Description and Brand Names
Drug information provided by: Merative, Micromedex®
US Brand Name
- Tikosyn
Descriptions
Dofetilide is used to correct irregular heartbeat of patients with atrial fibrillation or atrial flutter to a normal heart rhythm. Dofetilide belongs to the group of medicines known as antiarrhythmics. It works by slowing nerve impulses in the heart.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of dofetilide in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dofetilide in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving dofetilide.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Bictegravir
- Cephalexin
- Cimetidine
- Cisapride
- Dolutegravir
- Dronedarone
- Fingolimod
- Fluconazole
- Hydrochlorothiazide
- Itraconazole
- Ketoconazole
- Lefamulin
- Levoketoconazole
- Levomethadyl
- Megestrol
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Prochlorperazine
- Saquinavir
- Sparfloxacin
- Sulfamethoxazole
- Terfenadine
- Thioridazine
- Trimethoprim
- Verapamil
- Vernakalant
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Acecainide
- Adagrasib
- Alfuzosin
- Amiloride
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Aprindine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asciminib
- Asenapine
- Astemizole
- Avacopan
- Azimilide
- Azithromycin
- Azosemide
- Bedaquiline
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benzthiazide
- Berotralstat
- Bretylium
- Bumetanide
- Buprenorphine
- Buserelin
- Buthiazide
- Capmatinib
- Ceritinib
- Chloral Hydrate
- Chloroquine
- Chlorothiazide
- Chlorpromazine
- Chlorthalidone
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clopamide
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Cyclopenthiazide
- Cyclothiazide
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desipramine
- Deslorelin
- Deutetrabenazine
- Dexmedetomidine
- Diazoxide
- Dibenzepin
- Digoxin
- Dirithromycin
- Disopyramide
- Dolasetron
- Domperidone
- Donepezil
- Doxepin
- Droperidol
- Efavirenz
- Eliglustat
- Encorafenib
- Enflurane
- Entrectinib
- Enzalutamide
- Erdafitinib
- Erythromycin
- Escitalopram
- Ethacrynic Acid
- Etozolin
- Fenquizone
- Fexinidazole
- Flecainide
- Fluoxetine
- Formoterol
- Foscarnet
- Fosnetupitant
- Fostemsavir
- Furosemide
- Gatifloxacin
- Gemifloxacin
- Gilteritinib
- Glasdegib
- Gonadorelin
- Goserelin
- Granisetron
- Halofantrine
- Haloperidol
- Halothane
- Histrelin
- Hydroflumethiazide
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Iloperidone
- Imipramine
- Indapamide
- Inotuzumab Ozogamicin
- Isoflurane
- Isradipine
- Ivabradine
- Ivosidenib
- Josamycin
- Lacosamide
- Lamotrigine
- Lanreotide
- Lapatinib
- Lenacapavir
- Lenvatinib
- Leuprolide
- Levofloxacin
- Lidoflazine
- Lofexidine
- Lopinavir
- Lorcainide
- Lorlatinib
- Lumefantrine
- Macimorelin
- Mefloquine
- Metformin
- Methadone
- Methyclothiazide
- Metolazone
- Metronidazole
- Mifepristone
- Mirtazapine
- Mitotane
- Mobocertinib
- Moricizine
- Moxifloxacin
- Nafarelin
- Netupitant
- Nilotinib
- Norfloxacin
- Nortriptyline
- Octreotide
- Ofloxacin
- Omaveloxolone
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Ozanimod
- Pacritinib
- Palbociclib
- Paliperidone
- Panobinostat
- Pasireotide
- Pazopanib
- Pentamidine
- Pimavanserin
- Piretanide
- Pirtobrutinib
- Pitolisant
- Polythiazide
- Ponesimod
- Prilocaine
- Probucol
- Procainamide
- Promethazine
- Propafenone
- Protriptyline
- Quetiapine
- Quinethazone
- Quinidine
- Ranolazine
- Ribociclib
- Risperidone
- Ritonavir
- Roxithromycin
- Selpercatinib
- Sematilide
- Sertindole
- Sertraline
- Sevoflurane
- Siponimod
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Solifenacin
- Sorafenib
- Sotalol
- Sotorasib
- Spiramycin
- Sulpiride
- Sultopride
- Sunitinib
- Tacrolimus
- Tafenoquine
- Taurursodiol
- Tedisamil
- Telavancin
- Telithromycin
- Tetrabenazine
- Toremifene
- Torsemide
- Trazodone
- Triamterene
- Trichlormethiazide
- Triclabendazole
- Trifluoperazine
- Trilaciclib
- Trimipramine
- Triptorelin
- Trofinetide
- Troleandomycin
- Tucatinib
- Vandetanib
- Vardenafil
- Vemurafenib
- Vilanterol
- Vinflunine
- Voclosporin
- Voriconazole
- Voxelotor
- Xipamide
- Zolmitriptan
- Zotepine
- Zuclopenthixol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Semaglutide
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Electrolyte imbalance (eg, low magnesium or potassium levels in the blood) or
- Heart disease or
- Heart rhythm problems—Use with caution. May make these conditions worse.
