TABLE OF CONTENTS

1. QuickView
   1. Lipitor Medication Guide (Click icon to download)
2. What is Atorvastatin
   1. Indications for Atorvastatin
   2. Dosages for Atorvastatin
   3. Possible Side Effects of Atorvastatin
   4. Contra-indications and Cautions for Atorvastatin
   5. Drug Interactions for Atorvastatin
   6. Safety in Pregnancy for Atorvastatin

QuickView

Brand Names: Lipitor
Primary Use: Antihyperlipidemic Agent, reduces elevated LDL levels
Drug Classes: Antihyperlipidemic Agents, HMG-CoA Reductase Inhibitors (statins), Metabolic Agents
Generic Drug Synonyms and Salts: Atorvastatin Calcium, Atorvastatin Calcium Trihydrate, Atorvastatin
Related Drugs: Simvastatin, Rosuvastatin, Pravastatin Sodium, Lovastatin, Pitavastatin, Ezetimibe; Simvastatin
Schedule: Rx (Prescription required)
FDA Established Pharmacologic Class (EPC): HMG-CoA Reductase Inhibitor
Initial FDA approval date: 12/17/1996

What is Atorvastatin

Atorvastatin (Lipitor) belongs to a class of drugs called statins and is currently the most prescribed drug in America. It is prescribed by a doctor to lower cholesterol in people who have been diagnosed with high cholesterol (high levels of LDL cholesterol in the blood). Doctors diagnose high cholesterol through a simple blood test. Cholesterol (and triglycerides) are fats that are made in your body. While some cholesterol is necessary for the body, too much cholesterol is dangerous to your health. Cholesterol, specifically, is made in the liver. Lowering “bad” cholesterol and triglycerides and raising “good” cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks This drug can also lower the risk for heart attack or stroke in patients with diabetes.

Note: Some research has shown a possible relationship between the use of statins and the risk of diabetes, however, the risk of developing diabetes from the use of statins is very small.

Atorvastatin is available under the following different brand names: Lipitor.

ClinCalc Drug Statistics for Atorvastatin

Indications 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 have been inadequate. In patients with CHD or multiple risk factors for CHD, Atorvastatin 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 is 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 is indicated to:

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

In adult patients with clinically evident coronary heart disease, Atorvastatin is 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 is 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:
  1. LDL-C remains ≥ 190 mg/dL or
  2. 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 has not been studied in conditions where the major lipoprotein abnormality is the elevation of chylomicrons (Fredrickson Types I and V).

Dosages for Atorvastatin

Presentation

Atorvastatin is available in tablet form in the strengths indicated below.

Storage And Handling

10 mg tablets (10 mg of atorvastatin): coded “PD 155” on one side and “10” on the other.

NDC 0071-0155-23 bottles of 90
NDC 0071-0155-34 bottles of 5000
NDC 0071-0155-40 10 x 10 unit dose blisters
NDC 0071-0155-10 bottles of 1000

20 mg tablets (20 mg of atorvastatin): coded “PD 156” on one side and “20” on the other.

NDC 0071-0156-23 bottles of 90
NDC 0071-0156-40 10 x 10 unit dose blisters
NDC 0071-0156-94 bottles of 5000
NDC 0071-0156-10 bottles of 1000

40 mg tablets (40 mg of atorvastatin): coded “PD 157” on one side and “40” on the other.

NDC 0071-0157-23 bottles of 90
NDC 0071-0157-73 bottles of 500
NDC 0071-0157-88 bottles of 2500
NDC 0071-0157-40 10 x 10 unit dose blisters

80 mg tablets (80 mg of atorvastatin): coded “PD 158” on one side and “80” on the other.

NDC 0071-0158-23 bottles of 90
NDC 0071-0158-73 bottles of 500
NDC 0071-0158-88 bottles of 2500
NDC 0071-0158-92 8 x 8 unit dose blisters

Storage

Store at controlled room temperature 20 -25°C (68 -77°F).

Dosage

The recommended starting dose of Atorvastatin is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of Atorvastatin is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of Atorvastatin should be individualized according to patient characteristics such as the goal of therapy and response. After initiation and/or upon titration of Atorvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

• Hyperlipidemia (10-20 mg PO qDay initially)
• Hypertriglyceridemia (10 mg PO qDay initially)
• Primary dysbetalipoproteinemia (10-80 mg PO qDay)
• Homozygous familial hypercholesterolemia (10-80 mg PO qDay)
• Cardiovascular Disease Prevention (10-80 mg PO qDay)

OVERDOSE

There is no specific treatment for Atorvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance Atorvastatin clearance.

