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ALFUSIN-D (ALFUZOSIN/DUTASTERIDE) TABLETS: PHARMACOKINETICS
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.
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).
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.
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.
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.
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.
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.
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.
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