Sotalol tablet use in specific populations: Difference between revisions
Gerald Chi (talk | contribs) mNo edit summary |
Gerald Chi (talk | contribs) mNo edit summary |
||
| Line 14: | Line 14: | ||
Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Because of the potential for adverse reactions in nursing infants from Betapace, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. | Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Because of the potential for adverse reactions in nursing infants from Betapace, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. | ||
====Pediatric Use==== | ====Pediatric Use==== | ||
Revision as of 06:01, 10 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Use in Specific Populations
Reproduction studies in rats and rabbits during organogenesis at 100 and 22 times the MRHD as mg/kg (9 and 7 times the MRHD as mg/m2), respectively, did not reveal any teratogenic potential associated with sotalol HCl. In rabbits, a high dose of sotalol HCl (160 mg/kg/day) at 16 times the MRHD as mg/kg (6 times the MRHD as mg/m2) produced a slight increase in fetal death likely due to maternal toxicity. Eight times the maximum dose (80 mg/kg/day or 3 times the MRHD as mg/m2) did not result in an increased incidence of fetal deaths. In rats, 1000 mg/kg/day sotalol HCl, 100 times the MRHD (18 times the MRHD as mg/m2), increased the number of early resorptions, while at 14 times the maximum dose (2.5 times the MRHD as mg/m2), no increase in early resorptions was noted. However, animal reproduction studies are not always predictive of human response.
Although there are no adequate and well-controlled studies in pregnant women, sotalol HCl has been shown to cross the placenta, and is found in amniotic fluid. There has been a report of subnormal birth weight with Betapace. Therefore, Betapace should be used during pregnancy only if the potential benefit outweighs the potential risk.
Nursing Mothers
Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Because of the potential for adverse reactions in nursing infants from Betapace, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of Betapace in children have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old (see CLINICAL PHARMACOLOGY).[1]
References
Adapted from the FDA Package Insert.