Version May 2024
Note: Assess ALT, AST, and total bilirubin prior to initiating treatment, with dose changes, and with the addition of or changes to concomitant hepatotoxic medications.
Seizure associated with Lennox-Gastaut syndrome or Dravet syndrome:
Oral: Initial: 2.5 mg/kg/dose twice daily; may increase after 1 week to a maintenance dose of 5 mg/kg/dose twice daily. If needed based on response and tolerability, may increase weekly in increments of 2.5 mg/kg/dose twice daily to a maximum of 20 mg/kg/day. In patients needing a more rapid titration from 5 mg/kg/dose twice daily to 10 mg/kg/dose twice daily, may increase dose as quickly as every other day in increments of 2.5 mg/kg/dose twice daily.
Seizure associated with tuberous sclerosis complex :
Oral: Initial: 2.5 mg/kg/dose twice daily; may increase dose in weekly increments of 2.5 mg/kg/dose twice daily to the recommended maintenance dose of 12.5 mg/kg/dose twice daily. In patients needing a more rapid titration from 2.5 mg/kg/dose twice daily to 12.5 mg/kg/dose twice daily, may increase dose as quickly as every other day in increments of 2.5 mg/kg/dose twice daily. Note: The effectiveness of doses <12.5 mg/kg/dose twice daily has not been studied.
Discontinuation of therapy: Unless safety concerns require rapid withdrawal, withdraw therapy gradually to minimize the potential of increased seizure frequency and status epilepticus.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Hepatic impairment prior to treatment initiation:
Lennox-Gastaut syndrome or Dravet syndrome:
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate impairment (Child-Pugh class B): Initial: 1.25 mg/kg/dose twice daily; may increase after 1 week to a maintenance dose of 2.5 mg/kg/dose twice daily; if needed and tolerated, may increase after 1 week to 5 mg/kg/dose twice daily. Slower dosage increases may be necessary.
Severe impairment (Child-Pugh class C): Initial: 0.5 mg/kg/dose twice daily; may increase after 1 week to a maintenance dose of 1 mg/kg/dose twice daily; if needed and tolerated, may increase after 1 week to 2 mg/kg/dose twice daily. Slower dosage increases may be necessary.
Tuberous sclerosis complex:
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate impairment (Child-Pugh class B): Initial: 1.25 mg/kg/dose twice daily; may increase dose in weekly increments of 1.25 mg/kg/dose twice daily to a maintenance dose of 6.25 mg/kg/dose twice daily. Slower dosage increases may be necessary.
Severe impairment (Child-Pugh class C): Initial: 0.5 mg/kg/dose twice daily; may increase dose in weekly increments of 0.5 mg/kg/dose twice daily to a maintenance dose of 2.5 mg/kg/dose twice daily. Slower dosage increases may be necessary.
Hepatotoxicity during treatment:
Hepatic dysfunction symptoms (eg, unexplained anorexia, dark urine, fatigue, jaundice, nausea, right upper quadrant pain, vomiting): Promptly evaluate AST, ALT, and bilirubin; interrupt and/or discontinue treatment as appropriate.
AST and/or ALT >3 times ULN and total bilirubin >2 times ULN: Discontinue treatment.
AST and/or ALT >5 times ULN, sustained: Discontinue treatment.
Refer to adult dosing; use with caution and initiate at the low end of the dosing range.
(For additional information see "Cannabidiol (pharmaceutical): Pediatric drug information")
Note: Assess baseline serum transaminases (ALT and AST) and total bilirubin levels.
Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) : Children and Adolescents: Oral: Initial: 2.5 mg/kg/dose twice daily, may increase in 1 week to a maintenance dose of 5 mg/kg/dose twice daily. If additional seizure control is needed, may further increase at weekly intervals by 2.5 mg/kg/dose twice daily increments; maximum daily dose: 20 mg/kg/day. For rapid titration, may increase no more frequently than every other day.
