It is not known if TIKOSYN will harm your unborn baby.

Although no study specifically investigated this risk, in post-hoc analyses, no increased mortality was observed in females on TIKOSYN compared to females on placebo. Pfizer will ensure that healthcare providers who prescribe Tikosyn (Prescribers) are specially certified. There were no cases of TdP on placebo. Treatment of Torsade de Pointes or overdose may include administration of isoproterenol infusion, with or without cardiac pacing. For more information, ask your doctor or pharmacist. TIKOSYN should be used with particular caution in these patients.Animal and human studies have not shown any adverse effects of dofetilide on conduction velocity. For detailed instructions regarding dose selection, see CLINICAL PHARMACOLOGY and Dose-Response and Concentration Response for Increase in QT IntervalTable 4: Summary of Torsade de Pointes in Patients Randomized to Dofetilide by Dose; Patients with Supraventricular ArrhythmiasTable 5: Incidence of Torsade de Pointes Before and After Introduction of Dosing According to Renal FunctionPrior to initiation of TIKOSYN therapy, the patient should be advised to read the Medication Guide and reread it each time therapy is renewed in case the patient's status has changed. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm.

The trials did not demonstrate a reduction in mortality; however, they provide reassurance that, when initiated carefully, in a hospital or equivalent setting, TIKOSYN did not increase mortality in patients with structural heart disease, an important finding because other antiarrhythmics [notably the Class IC antiarrhythmics studied in the Cardiac Arrhythmia Suppression Trial (CAST) and a pure Class III antiarrhythmic, d-sotalol (SWORD)] have increased mortality in post-infarction populations. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. If you … As shown in Table 5, the rate of TdP was reduced when patients were dosed according to their renal function (see The majority of the episodes of TdP occurred within the first three days of TIKOSYN therapy (10/11 events in the studies of patients with supraventricular arrhythmias; 19/25 and 4/7 events in DIAMOND CHF and DIAMOND MI, respectively; 2/4 events in the DIAMOND AF subpopulation).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. Such drugs include phenothiazines, cisapride, bepridil, tricyclic antidepressants, certain oral macrolides, and certain fluoroquinolones. The next dose should be taken at the usual time.Dofetilide is eliminated in the kidney by cationic secretion. If renal function deteriorates, adjust dose as described in The dosing algorithm shown above should be used to determine the individualized dose of TIKOSYN. No clinically relevant effects were noted in serum alkaline phosphatase, serum GGT, LDH, AST, ALT, total bilirubin, total protein, blood urea nitrogen, creatinine, serum electrolytes (calcium, chloride, glucose, magnesium, potassium, sodium), or creatine kinase.

You and your doctor should decide if you will … See "What is the most important information I should know about TIKOSYN? In normal female volunteers, hormone replacement therapy (a combination of conjugated estrogens and medroxyprogesterone) did not increase dofetilide exposure.Increase in QT interval is directly related to dofetilide dose and plasma concentration.

The increase in QT interval observed on the surface ECG is a result of prolongation of both effective and functional refractory periods in the His-Purkinje system and the ventricles.Dofetilide did not influence cardiac conduction velocity and sinus node function in a variety of studies in patients with or without structural heart disease. Dofetilide does not increase the electrical energy required to convert electrically induced ventricular fibrillation, and it significantly reduces the defibrillation threshold in patients with ventricular tachycardia and ventricular fibrillation undergoing implantation of a cardioverter-defibrillator device.In hemodynamic studies, dofetilide had no effect on cardiac output, cardiac index, stroke volume index, or systemic vascular resistance in patients with ventricular tachycardia, mild to moderate congestive heart failure or angina, and either normal or low left ventricular ejection fraction.

As shown, both the probability of a patient's remaining in sinus rhythm at six months and the change in QTc from baseline at steady state of dosing increased in an approximately linear fashion with increasing dose of TIKOSYN. TIKOSYN and other medicines may affect each other, causing serious side effects. No overall differences in safety, effect on QTc, or effectiveness were observed between elderly and younger patients. A total of 8.7% of patients in the dofetilide groups were discontinued from clinical trials due to adverse events compared to 8.0% in the placebo groups. There was no increase in heart failure in patients with significant left ventricular dysfunction (see The oral bioavailability of dofetilide is >90%, with maximal plasma concentrations occurring at about 2–3 hours in the fasted state. DOFETILIDE. Placebo (Study 1)Figure 4: Maintenance of Normal Sinus Rhythm, TIKOSYN Regimen vs. Patients should be advised not to breast-feed an infant if they are taking TIKOSYN.Of the total number of patients in clinical studies of TIKOSYN, 46% were 65 to 89 years old. One study was in patients with moderate to severe (60% NYHA Class III or IV) congestive heart failure (DIAMOND CHF) and the other was in patients with recent myocardial infarction (DIAMOND MI) (of whom 40% had NYHA Class III or IV heart failure). Factors such as reduced creatinine clearance or certain dofetilide drug interactions will increase dofetilide plasma concentration.

The studies examined the effectiveness of TIKOSYN in conversion to sinus rhythm and maintenance of normal sinus rhythm after conversion in patients with atrial fibrillation/flutter of >1 week duration. A message has been sent to your recipient's email address with a link to the content webpage. Class I or Class III antiarrhythmic agents should be withheld for at least three half-lives prior to dosing with TIKOSYN. As with other drugs that cause Torsade de Pointes, TIKOSYN was associated with a greater risk of Torsade de Pointes in female patients than in male patients.