CBD Oil Dosage For Seizures

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Cannabidiol oral solution Epidiolex ® (EH-peh_DYE-oh-lex) oral solution CV is the brand name for the cannabidiol oral solution, also referred to as CBD, from Greenwich Biosciences. The name or Children with drug-resistant epilepsy may find relief with the help of medical cannabis oil that contains both CBD and lose dose THC. The oil, which contains 95% CBD and 5% THC, can reduce or prevent epileptic seizures in those with epileptic encephalopathy. Approximately one-third of epilepsy patients do not become seizure free with antiseizure medications (ASMs). This treatment gap motivates research for new therapeutic options such as cannabidiol (CBD). CBD differs from other cannabis derivatives because of its consistent efficacy and lack of a psychoactive effect. CBD can be recommended as adjunctive therapy in patients with Dravet and Lennox-Gastaut syndromes. The most common adverse effects (AEs) are drowsiness, reduced appetite, diarrhea and vomiting. Transaminase elevation is the most common AE that leads to CBD discontinuation. Coadministration with valproate may increase the risk of hepatotoxicity. The combination of CBD and clobazam may increase both the effectiveness and the risk of AEs associated with these drugs. The most striking gaps in knowledge are the efficacy and optimal dose of cannabidiol for adults with focal epilepsies, thelong-term safety of CBD use and strategies to improve access to CBD for people living with epilepsy.

Cannabidiol oral solution

Epidiolex ® (EH-peh_DYE-oh-lex) oral solution CV is the brand name for the cannabidiol oral solution, also referred to as CBD, from Greenwich Biosciences. The name or look may be different in other countries, but the dose (measured in milligrams, abbreviation “mg”) usually will be the same. Epidiolex is a quality grade of cannabidiol oil that is different from CBD or cannabidiol that is not U.S. Food and Drug Administration (FDA) approved.

Epidiolex is Approved for Use:

EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older.

Blood tests for liver function, called serum transaminases (ALT and AST) and total bilirubin levels should be done in each person before starting Epidiolex.

The dose in children is based on weight, written as milligrams per kilograms or “mg per kg”. It is important to follow the instructions given by the prescribing health care provider.

  • The recommended starting dose is 2.5 mg per kg taken twice a day. (Total daily dose would be 5 mg per kg).
  • Your provider may recommend increasing the dose after 1 week to 5 mg per kg twice a day. (Total daily dose would be 10 mg per kg).
  • Epidiolex can be increased higher if needed to 10 mg per kg twice a day. (Total daily dose would be 20 mg per kg).
  • The dose may be different or changed for people with liver problems.
Brand Name(s)

Cannabidiol oral solution is availabe as 100 mg in each milliliter (abbreviated as “mL”).

  • Each bottle contains 100 mL of a clear colorless to yellow solution with a strawberry flavor.
  • Two 5 mL syringes will come with each bottle of medicine. These can be reused.
  • A 1 mL syringe is available from the pharmacist when smaller doses are needed.
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Frequently Asked Questions
How to take and store Cannabidiol oral solution?

How To Take:

Take Epidiolex exactly as your health care provider prescribes it. Do not change your dose without talking to your provider first. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).

  • Take the medicine twice a day by mouth.
  • Check the amount and concentration of the oral solution from the pharmacy.
  • A special measuring device (called a syringe) will come with each prescription bottle. Use this syringe to measure the exact dose of medicine. Do not use a regular teaspoon to measure the medicine.
  • Use a dry syringe each time you measure a dose of Epidiolex. Water inside the syringe could make the oil-based medicine look cloudy.
  • Take the medicine about the same time each day with or without food. Certain foods can increase the amount of Epidiolex that is absorbed in your body, so take it the same way each day.
  • Take only the amount that your provider tells you to take.
  • If you take an extra dose, call your provider for advice.
  • If you take a larger amount of the liquid, call the poison control center (800-222-1222) or call your hospital emergency department for instructions.
  • When Epidiolex is stopped, the dose should be lowered slowly. Your provider will give you specific instructions on how to do this.

How To Store:

  • Store Epidiolex in its original bottle in an upright position at 68°F to 77°F.
  • Do not refrigerate or freeze the medicine.
  • Keep the child proof cap closed tightly.
  • Use the medicine within 12 weeks of first opening the bottle. Throw away any unused medicine after 12 weeks.
  • Keep Epidiolex out of reach of children.
What if I forget?

Taking the right amount of seizure medicine, on time every day, is the most important way to control seizures.

