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Epidiolex

Generically: Cannabidiol cannabidiol KAN-abi-DYE-ol KAN-a-bi-DYEOL
Drug Class: Miscellaneous anticonvulsants

What is Epidiolex?

Epidiolex is a prescribed medicine which is used in treating seizures for people suffering from Lennox-Gastaut disorder, Dravet syndrome or the tuberous complex sclerosis.Epidiolex is intended for adults and children who are one year old.

In April 2020, the U.S. Drug Enforcement Administration (DEA) announced the removal of cannabidiol's name from Schedule V in the Controlled Substances Act. Epidiolex has been removed from the list of controlled substances.

Warnings

It is not recommended to take Epidiolex if you have an allergy to sesame seed oil.Cannabidiol may damage the liver. The function of your liver may have to be assessed prior to and during the treatment.

Contact your physician immediately if you experience symptoms like vomiting, nausea, a loss of appetite, upper stomach pain on the right side, fatigue, itching, dark urine, or eyes that are yellow.Avoid driving or engaging in hazardous activities until you are aware of how Epidiolex can affect you.

Certain people are contemplating suicide when taking Epidiolex. Pay attention to any mood changes or any symptoms. It is important to notify any symptoms that are becoming worse or more severe with your doctor.

Before you Take this Drug

Epidiolex is not a product that has been approved to be used by anyone less than one year old.

To ensure Epidiolex is safe for you, ask your doctor if you have previously had:

  • Liver disease;
  • Alcohol or drug addiction;
  • Depression is a depression disorder
  • Suicidal thoughts or behaviours.

Many people contemplate suicide when taking Epidiolex. Your doctor should examine your progress every few appointments. Family members or other carers should be aware of changes in your symptoms or mood.

It is unclear if cannabidiol is harmful to the unborn baby. Consult your physician if you are expecting or planning to become pregnant.If you're pregnant and you are a registered mother, your name could be included on the registry for pregnancy to monitor the effects of cannabidiol on the child.

It might not be safe to breastfeed while taking Epidiolex. Consult your physician about any potential risks.

How to Take Epidiolex?

You should take Epidiolex exactly as directed by your physician. Follow the instructions on the prescription label, and make sure you read all the instructions or medication guides. The doctor might alter your dosage. Follow the medication exactly as prescribed.

Epidiolex is typically taken two times a day. It is advised that you take the medicine every morning.You can consume Epidiolex in combination with or without meals; however, follow the same procedure each time.

Make sure to measure this medicine with care. Use the dosing needle provided or a dosage-measuring device (not an ordinary spoon). Be sure that the dosing syringe is completely dry prior to determining the dosage.Epidiolex liquid is available via a feeding tube that is not composed of polyvinyl chloride (PVC).

Cannabidiol could cause harm to the liver. The liver's function could be examined prior to as well as during the treatment. It is possible that you have to discontinue using Epidiolex according to the results.Keep it in a cool, dry place far from heat and moisture. Avoid freezing or refrigerating. Make sure the bottle is tightly sealed and upright when not in use.Dispose of any liquid that is not used within 12 weeks of the first time you opened the bottle.

Epidiolex could affect a drug screening test, and you may be positive for the presence of cannabis (marijuana). Inform the laboratory personnel that you are using cannabidiol.

Don't stop using Epidiolex immediately, even if you are well. A sudden stop could trigger increased seizures. Follow the advice of your doctor about increasing your dosage.

Details on Dosage

Usual Adult Dose for Lennox-Gastaut Syndrome:

Initial dosage: 2.5 mg/kg orally twice each day.
After one week, you can up the dose to 5 mg/kg, taken orally at least twice per day.
For patients who have tolerated treatment and who require additional seizure reduction, doses could be increased to 2.5 mg/kg in two-times-a-day increments, as tolerated, but no more often than once every other day.
Dosage for maintenance daily: 10–20 mg/kg
Maximum dose: 20 mg/kg/day
Comments:
20 mg/kg/day has been proven to have a greater reduction in the rate of seizures; however, it is also associated with an increased risk of adverse reactions.
A consistent dose according to meal times is recommended to decrease the variation in plasma exposure to cannabidiol.
Use: To treat seizures that are caused by Lennox-Gastaut syndrome as well as Dravet syndrome.

Usual Adult Dose for Dravet Syndrome:

Initial dosage: 2.5 mg/kg orally twice every day.
After 1 week, increase dosage to 5 mg/kg, orally at least twice per day.
For patients who have tolerated treatment and who require additional seizure reduction, doses can be increased to 2.5 mg/kg in two daily increments if tolerated, but not more often than once every other day.
Dosage for maintenance daily: 10–20 mg/kg
Maximum dose: 20 mg/kg/day
Comments:
A dose of 20 mg/kg/day is associated with an increase in the rate of seizures; however, it is also associated with a rise in adverse reactions.
A consistent dose according to meal times is recommended to decrease the variation in plasma exposure to cannabidiol.
Use: To treat seizures resulting from Lennox-Gastaut syndrome and Dravet syndrome.

