Trandolapril use in specific populations: Difference between revisions
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{{CMG}}; {{AE}} {{AM}} | {{CMG}}; {{AE}} {{AM}} | ||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MAVIK (TRANDOLAPRIL) TABLET [ABBVIE INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ad67ea2-409c-4f52-a9b8-38216209609a | publisher = | date = | accessdate = }}</ref> | |||
===Nursing Mothers=== | |||
Radiolabeled trandolapril or its metabolites are secreted in rat milk. MAVIK should not be administered to nursing mothers. | |||
===Geriatric Use=== | |||
In placebo-controlled studies of MAVIK, 31.1% of patients were 60 years and older, 20.1% were 65 years and older, and 2.3% were 75 years and older. No overall differences in effectiveness or safety were observed between these patients and younger patients. (Greater sensitivity of some older individual patients cannot be ruled out). | |||
===Pediatric Use=== | |||
====Neonates with a history of in utero exposure to MAVIK==== | |||
If [[oliguria]] or [[hypotension]] occurs, direct attention toward support of blood pressure and renal perfusion. [[Exchange transfusions]] or [[dialysis]] may be required as a means of reversing [[hypotension]] and/or substituting for disordered renal function. | |||
The safety and effectiveness of MAVIK in pediatric patients have not been established.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MAVIK (TRANDOLAPRIL) TABLET [ABBVIE INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ad67ea2-409c-4f52-a9b8-38216209609a | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 21:34, 18 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Amr Marawan, M.D. [2]
Nursing Mothers
Radiolabeled trandolapril or its metabolites are secreted in rat milk. MAVIK should not be administered to nursing mothers.
Geriatric Use
In placebo-controlled studies of MAVIK, 31.1% of patients were 60 years and older, 20.1% were 65 years and older, and 2.3% were 75 years and older. No overall differences in effectiveness or safety were observed between these patients and younger patients. (Greater sensitivity of some older individual patients cannot be ruled out).
Pediatric Use
Neonates with a history of in utero exposure to MAVIK
If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
The safety and effectiveness of MAVIK in pediatric patients have not been established.[1]
References
Adapted from the FDA Package Insert.