Tikosyn
Product Images NDC 69189-5820

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tikosyn (NDC 69189-5820). 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 0.5 mg Capsule (6918958201)

Packaging label for Tikosyn 0.5 mg capsule containing dofetilide, manufactured by Pfizer. The label includes manufacturing and hospital lot numbers, an expiration date of 03/28/2017, and the NDC number 69189-5820-1. Labeler is Avera McKennan Hospital, Sioux Falls, SD.*

FDA Label Image

Chemical Structure (Tikosyn 01)

Chemical structure diagram of the active ingredient in Tikosyn, illustrating the molecular arrangement with labeled functional groups including sulfonamide and ether. The diagram shows atoms and bonds representing the chemical composition of the drug ingredient.*

FDA Label Image

Figure 1 (Tikosyn 02)

A scatter plot graph showing the mean change from baseline QTc (milliseconds) on the y-axis against mean plasma dofetilide concentration (ng/mL) on the x-axis. Data points are differentiated between Day 1 (open squares) and Day 23 steady state (solid diamonds) with two trend lines representing these two time points.*

FDA Label Image

Figure 2 (Tikosyn 03)

A bar and scatter plot chart showing 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. The x-axis compares placebo and dofetilide dosages of 125 mcg BID, 250 mcg BID, and 500 mcg BID. QTc change values are shown with 95% confidence intervals, along with probability of NSR at 6 months.*

FDA Label Image

Figure 3 (Tikosyn 04)

A Kaplan-Meier survival curve chart showing the probability of remaining in NSR (normal sinus rhythm) over time in months up to 12 months. The chart compares four groups: placebo, and three doses of Dofetilide (125 mcg BID, 250 mcg BID, and 500 mcg BID), with higher doses showing higher probabilities of remaining in NSR. A p-value Log Rank Test summary is included, indicating statistical significance at the 500 mcg dose level.*

FDA Label Image

Figure 4 (Tikosyn 05)

A Kaplan-Meier survival curve chart showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for patients taking different doses of Dofetilide (125 mcg, 250 mcg, 500 mcg twice daily) compared to placebo. The chart includes p-values from a log-rank test assessing statistical significance of differences between treatment groups.*

FDA Label Image

Flow Chart (Tikosyn 06)

Flowchart illustrating dosing and monitoring guidelines for Tikosyn (dofetilide). It includes instructions to check baseline QTc, calculate creatinine clearance for dosage adjustment, contraindications based on renal function, dose recommendations based on clearance levels, and guidance for post-dose QTc monitoring and dose adjustments.*

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.