Usual Adult Dose for Tuberous Sclerosis Complex:

Initial dosage: 2.5 mg/kg orally twice each day.
Increase dosage at weekly intervals to 2.5 mg twice per day (5 mg/kg/day) until you are able to tolerate it. 12.5 mg/kg twice daily
For patients who require greater titration speed, the dosage may be increased no more frequently than once every other day.
Maintenance dose: 25 mg/kg/day
Maximum dose: 25 mg/kg/day
Comments:
The effectiveness of doses less than 25 mg/kg/day has not been investigated.
Consistent dosage according to meal times is recommended to decrease the variation in plasma exposure to cannabidiol.
Use: To treat seizures resulting from tuberculous sclerosis complex.

Usual Paediatric Dose for Lennox-Gastaut Syndrome:

1 year old or older:
Initial dosage: 2.5 mg/kg orally twice each day.
After one week, you can increase the dosage up to 5 mg/kg at least twice per day.
For patients who have tolerated therapy but still need more seizure relief, dosage can be increased to 2.5 mg/kg in two daily increments as tolerated, but no more often than once every other day.
Dosage for maintenance daily: 10–20 mg/kg
Maximum dose: 20 mg/kg/day
Comments:
A dose of 20 mg/kg/day is associated with an increase in the rate of seizures; however, it is also associated with a rise in adverse reactions.
Consistent dosage according to meal times is suggested to minimise variation in plasma exposure to cannabidiol.
Use: To treat seizures resulting from Lennox-Gastaut disorder and Dravet syndrome among patients aged 1 year and over.

Usual Paediatric Dose for Dravet Syndrome:

1 year and older:
Initial dosage: 2.5 mg/kg orally twice every day.
After one week, you can up the dose to 5 mg/kg every day, twice.
For patients who are able to tolerate treatment and who require more seizure relief, dosage could be increased to 2.5 mg/kg in two daily increments as tolerated, but no more often than once every other day.
Dosage for maintenance: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day
Comments:
A dosage of 20 mg/kg/day has shown an increase in the rate of seizures; however, it is linked to a rise in adverse reactions.
A consistent dose according to meal times is suggested to minimise variation in plasma exposure to cannabidiol.
Use: To treat seizures resulting from Lennox-Gastaut and Dravet syndrome in patients aged 1 year and over.

Usual Paediatric Dose for Tuberous Sclerosis Complex:

1 year old or older:
Initial dosage: 2.5 mg/kg orally twice each day.
Increase dose weekly in the range of 2.5 mg twice daily (5 mg/kg/day) in order to tolerate up to 12.5 mg/kg twice daily.
For patients who require greater titration speed, the dosage can be increased no more frequently than once every other day.
Maintenance dose: 25 mg/kg/day
Maximum dose: 25 mg/kg/day
Comments:
The efficacy of doses lower than 25 mg/kg/day has not been examined.
A consistent dose in relation to meals is suggested to minimise the variability of plasma exposure to cannabidiol.
Use: To treat seizures resulting from complex tuberous sclerosis in patients who are 1 year old or older.

What Happens If I Miss a Dose?

Do not take the medicine for as long as you are able, but avoid your missed dose if it's nearing the time to take the next dose.

What Happens If I Overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line toll-free at 1-800-222-1222.

What Should be Avoided?

Consuming alcohol while taking Epidiolex could cause increased drowsiness.

Avoid driving or engaging in hazardous activities until you understand the effects of this medicine on you. Dizziness or drowsiness could result in accidents, falls, or even serious injuries.

Side effects of Epidiolex

See a doctor immediately. If you show symptoms of an allergic reaction to Epidiolex, such as hives, breathing problems, and swelling of your lips, face, or tongue,

Inform your doctor about any new or worsening symptoms, for example, a change in behaviour or mood, anxieties, panic attacks, trouble sleeping, or if you are feeling uncontrollably angry, irritable, or aggressive. active, restless (mentally and physically), depressed, or think about taking your own life or hurting yourself.

Contact your physician immediately. If you are suffering from symptoms of liver issues, For example:

  • Nausea, nausea, vomiting, loss of appetite
  • Fatigue, feeling unwell;
  • Right-sided upper stomach pain
  • Itching;
  • Dark urine dark urine
  • Jaundice (yellowing of the eyes or skin).

Common Epidiolex adverse effects could include:

  • Drowsiness;
  • Changes in weight or appetite;
  • Fatigue or feeling weak;
  • Infections (fever and flu symptoms and cough inflammation, itching, and redness);
  • Diarrhoea;
  • Sleep problems (insomnia);
  • The rash
  • Abnormal tests for liver function.

This isn't a complete list of possible side effects, and other effects may also be present. Contact your doctor to seek medical advice on the effects. You can report any side effects to the FDA at 1-800-FDA-1088.

Interaction with Other Drugs

Utilising Epidiolex together with other medications that cause you to become drowsy could increase the severity of this effect. Talk to your doctor prior to using opioid medications, a sleeping pill, a muscle relaxer, or medication for seizures or anxiety.

It is sometimes not safe to take certain medications simultaneously. Certain medications can alter the blood levels and the other medications you are taking, which could cause more side effects or make the medication less effective.

Discuss with your doctor any other medications you take, particularly:

  • Other seizure medications (especially clobazam and valproate) as well as
  • Cannabis-based products.

This isn't a complete list. Other drugs may be a potential cause of interaction with cannabidiol. These include prescription and over-the-counter medicines, vitamins, and herbal products. The interactions of all potential drugs are not included in this list. Discuss with your physician all the medications you are currently taking and any medications you begin or stop taking.

DRUG STATUS

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Prescription only

Pregnancy & Lactation

CSA Schedule*

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