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|Dofetilide

DOFETILIDE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Tikosyn

Category

• Antiarrhythmic

Description

Dofetilide (DOH-fet-a-lyed) belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm

Dofetilide produces its helpful effects by slowing nerve impulses in the heart.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Capsules (U.S)

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. The following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to dofetilide.

Pregnancy—Dofetilide has not been studied in pregnant women. However, studies in animals have shown that dofetilide causes birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding— It is not known whether dofetilide passes into breast milk. However, the manufacturer does not recommend breast-feeding while taking dofetilide.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of dofetilide in children less than 18 years of age with use in other age groups.

Older adults—This medicine has been tested in patients 65 to 89 years old and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 dofetilide, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antiarrhythmic or other heart medicine, such as amiodarone (e.g., Cordarone) taken within the last 3 months or
• Antibiotics like macrolides or trimethoprim, alone or in combination with sulfamethoxazole (e.g., Biaxin, E-Mycin, ERYC, Ery-Tab, Trimpex, Bactrim, Septra) or
• Bepridil (e.g., Vascor) or
• Cimetidine (e.g., Tagamet) or
• Cisapride (e.g., Propulsid) or
• Ketoconazole (e.g., Nizoral) or
• Megestrol (e.g., Megace) or
• Phenothiazines like prochlorperazine or trifluoperazine (e.g., Compazine, Stelazine) or
• Tricyclic antidepressants like amitriptyline or desipramine (e.g., Elavil or Norpramin) or
  Verapamil (e.g., Calan, Covera-HS, isoptin SR, Verelan)—may cause irregular heartbeats

• Hydrochlorothiazide/Triamterene (e.g., Dyazide, Maxzide)—may increase the amount of dofetilide in your blood

Other medical problems—The presence of other medical problems may affect the use of dofetilide. Make sure you tell your doctor if you have any other medical problems, especially:

• Electrolyte disorders, such as low potassium or magnesium levels or
• Heart rhythm problems—may cause irregular heartbeats
• Liver disease (severe)—Safety in this condition is unknown
• Kidney disease—Higher blood levels may occur, which may increase the chance of side effects. Your doctor may need to change your dose.

Proper Use of This Medicine

Patient information about dofetilide is available. Read this information carefully.

Use this medicine exactly as directed by your doctor . Do not use more or less of it, and do not use 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.

Dosing—The dose of dofetilide 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 dofetilide. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine.

• For oral dosage form (capsules):
  • For abnormal heart rhythm:
    • Adults—125 to 500 micrograms (mcg) two times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you do miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

• Keep out of the reach of children. Overdose of dofetilide is very dangerous in young children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.

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.

Other medicines: Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as Tagamet and Tagamet HB.

Side Effects of This Medicine

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 as soon as possible if any of the following side effects occur:

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