Dofetilide (Oral route)
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous ECG monitoring, and cardiac resuscitation. Dofetilide is available only to hospitals and prescribers who have received appropriate dofetilide dosing and treatment initiation education .
Antiarrhythmic, Group III
Uses of This Medicine:
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.
Before Using This Medicine:
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:
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.
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.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
- Dolutegravir Sodium
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.
- Arsenic Trioxide
- Chloral Hydrate
- Ethacrynic Acid
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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 of This Medicine:
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.
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:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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 While Using This Medicine:
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 of This Medicine:
- More common
- fast heartbeat
- Less common
- Chest pain
- facial or flaccid paralysis
- numbness or tingling of the hands, feet, or face
- 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
- Less common
- Abdominal or stomach pain
- accidental injury
- back pain
- flu-like symptoms
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- runny nose
- sore throat
- trouble sleeping
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:
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:
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.
Last Updated: 11/4/2014