Dofetilide Oral capsule

What is this medicine?

DOFETILIDE (doe FET il ide) is an antiarrhythmic drug. It helps make your heart beat regularly. This medicine also helps to slow rapid heartbeats.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of low levels of potassium or magnesium

• kidney disease

• liver disease

• an unusual or allergic reaction to dofetilide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Do not drink grapefruit juice with this medicine. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly. This may cause serious, heart-related side effects. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

Talk to your pediatrician regarding the use of this medicine 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.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cimetidine

• dolutegravir

• hydrochlorothiazide alone or in combination with other medicines

• ketoconazole

• megestrol

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• prochlorperazine

• trimethoprim alone or in combination with sulfamethoxazole

• verapamil

This medicine may also interact with the following medications:

• amiloride

• certain antidepressants like fluvoxamine or paroxetine

• certain antiviral medicines for HIV or AIDS like atazanavir or darunavir

• certain medicines for fungal infections like clotrimazole or miconazole

• digoxin

• diltiazem

• dronabinol, THC

• grapefruit juice

• metformin

• nefazodone

• triamterene

• zafirlukast

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

Check your heart rate and blood pressure regularly while you are taking this medicine. Ask your doctor or health care professional what your heart rate and blood pressure should be, and when you should contact him or her. Your doctor or health care professional also may schedule regular tests to check your progress.

You will be started on this medicine in a specialized facility for at least three days. You will be monitored to find the right dose of medicine for you. It is very important that you take your medicine exactly as prescribed when you leave the hospital. The correct dosing of this medicine is very important to treat your condition and prevent possible serious side effects.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• dizziness

• fast or rapid beating of the heart

• feeling faint or lightheaded

• swelling of the ankles

• unusually weak or tired

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough

• diarrhea

• difficulty sleeping

• headache

• nausea

• stomach pain

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect the medicine from moisture or humidity. Keep container tightly closed. Throw away any unused medicine after the expiration date.