  • If you miss a dose, take it as soon as you remember it.
  • If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time.
  • Avoid taking 2 doses at the same time or taking extra doses.
  • If you are not sure about what to do, call your provider’s office for advice and follow their directions.
  • To avoid missed doses, set an alarm on your watch, phone or other digital device.
  • Use an online seizure diary or text message system (Texting 4 Control) to send you reminders of when to take medicines.
  • Write down any missed doses in your seizure diary. Share this with your health care provider at each visit.
How does Cannabidiol oral solution affect the brain?

There are different ways that medicines can affect the brain to stop seizures. In general, seizure medicines make the brain less likely to have seizures by lowering the excitability of brain cells that cause seizures.

  • The exact way that Epidiolex works to control seizures is unknown. Scientists believe Epidiolex works in more than one way.
  • Epidiolex may inhibit or slow down the way messages or signals are sent in the brain. It may change calcium levels in brain cells that are important for sending messages or signals between cells. The medicine may also decrease inflammation in the brain.
  • Researchers continue to study how cannabidiol works to help stop seizures.
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How does the body digest Cannabidiol oral solution?
  • After a medicine is swallowed, it is absorbed into the bloodstream and travels through the body and to the brain.
  • The way the body metabolizes or breaks down a medicine affects how often it must be taken.
  • Epidiolex is broken down primarily in the liver and the gut. It is cleared from the body through the feces and in a small amount through urine.
How well does the Cannabidiol oral solution work?

Epidiolex has been tested in people with Lennox-Gastaut (LGS) and Dravet Syndrome (DS).

  • In controlled trials in people with LGS (age 2 to 55 years), the number of drop seizures (atonic, tonic, or tonic-clonic seizures) decreased significantly from baseline for people taking 10 mg per kg per day and 20 mg per kg per day. Improvements were also seen in non-drop seizures.
  • In trials of 120 people with DS (age 2 to 18 years), the average (median) decrease in number of convulsive seizures was significantly greater for people taking 20 mg per kg per day (39% decrease) than for people taking placebo (13% decrease).
What are the most common side effects of Cannabidiol oral solution?

Call your health care provider if side effects occur that bother you. These may go away on their own or the dose of medicine may need to be changed. Sometimes side effects mean that you don’t tolerate the medicine and the medicine may need to be stopped. Don’t stop taking any medicine suddenly on your own.

  • Sleepiness
  • Decreased appetite
  • Diarrhea
  • Increase in liver enzymes
  • Rash
  • Sleep problems
  • Infections

Since Epidiolex may make some people sleepy, do not drive, use heavy equipment or do other dangerous activities until you know how Epidiolex affects you. People who are not seizure free also may not drive due to legal restrictions. Talk to your doctor about your seizure control, medicines, and ability to drive.

What are the most serious side effects of Cannabidiol oral solution?

Serious side effects of Epidiolex are rare. It is important to be aware of possible reactions and what to do if they happen. Only a very small number of people have died from them.

  • Read the package insert for a complete list of all reactions to Epidiolex.
  • Call your provider’s office right away if any of these problems occur.

Allergic or hypersensitivity reactions: Tell your provider if you develop any redness, itching, rash, or swelling after starting Epidiolex. These may need treatment or the drug may be stopped.

  • Epidiolex should not be given to anyone with a prior reaction or sensitivity to cannabidiol or any of the other ingredients in the product. Sesame seed oil is present in Epidiolex.

Liver problems: Increases in liver function can be seen on blood tests in some people taking Epidiolex, especially people who may also be taking valproate (also called valproic acid or sodium valproate). It has also been seen in people taking clobazam with Epidiolex.

  • Increases in the liver function tests were usually seen in the first two months of starting the drug. The changes can be seen months later however, especially if a person also takes valproate.
  • In 1 out of 3 people the blood tests returned to normal without any changes in medicine. In other people, the problems went away when Epidiolex was stopped or the dose of valproate or Epidiolex was lowered.

Monitoring for liver function: Blood tests for liver function should be done before starting Epidiolex and after taking it for 1, 3 and 6 months. Talk to your health care provider about when to have these done.

Some symptoms of liver problems may include:

  • Black or pale color of bowel movements
  • Loss of appetite
  • Nausea, upset stomach, vomiting
  • Stomach pain
  • Tired
  • Yellow eyes or skin
  • Dark urine

Tell your health care provider right away if you notice any of these problems. Do not stop taking Epidiolex or any seizure medicine without your doctor’s advice.

Somnolence and Sedation: Some people taking Epidiolex may be unusually tired, sleepy or sedated. In controlled trials, these symptoms were seen in 1 out of 3 people taking the drug compared to 1 out of 10 people taking a placebo (inactive pill).

