Sotalol injection use in specific populations: Difference between revisions
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== | ==Use in Specific Populations== | ||
====8.1 Pregnancy==== | |||
{{pcat}} '''B''' | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SOTALOL HYDROCHLORIDE INJECTION [BIONICHE PHARMA USA LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2afe7385-2441-4e22-b63e-ab8614b275df | publisher = | date = | accessdate = }}</ref> | There are no adequate and well-controlled studies in pregnant women. Sotalol crosses the placenta. In animal studies there was no increase in congenital anomalies, but an increase in early resorptions occurred at sotalol doses 18 times the maximum recommended human dose (MRHD, based on body surface area). Because, animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. | ||
Reproduction studies in rats and rabbits during organogenesis at sotalol doses 9 and 7 times the MRHD (based on body surface area), respectively, did not reveal any increase in congenital abnormalities. In rabbits, a sotalol dose 6 times the MRHD produced a slight increase in fetal death, but this was associated with maternal toxicity. This effect did not occur at a sotalol dose 3 times the MRHD. In rats, a sotalol dose 18 times the MRHD increased the number of early resorptions, while a dose 2.5 times the MRHD produced no increase in early resorptions. | |||
====8.3 Nursing Mothers==== | |||
Sotalol is secreted in human milk in high levels. In five mothers whose mean sotalol dose was 433 mg/day, sotalol concentrations in milk ranged from 4.8 to 20.2 mg/L (mean=10.5 mg/L), with a milk:plasma ratio of 5.5:1 (range 2.2-8.8). The calculated infant dose was 0.8-3.4 mg/kg, which is similar to recommended therapeutic doses in neonates. Two other case reports showed similar findings. Because of the potential for adverse reactions in nursing infants from sotalol, 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. | |||
====8.4 Pediatric Use==== | |||
The safety and effectiveness of sotalol 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 (12)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SOTALOL HYDROCHLORIDE INJECTION [BIONICHE PHARMA USA LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2afe7385-2441-4e22-b63e-ab8614b275df | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 06:17, 10 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Use in Specific Populations
8.1 Pregnancy
There are no adequate and well-controlled studies in pregnant women. Sotalol crosses the placenta. In animal studies there was no increase in congenital anomalies, but an increase in early resorptions occurred at sotalol doses 18 times the maximum recommended human dose (MRHD, based on body surface area). Because, animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Reproduction studies in rats and rabbits during organogenesis at sotalol doses 9 and 7 times the MRHD (based on body surface area), respectively, did not reveal any increase in congenital abnormalities. In rabbits, a sotalol dose 6 times the MRHD produced a slight increase in fetal death, but this was associated with maternal toxicity. This effect did not occur at a sotalol dose 3 times the MRHD. In rats, a sotalol dose 18 times the MRHD increased the number of early resorptions, while a dose 2.5 times the MRHD produced no increase in early resorptions.
8.3 Nursing Mothers
Sotalol is secreted in human milk in high levels. In five mothers whose mean sotalol dose was 433 mg/day, sotalol concentrations in milk ranged from 4.8 to 20.2 mg/L (mean=10.5 mg/L), with a milk:plasma ratio of 5.5:1 (range 2.2-8.8). The calculated infant dose was 0.8-3.4 mg/kg, which is similar to recommended therapeutic doses in neonates. Two other case reports showed similar findings. Because of the potential for adverse reactions in nursing infants from sotalol, 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.
8.4 Pediatric Use
The safety and effectiveness of sotalol 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 (12)].[1]
References
Adapted from the FDA Package Insert.