Cordarone tablet use in specific populations
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Use in Specific Populations
Pregnancy: Pregnancy Category D
See "WARNINGS, Neonatal Hypo- or Hyperthyroidism".
Labor and Delivery
It is not known whether the use of Cordarone during labor or delivery has any immediate or delayed adverse effects. Preclinical studies in rodents have not shown any effect of Cordarone on the duration of gestation or on parturition.
Nursing Mothers
Cordarone and one of its major metabolites, desethylamiodarone (DEA), are excreted in human milk, suggesting that breast-feeding could expose the nursing infant to a significant dose of the drug. Nursing offspring of lactating rats administered Cordarone have been shown to be less viable and have reduced body-weight gains. Therefore, when Cordarone therapy is indicated, the mother should be advised to discontinue nursing.
Pediatric Use
The safety and effectiveness of Cordarone Tablets in pediatric patients have not been established.
Geriatric Use
Clinical studies of Cordarone Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.[1]
References
Adapted from the FDA Package Insert.