeling of discomfort (malaise)
  • fever
  • neck pain
  • joint swelling
  • hives

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.

Atorvastatin Overdose

If you take too much atorvastatin or overdose, call your doctor or Poison Control Center right away. Or go to the nearest emergency room.

Other Requirements

  • 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  • Do not keep medicine that is out of date or that you no longer need.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.

Uses For atorvastatin

Atorvastatin is used together with a proper diet to lower cholesterol and triglyceride (fats) levels in the blood. atorvastatin may help prevent medical problems (e.g., chest pain, heart attack, or stroke) that are caused by fats clogging the blood vessels. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.

Atorvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood.

atorvastatin is available only with your doctor's prescription.

Precautions While Using atorvastatin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using atorvastatin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These could be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver damage.

Make sure any doctor or dentist who treats you knows that you are using atorvastatin. You may need to stop using atorvastatin if you have a major surgery, major injury, or you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Indications and Usage for Atorvastatin

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, Atorvastatin calcium tablets can be started simultaneously with diet.

Prevention of Cardiovascular Disease in Adults 

In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, Atorvastatin calcium tablets are indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke
  • Reduce the risk for revascularization procedures and angina

In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, Atorvastatin calcium tablets are indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke 

In adult patients with clinically evident coronary heart disease, Atorvastatin calcium tablets are indicated to:

  • Reduce the risk of non-fatal myocardial infarction
  • Reduce the risk of fatal and non-fatal stroke
  • Reduce the risk for revascularization procedures
  • Reduce the risk of hospitalization for CHF
  • Reduce the risk of angina  

Hyperlipidemia 

Atorvastatin calcium tablets are indicated:

  • As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
  • As an adjunct to diet for the treatment of adult patients with elevated serum TG levels (Fredrickson Type IV);
  • For the treatment of adult patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
  • To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
  • As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present:

    a. LDL-C remains ≥ 190 mg/dL or

    b. LDL-C remains ≥ 160 mg/dL and:

    • there is a positive family history of premature cardiovascular disease or
    • two or more other CVD risk factors are present in the pediatric patient

Limitations of Use

Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Patient Counseling Information

Advisethe patient to read the FDA-approved patient labeling (Patient Information).

Patients taking Atorvastatin calcium 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 calcium.

Muscle Pain

All patients starting therapy with Atorvastatin calcium 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 calcium. 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 calcium and if signs or symptoms of liver injury occur. All patients treated with Atorvastatin calcium should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

Embryofetal Toxicity

Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with Atorvastatin calcium [see Contraindications (4) and Use in Specific Populations (8.2)].

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA

Rev: 08/17

PATIENT INFORMATION

Atorvastatin Calcium Tablets
(a tor″ va stat′ in kal′ see um)

 

Read the Patient Information that comes with Atorvastatin calcium tablets 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 calcium tablets, ask your doctor or pharmacist.  

What is Atorvastatin Calcium Tablet?

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

Atorvastatin calcium tablets 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 calcium tablets 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 calcium tablets 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 Calcium Tablets?

Do not take Atorvastatin Calcium Tablets if you:

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

Atorvastatin calcium tablets dosing has not been established in children under 10 years of age.

Before You Start Atorvastatin Calcium Tablets

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 calcium tablets. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Atorvastatin calcium tablets 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 Calcium Tablets?

  • Take Atorvastatin calcium tablets exactly as prescribed by your doctor. Do not change your dose or stop Atorvastatin calcium tablets without talking to your doctor. Your doctor may do blood tests to check your cholesterol levels during your treatment with Atorvastatin calcium tablets. Your dose of Atorvastatin calcium tablets may be changed based on these blood test results. 
  • Take Atorvastatin calcium tablets each day at any time of day at about the same time each day. Atorvastatin calcium tablets can be taken with or without food. Don't break Atorvastatin calcium tablets before taking.
  • Your doctor should start you on a low-fat diet before giving you Atorvastatin calcium tablets. Stay on this low-fat diet when you take Atorvastatin calcium tablets. 
  • If you miss a dose of Atorvastatin calcium tablets, take it as soon as you remember. Do not take Atorvastatin calcium tablets 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 calcium tablets at the same time. 
  • If you take too much Atorvastatin calcium tablets 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 Calcium Tablets?

