Ezetimibe/Atorvastatin, Oral

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KEY POINTS

• This medicine is taken by mouth to lower levels of total cholesterol, LDL (bad) cholesterol, and triglycerides in the blood. It also helps to increase the amount of HDL (good) cholesterol. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: cholesterol absorption inhibitor/HMG CoA reductase inhibitor (statin); cholesterol-lowering medicine

Generic and brand names: ezetimibe/atorvastatin, oral

What is this medicine used for?

This medicine is taken by mouth to lower levels of total cholesterol, LDL (bad) cholesterol, and triglycerides in the blood. It also helps to increase the amount of HDL (good) cholesterol. It is used when you cannot control your cholesterol levels by diet and exercise alone.

It is also used to treat people who have inherited a gene that causes high levels of LDL (homozygous familial hypercholesterolemia).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Diabetes
• Liver or kidney problems
• Low blood pressure
• Problems with alcohol abuse or if you have more than 2 drinks per day
• Seizures
• Thyroid problems
• Unexplained muscle pain or weakness

This medicine may interact with many other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements. Ask your healthcare provider or pharmacist to make sure you can take this medicine with your other medicines. Tell your healthcare provider about any new medicines you might take even for only a short time.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes for the length of time prescribed. Do not stop taking this medicine without your healthcare provider's approval. This medicine will lower your cholesterol level only when you take it regularly. Continue to follow the diet or exercise program your healthcare provider prescribes.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Swallow the tablets whole. Do not break, crush, or chew them.

What if I miss a dose?

If you miss a dose of this medicine, take the missed dose as soon as you remember that same day. If you do not remember until the next day, skip the missed dose. Do not take double doses. If you are not sure of what to do if you miss a dose or you miss more than one dose, contact your healthcare provider.

What if I overdose?

An acute overdose of this medicine is not likely to cause life-threatening symptoms. If you think that you or anyone else may have taken too much of this medicine, call the poison control center at 800-222-1222.

What should I watch out for?

While you are taking this medicine, report any unusual or ongoing muscle pain, tenderness, or weakness to your healthcare provider right away, especially if you also have a fever or unusual tiredness. Also, contact your healthcare provider right away if these symptoms do not go away even after your healthcare provider has advised you to stop taking this medicine.

You will need blood tests regularly to see if the medicine is working. Keep all appointments.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

A low-fat diet and regular exercise are important to reduce cholesterol. Follow your healthcare provider's advice.

Alcohol may increase the risk of side effects. Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Chest pain; unusual or ongoing muscle pain, tenderness, or weakness, especially if you also have a fever, unusual tiredness, or vision changes; yellowing of your skin or eyes; severe nausea or vomiting; severe stomach pain; dark urine or trouble urinating; light-colored bowel movements; unusual tiredness or weakness; loss of appetite; severe skin rash or itching.

Other: Mild nausea or stomach pain, gas, heartburn, diarrhea, runny or stuffy nose, mild rash or itching, cough, sore throat, dizziness, trouble sleeping, depression, memory loss, confusion, mild joint or tendon pain, hot flashes.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antibiotics such as azithromycin (Zithromax, Zmax), chloramphenicol, clarithromycin (Biaxin), daptomycin (Cubicin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and simeprevir (Olysio)
• Aprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), bosutinib (Bosulif), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and pazopanib (Votrient)
• Colchicine (Colcrys)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Danazol
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Digoxin (Lanoxin)
• Eliglustat (Cerdelga)
• Eltrombopag (Promacta)
• Everolimus (Afinitor, Zortress)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Lanthanum (Fosrenol) (Take lanthanum at least 2 hours before or 2 hours after you take this medicine.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), omeprazole (Prilosec), and ranitidine (Zantac)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Natural remedies such as red yeast rice and St. John’s wort
• Nefazodone
• Niacin
• Other cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), fluvastatin (Lescol), gemfibrozil (Lopid), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor) (Take this medicine at least 2 hours before or 4 to 6 hours after you take cholestyramine, colesevelam, or colestipol.)
• Pimozide (Orap)
• Quinine
• Silodosin (Rapaflo)
• Spironolactone (Aldactone)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Do not drink alcohol while you are taking this medicine without your healthcare provider's approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the foil pouch at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Discard any unused tablets 30 days after you open the pouch.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.