Generic equivalent of Dofetilide
3 SKUs available · Available to order · NABP accredited · DSCSA compliant
Dofetilide is the generic equivalent of the brand-name drug Dofetilide. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Dofetilide through Premier Pharma with same-day fulfillment on in-stock SKUs.
INDICATIONS AND USAGE Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some…
WARNINGS Ventricular Arrhythmia Dofetilide can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to dofetilide plasma concentration. Factors such as reduced creatinine clearance or certain dofetilide drug interactions will increase dofetilide plasma concentration. The risk of TdP can be reduced by controlling the plasma…
ADVERSE REACTIONS The dofetilide clinical program involved approximately 8,600 patients in 130 clinical studies of normal volunteers and patients with supraventricular and ventricular arrhythmias. Dofetilide was administered to 5,194 patients, including two large, placebo-controlled mortality trials (DIAMOND CHF and DIAMOND MI) in which 1,511 patients received dofetilide for up to three years. In the following section, adverse reaction data for cardiac arrhythmias and non-cardiac adverse reactio…
DOSAGE AND ADMINISTRATION Therapy with dofetilide capsules must be initiated (and, if necessary, re-initiated) in a setting that provides continuous electrocardiographic (ECG) monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias. Patients should continue to be monitored in this way for a minimum of three days. Additionally, patients should not be discharged within 12 hours of electrical or pharmacological conversion to normal sinus rhythm. The…
Information for Patients Please refer patient to the Medication Guide. Prior to initiation of dofetilide 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. The patient should be fully instructed on the need for compliance with the recommended dosing of dofetilide and the potential for drug interactions, and the need for periodic monitoring of QTc and renal function to minimize the risk of serious abnormal rhythms. Medications and Supplements Assessment of patients' medication history should in…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| DOFETILIDE 125MCG 60 CAP Accord Healthcare, Inc. | 2-Day |
| DOFETILIDE 250MCG 60 CAP Accord Healthcare, Inc. | 2-Day |
| DOFETILIDE 500MCG 60 CAP Accord Healthcare, Inc. | 2-Day |
Premier Pharma stocks 3 Dofetilide SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Dofetilide is the generic equivalent of Dofetilide. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Dofetilide in .125 mg/1, .25 mg/1, .5 mg/1 and CAPSULE. Available from manufacturers including Accord Healthcare, Inc..
Dofetilide carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
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