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epidiolex definition

It is important to know that even though marijuana is a plant, it is broken down in a person’s liver like many medicines. People mistakenly believe that marijuana is completely safe because it is a plant or oil from a plant. However, medication interactions can occur.

The use of cannabis to treat epilepsy and other neurological conditions has been studied for a number of years. It has been hotly debated too.

NEJM May 2018

Does cannabis have side effects?

Epidiolex is a purified (> 98% oil-based) CBD extract from the cannabis plant. It is produced by Greenwich Biosciences (the U.S. based company of GW Pharmaceuticals) to give known and consistent amounts in each dose.

While the carry-on quantity of liquids is less than 3.4 ounces/100mL, TSA allows larger amounts of medically necessary liquids in reasonable quantities for your trip. However, you must declare them to security officers at the checkpoint for inspection. In checked baggage, liquid medications are allowed without packing requirements, quantity limitations, or notification requirements. Learn more on TSA’s website.

A summary of the Epidiolex clinical trials is found below:

In May 2019, the Transportation Security Administration (TSA) updated its guidelines on traveling with CBD products. When you fly, you can now carry on or pack in checked baggage products/medications that contain hemp-derived CBD (with less than 0.3% THC) or are approved by the FDA, such as Epidiolex.

You can ask your pharmacist or healthcare provider for information about EPIDIOLEX that is written for health professionals.

The effectiveness of EPIDIOLEX for the treatment of seizures associated with TSC was demonstrated in a randomized, double-blind, placebo-controlled trial in 224 patients aged 1 to 65 years (Study 4; NCT02544763).

EPIDIOLEX can cause elevations in serum creatinine. The mechanism has not yet been determined. In controlled studies in healthy adults and in patients with LGS, DS, and TSC, an increase in serum creatinine of approximately 10% was observed within 2 weeks of starting EPIDIOLEX. The increase was reversible in healthy adults. Reversibility was not assessed in studies in LGS, DS, or TSC.

Mechanism Of Action

Effect Of Food

Cannabidiol was negative for genotoxicity in in vitro (Ames) and in vivo (rat Comet and bone marrow micronucleus) assays.

Coadministration with the potent CYP3A4 and CYP2C19 inducing agent rifampin caused a decrease in cannabidiol exposure of 32% and 34% for AUC and Cmax [see DRUG INTERACTIONS]. There were moderate changes in exposure to the active metabolite (7-OH-CBD decreased by 63% and 67% for AUC and Cmax, 7-COOH-CBD decreased by 48% for AUC, whereas there was no change in Cmax).

Discard any unused EPIDIOLEX remaining 12 weeks after first opening the bottle [see HOW SUPPLIED/ Storage and Handling].