Tuberous sclerosis complex (TSC): Children and Adolescents: Oral: Initial: 2.5 mg/kg/dose twice daily, increase at weekly intervals by 2.5 mg/kg/dose twice daily increments to the recommended maintenance dose of 12.5 mg/kg/dose twice daily. Maximum daily dose: 25 mg/kg/day. For rapid titration, may increase no more frequently than every other day. Note: Effectiveness of doses below 25 mg/kg/day have not been studied in patients with TSC.
Discontinuation of therapy: Children and Adolescents: Oral: Withdraw gradually by decreasing the total daily dosage; abrupt discontinuation should be avoided to minimize the risk of increased seizures.
There are no dosage adjustments provided in the manufacturer's labeling.
Baseline hepatic impairment:
Children and Adolescents: Oral:
Mild impairment: No adjustment needed.
Moderate impairment:
Dravet syndrome, Lennox-Gastaut syndrome: Initial: 1.25 mg/kg/dose twice daily; maintenance dose: 2.5 to 5 mg/kg/dose twice daily; maximum daily dose: 10 mg/kg/day.
Tuberous sclerosis complex: Initial: 1.25 mg/kg/dose twice daily; maintenance dose: 6.25 mg/kg/dose twice daily; maximum daily dose: 12.5 mg/kg/day.
Severe impairment:
Dravet syndrome, Lennox-Gastaut syndrome: Initial: 0.5 mg/kg/dose twice daily; maintenance dose: 1 to 2 mg/kg/dose twice daily; maximum daily dose: 4 mg/kg/day.
Tuberous sclerosis complex: Initial: 0.5 mg/kg/dose twice daily; maintenance dose: 2.5 mg/kg/dose twice daily; maximum daily dose: 5 mg/kg/day.
Hepatotoxicity during therapy: Adjustment based on transaminases elevation:
Children and Adolescents:
Clinical symptoms of hepatic dysfunction, AST/ALT >3 times ULN, and bilirubin >2 times ULN: Discontinue therapy.
Prolonged elevation of AST/ALT >5 times ULN: Discontinue therapy.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Dermatologic: Skin rash (7% to 13%)
Endocrine & metabolic: Weight loss (3% to 31%)
Gastrointestinal: Decreased appetite (16% to 22%), diarrhea (20% to 31%), vomiting (17%)
Hematologic & oncologic: Anemia (7% to 38%)
Hepatic: Increased serum alanine aminotransferase (>3x ULN: 1% to 17%; >20x ULN: <1%), increased serum transaminases (8% to 25%)
Infection: Infection (40% to 41%), viral infection (7% to 11%)
Nervous system: Drowsiness (≤32%), fatigue (≤12%), insomnia (≤11%), lethargy (≤32%), malaise (≤12%), sedated state (≤32%), sleep disorder (≤11%), sleep disturbance (≤11%)
Neuromuscular & skeletal: Asthenia (≤12%)
Miscellaneous: Fever (19%)
1% to 10%:
Gastrointestinal: Abdominal distress (≤3%), abdominal pain (≤3%), gastroenteritis (4% to 8%), nausea (9%), sialorrhea (≤4%)
Genitourinary: Urinary tract infection (5%)
Hematologic & oncologic: Decreased platelet count (5%), eosinophilia (5%)
Infection: Fungal infection (1% to 3%)
Nervous system: Abnormal gait (2% to 9%), aggressive behavior (≤5%), agitation (≤9%), drooling (≤4%), irritability (≤9%), outbursts of anger (≤5%)
Otic: Otic infection (8%)
Renal: Increased serum creatinine (10%)
Respiratory: Hypoxia (≤3%), pneumonia (4% to 8%), respiratory failure (≤3%), rhinorrhea (4%)
<1%: Hepatic: Increased serum aspartate aminotransferase (>20% ULN)
Frequency not defined:
Dermatologic: Erythema of skin, pruritus
Hypersensitivity: Angioedema
Postmarketing: Nervous system: Suicidal ideation, suicidal tendencies
Hypersensitivity to cannabidiol or any component of the formulation.
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving). Sedation and somnolence are dose-related, most common early in treatment, have a higher incidence in combination with clobazam, and may resolve with continued use.
