Tirofiban use in specific populations: Difference between revisions

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(Created page with "__NOTOC__ {{Tirofiban}} {{CMG}}; {{AE}} {{SS}} ==Use In Specific Populations== ===Pregnancy=== Pregnancy Category B There are no adequate and well-controlled studies in pr...")
 
 
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{{CMG}}; {{AE}} {{SS}}
 
==Use In Specific Populations==
 
===Pregnancy===
 
Pregnancy Category B
 
There are no adequate and well-controlled studies in pregnant women. Tirofiban has been shown to cross the placenta in pregnant rats and rabbits. Studies with tirofiban HCl at intravenous doses up to 5 mg/kg/day (about 5 and 13 times the maximum recommended daily human dose for rat and rabbit, respectively, when compared on a body surface area basis) have revealed no harm to the fetus.
 
===Nursing Mothers===
 
It is not known whether tirofiban is excreted in human milk. However, significant levels of tirofiban were shown to be present in rat milk. Because many drugs are excreted in human milk, and because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue AGGRASTAT.
 
===Pediatric Use===
 
Safety and effectiveness in pediatric patients have not been established.
 
===Geriatric Use===
 
Of the total number of patients in controlled clinical studies of AGGRASTAT, 43% were 65 years and over, while 12% were 75 and over. With respect to efficacy, the effect of AGGRASTAT in the elderly (≥65 years) appeared similar to that seen in younger patients (<65 years). Elderly patients receiving AGGRASTAT with [[heparin]] or [[heparin]] alone had a higher incidence of bleeding complications than did younger patients, but the incremental risk of bleeding in patients treated with AGGRASTAT in combination with [[heparin]] compared to the risk in patients treated with[[ heparin]] alone was similar regardless of age. No dose adjustment is recommended for the elderly population [see Dosage and Administration (2)].
 
===Renal Insufficiency===
 
Patients with moderate to severe[[ renal insufficiency]] have decreased plasma clearance of AGGRASTAT. Reduce the dosage of AGGRASTAT in patients with severe [[renal insufficiency]] [see Dosage and Administration (2) and Clinical Pharmacology (12.3)].
 
Safety and efficacy of AGGRASTAT has not been established in patients on hemodialysis.
 
<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f | publisher =  | date =  | accessdate = 6 February 2014 }}</ref>
 
 
==References==
 
{{Reflist|2}}
 
[[Category:Antiplatelet drugs]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
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Latest revision as of 02:53, 22 July 2014