Atorvastatin

Atorvastatin (Lipitor) is a medication prescribed by a doctor to lower cholesterol in people who have been diagnosed with high cholesterol (high levels of 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.

About Cholesterol and Statins

This medication is used along with a proper diet to help people lower "bad" cholesterol and fats (such as LDL(low-density lipoprotein), triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "statins." Statins (also HMG-CoA reductase inhibitors) like this medication work by reducing the amount of cholesterol found in the blood.

Statins are safe medication for most people. It is important to note that statins are not recommended for pregnant patients or people with active or chronic liver disease. Also, statins can cause serious muscle problems. Some statins interact negatively with other drugs, so it is important that your doctor knows all the medicines that you are taking. If you have problems (such as pain or other symptoms) with one particular prescription statin, you may have fewer side effects with an alternative statin drug. Your doctor may prescribe an alternative medication to see if you feel better or notice a difference. Doctors commonly prescribe statins like Lipitor because of their ability to lower cholesterol levels and risks of cardiovascular events. Patients should closely follow the instructions included on the prescription label to ensure the effectiveness of the medicine. Due to changes and updates, patients should read the health information that accompanies this medicine each and every time this prescription is filled.

In addition to eating a proper diet for optimal health (such as low cholesterol and a low-fat diet), there are other lifestyle changes that people can make that may help this medication work better. These include exercising, weight loss, and stopping smoking. Consult your doctor for more details and medical information about this drug and for medical advice about your health while taking this drug. This medication is only available by prescription.

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

Side effects of atorvastatin include:

• 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, land 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

The information contained in this document does not contain all possible side effects and other side effects or problems that may occur as a result of using this medicine. Check with your doctor for additional medical information about side effects or other health concerns. Call your doctor immediately if you experience any unusual or troublesome symptoms including significant weight loss or gain, dark urine, fever, or fatigue.

Dosages of Atorvastatin Should Be Given As Follows:

Adult and Pediatric Dosage Forms & Strengths

Tablets

• 10 mg
• 20 mg
• 40 mg
• 80 mg

See below for dosage considerations and other information.

Primary hypercholesterolemia (high cholesterol) and mixed dyslipidemia

• This drug is indicated as an adjunct to diet for treatment of elevated total-C, Apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson type IIa and IIb)
• 10-20 mg taken orally once daily initially
• Starting drug dose in patients requiring larger LDL-C reduction (i.e., greater than 45%): 40 mg taken orally once daily
• Maintenance: 10-80 mg taken orally once daily
• After initiation and/or upon dose titration, check lipid levels after 2-4 weeks and adjust drug dose accordingly

Hypertriglyceridemia (High Triglycerides)

• Lipitor is prescribed as an adjunct to diet for elevated TG levels (Fredrickson type IV)
• 10 mg taken orally once daily initially
• Maintenance: 10-80 mg taken orally once daily maintenance
• After initiation and/or upon dose titration, check lipid levels after 2-4 weeks and adjust the dose of the drug accordingly

Primary Dysbetalipoproteinemia

• Dysbetalipoproteinemia (Fredrickson type III) in patients with inadequate response to diet
• Lipitor Maintenance: 10-80 mg taken orally once daily
• After initiation and/or upon dose titration, check lipid levels after 2-4 weeks and adjust the dose of the drug accordingly

Homozygous Familial Hypercholesterolemia

• This medication is used for the reduction of total-C and LDL-C in HoFH as an adjunct to other lip-lowering drugs (e.g., LDL apheresis) or if such treatments are unavailable
• 10 mg to 80 mg of Lipitor taken orally once daily

Cardiovascular Disease Prevention

• 10 mg to 80 mg of Lipitor taken orally once daily

Indications

• Lipitor is used for the reduction of risk of stroke and heart attack in type 2 diabetes patients without evidence of heart disease but with other CV risk factors
• Reduction of risk of stroke, heart attack, and revascularization procedures in patients without evidence of coronary heart disease (CHD) but with multiple risk factors other than diabetes (eg, smoking, HTN, low HDL-C, family history of early CHD)
• Patients with CHD, to reduce risks of MI, stroke, revascularization procedures, hospitalization for CHF, and angina

Dosage Considerations of Lipitor

Co-administration of this medication with other drugs

• Bile acid sequestrant: Administer medication atorvastatin/ezetimibe 2 hours or more before or 4 hours or more after administering bile acid sequestrant
• Cyclosporine, tipranavir plus ritonavir, telaprevir, gemfibrozil: Avoid co-administration with atorvastatin (increased risk of rhabdomyolysis)
• Lopinavir plus ritonavir: Use the lowest dose of medicine necessary
• Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir: Do not exceed the atorvastatin dose of 20 mg/day
• Nelfinavir, boceprevir: Do not exceed the atorvastatin dose of 40 mg/day

Overdose management

• This medication is generally considered safe in acute overdose, although not formally studied
• Adverse drug reactions and side effects from overdose may include peripheral neuropathy, diarrhea, increased K+, myopathy, rhabdomyolysis, acute renal failure, elevated LFTs, eye lens opacities
• Treatment is supportive

Heterozygous Familial Hypercholesterolemia

This medication is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and post-menarchal girls aged 10-17 years with HeFH who have an inadequate response to diet alone (i.e., LDL-C remains greater than or equal to 190 mg/dL or LDL-C remains greater than or equal to 160 mg/dL and there is a positive family history of early CV disease or 2 or more other CVD risk factors present)

• People younger than 10 years: Safety and efficacy of Lipitor not established
• People 10 years and older: Initially, Lipitor should be given as 0 mg taken orally once daily; titrate at 4-week intervals; not to exceed 20 mg taken orally once daily

Homozygous Familial Hypercholesterolemia (Off-label)

• Younger than 10 years: Safety and efficacy of Lipitor have not been established
• 10 years and older: 10-40 mg taken orally once daily

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and side effects and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first for more information.

Severe interactions of atorvastatin include:

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

Atorvastatin has serious interactions with at least 45 different drugs.

Atorvastatin has 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

This information is not a complete list and does not contain all possible interactions. Therefore, before using this drug, tell your doctor or pharmacist about all the drugs you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your doctor if you have health questions, concerns, or problems with this medication.

Warnings

• Lipitor is a medication that contains atorvastatin. Do not take Lipitor if you are allergic to atorvastatin or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get call your doctor for medical attention or contact a Poison Control Center immediately.

Contraindications

• 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

Effects of Drug Abuse

• None

Short-term Effects

• See information called "What Are Side Effects Associated with Using Atorvastatin (Lipitor)?"

Long-term Effects

• See information called "What Are Side Effects Associated with Using Atorvastatin (Lipitor)?"

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 were reported with the intake of statins like Lipitor.
• Use with caution Lipitor in the elderly; risk of myopathy.
• Heavy alcohol use, renal failure, history of liver disease, or liver problems.
• Fatal and nonfatal liver failure was 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.

Pregnancy and Lactation

• Do not use this drug if you are pregnant
• The health risks associated with this medicine outweigh the 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