• Hepatic effects: Dose-related elevations of liver transaminases (ALT and/or AST) have been reported, some resulting in hospitalization. Elevations typically occur within the first 2 months of treatment, but have occurred as late as 18 months after treatment initiation. Risk factors include high cannabidiol dose, concomitant hepatotoxic drugs (especially clobazam and valproate), and elevated baseline transaminases. Identifying elevated transaminases early may decrease the risk of serious hepatocellular injury. Although in clinical trials, transaminase levels normalized after continuing cannabidiol in some patients, others required discontinuation or lowering the dose of cannabidiol and/or concomitant hepatotoxic drugs. In patients with elevated transaminases and bilirubin at baseline or prolonged elevations during cannabidiol treatment, assess for other possible causes of hepatotoxicity.
• Hypersensitivity: Hypersensitivity reactions (including angioedema, erythema, and pruritus requiring antihistamines and corticosteroids) have been reported. Discontinue cannabidiol if hypersensitivity reactions occur.
• Suicidal ideation: Pooled analysis of trials involving various antiseizure medications (regardless of indication) showed an increased risk of suicidal thoughts/behavior (incidence rate: 0.43% treated patients compared to 0.24% of patients receiving placebo); risk observed as early as 1 week after initiation and continued through duration of trials (most trials ≤24 weeks). Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; notify health care provider immediately if symptoms occur.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment required in moderate or severe hepatic impairment.
Other warnings/precautions:
• Withdrawal: Antiseizure medications should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency and status epilepticus, unless safety concerns require a more rapid withdrawal.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Oral:
Epidiolex: 100 mg/mL (60 mL) [contains alcohol, usp, sesame oil]
Epidiolex: 100 mg/mL (100 mL) [contains alcohol, usp, sesame oil; strawberry flavor]
No
Solution (Epidiolex Oral)
100 mg/mL (per mL): $19.62
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administration with food or milk significantly increases absorption; administer consistently in the fasted or fed state to avoid variability in drug levels. Administer using the provided calibrated oral syringe (for doses ≤1 mL, use the provided 1 mL oral syringe; for other doses, use the provided 5 mL oral syringe). Syringe should be dry prior to measuring dose. Do not use a household teaspoon or tablespoon (overdosage may occur).
Gastrostomy/NG tube: Administer enterally via a silicone gastrostomy or NG tube; avoid tubes made of PVC or polyurethane or silicone NG tubes <50 cm in length or <5 FR in diameter. Flush tube with ~5 times the priming volume of room temperature drinking water after each dose; may modify flushing volume for fluid-restricted patients.
Oral: Administer consistently with respect to food to reduce variability in cannabidiol exposure; the absorption of cannabidiol is increased by food or milk. Use a calibrated measuring device (oral syringe) to accurately measure and administer the prescribed dose of liquid; for doses ≤1 mL, use the provided 1 mL oral syringe, and for other doses, the provided 5 mL oral syringe should be used; do not use a household spoon (overdosage may occur). After use, clean the inside of oral syringe with warm, soapy water by drawing water in and out of syringe using plunger, then separate plunger and oral syringe, give a final rinse with water (shaking off any excess), and allow separate parts to air dry. The inside of the oral syringe should be dry prior to measuring dose.
Silicone feeding tubes (eg, NG or gastrostomy tube) of adequate length and diameter: Silicone tube to be used should be ≥50 cm in length and ≥5 French diameter. After administration of each dose, flush tube with ~5 times the priming volume of the tube with room temperature drinking water; may modify flushing volume for fluid-restricted patients. Do not administer through tubes made of PVC or polyurethane
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Epidiolex: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210365s020lbl.pdf#page=31
Seizure disorders: Treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients ≥1 year of age.
