Dosing & Uses
Dosage Forms & Strengths
capsule: Schedule III (Marinol)
- 2.5mg
- 5mg
- 10mg
oral solution: Schedule II (Syndros)
- 5mg/mL
Chemotherapy-Induced Nausea & Vomiting
Indicated for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments
Oral capsules: 5 mg/m² PO 1-3 hr before and q2-4hr after chemotherapy; may be increased in 2.5 mg/m² increments to 15 mg/m²; not to exceed 4-6 doses/day
Oral solution
- Starting dose: 4.2 mg/m² PO 1-3 hr before chemotherapy, THEN q2-4 hr after chemotherapy for a total of 4-6 doses/day
- Give first dose on an empty stomach at least 30 minutes before a meal; subsequent doses can be given without regard to meals
Calculate starting dose
- Starting dose (mg) = Patient body surface area (BSA) in m² multiplied by 4.2 mg/m²
- Round dose to the nearest 0.1 mg increment
- To correspond with the calibrated oral dosing syringe, the dose may need to be rounded to the nearest 0.1 mL increment
Dose titration
- Titrate to clinical response during a chemotherapy cycle or subsequent cycles, based upon initial effect, as tolerated to achieve a clinical effect, in increments of 2.1 mg/m²
- Maximum dosage: 12.6 mg/m² per dose for 4-6 doses/day
- Adverse reactions are dose-related and psychiatric symptoms increase significantly at the maximum dosage
Anorexia
Indicated for anorexia associated with weight loss in patients with AIDS
Oral capsules: 2.5 mg PO q12hr initially, taken right before meals; may be increased to no more than 20 mg/day or decreased to 2.5 mg at bedtime PRN
Oral solution
Starting dose
- 2.1 mg PO BID, 1 hr before lunch and 1 hr before dinner Dosing later in the day may reduce the frequency of CNS adverse reactions
- If CNS adverse reactions of feeling high, dizziness, confusion, and somnolence occur, they usually resolve in 1-3 days and usually do not require dosage reduction
- If CNS adverse reactions are severe or persistent, reduce the dose to 2.1 mg qDay 1 hr before dinner or in the evening at bedtime
Dose titration
- If tolerated and further therapeutic required, increase dose gradually to 2.1 mg 1 hr before lunch and 4.2 mg 1 hr before dinner
- Gradually increase dose to reduce the frequency of dose-related adverse reactions
- Most patients respond to 2.1 mg BID, but the dose may be further increased to 4.2 mg 1 hr before lunch and 4.2 mg 1 hr before dinner, as tolerated to achieve a therapeutic effect
- Maximum dosage: 8.4 mg BID
Dosing Considerations
The pharmacologic effects of dronabinol are dose-related and subject to considerable interpatient variability; dosage individualization is critical in achieving maximum benefit of dronabinol capsules treatment
Dosage Forms & Strengths
capsule: Schedule III (Marinol)
- 2.5mg
- 5mg
- 10mg
Chemotherapy-Induced Nausea & Vomiting
Indicated for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments
NOTE: Has not been studied in pediatric patients with AIDS-related anorexia
Oral capsule: 5 mg/m² PO 1-3 hr before and q2-4hr after chemotherapy; may be increased in 2.5 mg/m² increments to 15 mg/m²; not to exceed 4-6 doses/day
Elderly patients may be more sensitive to neurologic, psychoactive, and postural-hypotensive effects of drug; lowest possible dosage should be used initially and increased as needed
Chemotherapy-Induced Nausea & Vomiting
In elderly patients, consider initiating at 2.1 mg/m² PO qDay 1-3 hr before to chemotherapy to reduce the risk of CNS symptoms
See adult dose for titration
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (5)
- cefotetan
cefotetan increases toxicity of dronabinol by aldehyde dehydrogenase inhibition. Contraindicated. Dronabinol oral solution (Syndros) contains 50% (w/w) dehydrated alcohol 5.5% (w/w) propylene glycol, which can produce disulfiramlike reactions if coadministered with cefotetan. Discontinue cefotetan at least 14 days before starting dronabinol solution and do not administer cefotetan within 7 days of completing treatment with dronabinol solution.
