Flecainide use in specific populations
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Drug Interactions
Pregnancy. Pregnancy Category C. Flecainide has been shown to have teratogenic effects (club paws, sternebrae and vertebrae abnormalities, pale hearts with contracted ventricular septum) and an embryotoxic effect (increased resorptions) in one breed of rabbit (New Zealand White) when given doses of 30 and 35 mg/kg/day, but not in another breed of rabbit (Dutch Belted) when given doses up to 30 mg/kg/day. No teratogenic effects were observed in rats and mice given doses up to 50 and 80 mg/kg/day, respectively; however, delayed sternebral and vertebral ossification was observed at the high dose in rats. Because there are no adequate and well-controlled studies in pregnant women, flecainide acetate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery. It is not known whether the use of flecainide acetate during labor or delivery has immediate or delayed adverse effects on the mother or fetus, affects the duration of labor or delivery, or increases the possibility of forceps delivery or other obstetrical intervention.
Nursing Mothers. Results from a multiple dose study conducted in mothers soon after delivery indicates that flecainide is excreted in human breast milk in concentrations as high as 4 times (with average levels about 2.5 times) corresponding plasma levels; assuming a maternal plasma level at the top of the therapeutic range (1 mcg/mL), the calculated daily dose to a nursing infant (assuming about 700 mL breast milk over 24 hours) would be less than 3 mg.
Pediatric Use. The safety and efficacy of flecainide acetate in the fetus, infant, or child have not been established in double-blind, randomized, placebo-controlled trials (seeCLINICAL PHARMACOLOGY,WARNINGS, and DOSAGE AND ADMINISTRATION).
Hepatic Impairment. Since flecainide elimination from plasma can be markedly slower in patients with significant hepatic impairment, flecainide acetate should not be used in such patients unless the potential benefits clearly outweigh the risks. If used, frequent and early plasma level monitoring is required to guide dosage (see DOSAGE AND ADMINISTRATION, Plasma Level Monitoring); dosage increases should be made very cautiously when plasma levels have plateaued (after more than four days).[1]
References
- ↑ "FLECAINIDE ACETATE TABLET [APOTEX CORP.]". Retrieved 11 March 2014.