  • Sleepiness and sedation happened more often in people also taking clobazam (Onfi).
  • The symptoms were seen early when the medicine was started and tended to improve over time.
  • Other medicines that cause sedation or sleepiness or using alcohol could make this worse in people taking Epidiolex.
  • Talk to your health care provider if sleepiness happens and if you are taking clobazam (Onfi) or other substances that cause sleepiness.

Suicidal thoughts and behavior: In 2008, the Food and Drug Administration (FDA) reviewed data from drug studies that showed a possible relationship between many seizure medicines and suicidal thoughts and behavior. Together, these thoughts and behavior are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance – 3.5 of 1,000 people taking a seizure medicine had suicidality compared to 1 of 1,000 people taking a placebo.

  • Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
  • Do not make any changes to the medicines without first talking to your prescribing health care provider.
  • Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
  • Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
    • Talking or thinking about wanting to hurt yourself or end your life
    • Withdrawing from friends and family
    • Becoming depressed or having your depression get worse
    • Becoming preoccupied with death and dying
    • Giving away prized possessions

    Withdrawal of seizure medicines: Epidiolex, just like any seizure medicine, should be withdrawn slowly when it is being stopped. Stopping Epidiolex or any seizure medicine suddenly can lead to more seizures and life-threatening status epilepticus.

    Cannabis dosage studied to reduce seizures in children with severe epilepsy

    Summary: Children with drug-resistant epilepsy may find relief with the help of medical cannabis oil that contains both CBD and lose dose THC. The oil, which contains 95% CBD and 5% THC, can reduce or prevent epileptic seizures in those with epileptic encephalopathy.

    Source: University of Saskatchewan

    Medicinal cannabis oil containing both cannabidiol (CBD) and a small amount of THC can reduce or end seizures in children with severe, drug-resistant epilepsy, a study by the University of Saskatchewan (USask), Canada has found.

    Children with severe epilepsy also experienced improvements in their quality of life after taking low doses of the medicinal cannabis oil, according to research published in Frontiers in Neurology.

    The study tested the effects of medicinal cannabis oil with 95 percent CBD, a chemical which does not create a high, and 5 percent THC, a substance which can be intoxicating in large enough doses.

    Studying an evidence-based scientifically guided dosage regimen, the research team found no evidence of THC intoxication when using CBD-enriched whole plant extracts.

    “What makes these results really exciting is it opens up as a treatment option for kids who have failed to respond to traditional medications,” said Dr. Richard Huntsman (M.D), a pediatric neurologist who led the study.

    Three of the seven children in the USask study–mainly funded by Saskatchewan’s Jim Pattison Children’s Hospital Foundation–stopped having seizures altogether.

    “Some of the improvements in quality of life were really dramatic with some of the children having huge improvements in their ability to communicate with their families. Some of these children started to talk or crawl for the first time. They became more interactive with their families and loved ones,” said Dr. Huntsman.

    Several studies have shown that cannabis products containing CBD can be effective in helping to control seizures in children with epileptic encephalopathy, a severe form of epilepsy which begins in childhood. Despite this, many children cannot access these products because there is very little guidance for physicians on which doses to use and some health-care providers are concerned about possible intoxication from THC.

    This research found that most of the children had a reduction in seizures with a twice-daily dose of CBD totaling 5-6 milligrams of cannabis extract per kilogram of weight (mg/kg) per day. By the time a CBD dose of 10-12 mg/kg per day was achieved, all children experienced a reduction in their seizures, most by more than 50 percent.

    “What is really important is that we have been able to dispel in a scientific manner some of the concerns about how to dose these products and the possibility of them causing a ‘high’ in these children. We did this by slowly increasing the dose of cannabis extract in a very tightly regulated manner. We watched the children very closely for side effects and measured blood levels of CBD and THC,” said Dr. Huntsman,

    The children had drug-resistant epilepsy, failing to respond to at least two forms of anti-convulsant medication. They had been prescribed several anti-convulsant medications yet continued to have seizures, with one child experiencing 1,223 in the month leading up to the study.

    “We are very proud to support this important pediatric research, which is making such a difference in the lives of children who have severe epilepsy,” said Brynn Boback-Lane, President and CEO of Jim Pattison Children’s Hospital Foundation.

    “This groundbreaking study is giving hope and improved health outcomes. It is heartening to have donors that see the value of such important work.”

    Allyssa Sanderson’s eight-year-old son Ben from Prince Albert, Sask. was one of the participants in the study. Ben was born without complications but later developed infantile spasms. When Ben was two, he was diagnosed with Lennox-Gastaut syndrome, a severe form of epilepsy.