Substrate of CYP2C19 (minor), CYP3A4 (major), UGT1A7, UGT1A9, UGT2B7; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits BSEP/ABCB11, CYP1A2 (weak), CYP2C19 (moderate), CYP2C9 (weak), CYP3A4 (weak), P-glycoprotein/ABCB1
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Abrocitinib. Risk C: Monitor therapy
Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Afatinib. Management: If combined, administer the P-gp inhibitor simultaneously with, or after, the dose of afatinib. Monitor closely for signs and symptoms of afatinib toxicity and if the combination is not tolerated, reduce the afatinib dose by 10 mg. Risk D: Consider therapy modification
Aliskiren: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Aliskiren. Risk C: Monitor therapy
ALPRAZolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ALPRAZolam. Risk C: Monitor therapy
Belzutifan: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Belzutifan. Risk C: Monitor therapy
Berotralstat: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Berotralstat. Management: Decrease the berotralstat dose to 110 mg daily when combined with P-glycoprotein (P-gp) inhibitors. Risk D: Consider therapy modification
Bilastine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Bilastine. Risk X: Avoid combination
Brivaracetam: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Brivaracetam. Risk C: Monitor therapy
CarBAMazepine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of CarBAMazepine. Risk C: Monitor therapy
Carisoprodol: CYP2C19 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Carisoprodol. CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Carisoprodol. Risk C: Monitor therapy
Celiprolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Celiprolol. Risk C: Monitor therapy
Cilostazol: CYP2C19 Inhibitors (Moderate) may increase serum concentrations of the active metabolite(s) of Cilostazol. CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Cilostazol. Management: Reduce the cilostazol dose to 50 mg twice daily in patients who are also receiving moderate inhibitors of CYP2C19. Monitor clinical response to cilostazol closely. Risk D: Consider therapy modification
Citalopram: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Citalopram. Management: Limit citalopram dose to a maximum of 20 mg/day if used with a moderate CYP2C19 inhibitor. Patients using this combination should be monitored closely for evidence of citalopram toxicity (eg, serotonin syndrome, QT prolongation). Risk D: Consider therapy modification
CloBAZam: May enhance the hepatotoxic effect of Cannabidiol. Cannabidiol may increase serum concentrations of the active metabolite(s) of CloBAZam. Cannabidiol may increase the serum concentration of CloBAZam. Risk C: Monitor therapy
Clopidogrel: CYP2C19 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Risk C: Monitor therapy
CloZAPine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of CloZAPine. Risk C: Monitor therapy
CNS Depressants: May enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: This combination is often contraindicated, but combined use may be permitted with dose adjustment and monitoring. Recommendations vary based on brand, indication, use of CYP3A4 inhibitors, and hepatic/renal function. See interaction monograph for details. Risk D: Consider therapy modification
CycloSPORINE (Systemic): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
CYP2C19 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Cannabidiol. CYP2C19 Inducers (Strong) may decrease the serum concentration of Cannabidiol. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Cannabidiol. CYP3A4 Inducers (Strong) may decrease the serum concentration of Cannabidiol. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Cannabidiol. Risk C: Monitor therapy
Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Risk C: Monitor therapy
Dexlansoprazole: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Dexlansoprazole. Risk C: Monitor therapy
DiazePAM: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of DiazePAM. Risk C: Monitor therapy
Digoxin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Digoxin. Management: Measure digoxin serum concentrations before initiating treatment with these P-glycoprotein (P-gp) inhibitors. Reduce digoxin concentrations by either reducing the digoxin dose by 15% to 30% or by modifying the dosing frequency. Risk D: Consider therapy modification
Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Risk C: Monitor therapy
DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of DOXOrubicin (Conventional). Risk X: Avoid combination
DOXOrubicin (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of DOXOrubicin (Liposomal). Risk C: Monitor therapy
Edoxaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Edoxaban. Risk C: Monitor therapy
Escitalopram: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Escitalopram. Risk C: Monitor therapy
Etoposide: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Etoposide. Risk C: Monitor therapy
Etoposide Phosphate: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Etoposide Phosphate. Risk C: Monitor therapy
