Amlodipine Besylate/Atorvastatin Calcium, Oral

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KEY POINTS

• This medicine is taken by mouth to treat high blood pressure, high cholesterol, and chest pain. Take it exactly as directed.
• 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: calcium channel blocker/statin

Generic and brand names: amlodipine besylate/atorvastatin calcium, oral; Caduet

What is this medicine used for?

This medicine is a combination of a calcium channel blocker and a statin medicine. It is taken by mouth to treat:

• High blood pressure
• High cholesterol (It lowers bad cholesterol and triglycerides, and increases good cholesterol.)
• Chest pain

This medicine may also be used to reduce the risk for heart attack, stroke, and certain types of heart surgery in people who have heart disease or risk factors for heart disease.

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
• Diabetes
• Heart disease, heart failure, or heart valve problems
• Liver or kidney disease
• Low blood pressure
• Seizures
• Thyroid problems
• Unexplained muscle aches or weakness

Tell your healthcare provider if you have recently had surgery, or if you have had a stroke or TIA (transient ischemic attack) in the past 6 months. Also tell your provider if you have more than 2 alcoholic drinks per day.

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 you are taking this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider for the length of time prescribed. Take it regularly every day, even if you feel better. Take it at the same time each day to help you remember. Do not change your dosage. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 10.

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

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 12 hours of the next dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: fainting, severe dizziness, flushing, fast heartbeat, weakness, confusion.

What should I watch out for?

While you are taking this medicine, report any unusual muscle pain, tenderness, or weakness to your healthcare provider right away, especially if you also have a fever or feel ill.

Your healthcare provider will want to see you regularly to check your progress and may adjust your dosage. You will need blood tests to see if the medicine is working and how it affects you. Keep all appointments.

This medicine may make you dizzy or faint, especially if you get up quickly after sitting or lying down. Getting up slowly may help. Also, drinking alcohol may make it worse. Do not drink alcohol unless your healthcare provider approves. Do not drive or operate machinery until you know how this medicine affects you.

Follow your healthcare provider's instructions about exercise and diet while taking this medicine.

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

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.): New or worsening chest pain; unusual muscle pain, tenderness, stiffness, or weakness, especially if you also have a fever or unusual tiredness; yellowing of your skin or eyes; dark urine; light-colored bowel movements; severe nausea or vomiting; severe stomach pain; unexplained loss of appetite; trouble urinating or decreased urination; fast, irregular, or pounding heartbeat; swelling in the ankles or feet; trouble breathing; tremor; severe dizziness or fainting; severe skin rash or itching; memory loss, confusion.

Other: Mild nausea or vomiting, diarrhea, mild stomach pain, pain or burning when you urinate, gas, constipation, headache, mild dizziness, runny nose, flushing, mild tiredness, trouble sleeping.

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:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), and terazosin
• Amifostine (Ethyol)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• 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.)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), dronedarone (Multaq), and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), daptomycin (Cubicin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, quinupristin/dalfopristin (Synercid), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as fluvoxamine (Luvox) and nefazodone
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), haloperidol (Haldol), olanzapine (Zyprexa), pimozide (Orap), and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), betaxolol, bisoprolol (Zebeta), carteolol, carvedilol (Coreg), esmolol (Brevibloc), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), sotalol (Betapace, Sorine), and timolol
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Bosentan (Tracleer)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac) and verapamil (Calan, Covera, Verelan)
• Calcium supplements
• Cancer medicines such as abiraterone (Zytiga), bosutinib (Bosulif), ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), topotecan (Hycamtin), and vincristine (Marqibo)
• Clonidine (Catapres, Kapvay)
• Colchicine (Colcrys)
• Danazol
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Eliglustat (Cerdelga)
• Eltrombopag (Promacta)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Everolimus (Afinitor, Zortress)
• Flibanserin (Addyi)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), 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.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lanthanum (Fosrenol) (Take lanthanum at least 2 hours before or 2 hours after you take this medicine.)
• Lumacaftor/ivacaftor (Orkambi)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), omeprazole (Prilosec), and ranitidine (Zantac)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), edoxaban (Savaysa), rivaroxaban (Xarelto), and ticagrelor (Brilinta)
• Mifepristone (Korlym, Mifeprex)
• Natural remedies such as dong quai, ephedra, garlic, ginseng, hawthorn, red yeast rice, St. John's wort, and yohimbe
• Nausea medicines such as aprepitant (Emend) and netupitant/palonosetron (Akynzeo)
• Nesiritide (Natrecor)
• Other cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), fluvastatin (Lescol), gemfibrozil (Lopid), lomitapide (Juxtapid), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Tizanidine (Zanaflex)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

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 at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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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.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.