Dofetilide
Product Images NDC 84280-5250

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 84280-5250). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by The Janz Corporation, 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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Gualt-eq (Dofetilide Capsules Gault Eq)

This text provides guidance on the management of patients receiving dofetilide therapy based on criteria such as baseline QTc/QT interval, creatinine clearance (Clcr), and post-dose QTc/QT measurements. It includes instructions on when to administer, adjust, or discontinue dofetilide based on these parameters. The text outlines dosage recommendations for different Clcr levels and advises on how to monitor and respond to changes in QTc/QT intervals post-dose. This information aims to assist healthcare providers in safe and effective dofetilide administration in patients.*

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Fig01 (Dofetilide Figure 01)

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Fig02 (Dofetilide Figure 02)

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Fig-03 (Dofetilide Figure 03)

This text includes information related to a Falve Log Rark Test for different dosages over a period of time (in months) to determine the probability of remaining in NSR (Normal Sinus Rhythm). The probabilities of maintaining NSR with different dosages (125 mg BID, 250 mg QD, and 50 mg QD) are provided as p=0.21, p=0.10, and p=0.001 respectively.*

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Fig-04 (Dofetilide Figure 04)

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Image Description (Image 125 Mcg Cap)

This is a description of Dofetilide Capsules containing 125 mcg (0 mg) in a pack of 60 capsules. The usual dosage information is provided in the prescribing information accompanying the product. It is advised to store the capsules at a temperature range of 15° to 30° C (59° to 86° F) and protect them from moisture and humidity. The capsules should be dispensed in tight, child-resistant containers. The medication is manufactured for JANZ Corporation by HISN Laboratories Private Limited in Telangana, India, and distributed by Novadoz Pharmaceuticals LLC. The Rx Only medication guide is available at the mentioned website.*

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Image Description (Image 250 Mcg Cap)

This is a description for Dofetilide Capsules. Each bottle contains 250 micrograms (1 milligram) of Dofetilide in 60 capsules. The usual dosage is specified in the accompanying prescribing information. Store the capsules at a temperature between 15°C to 30°C (59°F to 86°F) to prevent deterioration. It is recommended to dispense the capsules in tight, child-resistant containers to protect them from moisture. This medication is distributed by Novadoz Pharmaceuticals LLC and comes with a Medication Guide for each patient.*

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Image Description (Image 500 Mcg Cap)

Each capsule contains 500 mg. 60 Capsules NDC 84280-5500-60. Usual Dosage: See accompanying prescribing information. Store at 15°C to 30°C (59°F to 86°F) Dofetilide Capsules 500 mcg (0.5 g) Dispense in tight (USP), child-resistant containers. Dispense the accompanying Medication Guide to each patient. Distributed by: Indore, India. Available at Novadoz.*

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Struct (Structure)

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