- chlorpropamide
chlorpropamide increases toxicity of dronabinol by aldehyde dehydrogenase inhibition. Contraindicated. Dronabinol oral solution (Syndros) contains 50% (w/w) dehydrated alcohol 5.5% (w/w) propylene glycol, which can produce disulfiramlike reactions if coadministered with chlorpropamide. Discontinue chlorpropamide at least 14 days before starting dronabinol solution and do not administer chlorpropamide within 7 days of completing treatment with dronabinol solution.
- disulfiram
disulfiram increases toxicity of dronabinol by aldehyde dehydrogenase inhibition. Contraindicated. Dronabinol oral solution (Syndros) contains 50% (w/w) dehydrated alcohol 5.5% (w/w) propylene glycol, which can produce disulfiramlike reactions if coadministered. Discontinue disulfiram at least 14 days before starting dronabinol solution and do not administer disulfiram within 7 days of completing treatment with dronabinol solution.
- metronidazole
metronidazole increases toxicity of dronabinol by aldehyde dehydrogenase inhibition. Contraindicated. Dronabinol oral solution (Syndros) contains 50% (w/w) dehydrated alcohol 5.5% (w/w) propylene glycol, which can produce disulfiramlike reactions if coadministered with metronidazole. Discontinue metronidazole at least 14 days before starting dronabinol solution and do not administer metronidazole within 7 days of completing treatment with dronabinol solution.
- tinidazole
tinidazole increases toxicity of dronabinol by aldehyde dehydrogenase inhibition. Contraindicated. Dronabinol oral solution (Syndros) contains 50% (w/w) dehydrated alcohol 5.5% (w/w) propylene glycol, which can produce disulfiramlike reactions if coadministered with tinidazole. Discontinue tinidazole at least 14 days before starting dronabinol solution and do not administer tinidazole within 7 days of completing treatment with dronabinol solution.
Serious - Use Alternative (8)
- abametapir
abametapir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
- apalutamide
apalutamide will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- fexinidazole
fexinidazole will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- ivosidenib
ivosidenib will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2C9 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
- metoclopramide intranasal
dronabinol, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.
- nelfinavir
nelfinavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- tucatinib
tucatinib will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- voxelotor
voxelotor will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (92)
- alpelisib
alpelisib will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Modify Therapy/Monitor Closely.
- amiodarone
amiodarone will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- amobarbital
amobarbital will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- amphotericin B cholesteryl sulfate
dronabinol increases levels of amphotericin B cholesteryl sulfate by plasma protein binding competition. Modify Therapy/Monitor Closely. Dronabinol is highly bound to plasma proteins and may displace and increase the free fraction of other concomitantly administered highly protein-bound drugs. This has not been confirmed in vivo. Caution with narrow therapeutic index drugs that are highly protein bound when initiating or increasing the dose of dronabinol.
- apalutamide
apalutamide will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Coadministration of apalutamide, a weak CYP2C9 inducer, with drugs that are CYP2C9 substrates can result in lower exposure to these medications. Evaluate for loss of therapeutic effect if medication must be coadministered.
- atazanavir
atazanavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- belzutifan
belzutifan will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.
- bosentan
bosentan will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
bosentan will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - butabarbital
butabarbital will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- butalbital
butalbital will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- cannabidiol
cannabidiol will increase the level or effect of dronabinol by decreasing metabolism. Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit CYP2C9 activity. Consider reducing the dose when concomitantly using CYP2C9 substrates.
- capecitabine
capecitabine will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- carbamazepine
carbamazepine will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
carbamazepine will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - cenobamate
cenobamate will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
cenobamate, dronabinol. Either increases effects of the other by sedation. Use Caution/Monitor. - chloramphenicol
chloramphenicol will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clarithromycin
clarithromycin will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- clobazam
dronabinol, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).
