Dofetilide Capsule
Product Images NDC 0904-7523

This text provides details about Dofetilide capsules in 500 mcg dosage. It includes the NDC number, quantity, storage instructions, dosage information, and manufacturer details. The medication guide is advised for dispense with the product. The capsules are intended for institutional use and not child-resistant.*

This text describes a medication called Dofetilide in capsule form, with each capsule containing 250 mcg (0.250 mg) of the active ingredient. The medication guide should be dispensed with this product. The usual dosage information is available in the product insert, along with prescribing details, precautions, and warnings. It is recommended to store the capsules at a temperature between 20°C to 25°C (68°F to 77°F) and protect them from moisture and humidity. The packaging is not child-resistant and intended for institutional use only. The drug product is from NDC 475907085, Dr. Foley's Laboratories Inc., and it is packaged and distributed by Major Pharmaceuticals in the USA.*

This text provides information about Dofetilide capsules in a unit dose format. The capsules contain 125 mcg (0.125 mg) each. It mentions storing instructions, dosage details, and guidance on protecting the medication from moisture and humidity. The packaging contains 40 capsules in total. The product is intended for institutional use only. It advises keeping the drugs out of the reach of children and dispense in a child-resistant container. It also includes important information about the manufacturer Major Pharmaceuticals.*

This is a table showing the mean change from baseline QTc in milliseconds at different mean plasma dofetilide concentrations in ng/mL. This data may be used to evaluate the relationship between dofetilide concentration and QTc prolongation.*

This text appears to contain information related to a study or experiment. It includes details about different dosages of a drug (BID Dofetilide) administered and their corresponding p-values from a Log Rank test. The dosages mentioned are 125 mg, 250 mg, and 500 mg BID Dofetilide, along with a placebo group. The text also includes a graph or data representation showing the time in months.*

This description provides data on the survival rates of participants in a study over a period of 12 months under different doses of medication (125mg, 250mg, and 500mg taken twice daily). A p-value log rank test was conducted to assess the significance of the results, revealing p-values of 0.006 for 125mg, and below 0.001 for 250mg and 500mg. The data suggests that higher doses may be associated with better outcomes in terms of survival rates over time.*

This text provides guidelines for the use of dofetilide in patients, focusing on monitoring parameters such as baseline QTc or QT interval, calculating creatinine clearance for dosage adjustment, and managing dose adjustments based on QT interval changes. It emphasizes contraindications, dosing regimens based on creatinine clearance levels, and recommendations for dose adjustments. The text also specifies when to discontinue dofetilide in case of significant QT interval prolongation.*