Dofetilide capsules

What are dofetilide capsules?

DOFETILIDE (Tikosyn®) is a medicine that is given to patients with atrial fibrillation (irregular heartbeats). Atrial fibrillation happens when certain parts of the heart (the chambers known as atria) beat too fast or irregularly. You may get an uncomfortable feeling in your chest and 'fluttering' or 'palpitations.' Dofetilide may help your heart to beat more regularly and stay beating regularly for a longer period of time. Generic dofetilide is not yet available.

What should my health care professional know before I take dofetilide?

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

• heart disease or heart failure

• heart rhythm problems

• heart valve problems

• 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 take this medicine?

Take dofetilide capsules by mouth. Swallow the capsules with a drink of water.Take the medicine with or without food.Follow the directions on the prescription label. Do not drink grapefruit juice with this medicine. Take dofetilide on a regular schedule as prescribed. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Elderly patients over 65 years old may have a stronger reaction to this medicine and need smaller doses.

What if I miss a dose?

Never try to make up for a missed dose. If you miss a dose, skip it and get back on your regular dosage schedule. If it is almost time for your next dose, take only that dose at the next scheduled time. Do not take double or extra doses.

What drug(s) may interact with dofetilide?

Do not take dofetilide with any of the following medications:

• amiloride

• arsenic trioxide

• astemizole

• bendroflumethiazide

• bepridil

• chlorothiazide

• chlorthalidone

• cimetidine (Tagamet®)

• cisapride

• entecavir

• grapefruit juice

• hydrochlorothiazide

• indapamide

• itraconazole

• ketoconazole

• megestrol

• methyclothiazide

• metolazone

• mibefradil

• metformin

• probucol

• prochlorperazine

• some antibiotics (gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, sparfloxacin)

• some medicines for treating heart-rhythm problems (amiodarone, encainide, flecainide, ibutilide, moricizine, procainamide, propafenone, quinidine, tocainide, sotalol)

• some medicines for treating depression or mental illness (amoxapine, maprotiline, pimozide, phenothiazines, tricyclic antidepressants)

• terfenadine

• triamterene

• trimethoprim

• trospium

• verapamil

• ziprasidone

Dofetilide may also interact with the following medications:

• amphotericin B

• aprepitant

• bosentan

• bumetanide

• certain antibiotics (erythromycin, clarithromycin, metronidazole,norfloxacin, Synercid®, troleandomycin)

• certain antidepressants (fluoxetine, fluvoxamine, nefazodone)

• certain medicines for fungal infections (fluconazole, voriconazole)

• medicines for treating HIV virus infection or AIDS (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir)

• certain heart medicines (digoxin, diltiazem, nicardipine)

• cisplatin

• dronabinol, THC

• ethacrynic acid

• furosemide

• ginger

• hawthorn

• medicines for asthma or breathing difficulties (examples: formoterol, salmeterol)

• quinine

• sevelamer

• torsemide

• zafirlukast

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Tell your prescriber or health care professional before stopping or starting any of your medicines.

What should I watch for while taking dofetilide?

Visit your prescriber or health care professional for a regular check on your progress. Do not stop taking dofetilide suddenly; this may cause serious, heart-related problems. Because your condition and the use of dofetilide carry some risk, it is a good idea to carry an identification card, necklace or bracelet with details of your condition, medications, and prescriber or health care professional.

Check your heart rate (pulse) and blood pressure regularly while you are taking dofetilide. Ask your prescriber or health care professional what your heart rate and blood pressure should be, and when you should contact him or her. Your prescriber or health care professional also may schedule regular blood tests and electrocardiograms to check your progress.

If you have fast or irregular beating of the heart with lightheadedness or fainting, contact your health care professional immediately for evaluation.

You will be started on dofetilide in a specialized facility for at least three days to begin treating your heart rhythm problem. You will be monitored to find the right dose of the medicine for you. It is very important that you take your medication exactly as prescribed when you leave the hospital since the correct dosing of dofetilide is very important to effectively treat your heart rhythm and prevent possible serious side effects.

Do not drink grapefruit juice while you are taking dofetilide. Grapefruit juice may interact with this medication.

If you are going to have surgery, tell your prescriber or health care professional that you are taking dofetilide.

What side effects may I notice from taking dofetilide?

Stop taking this medication immediately and report these side effects to your prescriber or health care professional right away:

• chest pain

• fainting or falling spells

• fast or rapid beating of the heart, or irregular hearbeat

• swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat

Contact your health care professional right away for evaluation.

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

• difficulty breathing, shortness of breath

• dizziness

• unusual or persistent rash

• unusual weakness or tiredness

• swelling of the ankles

• vomiting

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

• cough

• diarrhea

• difficulty sleeping

• headache

• nausea

• stomach pain

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store in a cool, dry place at a controlled room temperature between 15 degrees—30 degrees C (59 degrees—86 degrees F). Protect the medicine from moisture or humidity. Throw away any unused medicine after the expiration date.