WHAT IS EPIDIOLEX?
Epidiolex is a pharmaceutical-grade CBD oral solution. It is a clear, colorless-to-yellow liquid containing CBD at a concentration of 100 milligrams per milliliter (100 mg/mL). Other ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.
Epidiolex is the first FDA-approved cannabis-based medication in the US, initially for treating seizures in treatment-resistant forms of Dravet syndrome and LGS. Phase 3 clinical trials were initiated in 2015, and the FDA approved Epidiolex in June 2018. The trials showed a positive result in reducing seizures in children with Dravet syndrome and LGS.
Also, Epidiolex is approved for those with treatment-resistant seizures associated with Dravet, LGS, or tuberous sclerosis complex, but physicians may prescribe it off-label for other conditions.
cannabidiol oral solution is made with CBD derived from cannabis instead of being a synthetic cannabinoid. Epidiolex is a 99% pure oral CBD extract and does not contain tetrahydrocannabinol (THC), other cannabinoids, or terpenes.
CBD OIL VS EPIDIOLEX
Patients have a common question: “Are CBD oil and cannabidiol oral solution the same thing?” The answer is “No.”
When people talk about CBD oil, they usually refer to hemp-derived CBD oil that is legally available on the market. However, this is not approved for use for any particular medical condition by the FDA. CBD oils can be CBD-only (CBD isolates), broad-spectrum (CBD and terpenes, with no THC), or full-spectrum (CBD, terpenes, and up to 0.3% THC). Their quality is variable, and how accurate their labels are regarding cannabinoid content is up for debate (i.e., there is no standardization of hemp products).
Although 0.3% THC may not seem like much in theory, it may end up being up to 3 mg of THC per 1000 mg (gram) of product. Again, not necessarily a lot for many, but it can affect some who might be particularly sensitive to THC or need specific, extremely low doses. If large doses are required for any effect in a non-pharmaceutical product (e.g., three 30 ml bottles per day), this can end up being a larger amount of THC being ingested. This can cause great variability in a product’s effects. The fact that so many products are inaccurate in their THC and CBD measurements complicates matters further.
Indeed, one study shows that people who used artisanal CBD had a 70% increase in seizures, whereas people utilizing pharmaceutical-grade CBD showed a reduction in seizures. Although the study’s sample size was small (only 31 people), it is worth bearing in mind that the variability of non-regulated, hemp-derived CBD products and the cannabinoids and terpenes in them play a part in determining what effect they have when ingested.
USES & HEALTH BENEFITS OF EPIDIOLEX
CBD has displayed anti-inflammatory properties on top of its well-established anti-seizure properties, making it helpful in treating many different health problems. But we cannot say whether or not CBD is beneficial for health beyond those established by scientific research.
SIDE EFFECTS OF EPIDIOLEX
Adverse side-effects of Epidiolex can include, but are not limited to:
- Sedation and sleepiness
- Fatigue
- Sleep problems
- Rash
- Decreased appetite
- Nausea and vomiting
- Diarrhea
- Fever
- Infections
- An increase in liver enzymes
- Negative interactions with other anti-seizure medications
POTENTIAL INTERACTIONS
CBD may interact with the following antiepileptic drugs (AEDs):
- Firstly, Clobazam
- Secondly, Stiripentol
- Thirdly, Valproic acid and sodium valproate
- Fourthly, Topiramate
- Eslicarbazepine
- Zonisamide
- Brivaracetam
- Gabapentin
- Lastly, Pregabalin
CBD and medical cannabis may also interact with sedatives and antihistamines with sedative properties like zolpidem (Ambien), eszopiclone (Lunesta), and diphenhydramine (Benadryl). Anti-anxiety medications and antidepressants as well, like alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), sertraline (Zoloft), fluoxetine (Prozac), and escitalopram (Lexapro). CBD may also interact with blood thinners like warfarin.
FAQS ABOUT EPIDIOLEX
Is Epidiolex the same as CBD oil?
Is Epidiolex a narcotic?
BUY EPIDIOLEX WITHOUT PRESCRIPTION
Is it possible to test positive for marijuana when using Epidiolex?
Can I drive under the influence of Epidiolex?
EPIDIOLEX AVAILABILITY
Specialty pharmacies have expertise in preparing and filling medicines like cannabidiol oral solution. They fill FDA-approved prescriptions just as traditional pharmacies do. Certain specialty pharmacies can ship your medicine to a local store for pickup. If you are interested in this option, talk to your specialty pharmacy to find out more.
Taking EPIDIOLEX for the first time
Use this worksheet to keep track as you start EPIDIOLEX and work toward the dose that’s right for you.
EPIDIOLEX is an oral solution that is taken twice daily. Food may affect EPIDIOLEX levels, so be sure to take EPIDIOLEX consistently with or without food.
You should take EPIDIOLEX exactly as your doctor tells you. Do not stop taking EPIDIOLEX without first talking to your doctor. Stopping an antiseizure medicine suddenly can cause serious problems.
Your doctor may adjust your dose based on your response to EPIDIOLEX and whether you are experiencing side effects.
Be sure to tell your doctor if you are taking any other medicines so he or she can take that into account when creating your dosing schedule.
Your doctor may also request blood work to evaluate liver function before you start and during treatment.
When starting EPIDIOLEX, your doctor may begin with a lower dose and slowly increase the amount of medicine to reach the dose he or she believes is right for you.
Once that dose is reached, your doctor will evaluate your response.
If needed, your doctor may adjust your EPIDIOLEX dosing further.
What makes EPIDIOLEX different?
Highly Purified CBD
The active ingredient in cannabidiol oral solution is nearly 100% pure CBD, which means EPIDIOLEX will not make you feel “high”
Contaminant free
Strict regulations make sure cannabidiol oral solution contains no toxic heavy metals, no pesticides, and no contaminants
Accurately labeled
Each bottle is guaranteed to be consistent from dose to dose, and to contain the exact amount and concentration of CBD listed on the label. This is important because cannabidiol oral solution uses personalized dosing based on weight
Made without sugar or carbohydrates
EPIDIOLEX is compatible with different epilepsy diets, including the keto diet
Naturally grown
The active ingredient in cannabidiol oral solution is not synthetic. It is a highly purified form of CBD medicine that is greenhouse-grown from non-GMO plants
Rigorously tested safety
The safety profile of FDA-approved cannabidiol oral solution has been studied for over 3 years. More than 40,000 families made the choice to start on cannabidiol oral solution
Non–FDA approved CBD products may be inaccurately labeled
There have been studies of non–FDA approved CBD products that have shown wildly inaccurate labeling. This is because they aren’t regulated in the same way as cannabidiol oral solution.
In one study published in the Journal of the American Medical Association (JAMA), of the non–FDA approved CBD products tested:
26%
had less CBD than claimed
on the label
42%
contained more CBD than
claimed on the label
20%
included detectable levels of
tetrahydrocannabinol (THC) that
could cause intoxication,
especially among children
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