Bisoprolol use in specific populations: Difference between revisions

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Created page with "__NOTOC__ {{Bisoprolol }} {{CMG}}; {{AE}} {{SS}} ==Use In Specific Populations== ===Pregnancy Category C=== In rats, bisoprolol fumarate was not teratogenic at doses up to ..."
 
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__NOTOC__
#REDIRECT [[Bisoprolol#Use in Specific Populations]]
{{Bisoprolol }}
{{CMG}}; {{AE}} {{SS}}
 
==Use In Specific Populations==
 
===Pregnancy Category C===
 
In rats, bisoprolol fumarate was not teratogenic at doses up to 150 mg/kg/day which is 375 and 77 times the MRHD on the basis of body weight and body surface area, respectively. Bisoprolol fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and maternotoxic (decreased food intake and body weight gain) at 150 mg/kg/day. The fetotoxicity in rats occurred at 125 times the MRHD on a body weight basis and 26 times the MRHD on the basis of body surface area. The maternotoxicity occurred at 375 times the MRHD on a body weight basis and 77 times the MRHD on the basis of body surface area. In rabbits, bisoprolol fumarate was not teratogenic at doses up to 12.5 mg/kg/day, which is 31 and 12 times the MRHD based on body weight and body surface area, respectively, but was embryolethal (increased early resorptions) at 12.5 mg/kg/day.
 
There are no adequate and well-controlled studies in pregnant women. ZEBETA (bisoprolol fumarate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
 
===Nursing Mothers===
 
Small amounts of bisoprolol fumarate (< 2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when bisoprolol fumarate is administered to nursing women.
 
===Pediatric Use===
 
Safety and effectiveness in pediatric patients have not been established.
 
===Geriatric Use===
 
ZEBETA has been used in elderly patients with hypertension. Response rates and mean decreases in systolic and diastolic blood pressure were similar to the decreases in younger patients in the U.S. clinical studies. Although no dose response study was conducted in elderly patients, there was a tendency for older patients to be maintained on higher doses of bisoprolol fumarate.
 
Observed reductions in heart rate were slightly greater in the elderly than in the young and tended to increase with increasing dose. In general, no disparity in adverse experience reports or dropouts for safety reasons was observed between older and younger patients. Dose adjustment based on age is not necessary.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = ZEBETA (BISOPROLOL FUMARATE) TABLET [DURAMED PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a11548a0-9c0f-4729-907c-75d8f99a6c85 | publisher =  | date =  | accessdate = 4 February 2014 }}</ref>
 
==References==
 
{{Reflist|2}}


[[Category:Beta blockers]]
[[Category:Beta blockers]]
[[Category:Cardiovascular Drugs]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
[[Category:Drugs]]
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