a-tor-va-STAT-in

Commonly used brand name(s)

In the U.S.

• Lipitor

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: HMG-COA Reductase Inhibitor

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.

Before Using atorvastatin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For atorvastatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to atorvastatin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of atorvastatin in children 10 to 17 years of age. However, safety and efficacy have not been established in children younger than 10 years of age.

Teenage girls taking atorvastatin should be counseled on appropriate birth control methods to prevent pregnancy.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of atorvastatin in the elderly. However, elderly patients are more likely to have age-related muscle problems, which may require caution in patients receiving atorvastatin.

Pregnancy

Pregnancy Category Explanation All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking atorvastatin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using atorvastatin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Posaconazole

Using atorvastatin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Bezafibrate
• Carbamazepine
• Ceritinib
• Ciprofibrate
• Clarithromycin
• Clofibrate
• Cobicistat
• Colchicine
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Daclatasvir
• Dalfopristin
• Danazol
• Daptomycin
• Darunavir
• Diltiazem
• Domperidone
• Eliglustat
• Erlotinib
• Erythromycin
• Eslicarbazepine Acetate
• Fenofibrate
• Fenofibric Acid
• Fentanyl
• Fluconazole
• Fosamprenavir
• Fusidic Acid
• Gemfibrozil
• Idelalisib
• Indinavir
• Isavuconazonium Sulfate
• Itraconazole
• Ketoconazole
• Lopinavir
• Mibefradil
• Mitotane
• Nefazodone
• Nelfinavir
• Niacin
• Nilotinib
• Paritaprevir
• Piperaquine
• Primidone
• Quinupristin
• Saquinavir
• Siltuximab
• Simeprevir
• Telaprevir
• Telithromycin
• Teriflunomide
• Tipranavir
• Troleandomycin
• Verapamil

Using atorvastatin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Amprenavir
• Azithromycin
• Bexarotene
• Black Cohosh
• Boceprevir
• Bosentan
• Clopidogrel
• Digoxin
• Efavirenz
• Eltrombopag
• Etravirine
• Fosphenytoin
• Interferon Beta
• Oat Bran
• Pectin
• Phenytoin
• Pioglitazone
• Quinine
• Rifampin
• St John's Wort
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using atorvastatin with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use atorvastatin, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of atorvastatin. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Diabetes or
• Hypothyroidism (an underactive thyroid) or
• Liver disease, history—Use with caution. May cause side effects to become worse.

• Convulsions (seizures), not well-controlled or
• Electrolyte disorders, severe or
• Endocrine disorders, severe or
• Hypotension (low blood pressure) or
• Kidney disease, severe or
• Metabolic disorders, severe or
• Sepsis (severe infection)—Patients with these conditions may be at risk of developing muscle and kidney problems.

• Liver disease, active or
• Liver enzymes, elevated—Should not be used in patients with these conditions.

• Stroke, recent or
• Transient ischemic attack (TIA), recent—Atorvastatin may increase the risk of stroke in patients with these conditions.

Proper Use of atorvastatin

Take atorvastatin only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it or for a longer time than your doctor ordered.

In addition to atorvastatin, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

Take atorvastatin at the same time each day.

Swallow the tablet whole. Do not break, crush, or chew it. Take atorvastatin with or without food.

Do not drink large amounts of alcohol with atorvastatin. This could cause unwanted effects on the liver.

Tell your doctor if you regularly drink grapefruit juice. Drinking large amounts of grapefruit juice (more than 1.2 liters each day) while you take atorvastatin may increase your risk of muscle injury and could result in kidney problems.

Dosing

The dose of atorvastatin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of atorvastatin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults—At first, 10 or 20 milligrams (mg) once a day. Some patients may need to start at 40 mg per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per day.
    • Children 10 to 17 years of age—At first, 10 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day.
    • Children younger than 10 years of age)—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of atorvastatin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

However, do not take 2 doses of atorvastatin within 12 hours.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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.

atorvastatin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• hives
• itching
• muscle cramps, pain, stiffness, swelling, or weakness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest
• unusual tiredness or weakness
• wheezing

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• dark-colored urine
• diarrhea
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• red skin lesions, often with a purple center sore
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache
• hoarseness
• lower back or side pain
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• stuffy or runny nose

