Pronunciation:

a-tor-va-STAT-in

Brand Names:

• Atorvaliq
• Lipitor

Dosage Forms:

• Suspension
• Tablet

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

HMG-COA Reductase Inhibitor

Uses of This Medicine:

Atorvastatin is used together with a proper diet to lower cholesterol and triglyceride (fats) levels in the blood. This medicine may help prevent medical problems (eg, 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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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 to treat homozygous familial hypercholesterolemia (HoFH) and heterozygous familial hypercholesterolemia (HeFH) and in children to treat other types of high cholesterol.

Older adults—

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 kidney, liver, heart problems, or increased risk of muscle problems, which may require caution in patients receiving atorvastatin.

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.

Other 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 this medicine, 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 this medicine 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
• Ritonavir

Using this medicine 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.

• Abametapir
• Atazanavir
• Bezafibrate
• Ceritinib
• Ciprofibrate
• Clarithromycin
• Clofibrate
• Cobicistat
• Colchicine
• Conivaptan
• Cyclosporine
• Dabrafenib
• Dalfopristin
• Danazol
• Daptomycin
• Darolutamide
• Darunavir
• Digoxin
• Diltiazem
• Elbasvir
• Elexacaftor
• Enasidenib
• Encorafenib
• Erythromycin
• Fedratinib
• Fenofibrate
• Fenofibric Acid
• Fexinidazole
• Fluconazole
• Fosamprenavir
• Fosnetupitant
• Fusidic Acid
• Gemfibrozil
• Glecaprevir
• Grazoprevir
• Indinavir
• Isavuconazonium Sulfate
• Itraconazole
• Ketoconazole
• Ledipasvir
• Leflunomide
• Leniolisib
• Letermovir
• Levoketoconazole
• Lopinavir
• Mavacamten
• Mibefradil
• Midostaurin
• Nefazodone
• Nelfinavir
• Netupitant
• Niacin
• Nirmatrelvir
• Omaveloxolone
• Palbociclib
• Phenobarbital
• Pibrentasvir
• Piperaquine
• Primidone
• Quinupristin
• Ritlecitinib
• Saquinavir
• Simeprevir
• Telaprevir
• Telithromycin
• Teriflunomide
• Tipranavir
• Tocilizumab
• Trofinetide
• Troleandomycin
• Verapamil
• Voriconazole

Using this medicine 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
• Efavirenz
• Eltrombopag
• Ethinyl Estradiol
• Etravirine
• Fosphenytoin
• Fostemsavir
• Interferon Beta
• Norethindrone
• Oat Bran
• Pectin
• Phenytoin
• Pioglitazone
• Quinine
• Rifampin
• St John's Wort

Other interactions—

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 this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, 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 this medicine. 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 (eg, liver failure, decompensated cirrhosis)—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 This Medicine:

Take this medicine 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 this medicine, 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.

To use the suspension:

• Measure the oral liquid medicine with the provided oral dosing syringe.
• Take this medicine each day at any time of day. Take it on an empty stomach (1 hour before or 2 hours after a meal).

To use the tablet:

• Take the it at the same time each day.
• Swallow the tablet whole. Do not break, crush, or chew it. Take this medicine 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 this medicine may increase your risk of muscle injury and could result in kidney problems.

Dosing—

The dose of this medicine 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 this medicine. 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 and suspension):
  • 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 years of age and older with heterozygous familial hypercholesterolemia (HeFH)—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 10 years of age and older with homozygous familial hypercholesterolemia (HoFH)—At first, 10 to 20 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 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 this medicine, 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.

If you miss a dose and it has been more than 12 hours since your last dose, wait and take your next dose at your regular time. Do not take 2 doses of this medicine at the same time.

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 This Medicine:

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 this medicine 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, especially if you also have unusual tiredness or a fever. These may 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 this medicine. You may need to stop using this medicine 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.

Side Effects of This Medicine:

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

Chest tightness

cough

difficulty with swallowing

dizziness

fast heartbeat

fever

hives, itching, skin rash

muscle cramps, pain, stiffness, swelling, or weakness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unusual tiredness or weakness

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

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

stomach pain

sweating

trouble sleeping

vomiting

Incidence not known

Appetite increased

black, 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.