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Cannabidiol Dosage

Medically reviewed by Drugs.com. Last updated on Oct 11, 2018.

Applies to the following strengths: 100 mg/mL

Usual Adult Dose for Lennox-Gastaut Syndrome

Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day; for patients tolerating therapy and requiring further reduction in seizures, dose may be increased in increments of 2.5 mg/kg twice a day, as tolerated but no more frequently than every other day to 20 mg/kg/day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg /day has demonstrated a greater reduction in seizure rates, but with an increase in adverse reactions.
-Dose should be measured with a calibrated measuring device to ensure accuracy in dosing.

Use: For the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Usual Adult Dose for Dravet Syndrome

Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day; for patients tolerating therapy and requiring further reduction in seizures, dose may be increased in increments of 2.5 mg/kg twice a day, as tolerated but no more frequently than every other day to 20 mg/kg/day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg /day has demonstrated a greater reduction in seizure rates, but with an increase in adverse reactions.
-Dose should be measured with a calibrated measuring device to ensure accuracy in dosing.

Use: For the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Usual Pediatric Dose for Lennox-Gastaut Syndrome

2 years or older:
Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day; for patients tolerating therapy and requiring further reduction in seizures, dose may be increased in increments of 2.5 mg/kg twice a day, as tolerated but no more frequently than every other day to 20 mg/kg/day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg /day has demonstrated a greater reduction in seizure rates, but with an increase in adverse reactions.
-Dose should be measured with a calibrated measuring device to ensure accuracy in dosing.

Use: For the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Usual Pediatric Dose for Dravet Syndrome

2 years or older:
Initial dose: 2.5 mg/kg orally twice a day
-After 1 week, may increase dose to 5 mg/kg orally twice a day; for patients tolerating therapy and requiring further reduction in seizures, dose may be increased in increments of 2.5 mg/kg twice a day, as tolerated but no more frequently than every other day to 20 mg/kg/day
Maintenance dose: 10 to 20 mg/kg/day
Maximum dose: 20 mg/kg/day

Comments:
-A dose of 20 mg/kg /day has demonstrated a greater reduction in seizure rates, but with an increase in adverse reactions.
-Dose should be measured with a calibrated measuring device to ensure accuracy in dosing.

Use: For the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended

Moderate hepatic impairment (Child-Pugh B):
-Initial dose: 1.25 mg/kg orally twice a day
-Maintenance dose: 2.5 mg/kg orally twice a day
-Maximum dose: 5 mg/kg orally twice a day

Severe hepatic impairment (Child-Pugh C):
-Initial dose: 0.5 mg/kg orally twice a day
-Maintenance dose: 1 mg/kg orally twice a day
-Maximum dose: 2 mg/kg orally twice a day

Discontinue therapy for transaminase elevations greater than 3 times upper limit of normal (3 x ULN) and bilirubin levels greater than 2 x ULN

Discontinue therapy for sustained transaminase elevations greater than 5 x ULN

Precautions

CONTRAINDICATIONS:
-Hypersensitivity to active substance or any product excipients

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: V

Dialysis

Data not available

Other Comments

Administration advice:
-For oral administration only
-Take consistently with or without food
-A calibrated measuring device should be used to ensure accuracy in dosing

Storage requirements:
-Store upright at 20C to 25C (68F to 77F); excursions permitted 15C to 30C (59F to 86F)
-Do not refrigerate or freeze
-Keep cap tightly closed
-Use within 12 weeks of opening bottle; discard any remainder

Reconstitution/preparation techniques:
-Product will be dispensed with a bottle adapter and 5 mL oral syringe
-If dose is less than 100 mg (1 mL), the pharmacist should provide a 1 mL oral syringe

General:
-The maximum maintenance dose of 20 mg/kg/day has demonstrated a greater reduction in seizure rates, but with an increase in adverse reactions.

Monitoring:
-Obtain baseline serum transaminases (ALT and AST) and total bilirubin levels; repeat at 1, 3, and 6 months, then periodically or as clinically indicated.
-Additionally, serum transaminase and total bilirubin levels should also be obtained within 1 month a change in dose of this drug or changes in medications that are known to impact the liver
-Increased monitoring should be considered in those concomitantly taking valproate or who have elevated liver enzymes at baseline.

Patient Advice:
-Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
-Patients should understand that this drug may be taken with or without food, however, once decided, it must always be taken the same way.
-Patients should be advised of the signs and symptoms of hepatic dysfunction and the need to contact their healthcare provider if these occur.
-Patients should be advised not to drive or operate hazardous equipment until they understand how this drug affects them.
-Patients should be instructed not to abruptly discontinue therapy without talking with their health care provider.
-Patients, families, and caregivers should understand that this drug may increase the risk of suicidal thoughts and behavior and they should be instructed to report any unusual change in mood or behavior, worsening of depression, or suicidal thoughts or behaviors to their healthcare provider immediately.
-Women should speak with their healthcare provider if they are pregnant or planning on becoming pregnant

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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