- Heart rhythm problem (eg, congenital long QT syndrome) or
- Kidney disease, severe or
- Patients receiving dialysis treatment—Should not be used in patients with these conditions.
- Kidney disease—Higher blood levels may occur, which may increase the chance of side effects. Your doctor may need to change your dose.
- Liver disease, severe—Use with caution. This medicine has not been studied in patients with this condition.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. This medicine works best when there is a constant amount in the body. To help keep the amount constant, it is best to take the doses at the same time every day.
Your doctor will start you on this medicine in the hospital in order to check your heart rhythm and find the right dose for you. You will need to stay in the hospital for at least 3 days so the doctor can monitor your progress.
This medicines comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For abnormal heart rhythm:
- Adults—125 to 500 micrograms (mcg) two times a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For abnormal heart rhythm:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects. This will allow for changes to be made in the amount of medicine you are taking, if necessary.
Do not use this medicine together with cimetidine, dolutegravir, hydrochlorothiazide, hydrochlorothiazide/triamterene, ketoconazole, megestrol, prochlorperazine, trimethoprim, trimethoprim/sulfamethoxazole, or verapamil. Using these medicines together may cause serious unwanted effects.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium, or certain diuretics (eg, amiloride, spironolactone, triamterene).
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Dizziness
- fainting
- fast heartbeat
Less common
- Chest pain
- confusion
- facial or flaccid paralysis
- numbness or tingling of the hands, feet, or face
- paralysis
- pounding, slow heartbeat
- slurred speech
- swelling of the ankles, arms, face, feet, fingers, legs, lips, tongue, or throat
- troubled breathing
- unexplained shortness of breath
- unusual tiredness or weakness
- weight gain
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Abdominal or stomach pain
- accidental injury
- back pain
- chills
- cough
- diarrhea
- fever
- flu-like symptoms
- general feeling of discomfort or illness
- headache
- joint pain
- loss of appetite
- migraine
- muscle aches and pains
- nausea
- rash
- runny nose
- shivering
- sneezing
- sore throat
- sweating
- trouble sleeping
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Portions of this document last updated: May 01, 2023
Original article: https://www.mayoclinic.org/drugs-supplements/dofetilide-oral-route/proper-use/DRG-20063516
Copyright: © Merative US L.P. 1973, 2023. All rights reserved. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.
.
FAQs
Dofetilide (Oral Route) Proper Use? ›
For oral dosage form (capsules): For abnormal heart rhythm: Adults—125 to 500 micrograms (mcg) two times a day. Your doctor may adjust your dose as needed.
How should dofetilide be taken? ›Dofetilide comes as a capsule to take by mouth. It is usually taken twice a day, but may be taken once a day in people with certain conditions. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
What is the route of administration for TIKOSYN? ›TIKOSYN is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.
Does dofetilide need to be taken with food? ›You may take this medicine with or without food.
What is the most likely goal of administering dofetilide? ›Clinical uses of dofetilide include maintaining sinus rhythm in patients with atrial fibrillation.
What should you not take with dofetilide? ›Do not use this medicine together with cimetidine, dolutegravir, hydrochlorothiazide, hydrochlorothiazide/triamterene, ketoconazole, megestrol, prochlorperazine, trimethoprim, trimethoprim/sulfamethoxazole, or verapamil. Using these medicines together may cause serious unwanted effects.
Should I take TIKOSYN with food? ›You may take dofetilide with or without food. You should not skip doses or stop using dofetilide suddenly.
Is TIKOSYN a pill? ›Tikosyn belongs to a group of drugs called class III antiarrhythmics, which are medications that are used to treat arrhythmias. Tikosyn comes as a capsule that you swallow. The drug is available in three strengths: 125 micrograms (mcg), 250 mcg, and 500 mcg.
