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Metabolism: There is no evidence of systemic metabolism of risedronate. Elimination: Text Continues Below
Approximately half of the absorbed dose is excreted in urine within 24 hours, and 85% of an intravenous dose is recovered in the urine over 28 days. Mean renal clearance is 105 mL/ min (CV = 34%) and mean total clearance is 122 mL/ min (CV = 19%), with the difference primarily reflecting nonrenal clearance or clearance due to adsorption to bone. The renal clearance is not concentration dependent, and there is a linear relationship between renal clearance and creatinine clearance. Unabsorbed drug is eliminated unchanged in feces. Once risedronate is absorbed, the serum concentration-time profile is multi-phasic, with an initial half-life of about 1.5 hours and a terminal exponential half-life of 480 hours. This terminal half-life is hypothesized to represent the dissociation of risedronate from the surface of bone. Special Populations: Pediatric: Risedronate pharmacokinetics have not been studied in patients <18 years of age. Gender: Bioavailability and pharmacokinetics following oral administration are similar in men and women. Geriatric: Bioavailability and disposition are similar in elderly (> 60 years of age) and younger subjects. No dosage adjustment is necessary. Race: Pharmacokinetic differences due to race have not been studied. Renal Insufficiency: Risedronate is excreted unchanged primarily via the kidney. As compared to persons with normal renal function, the renal clearance of risedronate was decreased by about 70% in patients with creatinine clearance of approximately 30 mL/ min. ACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/ min) because of lack of clinical experience. No dosage adjustment is necessary in patients with a creatinine clearance Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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