Amiodarone, Oral/Injection

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KEY POINTS

• This medicine is used to prevent or treat irregular heart rhythms. Take it exactly as directed.
• This medicine may cause lung, thyroid, liver, or eye problems.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may interact with many other medicines. 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: antiarrhythmic (treats irregular heartbeat)

Generic and brand names: amiodarone, injection; Nexterone IV; amiodarone, oral; Cordarone; Pacerone

What is this medicine used for?

This medicine is taken by mouth or given by IV infusion (slow drip through a needle into a large vein) to prevent or treat irregular heart rhythms. Because this medicine may cause severe or deadly side effects, it is only used in people with irregular heart rhythms that may be life-threatening. 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
• Any other type of heart disease or heart problems, or if you have a pacemaker or defibrillator
• A very slow heart rate, or slow heart rate with dizziness or lightheadedness
• High blood pressure
• Imbalances of calcium, potassium, or magnesium in your blood
• Liver problems
• Lung disease or breathing problems
• Thyroid problems

There are many medicines that should NOT be taken while you are taking this medicine. Tell your healthcare provider about all prescription medicines, nonprescription medicines, and natural remedies you take. Do not start or stop any medicine or supplement unless you check with your healthcare provider or pharmacist.

Females of childbearing age: Do not take this medicine if you are pregnant or become plan to become pregnant because it may harm the baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is first given while you are in the hospital where you will be watched closely. When you are released from the hospital, read the information sheet that comes in the medicine package. Ask your healthcare provider or pharmacist about anything you do not understand.

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Taking too much of this medicine may cause side effects that could be fatal. Do not stop taking this medicine without your healthcare provider's approval, even if you feel better.

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

Take the medicine at the same time each day to help you remember to take it. Always take it the same way, either with food or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Take this medicine with a full glass of water.

What if I miss a dose?

Do not miss a dose. If you miss a dose, take it as soon as you remember unless it is almost time for your next scheduled dose. In that case, skip the missed dose and take the next dose 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: weakness, slow or irregular heartbeat, lightheadedness, fainting.

What should I watch out for?

This medicine may cause severe or life-threatening lung or liver problems, and may worsen heart problems. You may have regular lung tests, chest X-rays, and other tests while taking this medicine. Talk with your healthcare provider about this.

You may have side effects even after you stop taking this medicine because the medicine stays in your body for several months. Your healthcare provider will want to see you regularly to check your progress. Keep all your appointments.

This medicine may cause thyroid problems. If you notice sudden weight loss or weight gain, swelling in your neck, increased nervousness, heat or cold intolerance, increased sweating, thinning hair, or changes in menstrual periods, contact your healthcare provider.

Have regular eye exams while you are taking this medicine. If you notice changes in your vision while you are taking this medicine, contact your healthcare provider right away. You should not have laser surgery on your eyes while taking this medicine.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

If you take this medicine for a long time, it may cause your skin to turn bluish-gray. This may go away when you stop taking the medicine. If you have this reaction, tell your healthcare provider.

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. This includes laser surgery on the eyes.

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).

Serious (Report these to your healthcare provider right away.): Shortness of breath, painful breathing, coughing up blood, fever, numbness in your fingers or toes, trouble walking, vision problems, trembling hands, muscle movements you cannot control, palpitations, slow heartbeat (less than 60 beats per minute), fast heartbeat, new or worsening irregular heartbeat, severe dizziness or fainting, chest pain or discomfort, yellowing of the skin or eyes, brown or dark-colored urine, severe stomach pain, severe nausea or vomiting, severe or ongoing diarrhea, unusual tiredness or weakness, sudden weight loss or weight gain, swelling in your neck, increased nervousness, heat or cold intolerance, increased sweating, thinning hair, or changes in menstrual periods, problems concentrating, new or worsening depression, unusual bruising or bleeding, blue-gray skin color.

Other: Headache, nausea, vomiting, mild dizziness, constipation, flushed face, loss of appetite, mild tiredness, change in sense of taste or smell.

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:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Amphotericin b (Abelcet, AmBisome, Amphotec)
• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), flurazepam, temazepam (Restoril), and triazolam (Halcion)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, ibutilide (Corvert), lidocaine (Lidoderm, Xylocaine), mexiletine, procainamide, propafenone (Rythmol), and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gemifloxacin (Factive), levofloxacin (Levaquin), metronidazole, moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), sulfamethoxazole/trimethoprim (Bactrim, Septra), telithromycin (Ketek), and trimethoprim (Primsol)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as diphenhydramine (Benadryl), hydroxyzine (Vistaril), and loratadine (Alavert, Claritin)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ezogabine (Potiga), fosphenytoin (Cerebyx), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Apomorphine (Apokyn)
• 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), pindolol, sotalol (Betapace, Sorine), and timolol
• Bosentan (Tracleer)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), daunorubicin (Cerubidine), degarelix (Firmagon), docetaxel (Docefrez, Taxotere), doxorubicin (Doxil), enzalutamide (Xtandi), epirubicin (Ellence), eribulin (Halaven), erlotinib (Tarceva), goserelin (Zoladex), histrelin (Vantas), idarubicin (Idamycin), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), romidepsin (Istodax), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), vemurafenib (Zelboraf), vinblastine, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colestipol (Colestid), fluvastatin (Lescol), gemfibrozil (Lopid), lovastatin (Altoprev), and simvastatin (Zocor)
• Colchicine (Colcrys)
• Conivaptan (Vaprisol)
• Corticosteroids such as budesonide (Entocort, Rhinocort, Uceris) and dexamethasone
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and saxagliptin (Onglyza)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, eplerenone (Inspra), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Donepezil (Aricept)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Foscarnet (Foscavir)
• 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), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Laxatives
• Lithium (Lithobid)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, hydroxychloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and famotidine (Pepcid)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), indacaterol (Arcapta), olodaterol (Striverdi Respimat), and salmeterol (Serevent)
• Medicines to treat or prevent blood clots such as cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), rivaroxaban (Xarelto), ticagrelor (Brilinta) and warfarin (Coumadin)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Mifepristone (Korlym, Mifeprex)
• Mirabegron (Myrbetriq)
• Natural remedies such as hawthorn, red yeast rice, and St. John’s wort
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), droperidol (Inapsine), granisetron (Sancuso), ondansetron (Zofran), and promethazine
• Octreotide (Sandostatin)
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Ranolazine (Ranexa)
• Sevelamer (Renagel, Renvela)
• Tetrabenazine (Xenazine)
• Theophylline
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Tolterodine (Detrol)

Do NOT eat or drink products that contain grapefruit, Seville oranges, or 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.

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.