CANNABIDIOL

- Everything we could find out about it

Home ] [ Controlled Substances ] [ Cannabinoids ]

Created Mar 2019 | Updated Nov 2020

CANNABIDIOL

  • [CBD]
  • [EPIDIOLEX]

(AS DEFINED IN 21 CFR 1308.15(F)), A DRUG PRODUCT IN FINISHED DOSAGE FORMULATION THAT HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION THAT CONTAINS CANNABIDIOL DERIVED FROM CANNABIS AND NO MORE THAN 0.1 PERCENT (W/W) RESIDUAL TETRAHYDROCANNABINOLS.

DEA CODE 7367: Schedule 5

Cannabidiol is the major nonpsychoactive ingredient in cannabis. Cannabidiol demonstrates a range of effects that may be therapeutically useful, including anti-seizure, antioxidant, neuroprotective, anti-inflammatory, analgesic, anti-tumor, anti-psychotic, and anti-anxiety properties. Exact mechanism of action of cannabidiol is not known. GW Pharmaceuticals successfully developed the world's first prescription medicine derived from the cannabis plant, Sativex (buccal spray containing delta-9-tetrahydrocannabinol and cannabidiol) now approved in over 29 countries outside of the United States for the treatment of spasticity due to Multiple Sclerosis. GW Pharmaceuticals is developing Epidiolex (a liquid formulation of pure plant-derived cannabidiol) for certain rare and severe early-onset, drug-resistant epilepsy syndromes.

Cannabidiol: https://www.nonpsychotoxic.com/definition.php?term=cbd

Liver:
Cannabidiol is associated with frequent serum enzyme elevations during therapy particularly with higher doses but has not been linked to cases of clinically apparent liver injury with jaundice.

Cannabidiol Hepatotoxicity:
In prelicensure studies, serum aminotransferase elevations arose during cannabidiol therapy in 34% to 47% of patients compared to 18% of controls who were receiving other anticonvulsant medications. Elevations above 3 times ULN occurred in 13% of cannabidiol treated compared to 1% on placebo. ALT and AST elevations were more frequent with higher doses and were particularly common (and sometimes delayed) in patients who were receiving valproate and clobazam. The aminotransferase elevations typically arose within the first two months of treatment and were transient, mild-to-moderate in severity, and not associated with symptoms or jaundice. There have been no convincing reports of clinically apparent liver injury with jaundice attributable to cannabidiol, but it has had very limited general use.

E* Likelihood score: E* (unproven but suspected rare cause of clinically apparent liver injury).


Important Information:
Cannabidiol can harm your liver. Your liver function may need to be checked before and during treatment.

Call your doctor at once if you have symptoms such as:

  • nausea
  • vomiting
  • loss of appetite
  • right-sided upper stomach pain
  • tiredness
  • itching
  • dark urine
  • yellowing of the skin or eyes

Avoid driving or hazardous activity until you know how cannabidiol will affect you.

Some people have thoughts about suicide while taking cannabidiol. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Drinking alcohol with cannabidiol can increase drowsiness.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Interactions:

Drug Interactions (536) Alcohol/Food Interactions (2) Disease Interactions (2)


What other drugs will affect Cannabidiol?
Using cannabidiol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Tell your doctor about all your other medicines, especially:

  • other seizure medications (especially clobazam or valproate)
  • cannabis-based products
This list is not complete. Many other drugs can affect cannabidiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

A total of 536 drugs are known to interact with Cannabidiol.

Pediatric:
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cannabidiol in children 1 year of age and older.

Safety and efficacy have not been established.

Geriatric:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cannabidiol in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Other Interactions:

  • Ethanol

Other Medical Problems:
Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol or drug abuse, history of
  • Depression - Use with caution. May make these conditions worse
  • Liver disease, moderate to severe - Use with caution. The effects may be increased because of the slower removal of the medicine from the body

Breastfeeding:

Summary of Use During Lactation:
Cannabidiol is a component of cannabis.

Cannabidiol has not been studied in nursing women taking the pharmaceutical product, but it has been detected in the breastmilk of some mothers who used cannabis products.

Because no published information is available with cannabidiol use as an antiepileptic during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Alternate Drugs to Consider:

  • (Seizure Disorder) Carbamazepine
  • Divalproex
  • Gabapentin
  • Lamotrigine
  • Oxcarbazepine
  • Phenytoin
  • Valproic Acid

World Health Organization 2017:
  • Cannabidiol (CBD) is one of the naturally occurring cannabinoids found in cannabis plants. It can also be produced synthetically.
  • CBD can be converted totetrahydrocannabinol (THC)under experimental conditions; however, this does not appear to occur to any significant effectin patients undergoing CBD treatment.
  • In experimental models of abuse liability, CBD appears to have little effect on conditioned place preference or intracranial self-stimulation. In an animal drug discrimination model CBD failed to substitute for THC. In humans, CBD exhibits no effects indicative of any abuse or dependence potential.
  • CBD has been demonstrated as an effective treatment of epilepsy in several clinical trials,with one pure CBD product (Epidiolex) currently in Phase III trials.There is also preliminary evidence that CBD may be a useful treatment for a number of other medical conditions.
  • There is unsanctioned medical use of CBD based products with oils, supplements, gums, and high concentration extracts available online for the treatment of many ailments.
  • CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients' existing medications.
  • Several countries have modified their national controls to accommodate CBD as a medicinal product.
  • To date, there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD.