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

What are the Possible Side Effects of Atorvastatin Calcium Tablets?

Atorvastatin calcium tablets 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 calcium tablets are stopped. These serious side effects include: 

  • Muscle problems. Atorvastatin calcium tablets 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 calcium tablets.
  • Liver problems. Your doctor should do blood tests to check your liver before you start taking Atorvastatin calcium tablets and if you have symptoms of liver problems while you take Atorvastatin calcium tablets. 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 calcium tablets. 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 calcium tablets: diarrhea, upset stomach, muscle and joint pain, and alterations in some laboratory blood tests.  

The following additional side effects have been reported with Atorvastatin calcium tablets: 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 calcium tablets. Ask your doctor or pharmacist for a complete list.  

How do I store Atorvastatin Calcium Tablets 

  • Store Atorvastatin calcium tablets 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 calcium tablets 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 Calcium Tablets 

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Atorvastatin calcium tablets for a condition for which it was not prescribed. Do not give Atorvastatin calcium tablets 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 calcium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Atorvastatin calcium tablets that is written for health professionals.

What are the Ingredients in Atorvastatin Calcium Tablets?

Active Ingredient: Atorvastatin calcium

Inactive Ingredients: anhydrous lactose, NF; colloidal silicon dioxide, NF; copovidone, NF; croscarmellose sodium, NF; magnesium stearate, NF; mannitol, USP; silicified microcrystalline cellulose, NF; sodium bicarbonate, USP; sodium carbonate anhydrous, NF; sodium lauryl sulfate, NF; lecitihin, polyvinyl alcohol part hydrolyzed, talc, titanium dioxide, xanthan gum. 

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA

Rev: 08/17

Index Terms

  • Atorvastatin Calcium

Brand Names U.S.

  • Lipitor

Dosing Renal Impairment

No dosage adjustment necessary.

Dialysis: Due to the high protein binding, atorvastatin is not expected to be cleared by dialysis (not studied)

Dosing Adjustment for Toxicity

Severe muscle symptoms or fatigue: Promptly discontinue use; evaluate CPK, creatinine, and urinalysis for myoglobinuria (Stone 2013).

Mild to moderate muscle symptoms: Discontinue use until symptoms can be evaluated; evaluate patient for conditions that may increase the risk for muscle symptoms (eg, hypothyroidism, reduced renal or hepatic function, rheumatologic disorders such as polymyalgia rheumatica, steroid myopathy, vitamin D deficiency, or primary muscle diseases). Upon resolution, resume the original or lower dose of atorvastatin. If muscle symptoms recur, discontinue atorvastatin use. After muscle symptom resolution, may then use a low dose of a different statin; gradually increase if tolerated. In the absence of continued statin use, if muscle symptoms or elevated CPK continues after 2 months, consider other causes of muscle symptoms. If determined to be due to another condition aside from statin use, may resume statin therapy at the original dose (Stone 2013).

Pregnancy Risk Factor X Pregnancy Considerations

Studies in animals and pregnant women have shown evidence of fetal abnormalities and use is contraindicated in women who are or may become pregnant. There are reports of congenital anomalies following maternal use of HMG-CoA reductase inhibitors in pregnancy; however, maternal disease, differences in specific agents used, and the low rates of exposure limit the interpretation of the available data (Godfrey 2012; Lecarpentier 2012). Cholesterol biosynthesis may be important in fetal development; serum cholesterol and triglycerides increase normally during pregnancy. The discontinuation of lipid lowering medications temporarily during pregnancy is not expected to have significant impact on the long term outcomes of primary hypercholesterolemia treatment.

