Tikosyn
Product Images NDC 69189-5800

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tikosyn (NDC 69189-5800). 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.

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Dofetilide 0.125 mg Capsule (6918958001)

DOFETILIDE, also known as TIKOSYN, is a medication manufactured by PFIZER available in 0.125 MG capsules. The lot number for the manufacturing is N30313, and the lot number assigned by the hospital is APF16F28-AL. The expiration date of this medication is 06/28/2017. The National Drug Code assigned for this medication is 6918958001. This medication is associated with AVERA MCKENNAN hospital.*

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Chemical Structure (Tikosyn 01)

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Figure 1 (Tikosyn 02)

This is a table displaying the mean change from baseline in QTc (in milliseconds) on both day 1 and day 23 (steady state) with varying mean plasma dofetilide concentrations (in ng/mL).*

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Figure 2 (Tikosyn 03)

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Figure 3 (Tikosyn 04)

This appears to be a table of data, with three different dosage levels of a medication (125 BID Dofetide, 250 BID Dofetide, and 500 BID Dofetide) and corresponding p-values from a Log Rank Test with Placebo. The data includes a footnote indicating that "T" represents "Treatment" and "o" represents "Events" (the number of occurrences being measured). The table also has a time axis in months. Without additional context it is unclear what the medication is used for or the purpose of the study.*

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Figure 4 (Tikosyn 05)

This appears to be a chart or table showing different doses of a medication called Dofetilide being administered at different frequencies (BID = twice a day) and their corresponding p-values (statistical significance) in relation to a placebo. The time axis at the bottom indicates that the study or analysis was conducted for a period of 12 months. However, without further context or information, the purpose and interpretation of the chart/table is not clear.*

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Flow Chart (Tikosyn 06)

This is a medication guideline that provides instructions on the use of Dofetilide in patients with a predetermined creatinine clearance (Clcr) level. It advises against the use of Dofetilide if the Clcr is below 20mL/min and provides dosage amounts for various Clcr ranges. The text also recommends monitoring the patient's QT interval and discontinuing the medication if the QT interval increases by 500 msec or more.*

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Logo (Tikosyn 07)

This text provides information about the distributor of a product manufactured by Pfizer Labs. The name of the distributor is Pfizer Inc and it is located in NY, NY 10017.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.