Simetidin ve Hidrokodon etkileşimi

Cytochrome P450 3A4 Interaction The concomitant use of HYSINGLA ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression.

Regularly evaluate patients receiving HYSINGLA ER and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.6) , Drug Interactions (7) , and Clinical Pharmacology (12.3) ].

Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone.

The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint 5.6 Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers Concomitant use of HYSINGLA ER with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir),…

When using HYSINGLA ER with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in HYSINGLA ER-treated patients, evaluate patients at frequent intervals and consider dosage reduction of HYSINGLA ER until stable drug effects are achieved [see Drug Interactions (7) ].