HMG-CoA reductase inhibitors should be discontinued prior to pregnancy (ADA 2013). If treatment of dyslipidemias is needed in pregnant women or in women of reproductive age, other agents are preferred (Berglund 2012; Stone 2013). The manufacturer recommends administration to women of childbearing potential only when conception is highly unlikely and patients have been informed of potential hazards.

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 cholesterol-lowering 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. Avoid drinking more than 1 liter of grapefruit juice while taking this medicine.

Usual Adult Dose for Hyperlipidemia

-Initial dose: 10 mg or 20 mg orally once a day; an initial dose of 40 mg may be used in patients who require a reduction in low density lipoprotein (LDL-C) of more than 45%
-Maintenance dose: 10 mg to 80 mg orally once a day

Comments:
-Following initiation and/or upon titration, lipid levels should be evaluated within 2 to 4 weeks and dosages adjusted accordingly.

Uses: As an adjunct to diet in the following conditions: to reduced total cholesterol (total-C), LDL-C, apolipoprotein B (apo B), and triglyceride (TG) levels, and to increase high density lipoprotein (HDL-C) in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb); for the treatment of elevated TG levels (Fredrickson Type IV); and for the treatment of primary dysbetalipoproteinemia (Fredrickson Type III) in patients who do not respond adequately to diet

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia

10 to 17 years: 10 mg orally once a day
-Maximum dose: 20 mg/day

Comments:
-Doses greater than 20 mg/day have not been studied in this patient population.
-Dose adjustments should be made at intervals of 4 weeks or more.

Use: As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C remains 190 mg/dL or greater, or LDL-C remains 160 mg/dL or greater and there is a positive family history of premature cardiovascular disease (CVD) or 2 or more other CVD risk factors are present in the pediatric patient

Renal Dose Adjustments

No adjustment recommended.

Dialysis

Data not available

Tips

  • Take once daily. May be taken at any time of the day (morning or night); however, it is best to be consistent with the time you take your tablets.
  • The dosage of atorvastatin needs to be individualized but initially should start at 10-20 mg/day and be guided by the results of cholesterol tests taken 2 to 4 weeks later. Take atorvastatin exactly as directed by your doctor. Do not increase or decrease the dosage without his or her advice.
  • Avoid drinking large quantities of grapefruit juice or eating grapefruit or grapefruit products while taking atorvastatin.
  • Limit your alcohol intake and avoid drinking more than two glasses of alcohol per day while you are taking atorvastatin.
  • Seek urgent medical advice and consider temporarily withholding atorvastatin if you develop any acute muscle pain or have another condition that may increase your risk of serious muscle injury or kidney failure such as a severe infection, major surgery, trauma, uncontrolled seizures, severe electrolyte or metabolic disorders.
  • Adhere to the TLC diet, designed by the National Cholesterol Education Program (NCEP), or a similar diet, while taking atorvastatin.
  • Plan to do exercise regularly and stop smoking if you smoke. Try to avoid second-hand smoke.
  • See your doctor straight away if you notice any yellowing of your skin or shortness of breath, unexplained cough or general tiredness. 
  • Atorvastatin should not be taken during pregnancy or while breastfeeding. Ensure you use effective contraception while taking atorvastatin if you are a woman of childbearing age and talk to your doctor if you intend to become pregnant before you actually become pregnant.

Atorvastatin Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity, however, doses of 20, 100, or 225 mg/kg/day given to rats from day 7 of gestation through day 21 of weaning resulted in decreased pup survival at birth, developmental delays, pinnae detachment, and eye opening alterations. Rare cases of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been reported. There are no controlled data in human pregnancy. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hypercholesterolemia therapy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use in women who are or may become pregnant is contraindicated. AU TGA pregnancy category: D US FDA pregnancy category: X Comments: -This drug should only be used in women of childbearing potential who are highly unlikely to conceive and have been informed of the potential hazards. -If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient should be apprised of the potential harm to the fetus. -Use of adequate methods of contraception should be encouraged.

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