Tikosyn
Product Images NDC 69189-5810

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tikosyn (NDC 69189-5810). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avera Mckennan Hospital, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Dofetilide 0.25 mg Capsule (6918958101)

Tikosyn 250 mcg (0.25 mg) capsule packaging label showing dofetilide as the active ingredient. The label includes manufacturer information as Pfizer, hospital lot number APF100320Z, expiration date 07/29/2017, and the NDC number 69189-5810. Labeler is Avera McKennan in Sioux Falls.*

FDA Label Image

Chemical Structure (Tikosyn 01)

Chemical structure diagram of the active ingredient in Tikosyn, showing the molecular arrangement and functional groups present in the compound.*

FDA Label Image

Figure 1 (Tikosyn 02)

A scatter plot graph illustrating the mean change from baseline QTc (msec) versus mean plasma dofetilide concentration (ng/mL) for Tikosyn. Data points are shown for Day 1 and Day 23 (steady state) with separate trend lines for each time point, depicting the relationship between dofetilide concentration in plasma and QTc interval changes.*

FDA Label Image

Figure 2 (Tikosyn 03)

A bar and dot chart comparing the QTc change from baseline at steady state (msec) on the left y-axis and probability of remaining in NSR at 6 months (%) on the right y-axis for Placebo and three Dofetilide doses (125 mcg BID, 250 mcg BID, 500 mcg BID). The chart includes 95% confidence intervals for QTc change and NSR probability, showing an increase in both QTc change and NSR probability with higher Dofetilide doses.*

FDA Label Image

Figure 3 (Tikosyn 04)

A Kaplan-Meier curve chart showing the probability of remaining in NSR (normal sinus rhythm) over 12 months according to different doses of Dofetilide (125 mcg BID, 250 mcg BID, 500 mcg BID) versus placebo. The graph includes a p-value log rank test summary for each dose compared to placebo.*

FDA Label Image

Figure 4 (Tikosyn 05)

A survival curve chart showing the probability of remaining in NSR (normal sinus rhythm) over 12 months. The graph compares four groups: placebo and dofetilide at doses of 125 mcg, 250 mcg, and 500 mcg twice daily (BID). Each group exhibits a distinct curve with statistical significance values noted (p-values) for each dofetilide dose versus placebo based on a log rank test.*

FDA Label Image

Flow Chart (Tikosyn 06)

An instruction flowchart for Tikosyn (dofetilide) dosing and monitoring. It outlines telemetry placement, baseline QTc evaluation, creatinine clearance calculation for dose adjustment, contraindication if clearance is under 20 mL/min, specific dose recommendations based on clearance ranges, and guidance for post-dose QTc monitoring and dose adjustments or discontinuation.*

FDA Label Image

Logo (Tikosyn 07)

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.