Etravirine: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Etravirine. Risk C: Monitor therapy
Everolimus: Cannabidiol may increase the serum concentration of Everolimus. Risk C: Monitor therapy
Fezolinetant: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Fezolinetant. Risk X: Avoid combination
Finerenone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Finerenone. Risk C: Monitor therapy
Flibanserin: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Flibanserin. Risk C: Monitor therapy
Fosphenytoin-Phenytoin: Cannabidiol may increase the serum concentration of Fosphenytoin-Phenytoin. Fosphenytoin-Phenytoin may decrease the serum concentration of Cannabidiol. Risk C: Monitor therapy
Glecaprevir and Pibrentasvir: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Glecaprevir and Pibrentasvir. Risk C: Monitor therapy
Ixabepilone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Ixabepilone. Risk C: Monitor therapy
Lansoprazole: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Lansoprazole. Risk C: Monitor therapy
Lapatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Lapatinib. Risk C: Monitor therapy
Larotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Larotrectinib. Risk C: Monitor therapy
Lefamulin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Lefamulin. Management: Avoid concomitant use of lefamulin tablets with P-glycoprotein/ABCB1 inhibitors. If concomitant use is required, monitor for lefamulin adverse effects. Risk D: Consider therapy modification
Lemborexant: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Risk D: Consider therapy modification
Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Risk D: Consider therapy modification
Lonafarnib: Cannabidiol may increase the serum concentration of Lonafarnib. Lonafarnib may increase the serum concentration of Cannabidiol. Management: Avoid concomitant use if possible. If combined, reduce lonafarnib dose to 115 mg/m2 or continue lonafarnib at a dose of 115 mg/m2. Monitor for increased lonafarnib and cannabidiol effects/toxicities. Risk D: Consider therapy modification
Mavacamten: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Mavacamten. Risk X: Avoid combination
Methadone: Cannabidiol may enhance the CNS depressant effect of Methadone. Cannabidiol may increase the serum concentration of Methadone. Risk C: Monitor therapy
Methylphenidate: Cannabidiol may increase the serum concentration of Methylphenidate. Risk C: Monitor therapy
Midazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Midazolam. Risk C: Monitor therapy
Moclobemide: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Moclobemide. Risk C: Monitor therapy
Morphine (Systemic): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Morphine (Systemic). Risk C: Monitor therapy
Nadolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Nadolol. Risk C: Monitor therapy
Naldemedine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naldemedine. Risk C: Monitor therapy
Naloxegol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naloxegol. Risk C: Monitor therapy
NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Risk C: Monitor therapy
Omeprazole: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Omeprazole. Risk C: Monitor therapy
PAZOPanib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of PAZOPanib. Risk X: Avoid combination
Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination
Pralsetinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Pralsetinib. Management: If this combo cannot be avoided, decrease pralsetinib dose from 400 mg daily to 300 mg daily; from 300 mg daily to 200 mg daily; and from 200 mg daily to 100 mg daily. Risk D: Consider therapy modification
Proguanil: CYP2C19 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Proguanil. CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Proguanil. Risk C: Monitor therapy
Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ranolazine. Risk C: Monitor therapy
Relugolix: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Relugolix. Management: Avoid coadministration of relugolix with oral P-gp inhibitors whenever possible. If combined, take relugolix at least 6 hours prior to the P-gp inhibitor and monitor patients more frequently for adverse reactions. Risk D: Consider therapy modification
Relugolix, Estradiol, and Norethindrone: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Relugolix, Estradiol, and Norethindrone. Management: Avoid use of relugolix/estradiol/norethindrone with P-glycoprotein (P-gp) inhibitors. If concomitant use is unavoidable, relugolix/estradiol/norethindrone should be administered at least 6 hours before the P-gp inhibitor. Risk D: Consider therapy modification
Repotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Repotrectinib. Risk X: Avoid combination
RifAXIMin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RifAXIMin. Risk C: Monitor therapy
Rimegepant: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Rimegepant. Management: Avoid administration of another dose of rimegepant within 48 hours if given concomitantly with a P-glycoprotein (P-gp) inhibitor. Risk D: Consider therapy modification
RisperiDONE: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RisperiDONE. Risk C: Monitor therapy
