dministered radioactivity was recovered, with urine (76%) representing the primary route of excretion compared to feces (21%) over 168hours.
Following intravenous or oral administration of an immediate-release formulation, the elimination half-life of tamsulosin in plasma ranges from 5 to 7hours. Because of absorption rate-controlled pharmacokinetics with tamsulosin hydrochloride capsules, the apparent half-life of tamsulosin is approximately 9 to 13hours in healthy volunteers and 14 to 15hours in the target population.
Tamsulosin undergoes restrictive clearance in humans, with a relatively low systemic clearance (2.88L/hr).
Specific Populations:Pediatric: The pharmacokinetics of dutasteride and tamsulosin administered together have not been investigated in subjects younger than 18years.
Geriatric: Dutasteride and tamsulosin pharmacokinetics using JALYN have not been studied in geriatric patients. The following text reflects information for the individual components.
Dutasteride: No dosage adjustment is necessary in the elderly. The pharmacokinetics and pharmacodynamics of dutasteride were eva luated in 36healthy male subjects aged between 24 and 87years following administration of a single 5-mgdose of dutasteride. In this single-dose study, dutasteride half-life increased with age (approximately 170hours in men aged 20 to 49years, approximately 260hours in men aged 50 to 69years, and approximately 300hours in men older than 70years).
Tamsulosin: Cross-study comparison of tamsulosin overall exposure (AUC) and half-life indicate that the pharmacokinetic disposition of tamsulosin may be slightly prolonged in geriatric males compared to young, healthy male volunteers. Intrinsic clearance is independent of tamsulosin binding to AAG, but diminishes with age, resulting in a 40% overall higher exposure (AUC) in subjects aged 55 to 75years compared to subjects aged 20 to 32years.
Gender:Dutasteride: Dutasteride is contraindicated in pregnancy and women of childbearing potential and is not indicated for use in other women [see Contraindications (4), Warnings and Precautions (5.6)]. The pharmacokinetics of dutasteride in women have not been studied.
Tamsulosin: Tamsulosin is not indicated for use in women. No information is available on the pharmacokinetics of tamsulosin in women.
Race: The effect of race on pharmacokinetics of dutasteride and tamsulosin administered together or separately has not been studied.
Renal Impairment: The effect of renal impairment on dutasteride and tamsulosin pharmacokinetics has not been studied using JALYN. The following text reflects information for the individual components.
Dutasteride: The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, less than 0.1% of a steady-state 0.5-mg dose of dutasteride is recovered in human urine, so no adjustment in dosage is anticipated for patients with renal impairment.
Tamsulosin: The pharmacokinetics of tamsulosin have been compared in 6subjects with mild-moderate (30≤CLcr <70 mL/min/1.73m2) or moderate-severe (10≤CLcr <30mL/min/1.73m2) renal impairment and 6normal subjects (CLcr>90mL/min/1.73m2). While a change in the overall plasma concentration of tamsulosin was observed as the result of altered binding to AAG, the unbound (active) concentration of tamsulosin, as well as the intrinsic clearance, remained relatively constant. Therefore, patients wit |