WHO PDF Cannabidiol

FDA PDF Epidiolex

Cannabidiol:

CBD does not have the same psychoactivity as THC, and may change the effects of THC on the body if both are present. Cannabidiol does not appear to have any intoxicating effects.

  • A phytocannabinoid
  • Discovered in 1940
  • It is one of 113 identified cannabinoids in cannabis plants and accounts for up to 40% of the plant's extract.
  • In the United States, the cannabidiol drug Epidiolex was approved by the Food and Drug Administration in 2018 for the treatment of two epilepsy disorders. Since cannabis is a Schedule I controlled substance in the United States, other CBD formulations remain illegal under federal law.
  • Research indicates that cannabidiol may reduce adverse effects of THC, particularly those causing intoxication and sedation, but only at high doses.
  • The World Anti-Doping Agency removed CBD from its banned substances list.

Cannabidiol can be taken in multiple ways, including by inhalation of cannabis smoke or vapor, as an aerosol spray into the cheek, and by mouth.

As of 2019, clinical research on CBD included studies related to anxiety, cognition, movement disorders, and pain, but there is insufficient high-quality evidence that cannabidiol is effective for these conditions.

  
Hong Kong is criminalizing CBD as a ‘dangerous drug’ alongside heroin - Two years ago, cannabidiol was booming in Hong Kong. The compound, known as CBD, was popping up in cafes, restaurants and stores, with businesses eager to join an exciting new market already ...
Tuesday January 31, 2023 - msn.com

FDA Concludes that New Regulatory Frameworks for Foods and Supplements Containing Cannabidiol are Needed, Will Work with Congress - Janet Woodcock, M.D., the Principle Deputy Commissioner for the Office of the FDA Commissioner, released a statement regarding the Agency’s approach towards cannabidio ...
Friday January 27, 2023 - natlawreview.com

Hong Kong will ban ‘dangerous drug’ CBD next month - “Starting from February 1, cannabidiol, aka CBD, will be regarded as a dangerous drug and will be supervised and managed by the Dangerous Drugs Ordinance,” customs intelligence officer Au-Yeung Ka-lun ...
Friday January 27, 2023 - eastbaytimes.com

A Mother’s Journey To Save Her Son Through Cannabidiol Therapy - How Cannabis Saved My Son by Dr. Annabelle Manalo-Morgan, Ph.D. is now available. The book is published with Forbes Books, the exclusive business book publishing imprint of Forbes, and is available on ...
Monday February 06, 2023 - msn.com

Hong Kong’s ‘Dangerous Drug’ CBD Ban to Begin - In a starkly different approach from the U.S. and many other places around the world, Hong Kong moved to ban CBD and categorize it as a dangerous drug last October, and the ban begins on Wednesday.
Friday February 03, 2023 - hightimes.com

CBD Tends to Perplex Regulators. Hong Kong’s New Ban Reinforces Asia’s Strict Drug Approach - Still, products containing the cannabis-derived compound CBD have become increasingly popular in recent years, touted to have therapeutic benefits. And it’s long existed in a legal gray area for ...
Tuesday January 31, 2023 - msn.com

New Way Needed to Regulate Cannabidiol, FDA Says - Opens in a new tab or window The government needs to develop a better pathway for regulating cannabidiol (CBD ... association for over-the-counter drugs and dietary supplements whose petition ...
Thursday January 26, 2023 - medpagetoday.com

Hong Kong to ban CBD, label it a ‘dangerous drug’ - Hong Kong will ban CBD starting Wednesday, categorizing it as a “dangerous drug" and mandating harsh penalties for its smuggling, production and possession, customs authorities announced Friday.
Friday January 27, 2023 - sacbee.com

Hong Kong to ban CBD, label it a 'dangerous drug' - “Starting from February 1, cannabidiol, aka CBD, will be regarded as a dangerous drug and will be supervised and managed by the Dangerous Drugs Ordinance," customs intelligence officer Au-Yeung ...
Thursday January 26, 2023 - sfgate.com

Hong Kong to ban CBD, label it a 'dangerous drug' - HONG KONG (AP) — Hong Kong will ban CBD starting Wednesday, categorizing it as a “dangerous drug" and mandating harsh penalties for its smuggling, production and possession, customs ...
Thursday January 26, 2023 - yakimaherald.com

  
Cannabinoids | Link to this page

Home ] [ Controlled Substances ] [ Sources ]


· Controlled Substances
· Cannabinoids
· Cannabidiol