RomiDEPsin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RomiDEPsin. Risk C: Monitor therapy
Saquinavir: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy
Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Silodosin. Risk C: Monitor therapy
Simvastatin: CYP3A4 Inhibitors (Weak) may increase serum concentrations of the active metabolite(s) of Simvastatin. CYP3A4 Inhibitors (Weak) may increase the serum concentration of Simvastatin. Risk C: Monitor therapy
Sirolimus (Conventional): Cannabidiol may increase the serum concentration of Sirolimus (Conventional). Management: A dose reduction of sirolimus should be considered when combined with cannabidiol. Monitor for increased sirolimus concentrations/toxicity if combined. Risk D: Consider therapy modification
Sirolimus (Protein Bound): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Sirolimus (Protein Bound). Risk X: Avoid combination
Stiripentol: May increase the serum concentration of Cannabidiol. Cannabidiol may increase the serum concentration of Stiripentol. Risk C: Monitor therapy
Tacrolimus (Systemic): Cannabidiol may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Talazoparib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Talazoparib. Risk C: Monitor therapy
Tegaserod (Withdrawn from US Market): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Tegaserod (Withdrawn from US Market). Risk C: Monitor therapy
Teniposide: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Teniposide. Risk C: Monitor therapy
Tenofovir Disoproxil Fumarate: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy
Theophylline Derivatives: CYP1A2 Inhibitors (Weak) may increase the serum concentration of Theophylline Derivatives. Risk C: Monitor therapy
TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use is necessary, initiate tizanidine at an adult dose of 2 mg and increase in 2 to 4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Risk D: Consider therapy modification
TOLBUTamide: CYP2C9 Inhibitors (Weak) may increase the serum concentration of TOLBUTamide. Risk C: Monitor therapy
Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination
Triazolam: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Triazolam. Risk C: Monitor therapy
Ubrogepant: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a P-gp inhibitor. Risk D: Consider therapy modification
Valproate Products: May enhance the hepatotoxic effect of Cannabidiol. Risk C: Monitor therapy
Venetoclax: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients requiring concomitant treatment with P-glycoprotein (P-gp) inhibitors. Resume the previous venetoclax dose 2 to 3 days after discontinuation of a P-gp inhibitor. Risk D: Consider therapy modification
VinCRIStine (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of VinCRIStine (Liposomal). Risk X: Avoid combination
Vitamin K Antagonists (eg, warfarin): CYP2C9 Inhibitors (Weak) may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy
Voriconazole: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Voriconazole. Risk C: Monitor therapy
Warfarin: Cannabinoid-Containing Products may increase the serum concentration of Warfarin. Risk C: Monitor therapy
Food and milk increase extent of absorption. Management: Administer with or without food or milk, but consistent administration with regard to meals is recommended.
Cannabidiol can be detected in the umbilical cord serum and meconium following maternal use of inhaled, non-medicinal cannabis during pregnancy (Kim 2018).
Data collection to monitor pregnancy and infant outcomes following exposure to cannabidiol is ongoing. Patients exposed to cannabidiol during pregnancy are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. Additional information is available at www.aedpregnancyregistry.org.
It is not known if cannabidiol is present in breast milk following oral use of cannabidiol. Cannabidiol can be detected in breast milk following maternal use of marijuana (Bertrand 2018; Moss 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
ALT, AST, and total bilirubin (baseline and 1, 3, and 6 months after initiation, followed by periodic monitoring as clinically indicated [eg, with clinical signs or symptoms of hepatic dysfunction, and within 1 month of dose change or initiation of concomitant hepatotoxic drugs]; consider more frequent monitoring in patients with baseline elevated liver enzymes).
The exact antiseizure mechanism of action of cannabidiol is unknown; however, it does not appear to involve its effects on cannabinoid receptors.
Onset: Within 4 weeks.
Absorption: Food and milk increase extent of absorption.
Distribution: Vd: 20,963 L to 42,849 L.
Protein binding: >94%.
Metabolism: Hepatic (primarily) and gut by CYP2C19, CYP3A4, UGT1A7, UGT1A9, and UGT2B7 to active metabolite 7-OH-CBD and then to inactive metabolite 7-COOH-CBD.
Half-life elimination: 56 to 61 hours.
Time to peak: 2.5 to 5 hours at steady state.
Excretion: Feces; urine (minor).
Hepatic function impairment: Patients with moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment had a higher AUC
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