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epidiolex cbd concentration

Epidiolex cbd concentration

What is the most important information I should know about EPIDIOLEX?

Advise patients who are prescribed EPIDIOLEX to use the adapter and oral dosing syringes provided [see DOSAGE AND ADMINISTRATION and Instructions for Use]. Instruct patients to discard any unused EPIDIOLEX oral solution after 12 weeks of first opening the bottle [see DOSAGE AND ADMINISTRATION].

Prepare The Dose

Risk Summary

Animal abuse-related studies show that cannabidiol does not produce cannabinoid-like behavioral responses, including generalization to delta-9-tetrahydrocannabinol (THC) in a drug discrimination study. Cannabidiol also does not produce animal self-administration, suggesting it does not produce rewarding effects. In a human abuse potential study, acute administration of cannabidiol to non-dependent adult recreational drug users at therapeutic and supratherapeutic doses of 750, 1500, and 4500 mg in the fasted state (equivalent respectively to 10, 20, and 60 mg/kg in a 75 kg adult) produced responses on positive subjective measures such as Drug Liking and Take Drug Again that were within the acceptable placebo range. In contrast, 10 and 30 mg of dronabinol (synthetic THC) and 2 mg alprazolam produced large increases on positive subjective measures compared to placebo that were statistically significantly greater than those produced by cannabidiol. In other Phase 1 clinical studies conducted with cannabidiol, there were no reports of abuse-related adverse events.

Table 1: Dose Adjustments in Patients with Hepatic Impairment

Effect Of Food

Concomitant Use Of EPIDIOLEX And Valproate

Drug Interaction Studies With AEDs

Be sure that you read, understand and follow these instructions carefully to ensure proper dosing of the oral solution.

cannabidiol, duloxetine. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Owing to the potential for both CYP1A2 induction and inhibition with the coadministration of CYP1A2 substrates and cannabidiol, consider reducing dosage adjustment of CYP1A2 substrates as clinically appropriate.

Interaction Checker

Monitor Closely (1) darunavir will increase the level or effect of cannabidiol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider reducing the cannabidiol dose when coadministered with a strong CYP3A4 inhibitor.

Minor

Monitor Closely (1) cannabidiol, trifluoperazine. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Owing to the potential for both CYP1A2 induction and inhibition with the coadministration of CYP1A2 substrates and cannabidiol, consider reducing dosage adjustment of CYP1A2 substrates as clinically appropriate.