    Studying an evidence-based scientifically guided dosage regimen, the research team found no evidence of THC intoxication when using CBD-enriched whole plant extracts. The image is in the public domain.

    Despite trying multiple medications and treatments, Ben’s seizures were unpredictable. He was seizure-free on some days, but on others had 150 seizures a day.

    “Ben was very lethargic and would just lay there and have seizures all day. He wasn’t active and didn’t even want to eat. His eyes looked dull, and he didn’t focus on anything. He really looked lifeless,” Allyssa explained. “I knew this trial was a last resort for my son.”

    Once Ben started taking CBD, he began showing improvements in his seizure frequency and then became seizure-free during the study.

    “I was seeing the change in Ben every single day. I was thankful as I watched his little personality come out. He was back to his silly self that I hadn’t seen in years. He was stronger. I believe this research is one of the greatest things to happen for kids with epilepsy,” Allyssa said.

    Cannabidiol in the Treatment of Epilepsy: A Focused Review of Evidence and Gaps

    Approximately one third of epilepsy patients do not become seizure free with antiseizure medications. This treatment gap motivates research for new therapeutic options, such as cannabidiol (CBD). CBD differs from other cannabis derivatives because of its consistent efficacy and lack of a psychoactive effect. CBD can be recommended as adjunctive therapy in patients with Dravet and Lennox-Gastaut syndromes. The most common adverse effects (AEs) are drowsiness, reduced appetite, diarrhea, and vomiting. Transaminase elevation is the most common AE that leads to CBD discontinuation. Coadministration with valproate may increase the risk of hepatotoxicity. The combination of CBD and clobazam may increase both the effectiveness and the risk of AEs associated with these drugs. The most striking gaps in knowledge are the efficacy and optimal dose of CBD for adults with focal epilepsies, the long-term safety of CBD use, and strategies to improve access to CBD for people living with epilepsy.

    Introduction

    Epilepsy can be a therapeutic challenge. Despite the growing number of antiseizure medications (ASMs), approximately one third of patients with epilepsy have persistent seizures (1). Surgical treatment, although still underused, may be an alternative in up to 25% of these cases (2). Therefore, many patients are not seizure free. This treatment gap motivates research on new ASMs, such as cannabidiol (CBD).

    The medical use of marijuana has gained considerable interest in the press in the last two decades. Three reasons for this are (a) the appeal of being a “natural” alternative treatment (3); (b) the discovery of a complex cell-signaling system responsive to cannabis, the endocannabinoid system (4); and (c) prominent public cases, such as Charlotte Figi in the United States (5).

    Cochrane and American Academy of Neurology reviews determined that there was no scientific evidence to support the use of cannabis for epilepsy in 2014 (6, 7). At that time, there were only four placebo-controlled studies on cannabinoid use in epilepsy (8–11). All studies show inadequate power and methodological problems, but despite this, there has been an increasing use of CBD for the treatment of epilepsy (12).

    Cannabinoids are obtained from different species of cannabis. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are two of the most prominent cannabinoids found in the Cannabis plant (3). THC is responsible for the psychoactive effects of marijuana, but studies on its effects on epilepsy have shown conflicting results (13–16). THC binds to type 1 cannabinoid receptors (CB1) present in the basal ganglia, cerebellum, hippocampus, hypothalamus, and limbic system. Anandamide and 2-arachidonoylglycerol are endogenous cannabinoid agents that act on presynaptic CB1 and cause a reduction in excitatory activity. As THC is a partial agonist, this could explain the proconvulsant effect.

    CBD is a cannabinoid that lacks psychoactive effects. It has a more consistent antiepileptic efficacy than THC (17, 18). CBD does not activate cannabinoid receptors. It does, however, interact with several other signaling systems. Transient receptor potential vanilloid type 1 (TRPV1)-mediated signaling may be the most relevant pathway in the anticonvulsant effect of CBD (19–21).

    Evidence on Effectiveness

    In 2016, Dr. Orrin Devinsky presented an open-label study with 214 pharmacoresistant child-onset epilepsy patients who received CBD. Dravet (20%) and Lennox-Gastaut (19%) syndromes were the most frequent causes. The initial dose of 5 mg/kg/day was increased up to a maximum dose of 50 mg/kg/day if tolerated. The median monthly frequency of motor seizures was 30.0 at baseline and was reduced to 15.8 over the 12-week treatment period (22).

    Another open-label study was performed in patients with pharmacoresistant epilepsy with tuberous sclerosis who received CBD. The initial dose of 5 mg/kg/day was increased by 5 mg/kg/day every week up to a maximum dose of 50 mg/kg/day if tolerated. The median reduction in total weekly seizure frequency was 48.8% after 3 months of treatment (23).

