Epidiolex and Epilepsy – Everything you need to know about

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FDA Approved

Takeaway: Epidiolex is an oral solution containing CBD at the molecular concentration of 100 mg/mL. On 25th of June 2018, Epidiolex was approved by the US Food and Drug Administration department as a pharmaceutical for treatment of patients with high seizure diseases. This marked the entry of natural extracts of cannabis in the long chemical dominated pharmaceutical market. Known for helping patients with Epilepsy, it is advised to consume Epidiolex from a starting dosage of 2.5mg/kg of weight, twice a day. Higher doses must only be taken upon recommendation of a doctor.

The use of Cannabidiol or CBD oil for epilepsy treatment is undoubtedly one of the hottest debates in the medical environment today. While there are lots of contrasting arguments, many studies over the years have proven CBD potency in several neurological conditions.

For decades, Marijuana (Cannabis sativa) has been a Schedule I drug (termed illegal). But today Epidiolex an oral solution of CBD is now generally accepted as a prescription medicine used to treat seizures especially epilepsy. Lots of persons with reported seizures have confirmed its effectiveness long before its approval. What’s more, now it has become something of a trendy wellness product.  Read further, and you will find useful information about Epidiolex.

What is Epidiolex and is it really FDA approved?

Epidiolex is plant-derived cannabidiol (CBD) medication. Simply put, an oral cannabidiol solution with a strawberry flavor. The best part? It is a non-psychoactive extract from marijuana plant that does not have an altering effect on the mind. Reason being that it is void of THC (tetrahydrocannabinol) the main psychoactive component of the plant. Epidiolex (CBD) is now the most recent medication option for treatment of seizures, especially Lennox-Gastaut syndrome and Dravet syndrome. Two rare and awful forms of epilepsy that begin in childhood.

On the 25th of June 2018, Epidiolex was approved by the United States Food and Drug Administration as a pharmaceutical, highly purified form of cannabidiol for treatment of patients with epilepsy. Although other synthetic forms of THC has been approved before now, this approval is quite remarkable as it is the first time a drug made from natural “cannabis plant itself” is getting approved by the FDA. And this has led to its popularity over time. Both adults and children who are at least two years old can now turn to CBD for seizure treatment.

What are its benefits?

The benefits of CBD for epilepsy treatment cannot be overemphasized – especially in reducing the frequency of seizures. This has been confirmed in three large clinical trials. These clinical trials were conducted on about 516 children who had either Dravet syndrome or Lennox-Gastaut syndrome. According to reports, these children usually face multiple seizures per day which led to a high mortality rate. But upon administration of CBD over a period of time, data from the studies revealed CBD effectiveness and anti-seizure properties. Strong evidence was also seen in the reduction of the worst symptoms of these kinds of epilepsy.

So for persons who have battled with seizures, especially those associated with Epilepsy, this new medication helps to reduce the number of seizures they experience. More than that, although this drug is designed to treat epilepsy, other therapeutic benefits in neurological conditions such as chronic pain and anxiety have also been reported.

How to use Epidiolex?

It is advised to use this drug, strictly adhering to all prescription by your physician. The drug is administered orally (by mouth), basically twice daily. You can take it with or without food but be sure to stick to one pattern. The best way to administer Epidiolex is with a calibrated device (unlike other drugs that may advise the use of tablespoon). Your doctor will give you an oral syringe. This is in order to measure accurately, the prescribed dose at any time.  At the start they are usually smaller doses and can progress to higher ones, keeping the body’s reaction in check. Perhaps your doctor changes your dose for any reason, make sure you stick to taking the drug same time each day.

Are there any recommended doses?

CBD Oil

The use of Epidiolex is strictly based on recommended doses, especially by your physician. The dose is usually calculated per body weight. Other factors that may affect the dose includes the medical history and or any kind of medication being taken at the time. For a start, patients are advised to follow a dose of 2.5mg/kg twice daily. Thereafter, they can proceed to higher doses like 5mg/kg twice daily. In a case where the body is able to tolerate the aforementioned doses if more seizure reduction is required, a maximum dose of 10mg/kg is advised twice daily. The highest dose that is recorded is 20mg/kg at once per day.

Are there side effects?

Just like any other drug, clinical trials have shown that cannabidiol may result in side effects. Some of which may go away as the body adjusts to the treatment. But if they persist, please check with your health care professional. The most common side effects, however, include:

  • Diarrhea
  • Elevated liver enzymes (transaminases)
  • Infection
  • Irritability
  • Anger/ aggression
  • Lower back or side pain
  • Fatigue
  • Loss of appetite
  • Insomnia
  • Agitation
  • Rash
  • Sleepiness/ dizziness/ drowsiness
  • Poor quality sleep
  • Liver injury

What are the precautions to take?

CBD for seizure treatment

The use of CBD for seizure treatment must be done taking into cognizance important guides in order to avoid adverse effects from drug usage. Here are a few things to keep in mind:

  • The drug is not approved for use on children younger than 2 years.
  • Always measure the drug carefully using a well-calibrated device to avoid altering doses.
  • Keep the bottle tightly closed and store at room temperature.
  • Refrigerating or freezing is not advised.
  • If you have had any liver disease or another form of neurological disorder history, alert your doctor.
  • When discontinuing CBD use, do not do that at a blink. Follow a gradual decrease of doses.
  • The intake of high fat or high-calorie meal while taking these drugs may increase the extent of drug absorption.
  • People taking this medication should be monitored for any form of hypersensitivity.
  • For use during pregnancy, there are no recorded data regarding its harm to an unborn baby.
  • Some studies suggest that it may not be safe to use while breastfeeding.

Bottom line

If Epidiolex wasn’t beneficial, then it sure wouldn’t have been FDA approved. With this approval, many researchers and medical professionals believe that this is just one milestone that will lead to further positive changes in the medical marijuana industry. More than that, researchers are also delving into the hidden potentials of other cannabis compounds for therapeutic purposes. We can only hope for more positive breakthroughs.

2 COMMENTS

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