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PHARMACOKINETICS OF ALFUSIN-D
Absorption: The absolute bioavailability of alfuzosin hydrochloride 10 mg tablets under fed conditions is 49%. Following multiple dosing of 10 mg alfuzosin hydrochloride under fed conditions, the time to maximum concentration was 8 hours. The Cmax and AUC0-24 were 13.6 (SD = 5.6) ng / mL and 194 (SD = 75) ng.h / mL, respectively. Alfuzosin HCl exhibits linear kinetics following single and multiple dosing up to 30 mg. Steady-state plasma levels are reached with the second dose of alfuzosin hydrochloride administration. Steady-state alfuzosin plasma concentrations are 1.2- to1.6-fold higher than those observed after a single administration.
Effect of Food: The extent of absorption is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride should be taken with food and with the same meal each day.
Distribution: The volume of distribution following intravenous administration in healthy male, middle-aged volunteers was 3.2 L/kg. Results of in vitro studies indicate that alfuzosin hydrochloride is moderately bound to human plasma proteins (82-90%), with linear binding over a wide concentration range (5 to 5,000 ng / mL).
Metabolism: Alfuzosin HCl undergoes extensive metabolism by the liver, with only 11% of the administered dose excreted unchanged in the urine. Alfuzosin is metabolized by three metabolic pathways: oxidation, O-demethylation and N-dealkylation. The metabolites are not pharmacologically active. CYP3A4 is the principal hepatic enzyme isoform involved in its metabolism.
Excretion: Following oral administration of 14C-labelled alfuzosin hydrochloride solution, the recovery of radioactivity after 7 days (expressed as a percentage of the administered dose) was 69% in the faeces and 24% in the urine. Following oral administration of 10 mg alfuzosin hydrochloride, the apparent elimination half-life is 10 hours.
Pharmacokinetics in special populations
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.
Absorption: Following administration of a single 0.5 mg dose of dutasteride, time to peak serum concentrations (Tmax) occurs within 2-3 hours. Absolute bioavailability in 5 healthy subjects was approximately 60% (range: 40% to 94%). When the drug is administered with food, the maximum serum concentrations were reduced by 10-15%. This reduction is of no clinical significance.
Distribution: Pharmacokinetic data following single and repeat oral doses show that dutasteride has a large volume of distribution (300-500 L). Dutasteride is highly bound to plasma albumin (99.0%) and alpha1-acid glycoprotein (96.6%). In a study of healthy subjects (n = 26) receiving dutasteride 0.5 mg/day for 12 months, semen dutasteride concentrations averaged 3.4 ng / mL (range: 0.4 to 14 ng / mL) at 12 months and, similar to serum, achieved steady-state concentrations at 6 months. On average, at 12 months 11.5% of serum dutasteride concentrations partitioned into semen.
Metabolism: Dutasteride is extensively metabolized in humans. In vitro studies showed that dutasteride is metabolized by the CYP3A4 and CYP3A5 isoenzymes. Both of these isoenzymes produced the 4'-hydroxydutasteride, 6-hydroxydutasteride and the 6,4'-dihydroxydutasteride metabolites. In addition, the 15-hydroxydutasteride metabolite was formed by CYP3A4. In human serum following dosing to a steady state, unchanged dutasteride, three major metabolites (4'-hydroxydutasteride, 1,2-dihydrodutasteride and 6-hydroxydutasteride) and two minor metabolites (6,4-dihydroxydutasteride and 15-hydroxydutasteride), as assessed by mass spectrometric response, have been detected. In vitro, the 4-hydroxydutasteride and 1,2-dihydrodutasteride metabolites are much less potent than dutasteride against both isoforms of human 5 alpha-reductase. The activity of 6 beta-hydroxydutasteride is comparable to that of dutasteride.
Excretion: Dutasteride and its metabolites were excreted mainly in the faeces. As a percent of dose, there was approximately 5% unchanged dutasteride (~1% to ~15%) and 40% as dutasteride-related metabolites (~2% to ~90%). Only trace amounts of unchanged dutasteride were found in urine ( < 1%). Therefore, on average, the dose unaccounted for approximated 55% (range: 5% to 97%).The terminal elimination half-life of dutasteride is approximately 5 weeks at the steady state. The average steady-state serum dutasteride concentration was 40 ng / mL following 0.5 mg / day for 1 year. Following daily dosing, dutasteride serum concentrations achieve 65% of steady-state concentration after 1 month and approximately 90% after 3 months. Due to the long half-life of dutasteride, serum concentrations remain detectable (greater than 0.1 ng / mL) for up to 4-6 months after discontinuation of treatment.
Pharmacokinetics in special populations
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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