Is TIKOSYN and dofetilide the same? ›Dofetilide (Tikosyn®) is used to correct irregular heartbeats (arrhythmias). It relaxes an overactive heart and helps improve the heart's pumping action.
How are antiarrhythmics administered? ›Most arrhythmia medications are taken by mouth over a long period of time for lasting treatment. Some are delivered intravenously (injected into the bloodstream) for patients who are unstable or cannot take oral medications.
What are the cautions of TIKOSYN? ›
TIKOSYN (dofetilide) can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to dofetilide plasma concentration.
How many people have died from TIKOSYN? ›Mortality: In a pooled survival analysis of patients in the supraventricular arrhythmia population (low prevalence of structural heart disease), deaths occurred in 0.9% (12/1346) of patients receiving TIKOSYN and 0.4% (3/677) in the placebo group.
Can you take TIKOSYN at home? ›To establish the right dose of TIKOSYN, treatment with TIKOSYN must be started in a hospital where your heart rate and kidney function will be checked for the first 3 days of treatment. It is important that when you go home, you take the exact dose of TIKOSYN that your healthcare provider prescribed for you.
What medications should not be taken with TIKOSYN? ›The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with TIKOSYN is contraindicated (see WARNINGS and PRECAUTIONS, Drug-Drug Interactions), as each of these drugs cause a substantial increase in dofetilide ...
What is the black box warning for dofetilide? ›To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation.
Does dofetilide affect the kidneys? ›Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dofetilide in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving dofetilide.
What are the long term side effects of dofetilide? ›Dofetilide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
What should I monitor with dofetilide? ›TIKOSYN must be initiated in a setting that provides continuous electrocardiographic (ECG) monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias. Patients should continue to be monitored in this way for a minimum of 3 days.
Can you drink alcohol while on dofetilide? ›This medication may cause dizziness. Alcohol can cause dizziness.
Is TIKOSYN a long term drug? ›Tikosyn (dofetilide) is used long-term to keep your heart beating normally - maintain normal sinus rhythm - and delay the recurrence of abnormal heartbeats including atrial fibrillation or flutter.
Can you take TIKOSYN and metoprolol at the same time? ›
No interactions were found between metoprolol and Tikosyn. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.
Can you abruptly stop TIKOSYN? ›Do not stop taking TIKOSYN until your doctor tells you to stop. If you miss a dose, just take the next dose at your regular time.
Does TIKOSYN cause anxiety? ›Adverse events reported at a rate >2% but no more frequently on TIKOSYN than on placebo were: angina pectoris, anxiety, arthralgia, asthenia, atrial fibrillation, complications (application, injection, incision, insertion, or device), hypertension, pain, palpitation, peripheral edema, supraventricular tachycardia, ...
Is TIKOSYN an expensive drug? ›The cost for Tikosyn oral capsule 125 mcg is around $472 for a supply of 40 capsules, depending on the pharmacy you visit. Quoted prices are for cash-paying customers and are not valid with insurance plans. This price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
Does TIKOSYN require a hospital stay? ›You need a hospital stay to start dofetilide. Members of your health care team will give you an electrocardiogram (EKG) after each dose for the first 6 doses. This test helps them see how well your heart's electrical system is working. Your hospital stay may last up to 4 days.
How successful is TIKOSYN? ›In total, 148 patients treated with TIKOSYN (59%) and 86 patients treated with placebo (34%) were restored successfully to NSR (either pharmacologically or by direct current cardioversion). The primary end point in the DIAMOND studies was all-cause mortality.
What are the problems with TIKOSYN? ›Summary. Common side effects of Tikosyn include: ventricular arrhythmia, ventricular tachycardia, and chest pain. Other side effects include: flu-like symptoms.
Is dofetilide safer than amiodarone? ›Amiodarone had the highest incidence of adverse events (OR 2.41; 95% CI, 0.96-6.06) and treatment withdrawals (OR 2.91; 95% CI, 1.66-5.11). Dofetilide was more effective than placebo in restoration (12% vs. 1%) and maintenance (hazard ratio [HR] 0.35; 95% CI, 0.22-0.57; p < 0.001).
What is the first drug of choice for atrial fibrillation? ›A beta blocker, such as bisoprolol or atenolol, or a calcium channel blocker, such as verapamil or diltiazem, will be prescribed. The medicine you'll be offered will depend on what symptoms you're having and your general health. A medicine called digoxin may be offered if other drugs are not suitable.