Possible Side Effects of Atorvastatin

Atorvastatin is generally well tolerated. Possible side effects may include any of the following and the side effects experienced may be transitory (clears up after a few days) or may remain. Consult your doctor immediately if you experiencing serious side effects. Note the list below is not exhaustive.

• Gastrointestinal symptoms such as diarrhea
• Cold symptoms such as a runny or stuffy nose
• Joint pain
• Insomnia
• Urinary tract infection
• Nausea
• Loss of appetite
• Indigestion symptoms such as stomach discomfort or pain
• Increased transaminases
• Muscle spasms with or without pain
• Musculoskeletal pain (pain that affects the muscles, ligaments, tendons bones, and joints
• Muscle pain
• Limb pain
• Mouth and throat pain
• Chest pain (angina)
• Lightheadedness and fainting
• Shortness of breath or other breathing problems
• Muscle weakness or loss of muscle strength
• Muscle ache
• Severe allergic reaction (anaphylaxis)
• Stevens-Johnson syndrome
• Muscle inflammation, with or without pain

Adverse reactions associated with atorvastatin therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, and toxic epidermal necrolysis), rhabdomyolysis, myositis, fatigue, tendon rupture, fatal and non-fatal hepatic failure, dizziness, depression, peripheral neuropathy, pancreatitis and interstitial lung disease.

There have been rare reports of immune-mediated necrotizing myopathy associated with statin use

Contra-indications and Cautions for Atorvastatin

Contra-indications

• Hypersensitivity to atorvastatin
• Active liver disease or unexplained transaminase elevation
• Your doctor should not prescribe this medication if you are a patient with liver problems
• Women who are pregnant or breastfeeding should not take atorvastatin

Cautions

• Non-serious and reversible cognitive side effects may occur.
• Lipitor may react adversely with erythromycin, especially in older patients
• Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with intake of statins like Lipitor.
• Use with caution with Lipitor in the elderly; risk of myopathy.
• Heavy alcohol use, renal failure, history of liver disease or liver problems.
• Fatal and nonfatal liver failure reported (rare).
• Risk of rhabdomyolysis (breakdown of muscle tissue).
• Risk of myopathy: Increased by co-administration with fibrates, niacin, cyclosporine, macrolides, telaprevir, boceprevir, combinations of HIV protease inhibitors (e.g., saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir), or azole antifungals.
• Withhold or discontinue medical treatment with this drug in any patient developing myopathy, kidney failure, or transaminase levels greater than 3x ULN.
• Rare reports of immune-mediated necrotizing myopathy (IMNM), characterized by increased serum creatine kinase that persists despite discontinuation of statin.
• In people with liver impairment, people with poor liver health, and people who have recently suffered a stroke.
• CYP3A4 substrate; avoid grapefruit products and caution with other CYP3A4 inhibitors.
• Secondary causes of high cholesterol should be ruled out before starting this medication.

Drug Interactions for Atorvastatin

Your pharmacist will be aware of potential interactions between Atorvastatin and any other medications you use. It’s wise to double-check with your pharmacist and always read package inserts and check the drugs you currently use for possible interactions. If in doubt, revert to your pharmacist with a list of all your medication. It’s a great idea if you own a smartphone to add all your medications to an app on your phone. This can be a lifesaver.

Severe interactions of atorvastatin include:

• cyclosporine
• gemfibrozil
• pazopanib
• red yeast rice
• telaprevir
• tipranavir

Atorvastatin has serious interactions with at least 45 different drugs and moderate interactions with at least 173 different drugs.

Mild interactions of atorvastatin include:

• alvimopan
• armodafinil
• coenzyme q10
• colestipol
• fexofenadine
• fluvoxamine
• isradipine
• loratadine
• orlistat
• ruxolitinib
• trazodone

Safety in Pregnancy for Atorvastatin

Atorvastatin is not indicated for use in pregnant or breastfeeding women.

Pregnancy and Lactation

• Do not use this drug if you are pregnant
• Health risks associated with this medicine outweigh potential benefits
• Your doctor will inform you of safer alternatives
• Because of the potential for adverse reactions and side effects that may affect the health of nursing infants, women taking atorvastatin should not breastfeed. This medication is contraindicated in nursing mothers because it may be excreted into human breast milk
• If you become pregnant while taking this medicine, call your doctor immediately

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