TIKOSYN

Drug Name: TIKOSYN

TIKOSYN DESCRIPTION:
DOFETILIDE - ORAL (doh-FET-ill-ide)

COMMON TIKOSYN BRAND NAME(S):
Tikosyn

TIKOSYN SIDE EFFECTS:
Nausea or headache may occur. If these effects persist or worsen, notify your doctor. Tell your doctor immediately if you have any of these unlikely but serious side effects: dizziness, fainting, unusually fast/slow/irregular pulse. Mineral imbalances can increase the risk of developing drug side effects. Tell your doctor immediately if you have symptoms indicating a possible mineral imbalance such as: muscle cramps or weakness, prolonged diarrhea, excessive thirst or sweating, vomiting, loss of appetite. If you notice other effects not listed above, contact your doctor or pharmacist.

HOW TO USE TIKOSYN:
TIKOSYN: TIKOSYN is taken by mouth as directed. When your dosage of dofetilide is started, restarted, or increased you will be monitored in a hospital (e.g., EKG and kidney function tests, and observation). This special monitoring will minimize the chances of developing serious side effects. Your dofetilide dosage is based on your medical condition (including heart and kidney function) and response to therapy. It is very important to continue taking TIKOSYN exactly as prescribed by your doctor. Taken improperly, or without proper monitoring, TIKOSYN can build up in your bloodstream and may actually cause new, very serious irregular heartbeats. Do not eat grapefruit or drink grapefruit juice unless your doctor instructs you otherwise.

TIKOSYN WARNING:
TIKOSYN may sometimes produce new, irregular heartbeats (arrhythmias). It is recommended you stay in the hospital for 3 days where proper monitoring (e.g., renal function, EKG) and support (cardiac resuscitation) is available until your body adjusts to the effects of TIKOSYN. Consult your doctor or pharmacist for more information.

TIKOSYN USES:
TIKOSYN is used to treat irregular heartbeats (symptomatic atrial fibrillation/flutter arrhythmias). It is used to restore normal heart rhythm, and also to maintain regular, steady heartbeats.

TIKOSYN PRECAUTIONS:
Tell your doctor your medical history, including any heart (e.g., prolonged QT interval) or kidney disease, liver disease, low blood potassium or magnesium, or any allergies. Caution is advised when using TIKOSYN in the elderly, as they may have decreased kidney function. This may result in more side effects as dofetilide builds up in the bloodstream. Caution is advised when using TIKOSYN in females since they may be more sensitive to certain side effects (e.g., serious arrhythmias known as torsade de pointes). TIKOSYN should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether TIKOSYN passes into breast milk. Because of the potential risk to the infant, breast-feeding while using TIKOSYN is not recommended. Consult your doctor before breast-feeding.

TIKOSYN DRUG INTERACTIONS:
Tell your doctor of all prescription and nonprescription medication you may use, especially drugs that interfere with kidney action (cation transport inhibitors, including prochlorperazine, megestrol, cimetidine, ketoconazole, and drugs containing trimethoprim); drugs affecting the heart (QT prolongation) such as quinidine, procainamide, sotalol, bepridil, certain antipsychotics (e.g., chlorpromazine); "water pills" (diuretics such as furosemide), also amiloride or triamterene. Also report use of verapamil, diltiazem, metformin; azole antifungals (e.g., itraconazole); macrolide antibiotics (e.g., clarithromycin); protease inhibitors (e.g., ritonavir); quinine, zafirlukast, dronabinol, norfloxacin; or antidepressants (nefazodone, and SSRI-types such as fluoxetine). Certain other drugs for irregular heartbeats (Class I or III antiarrhythmic agents, including amiodarone) should be stopped for a period of time before starting dofetilide. Consult your doctor. If your doctor stops your dofetilide treatment in order to more safely prescribe an interacting drug, wait 2 days before starting the new drug, unless instructed otherwise. This allows the dofetilide to be removed from your bloodstream. Consult your doctor or pharmacist for more details. Do not start or stop any medicine without doctor or pharmacist approval.

TIKOSYN OVERDOSE:
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include fast or irregular heartbeat, fainting, and loss of consciousness.

TIKOSYN NOTES:
Do not share TIKOSYN with others. Laboratory and/or medical tests (e.g., EKG and kidney function) will be performed to monitor your progress.

MISSED TIKOSYN DOSE:
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

TIKOSYN STORAGE:
Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from light and moisture. Your condition can cause complications in a medical emergency. For information on enrollment call Medic Alert (TM) at 1-800-854- 1166. In Canada call 1-800-668-1507.