TIKOSYN is a medicine for highly symptomatic atrial fibrillation (irregular heartbeats). TIKOSYN may help your heart beat more regularly and stay beating regularly for a longer period of time.1
TIKOSYN has been in clinical use for more than 10 years.2
*Intended for Prescribers, Pharmacies, and Institutions.
Important Safety Information
To decrease the chance of your getting a different type of dangerous abnormal heartbeat, TIKOSYN treatment must be started or re-started while you are in the hospital. The doctor who prescribed TIKOSYN and the hospital must have gone through special TIKOSYN training. Feeling faint, dizziness/lightheadedness, or having fast heartbeats are symptoms of this abnormal heartbeat. Call your doctor or emergency room as soon as possible if you have any of these symptoms.
While in the hospital, your kidney function and heart rhythm will be monitored for a minimum of 3 days. This helps the doctor to choose the right TIKOSYN dose for you. Only doctors who have gone through TIKOSYN training will be able to prescribe or refill your TIKOSYN prescription.
Do not take TIKOSYN if you are taking certain other medicines, including cimetidine (TAGAMET®, TAGAMET HB®)† or verapamil (CALAN®, CALAN SR®, COVERA-HS®, ISOPTIN®, ISOPTIN SR®, VERELAN®, VERELAN PM®)† or ketoconazole (NIZORAL®)† or trimethoprim alone (PROLOPRIM®, TRIMPEX®)† or the combination of trimethoprim and sulfamethoxazole (BACTRIM™, SEPTRA®)† or prochlorperazine (COMPAZINE®)† or megestrol (MEGACE®)† or hydrochlorothiazide alone or in combination with other medicines (such as ESIDRIX®, EZIDE®, HYDRODIURIL®, HYDRO-PAR®, MICROZIDE®, or ORETIC®)†; have serious kidney problems or are on kidney dialysis; or have congenital or acquired long QT syndrome (a disorder of the heartbeat which may be present from birth, or it may be acquired as a result of certain medical conditions or from taking certain medications. People with long QT syndrome may have symptoms including an unusually rapid heartbeat, fainting, and seizures; however, some people with long QT syndrome do not have any of these symptoms. Sudden cardiac death may also result from long QT syndrome).
The most common side effects of TIKOSYN are headache, chest pain, and dizziness. TIKOSYN can also cause other side effects. If you are concerned about these or any other side effects, ask your doctor.
†Listed trademarks are the property of their respective owners.
Indication
TIKOSYN is a medicine that is given to patients with highly symptomatic atrial fibrillation or atrial flutter (irregular heartbeats). Atrial fibrillation or atrial flutter happens when certain parts of the heart (the chambers known as atria) beat too fast or irregularly. When this happens, your heart cannot pump blood through your body as well as it should. This may make you feel weak and tired, or get out of breath easily. You may get an uncomfortable feeling in your chest and "fluttering" or "palpitations." Atrial fibrillation and atrial flutter can be changed back (converted) to normal heart rhythm by an electric shock or by using certain medicines. However, atrial fibrillation and atrial flutter can return. TIKOSYN may help your heart to beat more regularly and stay beating regularly for a longer period of time.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Please see full Prescribing Information and Medication Guide.
REFERENCES
1. Tikosyn [prescribing information]. New York, NY: Pfizer Inc; 2006.
2. Drug Details. Drugs@FDA Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed February 3, 2011.
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