Chemstructure00001
Dofetilide Capsule
Product Images NDC 69452-131
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Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 69452-131). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Bionpharma Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Graph00005
The text provides instructions related to administering dofetilide, a medication used for heart arrhythmias. It outlines the importance of placing the patient on telemetry and checking their baseline QTc or QT. However, it warns against using dofetiide for a patient with a QTc <440 msec. The text offers guidelines for dosing based on the patient's Calculated Creatinine Clearance (Cler) and cautions against giving dofetiide if the Cler is <20 mI/min. Post-Dose adjustment guidelines are provided based on the percentage of increase in QTc or QT after the second dose. The text instructs to discontinue dofetilide if at any point after the second dose QTc or QT increases >500 msec.*
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Graph0004
This appears to be a graph or chart showing the probability of remaining in normal sinus rhythm (NSR) over time for different dosages of a medication called Dofet. The dosage levels are listed as 125 mcg, 250 mcg, and 500 mcg, taken twice a day (BID). There is also a line indicating the p-values obtained from a Log Rank Test. However, without additional context, it is difficult to determine the specific purpose or implications of this information.*
Figure 1 (Graph001)
The text describes the mean change in QTc from baseline, measured in millisecond (msec), and the mean plasma concentration of Dofetilide (measured in ng/mL) on Day 1 and Day 23 (Steady State) during a study. No further information is available.*
Figure 2 (Graph002)
This appears to be a table displaying QTc (a measurement of heart rate) changes from baseline at steady state for different doses of dofetilide medication and a placebo. The table also includes the probability of remaining in normal sinus rhythm (NSR) at 6 months for each dose. There is no information available about the study's purpose, sample size, or other research data.*
125 Mcg (0.125 mg) 60's Label (Image0001v1)
The text cannot be evaluated as it consists of random and unrelated characters and texts.*
250 Mcg (0.25 mg) 60's Label (Image0002v1)
BronPHARMA dispenses 60 capsules of Dofetilide, each containing 250 mcg (0.25 mg) as a treatment for abnormal heart rhythms. The NDC code is 69452-132.17.*
500 Mcg (0.5 mg) 60's Label (Image0003v1)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
