Dofetilide Capsule
Product Images NDC 59651-118

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 59651-118). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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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Figure 1: Mean Qtc-concentration Relation Ship In Young Volunteers Over 24 Days (Dofetilide Fig1)

A scatter plot titled 'Mean QTc-Concentration Relationship in Young Volunteers Over 24 Days' showing data points for Day 1 and Day 23 (Steady State). The x-axis represents mean plasma dofetilide concentration (ng/mL) ranging from 0 to 7, and the y-axis represents mean change from baseline QTc (msec) ranging from -10 to 80. The graph depicts a positive correlation between plasma concentration and QTc change over time, with distinct trend lines for Day 1 and Day 23.*

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Figure 2: Relationship Between Dofetilide Dose, Qtc Increase And Maintenance Of Nsr (Dofetilide Fig2)

A bar and scatter plot chart showing QTc change from baseline at steady state with 95% confidence intervals and the probability of remaining in NSR (normal sinus rhythm) at 6 months for placebo and three doses of Dofetilide capsules (125 mcg BID, 250 mcg BID, 500 mcg BID). The chart compares the effects across different treatment groups.*

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Figure 3: Maintenance Of Normal Sinus Rhythm, Dofetilide Regimen Vs. Placebo (study 1) (Dofetilide Fig3)

A Kaplan-Meier survival curve showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for four groups: placebo and Dofetilide at doses of 125 mcg BID, 250 mcg BID, and 500 mcg BID. The graph includes p-values from a Log Rank Test comparing each Dofetilide group to placebo.*

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Figure 4: Maintenance Of Normal Sinus Rhythm, Dofetilide Regimen Vs. Placebo (study 2) (Dofetilide Fig4)

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

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Figure 5 (Dofetilide Fig5)

A flowchart illustrating the monitoring and dosing protocol for oral Dofetilide capsules. It includes steps for patient telemetry placement, baseline QTc/QT assessment, creatinine clearance calculation for dose adjustment, contraindications based on clearance levels, dosing recommendations for different clearance ranges, post-dose QTc/QT monitoring, and criteria for dose continuation, reduction, or discontinuation.*

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Dofetilide-fig6 (Dofetilide Fig6)

Dofetilide Capsules 0.125 mg (125 mcg) oral dose packaging label from Aurobindo Pharma Limited. The label includes dosage strength, quantity of 60 capsules, NDC 59651-118-60, storage instructions, and distributor information for Aurobindo Pharma USA, Inc. Barcode and coding area are present on the right side.*

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Dofetilide-fig7 (Dofetilide Fig7)

Dofetilide Capsules 250 mcg (0.25 mg) oral capsules packaging label by Aurobindo Pharma Limited. The label states prescription use, active ingredient strength, dispensing instructions, storage conditions (20° to 25°C), and protection from moisture and humidity. It also includes distributor information for Aurobindo Pharma USA, Inc., barcode, and package quantity of 60 capsules.*

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Dofetilide-fig8 (Dofetilide Fig8)

Label for Dofetilide Capsules 500 mcg (0.5 mg) by Aurobindo Pharma Limited. The label indicates the product contains 60 capsules, with each capsule containing 0.5 mg dofetilide. It includes storage instructions and a barcode, distributed by Aurobindo Pharma USA, Inc. The label is marked Rx only and advises pharmacists to dispense with a Medication Guide.*

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Chemcial Structure (Dofetilide Str)

Chemical structure of the active ingredient dofetilide, showing its molecular arrangement with aromatic rings and functional groups as depicted in the image.*

* 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.