Less common

• Abdominal or stomach pain
• back pain
• belching or excessive gas
• constipation
• general feeling of discomfort or illness
• heartburn, indigestion, or stomach discomfort
• lack or loss of strength
• loss of appetite
• nausea
• shivering
• sweating
• trouble sleeping
• vomiting

Incidence not known

• Appetite increased
• , tarry stools
• bloody nose
• bloody or cloudy urine
• blurred vision
• continuing ringing or buzzing or other unexplained noise in the ears
• difficult, burning, or painful urination
• difficulty seeing at night
• excessive muscle tone or tension
• fruit-like breath odor
• groin or scrotum pain
• inability to have or keep an erection
• increased body movements
• increased sensitivity of the eyes to light
• increased sensitivity to touch or pain
• increased thirst
• increased urination
• loss of bladder control
• loss of sexual ability, drive, or desire
• menstrual bleeding occurring earlier or lasting longer than usual
• mental depression
• nervousness
• nightmares
• pale skin
• paranoia
• pinpoint red spots on the skin
• slurred speech
• swollen or tender lymph glands in the neck, armpit, or groin
• unable to move or feel face
• unusual bleeding or bruising
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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Usual Adult Dose for Prevention of Cardiovascular Disease

Initial dose: 10 mg to 80 mg orally once a day.

The initial dosage of atorvastatin recommended for this patient in the prevention of cardiovascular disease is 10 mg to 80 mg orally once a day. Atorvastatin may be administered at any time of the day without regard for meals.

Dose adjustments should be made at intervals of 2 to 4 weeks.

Studies have demonstrated that treatment with atorvastatin is associated with significant reductions in the risk of cardiovascular endpoints and stroke in various patient populations for both primary and secondary prevention.

For primary prevention, atorvastatin treatment was effective in hypertensive patients with normal or mildly elevated cholesterol levels as well as in patients with type II diabetes. Patients had relatively low cholesterol levels at baseline in both trials; however, treatment with atorvastatin still resulted in significant reductions in cardiovascular outcomes and stroke.

For secondary prevention, intensive lipid lowering therapy with atorvastatin 80 mg/day was associated with significant incremental clinical benefit beyond therapy with 10 mg/day in patients with stable coronary heart disease. It was also shown to significantly reduce the risk of clinical outcomes in coronary heart disease patients versus usual medical care.

Usual Adult Dose for Hyperlipidemia

Initial dose: 10, 20 or 40 mg orally once a day. The 40 mg starting dose is recommended for patients who require a reduction in LDL-cholesterol of more than 45%.

Dose adjustments should be made at intervals of 2 to 4 weeks.

Maintenance dose: 10 to 80 mg orally once a day.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia

10 to 17 years:
10 mg per day (max dose is 20 mg per day). Adjustments should be made at intervals of 4 weeks or more.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Atorvastatin is contraindicated in patients with active liver disease or with unexplained elevation of liver function enzyme levels.

Dose Adjustments

Adjustments in dosage should be made in intervals of 2 to 4 weeks.

In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, the dose of atorvastatin should not exceed 40 mg and monitoring is recommended.

Dialysis

Hemodialysis is not expected to significantly enhance clearance of atorvastatin
since the drug is extensively bound to plasma proteins.

Other Comments

Cholesterol levels should be monitored periodically with consideration given to reducing the dosage if cholesterol levels fall significantly below the targeted range.

Atorvastatin may be taken without regard to meals.

It has been suggested that prior to initiating statin therapy, all patients should have a baseline serum creatine kinase (CK) enzyme level measured and if at any time after initiating therapy a patient complains of muscle soreness, tenderness, or pain another CK level should be drawn for comparison. If elevated, the drug should be discontinued.

The results of one study indicate that withdrawal of HMG-CoA reductase inhibitors (statins; atorvastatin, fluvastatin, pravastatin, simvastatin) during the perioperative period in patients with acute coronary syndromes is associated with an increased risk for perioperative adverse cardiac events (i.e., increase postoperative troponin release and the combination of myocardial infarction and cardiovascular death). Patients receiving statins with extended-release formulations (i.e., fluvastatin) appeared to be associated with more favorable outcomes. Other studies appear to confirm these findings.

Lipitor Side Effects

Tablets of 10, 20, 40, and 80 mg