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ALFUSIN-D (ALFUZOSIN/DUTASTERIDE) TABLETS: DRUG INTERACTIONS
Potent CYP3A4 Inhibitors
CYP3A4 is the principal hepatic enzyme isoform involved in the metabolism of alfuzosin hydrochloride. Repeated administration of 400 mg of ketoconazole, a potent inhibitor of CYP3A4, increased the alfuzosin hydrochloride Cmax by 2.3-fold and the AUClast by 3.2-fold, following a single 10 mg dose of Alfuzosin HCl. In another study, repeated oral administration of a lower (200 mg/day) dose of ketoconazole increased the alfuzosin hydrochloride Cmax by 2.1-fold and the AUClast by 2.5-fold, following a single 10 mg dose of alfusion hydrochloride. Alfuzosin HCl should not be co-administered with potent inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole or ritonavir) because of increased alfuzosin hydrochloride exposure.
Dutasteride is extensively metabolized in humans by the CYP3A4 and CYP3A5 isoenzymes. No clinical drug interaction trials have been performed to evaluate the impact of CYP3A enzyme inhibitors on dutasteride pharmacokinetics. However, based on in vitro data, blood concentrations of dutasteride may increase in the presence of inhibitors of CYP3A4/5 such as ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, and ciprofloxacin. Because of the potential for drug-drug interactions, use caution when prescribing dutasteride to patients taking potent, chronic CYP3A4 enzyme inhibitors.
Dutasteride does not inhibit the in vitro metabolism of model substrates for the major human CYP450 isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) at a concentration of 1,000 ng/mL, 25 times greater than steady-state serum concentrations in humans.
Moderate CYP3A4 Inhibitors
Repeated co-administration of 240 mg/day of diltiazem, a moderately potent inhibitor of CYP3A4, with 7.5 mg/day (2.5 mg three times daily) alfuzosin hydrochloride increased the Cmax and AUC0-24 of alfuzosin hydrochloride 1.5- and 1.3-fold, respectively. Alfuzosin hydrochloride increased the Cmax and AUC0-12 of diltiazem 1.4-fold. Although no changes in blood pressure were observed in this study, diltiazem is an antihypertensive medication and the combination of alfuzosin hydrochloride and antihypertensive medications has the potential to cause hypotension in some patients.
In human liver microsomes, at concentrations that are achieved at the therapeutic dose, alfuzosin did not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6 or 3A4 isoenzymes. In primary culture of human hepatocytes, alfuzosin did not induce CYP1A, 2A6 or 3A4 isoenzymes.
The pharmacokinetic and pharmacodynamic interactions between alfuzosin hydrochloride and other alpha-blockers have not been determined. However, interactions may be expected and Alfusin-D tablets should not be used in combination with other alpha-blockers.
The administration of dutasteride in combination with tamsulosin or terazosin has no effect on the steady-state pharmacokinetics of either alpha-adrenergic antagonist. The effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters was not evaluated; the percent change in DHT concentrations was similar for dutasteride alone compared with the combination treatment.
Phosphodiesterase-5 (PDE5) Inhibitors
Caution is advised when alpha-adrenergic antagonists, including alfuzosin hydrochloride, are co-administered with PDE5 inhibitors. Alpha-adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.
Antihypertensive Medications and Nitrates
There may be an increased risk of hypotension/postural hypotension and syncope when taking Alfusin-D tablets concomitantly with antihypertensive medication and nitrates.
Repeated administration of 1 g/day cimetidine increased both the alfuzosin hydrochloride Cmax and AUC values by 20%.
Repeated co-administration of alfuzosin hydrochloride 10 mg and digoxin 0.25 mg/day for 7 days did not influence the steady-state pharmacokinetics of either drug. Dutasteride did not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks.
Multiple dose administration of an immediate-release tablet formulation of alfuzosin hydrochloride 5 mg twice daily for 6 days to 6 healthy male volunteers did not affect the pharmacological response to a single 25 mg oral dose of warfarin. Dutasteride 0.5 mg / day for 3 weeks did not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on the prothrombin time when administered with warfarin.
Single administration of 100 mg atenolol with a single dose of 2.5 mg of an immediate-release alfuzosin hydrochloride tablet in 8 healthy young male volunteers increased alfuzosin hydrochloride Cmax and AUC values by 28% and 21%, respectively. Alfuzosin HCl increased atenolol Cmax and AUC values by 26% and 14%, respectively. In this study, the combination of alfuzosin hydrochloride with atenolol caused significant reductions in the mean blood pressure and in mean heart rate.
Single administration of 25 mg hydrochlorothiazide did not modify the pharmacokinetic parameters of alfuzosin hydrochloride. There was no evidence of pharmacodynamic interaction between Alfuzosin HCl and HCTZ in the 8 patients in the study.
Calcium Channel Antagonists
In a population pharmacokinetics analysis, a decrease in clearance of dutasteride was noted when co-administered with the CYP3A4 inhibitors verapamil (37%, n=6) and diltiazem (44%, n=5). In contrast, no decrease in clearance was seen when amlodipine, another calcium channel antagonist that is not a CYP3A4 inhibitor, was co-administered with dutasteride (+7%, n=4).
The decrease in clearance and subsequent increase in exposure to dutasteride in the presence of verapamil and diltiazem is not considered to be clinically significant. No dose adjustment is recommended.
Administration of a single 5 mg dose of dutasteride followed 1 hour later by 12 g cholestyramine did not affect the relative bioavailability of dutasteride.
Other Concomitant Therapy
No clinically significant adverse interactions could be attributed to the combination of dutasteride and concurrent therapy when dutasteride was co-administered with anti-hyperlipidaemics, angiotensin-converting enzyme (ACE) inhibitors, beta-adrenergic blocking agents, calcium channel blockers, corticosteroids, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), PDE-5 inhibitors and quinolone antibiotics.
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