    In 2017, the first randomized, double-blinded, placebo-controlled study evaluating high-purity CBD in patients with Dravet syndrome was published (24). The intervention group received a highly pure 100 mg/ml CBD solution. The dose was increased up to 20 mg/kg. The percentage of patients who had at least a 50% reduction in convulsive-seizure frequency was 43% after a 14-week treatment period with CBD. The overall conditions improved by at least one category on the Caregiver Global Impression of Change scale for 62% of patients in the CBD group. Three patients in the CBD group were seizure free. There was no significant reduction in nonconvulsive seizures.

    In 2018, a randomized, double-blind, placebo-controlled study was published on patients with Lennox-Gastaut syndrome who used CBD (25). The patients had two or more drop seizures per week and a mean age of 16 years. Favorable outcomes were found in the 10 and 20 mg/kg CBD groups during the treatment period with a median percentage reduction from baseline in the frequency of drop seizures of 37.2 and 41.9% in the 10 and 20 mg/kg CBD groups, respectively.

    Secondary outcomes were also significant. Thirty-six percent and 39% of patients had at least a 50% reduction from their baseline in drop-seizure frequency in the CBD groups compared with 14% in the placebo group. Furthermore, compared with the placebo group, a greater percentage of patients had at least a 75% reduction from baseline in drop-seizure frequency (11 and 25% in the CBD groups, 3% with placebo). Some patients became free from drop seizures during the entire maintenance phase in the CBD groups (4% and 7%, 1% in the placebo group).

    The estimated median difference in reduction from baseline in the frequency of all seizures was 19.5 (p = 0.002) and 18.8 (p = 0.009) percentage points in the 10 and 20 mg CBD groups, respectively. Additionally, an improvement from baseline in overall condition according to the Patient or Caregiver Global Impression of Change at the last visit was reported in 66 and 57% of 10 and 20 mg CBD-treated patients, respectively, compared to 44% in the placebo group with an odds ratio of 2.57 (p = 0.002) for the 10-mg cannabidiol group vs. the placebo group and 1.83 (p = 0.04) for the 20 mg cannabidiol group.

    Another randomized, double-blind, placebo-controlled phase 3 trial investigated the efficacy of CBD as an add-on therapy for drop seizures in patients with treatment-resistant Lennox-Gastaut syndrome. The results confirmed the efficacy of CBD with a median percentage reduction in monthly drop seizure frequency from a baseline of 43.9% in patients treated with 20 mg/kg of CBD compared to 21.8% in the placebo group. Other secondary outcomes were positive, including a greater proportion of patients experiencing a reduction of ≥75% seizures during the treatment period (20% CBD vs. 8% on placebo; p = 0.0273) (26).

    A systematic review identified six randomized controlled studies (27). The average age of the participants was 16.1 years (0.5–55 years). At a dose of 20 mg/kg/day, the number needed to treat to one person experiencing 50%+ seizure reduction was 8. CBD was more effective than placebo at achieving complete seizure freedom. In 14 observational studies, 8.5% of patients were seizure free (95% CI, 3.8–14.5%).

    Another recent systematic review (28) evaluated the role of concomitant clobazam (CLB) use on the efficacy of CBD in patients with Dravet syndrome and Lennox-Gastaut syndrome and enrolled 714 participants in four trials (429 treated with CBD, 240 with taking concomitant CLB). The percentages of patients not taking CLB who had at least a 50% reduction in seizure frequency during the treatment period were 29.1% with CBD and 15.7% in the placebo group (RR 1.80, p = 0.015); among patients receiving CLB, a 50% reduction in seizure frequency was achieved by 52.9 and 27.8% in the CBD and placebo groups, respectively (RR 1.85, p < 0.001). This study suggests that despite the drug–drug interactions that occur between CBD and CLB, adjunctive treatment with CBD can reduce seizures independent of concomitant CLB, reinforcing that CBD has intrinsic antiseizure activity (28).

    Available data indicate that patients cotreated with CBD and CLB have higher response rates, highlighting that both pharmacodynamic and pharmacokinetic interactions may contribute to the efficacy of this combination (29).

    Therefore, CBD is effective as an adjunctive therapy in the treatment of drug-resistant childhood-onset epilepsy. Nevertheless, current evidence is restricted to rare and severe epileptic syndromes. A summary of CBD effectiveness can be seen in Table 1 and Figure 1 (12).

    Table 1. Major studies about CBD in the treatment of epilepsy.

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