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| __NOTOC__
| | #REDIRECT [[Propranolol#Use in Specific Populations]] |
| {{Propranolol}}
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| {{CMG}}; {{AE}} {{AZ}}
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| ==Use In Specific Populations==
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| ===Pregnancy===
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| '''Pregnancy Category C'''
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| In a series of reproductive and developmental toxicology studies, propranolol was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day, but not at doses of 80 mg/kg/day (equivalent to the MRHD on a body surface area basis), treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol hydrochloride also was administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (about 5 times the maximum recommended human oral daily dose). No evidence of embryo or neonatal toxicity was noted.
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| There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital abnormalities have been reported in neonates whose mothers received propranolol during pregnancy. Neonates whose mothers are receiving propranolol at parturition have exhibited bradycardia, hypoglycemia and/or respiratory depression. Adequate facilities for monitoring such infants at birth should be available. Inderal LA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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| ===Nursing Mothers===
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| Propranolol is excreted in human milk. Caution should be exercised when Inderal LA is administered to a nursing woman.
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| ===Pediatric Use===
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| Safety and effectiveness of propranolol in pediatric patients have not been established.
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| Bronchospasm and congestive heart failure have been reported coincident with the administration of propranolol therapy in pediatric patients.
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| ===Geriatric Use===
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| Clinical studies of Inderal LA 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 the decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.<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=fce692df-1e68-465e-8dda-0cb01320608c | publisher = | date = |accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Drugs]]
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