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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): DRUG INTERACTIONS
There have been no drug interaction studies for Duodart (Dutasteride and Tamsulosin). The following statements reflect the information available on the individual components.
Interactions of Dutasteride and Tamsulosin (Duodart) with cytochrome P450 Inhibitors
In vitro drug metabolism studies show that dutasteride is metabolised by human cytochrome P450 isoenzyme CYP3A4. Therefore blood concentrations of dutasteride may increase in the presence of inhibitors of CYP3A4.
Long-term combination of dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g.ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of dutasteride. Further inhibition of 5-alpha reductase at increased dutasteride exposure, is not likely. However, a reduction of the dutasteride dosing frequency can be considered if side effects are noted. It should be noted that in the case of enzyme inhibition, the long half-life may be further prolonged and it can take more than 6 months of concurrent therapy before a new steady state is reached.
Phase II data showed a decrease in clearance of dutasteride when co-administered with the CYP3A4 inhibitors verapamil (37%) and diltiazem (44%). In contrast no decrease in clearance was seen when amlodipine, another calcium channel antagonist, was co-administered with dutasteride. A decrease in clearance and subsequent increase in exposure to dutasteride, in the presence of CYP3A4 inhibitors, is unlikely to be clinically significant due to the wide margin of safety (up to 10-times the recommended dose has been given to patients for up to six months), therefore no dose adjustment is necessary.
In vitro, dutasteride is not metabolized by human cytochrome P450 isoenzymes CYP1A2, CYP2C9, CYP2C19, and CYP2D6. Dutasteride neither inhibits human cytochrome P450 drug-metabolizing enzymes in vitro nor induces cytochrome P450 isoenzymes CYP1A, CYP2B, and CYP3A in rats and dogs in vivo.
Strong and Moderate Inhibitor of CYP3A4 or CYP2D6
Tamsulosin is extensively metabolized, mainly by CYP3A4 or CYP 2D6.
Concomitant treatment with ketoaconazole (a strong inhibitor of CYP3A4) has resulted in increases in the Cmax and AUC of tamsulosin. The effects of concomitant administration of
a moderate CYP3A4 inhibitor (e.g., erythromycin) on the pharmacokinetics of tamsulosin have not been evaluated. Concomitant treatment with paroxetine (a strong inhibitor of
CYP2D6) has also resulted in increases in the Cmax and AUC of tamsulosin. The effects of concomitant administration of a moderate CYP2D6 inhibitor (e.g. terbinafine) on the
pharmacokinetics of tamsulosin have not been evaluated. The effects of concomitant administration of both a CYP3A4 and a CYP2D6 inhibitor with tamsulosin have not been evaluated. However, there is a potential for significant increase in tamsulosin exposure when tamsulosin 0.4 mg is coadministerd with a combination of both CYP3A4 and CYP2D6 inhibitors.
Interactions of Duodart (Dutasteride and Tamsulosin HCl) with particular drugs or classes of drugs
Concomitant administration of tamsulosin hydrochloride (0.4 mg) and cimetidine (400 mg every 6 hours for 6 days) resulted in a decrease in the clearance (26%) and an increase in the AUC (44%) of tamsulosin hydrochloride. Caution should be used when dutasteride-tamsulosin is used in combination with cimetidine.
There is a risk of additive hypotensive effects when tamsulosin hydrochloride is coadministered with drugs which can reduce blood pressure, including anaesthetic agents and other alpha-1 adrenergic blockers. Concurrent administration of Dutasteride with Tamsulosin HCl (Duodart) and other drugs containing alpha-1 adrenergic blockers is therefore contraindicated.
Caution is advised when alpha-adrenergic antagonists, including tamsulosincontaining products such as Duodart (Dutasteride and Tamsulosin Hydrochloride), are coadministered with PDE-5 inhibitors. Alphaadrenergic antagonists and PDE-5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these 2 drug classes can potentially cause symptomatic hypotension.
In vitro studies demonstrate that dutasteride does not displace warfarin. No clinically significant interactions have been observed following concomitant administration of dutasteride and tamsulosin.
A definitive drug-drug interaction study between tamsulosin hydrochloride and warfarin has not been conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and tamsulosin hydrochloride.
Nifedipine, Atenolol, Enalapril
In three studies, no interactions were seen when tamsulosin (0.4 mg for seven days followed by 800 mcg for 7 days) was given concomitantly with atenolol, enalapril or nifedipine for 3 months; therefore no dose adjustments are necessary when these drugs are co-administered with Dutasteride with Tamsulosin HCl (Duodart) capsules.
Digoxin and Theophylline
Dutasteride does not alter the steady-state pharmacokinetics of digoxin.
Dosage adjustements are not necessary when tamsulosin is administered concomitantly with digoxin.
Concomitant administration of tamsulosin hydrochloride (0.4 mg/day for two days, followed by 800 mcg/day for five to eight days) and a single i.v. dose of theophylline (5 mg/kg)
resulted in no change in the pharmacokinetics of theophylline; therefore no dose adjustment is necessary.
Concomitant administration of tamsulosin hydrochloride (0.8 mg /day) and a single I.V. dose of furosemide (20 mg) produced an 11% to 12% reduction in the Cmax and AUC of tamsulosin hydrochloride, however these changes are expected to be clinically insignificant and no dose adjustment is necessary.
Calcium Channel Blockers
Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. However, the change in dutasteride exposure is not considered clinically significant. No dosage adjustment of dutasteride is recommended.
Administration of a single 5-mg dose of dutasteride followed 1 hour later by a 12 g dose of cholestyramine does not affect the relative bioavailability of dutasteride.
In vitro studies demonstrate that dutasteride does not displace diazepam, or phenytoin from plasma protein, nor do these model compounds displace dutasteride.
Although specific interaction studies were not performed with other compounds, approximately 90% of the subjects in large Phase III studies receiving dutasteride were taking other medications concomitantly. No clinically significant adverse interactions were observed in clinical trials when dutasteride was co-administered with anti-hyperlipidemics, angiotensin-converting enzyme (ACE) inhibitors, beta-adrenergic blocking agents, calcium channel blockers, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), phosphodiesterase Type V inhibitors, and quinolone antibiotics.
A drug interaction study with tamsulosin or terazosin administered in combination with dutasteride for two weeks showed no evidence of pharmacokinetic or pharmacodynamic interactions.
Tamsulosin binds extensively to plasma proteins and may displace other protein-bound drugs. Conclusive clinical trials data are not available.
Ability to Drive and Use Machines
There have been no studies to investigate the effect of Duodart (Dutasteride and Tamsulosin HCl) capsules on the ability to perform tasks that require judgement, motor or cognitive skills. However, patients should be informed about the possible occurrence of symptoms related to orthostatic hypotension such as dizziness when taking Dutasteride with Tamsulosin Hydrochloride (Duodart).
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