Nadolol use in specific populations: Difference between revisions
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==Use In Specific Populations== | ==Use In Specific Populations== | ||
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===Pregnancy=== | ===Pregnancy=== | ||
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In animal reproduction studies with nadolol, evidence of embryo- and fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential was observed in any of these species. | In animal reproduction studies with nadolol, evidence of embryo- and fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential was observed in any of these species. | ||
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===Nursing Mothers=== | ===Nursing Mothers=== | ||
Nadolol is excreted in human milk. Because of the potential for adverse effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of CORGARD (nadolol) to the mother. | Nadolol is excreted in human milk. Because of the potential for adverse effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of CORGARD (nadolol) to the mother. | ||
===Pediatric Use=== | ===Pediatric Use=== | ||
Safety and effectiveness in pediatric patients have not been established.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = INDERAL LA (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AKRIMAX PHARMACEUTICALS, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c2e709d2-96a2-41ea-b5e9-9ce4ccb91f59 | publisher = | date = |accessdate = }}</ref> | Safety and effectiveness in pediatric patients have not been established.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = INDERAL LA (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AKRIMAX PHARMACEUTICALS, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c2e709d2-96a2-41ea-b5e9-9ce4ccb91f59 | publisher = | date = |accessdate = }}</ref> | ||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Revision as of 02:53, 10 February 2014
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
In animal reproduction studies with nadolol, evidence of embryo- and fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential was observed in any of these species.
There are no adequate and well-controlled studies in pregnant women. Nadolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates whose mothers are receiving nadolol at parturition have exhibited bradycardia, hypoglycemia, and associated symptoms.
Nursing Mothers
Nadolol is excreted in human milk. Because of the potential for adverse effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of CORGARD (nadolol) to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.[1]
References
Adapted from the FDA Package Insert.