What is the safest AFIB medication? ›Of all antiarrhythmic agents, dofetilide and amiodarone have been proven safe in patients with heart failure.
What is the new drug for atrial fibrillation? ›
The research team led by Professor Eric Chan from the NUS Department of Pharmacy discovered that a current drug for AF, called dronedarone, causes the inactivation of a key heart enzyme.
Is TIKOSYN a good drug for AFIB? ›This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation/flutter). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat.
What is the risk factor for dofetilide? ›Risk factors for dofetilide associated Tdp include older age, female sex, heart disease, electrolyte disorders (especially hypokalemia and hypomagnesemia), renal or hepatic dysfunction, bradycardia or rhythms with long pauses, treatment with other QT-prolonging drugs, and genetic predisposition.
Does dofetilide slow heart rate? ›Dofetilide, like other class 3 agents, has reverse use-dependent effects and prolongs repolarization and refractoriness to a greater degree at slower heart rates.
How long has TIKOSYN been on the market? ›Tikosyn was approved on October 1, 1999 for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter) in patients with atrial fibrillation /atrial flutter of greater than one week duration who have been converted to normal sinus rhythm (NSR).
Can dofetilide cause liver damage? ›Dofetilide has been described to cause liver damage in ≤2% of its overall use and numerically more frequent than placebo per manufacturer data.
Why is dofetilide started at a hospital? ›Taking the right dose can reduce the risk. TIKOSYN is started in the hospital. This is to make sure you get the right dose. And if this side effect occurs, doctors will be there to take care of you.
Can you exercise on TIKOSYN? ›Tikosyn (dofetilide) is an antiarrhythmic drug used to stop A fib (a chaotic heart beat) and keep people in normal heart rhythm. Exercise generally is considered safe with this medication, but I think a pulse monitor might be a good idea to make sure you aren't going into a dangerously high range.
Is dofetilide expensive? ›Local pharmacy prices
Pay $ 114.45 chevron_right at CVS Pharmacy with a GoodRx discount.
Interactions for Dofetilide
If discontinuance of dofetilide is necessary to permit administration of potentially interacting drug(s), allow a washout period of at least 2 days.
Which drug should not be used in atrial fibrillation? ›
Atrial Fibrillation Drugs to Avoid
Some of the most prominent ones include: Warfarin (also known as Coumadin and Jantoven) Apixaban (also known as Eliquis) Rivaroxaban (also known as Xarelto)
The most frequent reason for discontinuation (>1%) was ventricular tachycardia (2.0% on dofetilide vs. 1.3% on placebo). The most frequent adverse events were headache, chest pain, and dizziness.
Can dofetilide cause anxiety? ›Adverse events reported at a rate >2% but no more frequently on TIKOSYN than on placebo were: angina pectoris, anxiety, arthralgia, asthenia, atrial fibrillation, complications (application, injection, incision, insertion, or device), hypertension, pain, palpitation, peripheral edema, supraventricular tachycardia, ...
Can dofetilide cause weight loss? ›Based on the findings of this case, dofetilide was the likely cause of anorexia and subsequent unintentional weight loss in our patient.
Can you take ibuprofen with Tikosyn? ›Interactions between your drugs
No interactions were found between ibuprofen and Tikosyn. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.
TIKOSYN (dofetilide) can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to dofetilide plasma concentration.
How long does it take for TIKOSYN to take effect? ›In some cases, it may take your heart rhythm longer than 3 days to convert to a normal rhythm. Once you have a normal heart rhythm, your doctor will likely have you take the maintenance dosage of Tikosyn.
What is the success rate of TIKOSYN? ›In total, 148 patients treated with TIKOSYN (59%) and 86 patients treated with placebo (34%) were restored successfully to NSR (either pharmacologically or by direct current cardioversion). The primary end point in the DIAMOND studies was all-cause mortality. Incidence of arrhythmia was a secondary end point.
What is an alternative to TIKOSYN? ›Treating Atrial Fibrillation. Six antiarrhythmic drugs are often used to treat atrial fibrillation: propafenone (Rhythmol), flecainide (Tambocor), sotalol (Betapace), dofetilide (Tikosyn), amiodarone (Cordarone), and dronedarone (Multaq).
Can you take metoprolol with TIKOSYN? ›No interactions were found between metoprolol and Tikosyn. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.