Trandolapril use in specific populations: Difference between revisions
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===Pediatric Use=== | ===Pediatric Use=== | ||
Trandolapril pharmacokinetics have not been evaluated in patients < 18 years of age. | Trandolapril pharmacokinetics have not been evaluated in patients < 18 years of age. | ||
====Neonates with a history of in utero exposure to MAVIK==== | ====Neonates with a history of in utero exposure to MAVIK==== | ||
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The safety and effectiveness of MAVIK in pediatric patients have not been established. | The safety and effectiveness of MAVIK in pediatric patients have not been established. | ||
===Race=== | |||
Pharmacokinetic differences have not been evaluated in different races. | Pharmacokinetic differences have not been evaluated in different races. | ||
===Renal Insufficiency=== | |||
Compared to normal subjects, the plasma concentrations of trandolapril and trandolaprilat are approximately 2-fold greater and renal clearance is reduced by about 85% in patients with creatinine clearance below 30 ml/min and in patients on hemodialysis. Dosage adjustment is recommended in renally impaired patients. | Compared to normal subjects, the plasma concentrations of trandolapril and trandolaprilat are approximately 2-fold greater and renal clearance is reduced by about 85% in patients with creatinine clearance below 30 ml/min and in patients on hemodialysis. Dosage adjustment is recommended in renally impaired patients. | ||
===Hepatic Insufficiency=== | |||
Following oral administration in patients with mild to moderate alcoholic cirrhosis, plasma concentrations of trandolapril and trandolaprilat were, respectively, 9-fold and 2-fold greater than in normal subjects, but inhibition of ACE activity was not affected. Lower doses should be considered in patients with hepatic insufficiency.<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> | Following oral administration in patients with mild to moderate alcoholic cirrhosis, plasma concentrations of trandolapril and trandolaprilat were, respectively, 9-fold and 2-fold greater than in normal subjects, but inhibition of ACE activity was not affected. Lower doses should be considered in patients with hepatic insufficiency.<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> | ||
Revision as of 22:06, 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). Trandolapril pharmacokinetics have been investigated in the elderly (> 65 years) and in both genders. The plasma concentration of trandolapril is increased in elderly hypertensive patients, but the plasma concentration of trandolaprilat and inhibition of ACE activity are similar in elderly and young hypertensive patients. The pharmacokinetics of trandolapril and trandolaprilat and inhibition of ACE activity are similar in male and female elderly hypertensive patients.
Pediatric Use
Trandolapril pharmacokinetics have not been evaluated in patients < 18 years of age.
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.
Race
Pharmacokinetic differences have not been evaluated in different races.
Renal Insufficiency
Compared to normal subjects, the plasma concentrations of trandolapril and trandolaprilat are approximately 2-fold greater and renal clearance is reduced by about 85% in patients with creatinine clearance below 30 ml/min and in patients on hemodialysis. Dosage adjustment is recommended in renally impaired patients.
Hepatic Insufficiency
Following oral administration in patients with mild to moderate alcoholic cirrhosis, plasma concentrations of trandolapril and trandolaprilat were, respectively, 9-fold and 2-fold greater than in normal subjects, but inhibition of ACE activity was not affected. Lower doses should be considered in patients with hepatic insufficiency.[1]
References
Adapted from the FDA Package Insert.