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ALFUSIN-D (ALFUZOSIN/DUTASTERIDE) TABLETS: PHARMACOKINETICS IN SPECIAL POPULATIONS

Alfuzosin Hydrochloride

Pediatric Use

Alfuzosin tablets are not indicated for use in the pediatric population,

Geriatric Use

In a pharmacokinetic assessment during phase 3 clinical studies in patients with BPH, there was no relationship between peak plasma concentrations of alfuzosin and age. However, trough levels were positively correlated with age. The concentrations in subjects ?75 years of age were approximately 35% greater than in those below 65 years of age.

Renal Impairment

The Pharmacokinetic profiles of alfuzosin 10 mg tablets in subjects with normal renal function (CLCR > 80 mL / min), mild impairment (CLCR 60 to 80 mL / min), moderate impairment (CLCR 30 to 59 mL / min), and severe impairment (CLCR max and AUC values were increased by approximately 50% in patients with mild, moderate, or severe renal impairment.

Hepatic Impairment

The pharmacokinetics of alfuzosin have not been studied in patients with mild hepatic impairment. In patients with moderate or severe hepatic insufficiency (Child-Pugh categories B and C), the plasma apparent clearance (CL/F) was reduced to approximately one-third to one-fourth that observed in healthy subjects. This reduction in clearance results in three to four-fold higher plasma concentrations of alfuzosin in these patients compared to healthy subjects. Therefore, alfuzosin is contraindicated in patients with moderate to severe hepatic impairment.

Dutasteride

Paediatric

Dutasteride pharmacokinetics has not been investigated in subjects younger than 18 years of age.

Geriatric

No dose adjustment is necessary in the elderly. The pharmacokinetics and pharmacodynamics of dutasteride were evaluated in 36 healthy male subjects aged between 24 and 87 years following administration of a single 5 mg dose of dutasteride. In this single-dose trial, dutasteride half-life increased with age (approximately 170 hours in men aged 20 to 49 years, approximately 260 hours in men aged 50 to 69 years, and approximately 300 hours in men older than 70 years). Of 2167 men treated with dutasteride in the three pivotal trials, 60% were aged 65 years and over, and 15% were aged 75 years and over. No overall differences in safety or efficacy were observed between these patients and younger patients.

Gender

Dutasteride is contraindicated in pregnancy and women of childbearing potential and is not indicated for use in other women. The pharmacokinetics of dutasteride in women has not been studied.

Race

The effect of race on dutasteride pharmacokinetics has not been studied.

Renal Impairment

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.

Hepatic Impairment

The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized, exposure could be higher in hepatically impaired patients.

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