Pronunciation:

a-tor-va-STAT-in KAL-see-um, e-ZET-i-mibe

Brand Names:

• Liptruzet

Classifications:

Pharmacologic—

Atorvastatin

Uses of This Medicine:

Ezetimibe and atorvastatin combination is used together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood. This medicine may help prevent medical problems (eg, heart attack, stroke) caused by clogged blood vessels. It is also used to treat a condition called homozygous familial hypercholesterolemia (HoFH).

Ezetimibe is a cholesterol absorption inhibitor and atorvastatin is an HMG-CoA reductase inhibitor, or statin. These medicines will reduce the absorption of cholesterol from foods and the production of cholesterol in your body.

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

The atorvastatin/ezetimibe combination (Liptruzet(R)) was withdrawn from the United States market on June 2, 2015.

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 have not been performed on the relationship of age to the effects of atorvastatin and ezetimibe combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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.

• Cyclosporine
• Danazol
• Gemfibrozil
• 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
• Asciminib
• Atazanavir
• Bezafibrate
• Carbamazepine
• Ceritinib
• Cholestyramine
• Ciprofibrate
• Clarithromycin
• Clofibrate
• Cobicistat
• Colchicine
• Colesevelam
• Colestipol
• Conivaptan
• Cyclosporine
• Dabrafenib
• Dalfopristin
• Danazol
• Daptomycin
• Darolutamide
• Darunavir
• Digoxin
• Diltiazem
• Elbasvir
• Elexacaftor
• Eltrombopag
• 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
• Repotrectinib
• Ritlecitinib
• Saquinavir
• Simeprevir
• Telaprevir
• Telithromycin
• Teriflunomide
• Tipranavir
• 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
• 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
• Diabetes or
• Hypothyroidism (underactive thyroid) or
• Kidney disease or
• Liver disease, history of or
• Stroke, recent or
• Transient ischemic attack, within the last 6 months—Use with caution. May cause side effects to become worse.

• Hypotension (low blood pressure) or
• Infection, acute and severe or
• Kidney disease (severe), history of or
• Major surgery or
• Metabolic, endocrine, and electrolyte disorders or
• Seizures, uncontrolled or
• Trauma—Patients with these conditions may be at risk for muscle or kidney problems.

• Liver disease, active or
• Liver enzymes, elevated—Should not be used 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 for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

Swallow the tablet whole. Do not crush, break, chew, or dissolve it. You may take this medicine with or without food.

If you are taking certain medicines to lower cholesterol (eg, cholestyramine, colesevelam, colestipol, Questran®, Welchol®), take Liptruzet® 2 hours before or 4 hours after taking these medicines.

Do not drink more than 1.2 liters of grapefruit juice per day.

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

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):
  • For high cholesterol and triglycerides:
    • Adults—At first, one tablet per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg of ezetimibe and 80 mg of atorvastatin.
    • Children—Use and dose must be determined by your doctor.
  • For homozygous familial hypercholesterolemia (HoFH):
    • Adults—One tablet per day. Each tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin or 10 mg of ezetimibe and 80 mg of atorvastatin.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

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.

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

Keep your medicine in the blister pack until you are ready to use it. After opening the blister pack, store it in a dry place and protect from moisture and light. Once a tablet is removed, slide the blister card back into its folded card.

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 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 could be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).

Check with 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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, a 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

Abdominal or stomach pain

confusion

difficult breathing

difficulty with moving

irregular heartbeat

muscle, joint, or bone pain

muscle stiffness

muscle weakness

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

weakness or heaviness of the legs

Incidence not known

Black, tarry stools

blistering, peeling, or loosening of the skin

blood in the urine or stools

chills

dark-colored urine

diarrhea

fever

gaseous abdominal or stomach pain

general tiredness and weakness

hives, welts, or skin rash

itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

severe nausea or vomiting

sores, ulcers, or white spots in the mouth or on the lips

swelling of the eyes, face, or inside of the nose

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes and skin

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:

Less common

Cough

dizziness

feeling of warmth

pain or tenderness around the eyes and cheekbones

redness of the face, neck, arms, and occasionally, upper chest

stuffy or runny nose

sudden sweating

tightness in the chest

Incidence not known

Being forgetful

bloating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

constipation

discouragement

fast heartbeat

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

loss of memory

pains in the stomach, side, or abdomen, possibly radiating to the back

tiredness

trouble concentrating

trouble sleeping

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.