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cbd oil epilepsy dosage

cannabidiol (Rx)

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Dosing & Uses

Dosage Forms & Strengths

solution, oral
  • 100mg/mL

Seizures

Indicated for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC)

LGS or DS
  • 2.5 mg/kg PO BID initially; after 1 week, may increase to maintenance dose of 5 mg/kg BID
  • If 5 mg/kg BID tolerated and further seizure reduction required, patient may benefit from a dosage increase up to a maximum recommended maintenance dosage of 10 mg/kg BID (ie, 20 mg/kg/day)
  • Increasing to 10 mg/kg BID may be achieved by increased weekly increments of 2.5 mg/kg BID, as tolerated
  • If a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased no more frequently than every other day
  • Administration of the 20-mg/kg/day dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions
  • Starting dose: 2.5 mg/kg PO BID
  • Increase dose in weekly increments of 2.5 mg/kg BID as tolerated, to recommended maintenance dose of 12.5 mg/kg BID
  • If a more rapid titration is warranted, the dosage may be increased no more frequently than every other day
  • Effectiveness of doses 3 x ULN in presence of elevated bilirubin without alternative explanation are important predictors of severe liver injury and should be evaluated before initiating cannabidiol

Hepatitis (Orphan)

Orphan designation for treatment of autoimmune hepatitis

Orphan sponsor
  • Revive Therapeutics Ltd; 5 Director Court, Suite 105; Vaughan, Ontario; Canada

Huntington Disease (Orphan)

Orphan designation for delta-9-THC and cannabidiol for treatment of Huntington disease

Sponsor
  • MMJ International Holdings; 1895 Preston White Drive, Suite 101; Reston, Virginia 20191

Dosage Forms & Strengths

solution, oral
  • 100mg/mL

Seizures

Indicated for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients aged ≥1 yr

Age ≥1 year
LGS or DS
  • 2.5 mg/kg PO BID initially; after 1 week, may increase to maintenance dose of 5 mg/kg BID
  • If 5 mg/kg BID tolerated and further seizure reduction required, patient may benefit from a dosage increase up to a maximum recommended maintenance dosage of 10 mg/kg BID (ie, 20 mg/kg/day)
  • Increasing to 10 mg/kg BID may be achieved by increased weekly increments of 2.5 mg/kg BID, as tolerated
  • If a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased no more frequently than every other day
  • Administration of the 20-mg/kg/day dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions
    • Starting dose: 2.5 mg/kg PO BID
    • Increase dose in weekly increments of 2.5 mg/kg BID as tolerated, to recommended maintenance dose of 12.5 mg/kg BID
    • If a more rapid titration is warranted, the dosage may be increased no more frequently than every other day
    • Effectiveness of doses 3 x ULN in presence of elevated bilirubin without alternative explanation are important predictors of severe liver injury and should be evaluated before initiating cannabidiol

    Absence Epilepsy (Orphan)

    Orphan designation for treatment of childhood absence epilepsy

    Orphan sponsor
    • Insys Development Company, Inc; 1333 South Spectrum Blvd, Suite 100; Chandler, Arizona 85286

    Clinical trials did not include any patients aged >55 yr to determine whether or not they respond differently from younger patients

    In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy

    Interactions

    Interaction Checker
    Contraindicated
    Serious – Use Alternative
    Significant – Monitor Closely
    Minor

    Adverse Effects

    >10% (LGS or DS)

    Infections, all (40-41%)

    Infection, other (21-25%)

    Decreased appetite (16-22%)

    Transaminases elevated (8-16%)

    Fatigue, malaise, asthenia (11-12%)

    Infection, viral (7-11%)

    >10% (TSC)

    Elevated transaminases (25%)

    Decreased appetite (20%)

    1-10% (LGS or DS)

    Irritability, agitation (5-9%)

    Anger, aggression (3-5%)

    Decreased weight (3-5%)

    Hypoxia, respiratory failure (3%)

    Infection, fungal (1-3%)

    1-10% (TSC)

    Gait disturbance (9%)

    Ear infection (8%)

    Decreased weight (7%)

    Decreased platelet count (5%)

    Increased eosinophil count (5%)

    Fatigue, malaise, asthenia (5%)

    Urinary tract infection (5%)

    Warnings

    Contraindications

    Hypersensitivity to cannabidiol or any of the product ingredients

    Cautions

    Can cause somnolence and sedation that is dose-related; clobazam and other CNS depressants, including alcohol, may potentiate this adverse effect; monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on drug to gauge whether it adversely affects their ability to safely drive or operate machinery

    Antiepileptic drugs (AEDs), including cannabidiol, increase risk of suicidal thoughts or behavior in patients taking these drugs for any indication; patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior

    May cause hypersensitivity reactions (eg, pruritus, erythema, angioedema)

    As with other AEDs, cannabidiol should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus; if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered

    Therapy can cause weight loss, which may be dose-related

    A decrease in hemoglobin and hematocrit reported with no effect on red blood indices

    Elevation of serum creatinine reported within 2 weeks of initiating therapy that was reversible in healthy adults; mechanism not determined

    Medscape – Seizure dosing for Epidiolex (cannabidiol), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information.

    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.

    This shows a child sleeping with a teddy bear

    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.

    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.