Drug Interactions between ezogabine and Lumryz

CONTRAINDICATED: Alcohol may potentiate the central nervous system and respiratory depressant effects of sodium oxybate, which is the sodium salt of gamma hydroxybutyrate (GHB). An increased risk of serious adverse reactions such as respiratory depression, hypotension, profound sedation, syncope, coma, and even death should be anticipated.

ADJUST DOSING INTERVAL: Food may delay the absorption and significantly decrease the bioavailability of sodium oxybate. When sodium oxybate was administered immediately after a high-fat meal, the time to reach peak plasma concentration (Tmax) increased from 0.75 hour to 2 hours, the peak plasma concentration (Cmax) decreased by a mean of 59%, and the systemic exposure (AUC) decreased by a mean of 37%.

MANAGEMENT: The concomitant use of sodium oxybate with alcohol is considered contraindicated. The first dose of sodium oxybate should be taken at least 2 hours after a meal to ensure maximal absorption.

GENERALLY AVOID: Alcohol may increase the plasma concentrations of ezogabine. In a study of healthy volunteers, the administration of ezogabine 200 mg in combination with ethanol 1g/kg (5 standard alcohol drinks) over 20 minutes resulted in an increase in the ezogabine peak plasma concentration (Cmax) and systemic exposure (AUC) by 23% and 37%, respectively.

Food does not significantly affect the bioavailability of ezogabine. According to the product labeling, high-fat food does not affect the extent to which ezogabine is absorbed, but increases peak plasma concentration (Cmax) by approximately 38% and delays the time to reach peak concentration (Tmax) by 0.75 hour.

MANAGEMENT: In general, alcohol consumption should be avoided or limited during treatment with CNS-depressant agents. Patients should be advised of the potential for increased dose-related adverse reactions of ezogabine (e.g., dizziness, somnolence, nausea, constipation, urinary retention, blurred vision, memory impairment, tremor) when taken with alcohol, and to avoid hazardous activities that require mental alertness and motor coordination until they know how the medication affects them. Ezogabine can be taken with or without food.