Drug Interactions between Hetlioz and Yosprala

MONITOR: Coadministration with inducers of CYP450 1A2 and/or 3A4 may decrease the plasma concentrations of tasimelteon, which is primarily metabolized by these isoenzymes. When tasimelteon was administered after 11 days of treatment with the potent CYP450 inducer rifampin 600 mg/day, tasimelteon systemic exposure (AUC) decreased by approximately 90% compared to tasimelteon administered alone. No data are available for use with other, less potent inducers.

MANAGEMENT: The potential for diminished therapeutic effects of tasimelteon should be considered during coadministration with inducers of CYP450 1A2 and/or 3A4. Alternative treatments may be required if an interaction is suspected.

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Coadministration with proton pump inhibitors may decrease the oral bioavailability of aspirin and other salicylates. The interaction has been studied with omeprazole and aspirin, although data are conflicting. In one study, pretreatment with omeprazole (20 mg/day for 2 days) in 11 healthy volunteers led to a significant and progressively greater reduction in the mean serum salicylate level at 30, 60, and 90 minutes after administration of aspirin (650 mg single dose). The investigators suggest that acid suppression may reduce the lipophilic nature of aspirin, thereby adversely affecting its absorption from the gastrointestinal tract. Another study found no effect of omeprazole pretreatment (20 mg/day for 4 days) on plasma salicylate and aspirin levels, skin bleeding times, or antiplatelet effect of low-dose aspirin (125 mg single dose) in 14 healthy volunteers. However, these results do not exclude the possibility that omeprazole might interfere with the analgesic, antipyretic, or anti-inflammatory effects of aspirin, which has been demonstrated in rats.

Proton pump inhibitors may enhance the release rate of salicylates from enteric-coated formulations due to premature disruption of the coating and intragastric release of the drug secondary to an increase in gastric pH. In eight healthy volunteers, omeprazole pretreatment (20 mg/day for 4 days) did not affect the bioavailability of salicylate from uncoated aspirin tablets but significantly increased the absorption rate of salicylate from enteric-coated sodium salicylate tablets. The clinical significance of this interaction is unknown. Theoretically, it may increase the risk of gastric adverse effects associated with salicylates.

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