Dofetilide 0.125mg Capsule
Product Images NDC 70010-024

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide 0.125mg (NDC 70010-024). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Granules Pharmaceuticals 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.

FDA Label Image

Dofetilide-125label-jpg (Dofetilide 125label Jpg)

This is a description of Dofetilide Capsules with a dosage of 25 mcg (0.125 mg) per capsule. It includes instructions for pharmacists to dispense a Medication Guide to each patient, store the capsules in a child-resistant container, and protect them from moisture and humidity. The usual dosage information is provided in the prescribing information accompanying the product. The capsules contain 125 mcg (0.15 mg) of dofetilide USP and should be stored at 20° to 25°C (68° to 77°F). The medication is manufactured by Granules Pharmaceuticals Inc., located in Chantilly, VA. A lot number and expiration date are also mentioned in the text.*

FDA Label Image

Dofetilide-250label-jpg (Dofetilide 250label Jpg)

This is a description of a medication called Dofetilide in capsule form, with a strength of 250 mcg (0.25 mg) per capsule. The pharmacist is instructed to dispense each capsule with a Medication Guide to the patient. It is recommended to store the capsules in a child-resistant container, protect from moisture and humidity, and store at 20° to 25°C (68" to T7°F). The manufacturer is Granules Pharmaceuticals Inc.*

FDA Label Image

Dofetilide-500label-jpg (Dofetilide 500label Jpg)

This text provides important information about Dofetilide capsules, including the dosage, storage instructions, and manufacturer details. It also emphasizes the importance of dispensing the enclosed Medication Guide to each patient and storing the capsules in a tight, child-resistant container. The capsules contain 500 mcg of Dofetilide USP, and the usual dosage instructions are available in the accompanying prescribing information. It is important to protect the capsules from moisture and humidity and store them at a temperature between 20°C to 25°C (68°F to 77°F). This medication is available by prescription only.*

FDA Label Image

Dofetilide-figure1-jpg (Dofetilide Figure1 Jpg)

This text provides information on the mean change in QTc interval from baseline on Day 1 and Day 23 (steady state) in relation to the mean plasma concentration of Dofetilide (measured in ng/mL). This data can be used to assess the impact of Dofetilide on QTc interval over time and at steady state plasma levels.*

FDA Label Image

Dofetilide-figure2-jpg (Dofetilide Figure2 Jpg)

This text appears to be presenting information related to the change in QTc interval from the baseline, as well as the probability of maintaining normal sinus rhythm (NSR) at certain dose levels of Dofetilide. It includes data for different doses of Dofetilide, the QTc change at steady state, and the probability of remaining in NSR at 6 months. This information could be from a study or clinical trial assessing the effects of Dofetilide on cardiac parameters.*

FDA Label Image

Dofetilide-figure3-jpg (Dofetilide Figure3 Jpg)

FDA Label Image

Dofetilide-figure4-jpg (Dofetilide Figure4 Jpg)

This is a summary related to the probability of remaining in normal sinus rhythm (NSR) over a specified period of time. It includes p-values from Log Rank Test for different doses of a medication called Dofetilide. Time is also indicated in months on the graph provided.*

FDA Label Image

Dofetilide-flow-chart-jpg (Dofetilide Flow Chart Jpg)

This document provides guidance on managing patients taking dofetilide, a medication used to treat irregular heartbeats. It outlines the importance of monitoring the patient's QTc or QT intervals before and after administering the drug. It also discusses dose adjustments based on the patient's creatinine clearance levels. The text emphasizes the need for caution if certain conditions are met, such as a prolonged QT interval or a significant increase in QTc after administration. It ultimately advises discontinuing dofetilide if the QTc or QT interval exceeds 500 msec after the second dose.*

FDA Label Image

Dofetilide-structure-jpg (Dofetilide Structure Jpg)

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