Pacerone contains the active ingredient amiodarone hydrochloride, an antiarrhythmic drug available in tablet form. The tablets come in dosage strengths of 100 mg, 200 mg, 300 mg, and 400 mg for oral administration. Key inactive ingredients include colloidal silicon dioxide, corn starch, lactose anhydrous, magnesium stearate, and povidone.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. You should always take it the same way. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Bluish-gray skin -Change in vision such as blurry vision, seeing halos around lights, vision loss -Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue -Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing -High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression -Lung injury—shortness of breath or trouble breathing, cough, spitting up blood, chest pain, fever -Pain, tingling, or numbness in the hands or feet, muscle weakness, trouble walking, loss of balance or coordination Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Nausea -Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Liver disease -Lung disease -Other heart problems -Thyroid disease -An unusual or allergic reaction to amiodarone, iodine, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Abarelix -Apomorphine -Arsenic trioxide -Certain antibiotics, such as erythromycin, gemifloxacin, levofloxacin, or pentamidine -Certain medications for depression, such as amoxapine or tricyclic antidepressants -Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole -Certain medications for irregular heartbeat, such as disopyramide, dronedarone, ibutilide, propafenone, or sotalol -Certain medications for malaria, such as chloroquine or halofantrine -Cisapride -Droperidol -Haloperidol -Hawthorn -Maprotiline -Methadone -Phenothiazines, such as chlorpromazine, mesoridazine, or thioridazine -Pimozide -Ranolazine -Red yeast rice -Vardenafil This medication may also interact with the following: -Antivirals for HIV -Certain medications for blood pressure, heart disease, irregular heartbeat -Certain medications for cholesterol, such as atorvastatin, cerivastatin, lovastatin, or simvastatin -Certain medications for hepatitis C, such as sofosbuvir and ledipasvir; sofosbuvir -Certain medications for seizures, such as phenytoin -Certain medications for thyroid problems -Certain medications that prevent or treat blood clots, such as warfarin -Cholestyramine -Cimetidine -Clopidogrel -Cyclosporine -Dextromethorphan -Diuretics -Dofetilide -Fentanyl -General anesthetics -Grapefruit juice -Lidocaine -Loratadine -Methotrexate -Other medications that cause heart rhythm changes -Procainamide -Quinidine -Rifabutin, rifampin, or rifapentine -St. John's Wort -Trazodone -Ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored closely when you first begin therapy. This medication is often started in a hospital or other monitored health care setting. Once you are on maintenance therapy, visit your care team for regular checks on your progress. Because your condition and use of this medication carry some risk, it is a good idea to carry an identification card, necklace, or bracelet with details of your condition, medications, and care team. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths. You should have regular eye exams before and during treatment. Call your care team if you have blurred vision, see halos, or your eyes become sensitive to light. Your eyes may get dry. It may be helpful to use a lubricating eye solution or artificial tears solution. If you are going to have surgery or a procedure that requires contrast dyes, tell your care team that you are taking this medication.

What are the most serious risks of this medication?

This medicine can make your heart beat problems worse, which can lead to death. This medicine can cause serious, life-threatening liver damage. This medicine may cause serious, life threatening lung damage.