Nefecon Drug Interactions

Medicinal products/substances inhibiting CYP3A4: Budesonide is metabolised via CYP3A4. Potent inhibitors of CYP3A4 can increase plasma levels of budesonide. Co-administration of the potent CYP3A4 inhibitor ketoconazole or intake of grapefruit juice resulted in a 6.5-fold and 2-fold increase, respectively in the bioavailability of budesonide, compared to budesonide alone.
Thus, clinically relevant interactions with potent CYP3A inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, and grapefruit juice, are to be expected, and may increase systemic budesonide concentrations (see Precautions, and Pharmacology: Pharmacokinetics under Actions).
Medicinal products/substances inducing CYP3A4: Concomitant treatment with CYP3A4 inducers such as carbamazepine may reduce budesonide systemic exposure.
Medicinal products/substances metabolised by CYP3A4: Given its low affinity for CYP3A4 and P-gp, as well as the formulation, pharmacokinetic (PK) characteristics and low systemic exposure, Nefecon is unlikely to affect the systemic exposure of other medicinal products.
Oral contraceptives: Oral contraceptives containing ethinyl estradiol, which are also metabolised by CYP3A4, do not affect the pharmacokinetics of budesonide.
Proton pump inhibitors: The pharmacokinetics of budesonide have not been evaluated in combination with proton pump inhibitors (PPIs). In a study assessing intragastric and intraduodenal pH in healthy volunteers after repeated dosing with the PPI omeprazole 40 mg once daily, intragastric and intraduodenal pH did not exceed that required for disintegration of Nefecon. Beyond the duodenum, PPIs such as omeprazole are unlikely to affect pH.
Other interactions to be considered: Budesonide treatment may reduce serum potassium, which should be considered when Nefecon is co-administered with a medicinal product where the pharmacological effects may be potentiated by low serum potassium, such as cardiac glucosides, or when co-administered with diuretics that lower serum potassium.