TIKOSYN® Principal Display Panel (dofetilide) | Pfizer Medical Information

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0069-5800-60

Tikosyn®

(dofetilide) Capsules

125 mcg (0.125 mg)

60 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack

FOR INSTITUTION USE

Tikosyn®

(dofetilide) Capsule

125mcg (0.125mg)

PFIZER LABS
DIV. OF PFIZER INC, NY, NY 10017

LOT: XXXXXXX
EXP: YYYY MMM

PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0069-5800-43

Tikosyn®

(dofetilide) capsules

125 mcg (0.125 mg)

For in-institution use only

40 Capsules

Rx only
UNIT DOSE

PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0069-5810-60

Tikosyn®

(dofetilide) Capsules

250 mcg (0.25 mg)

60 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack

FOR INSTITUTION USE

Tikosyn®

(dofetilide) Capsule

250mcg (0.25mg)

PFIZER LABS
DIV. OF PFIZER INC, NY, NY 10017

LOT: XXXXXXX
EXP: YYYY MMM

PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0069-5810-43

Tikosyn®

(dofetilide) capsules

250 mcg (0.25 mg)

For in-institution use only

40 Capsules

Rx only
UNIT DOSE

PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0069-5820-60

Tikosyn®

(dofetilide) Capsules

500 mcg (0.5 mg)

60 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack

FOR INSTITUTION USE

Tikosyn®

(dofetilide) Capsule

500mcg (0.5mg)

PFIZER LABS
DIV. OF PFIZER INC, NY, NY 10017

LOT: XXXXXXX
EXP: YYYY MMM

PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack Carton

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0069-5820-43

Tikosyn®

(dofetilide) capsules

500 mcg (0.5 mg)

For in-institution use only

40 Capsules

Rx only
UNIT DOSE

PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack Carton

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

TIKOSYN® Quick Finder

Pfizer samples (for eligible HCPs)

Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com.
Report an adverse event or concern about the quality of a Pfizer product

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088.
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Resources

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To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac...

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INDICATIONS AND USAGE

Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence)

TIKOSYN is indicated for the maintenance of normal sinus rhythm (delay in time to...

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DOSAGE AND ADMINISTRATION

Therapy with TIKOSYN 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...

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CONTRAINDICATIONS

TIKOSYN is contraindicated in patients with congenital or acquired long QT syndromes. TIKOSYN should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients with...

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WARNINGS

Ventricular Arrhythmia

TIKOSYN (dofetilide) can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular...

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ADVERSE REACTIONS

The TIKOSYN clinical program involved approximately 8,600 patients in 130 clinical studies of normal volunteers and patients with supraventricular and ventricular arrhythmias. TIKOSYN was administered to 5,...

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OVERDOSAGE

There is no known antidote to TIKOSYN; treatment of overdose should therefore be symptomatic and supportive. The most prominent manifestation of overdosage is likely to be excessive prolongation of the QT interval...

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DESCRIPTION

TIKOSYN® (dofetilide) is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C19H...

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CLINICAL PHARMACOLOGY

Mechanism of Action

Dofetilide shows Vaughan Williams Class III antiarrhythmic activity. The mechanism of action is blockade of the cardiac ion...

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CLINICAL STUDIES

Chronic Atrial Fibrillation and/or Atrial Flutter

Two randomized, parallel, double-blind, placebo-controlled, dose-response trials evaluated the...

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HOW SUPPLIED

TIKOSYN 125 mcg (0.125 mg) capsules are supplied as No. 4 capsules with a light orange cap and white body, printed with TKN 125 PFIZER, and are available in:

TIKOSYN 250 mcg (0.25 mg) capsules are supplied...

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MEDICATION GUIDE

TIKOSYN® (Tee' ko sin)
(dofetilide) Capsules

Read the Medication Guide before you start taking TIKOSYN and each time you get a refill. This...

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Rx only

Logo

LAB-0067-10.0

Revised August 2019

...

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Resources

website

Tikosyn Website for Healthcare Professionals

Didn’t find what you were looking for? Contact us.

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Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985^*

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Medical Inquiry

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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.

TIKOSYN®Principal Display Panel (dofetilide)

PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack

PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack

PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack

PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack Carton

INDICATIONS AND USAGE

Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence)

DOSAGE AND ADMINISTRATION

CONTRAINDICATIONS

WARNINGS

Ventricular Arrhythmia

ADVERSE REACTIONS

OVERDOSAGE

DESCRIPTION

CLINICAL PHARMACOLOGY

Mechanism of Action

CLINICAL STUDIES

Chronic Atrial Fibrillation and/or Atrial Flutter

HOW SUPPLIED

MEDICATION GUIDE

Resources

TIKOSYN^®Principal Display Panel (dofetilide)