- clonidine
clonidine, dronabinol. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration enhances CNS depressant effects.
- cobicistat
cobicistat will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- conivaptan
conivaptan will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- cyclosporine
dronabinol increases levels of cyclosporine by plasma protein binding competition. Modify Therapy/Monitor Closely. Dronabinol is highly bound to plasma proteins and may displace and increase the free fraction of other concomitantly administered highly protein-bound drugs. This has not been confirmed in vivo. Caution with narrow therapeutic index drugs that are highly protein bound when initiating or increasing the dose of dronabinol.
- dabrafenib
dabrafenib will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- darunavir
darunavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- dexamethasone
dexamethasone will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- efavirenz
efavirenz will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- elagolix
elagolix will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- enzalutamide
enzalutamide will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- etravirine
etravirine will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- fedratinib
fedratinib will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- fluconazole
fluconazole will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- fluorouracil
fluorouracil will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- flurbiprofen
flurbiprofen will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- fosamprenavir
fosamprenavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- fosphenytoin
fosphenytoin will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
fosphenytoin will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - gemfibrozil
gemfibrozil will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- grapefruit
grapefruit will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- ibuprofen
ibuprofen will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- ibuprofen IV
ibuprofen IV will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- idelalisib
idelalisib will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- imatinib
imatinib will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- indinavir
indinavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- indomethacin
indomethacin will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- isoniazid
isoniazid will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- istradefylline
istradefylline will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- itraconazole
itraconazole will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ketoconazole
ketoconazole will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
ketoconazole will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - letermovir
letermovir increases levels of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lopinavir
lopinavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- lorlatinib
lorlatinib will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- lurasidone
lurasidone, dronabinol. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.
- mefenamic acid
mefenamic acid will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- methylphenidate
methylphenidate will increase the level or effect of dronabinol by pharmacodynamic synergism. Use Caution/Monitor. Risk of acute hypertensive episode.
- midazolam intranasal
midazolam intranasal, dronabinol. Either increases levels of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.
- mifepristone
mifepristone will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- mitotane
mitotane will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- nafcillin
nafcillin will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- naltrexone
naltrexone increases effects of dronabinol by Other (see comment). Use Caution/Monitor. Comment: Naltrexone may enhance therapeutic effects of cannabinoids. .
- nefazodone
nefazodone will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- nelfinavir
nelfinavir will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2E1 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- nevirapine
nevirapine will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- nicardipine
nicardipine will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
nicardipine will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - oxcarbazepine
oxcarbazepine will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- pentobarbital
pentobarbital will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- phenobarbital
phenobarbital will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
phenobarbital will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - phenytoin
phenytoin will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
phenytoin will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
dronabinol increases levels of phenytoin by plasma protein binding competition. Modify Therapy/Monitor Closely. Dronabinol is highly bound to plasma proteins and may displace and increase the free fraction of other concomitantly administered highly protein-bound drugs. This has not been confirmed in vivo. Caution with narrow therapeutic index drugs that are highly protein bound when initiating or increasing the dose of dronabinol. - piroxicam
piroxicam will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- posaconazole
posaconazole will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- primidone
primidone will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
primidone will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - ribociclib
ribociclib will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifabutin
rifabutin will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- rifampin
rifampin will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
rifampin will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - rifapentine
rifapentine will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
rifapentine will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - ritonavir
ritonavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- rucaparib
rucaparib will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- saquinavir
saquinavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- secobarbital
secobarbital will decrease the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
secobarbital will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - sirolimus
dronabinol increases levels of sirolimus by plasma protein binding competition. Modify Therapy/Monitor Closely. Dronabinol is highly bound to plasma proteins and may displace and increase the free fraction of other concomitantly administered highly protein-bound drugs. This has not been confirmed in vivo. Caution with narrow therapeutic index drugs that are highly protein bound when initiating or increasing the dose of dronabinol.
- St John's Wort
St John's Wort will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- stiripentol
stiripentol, dronabinol. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
stiripentol, dronabinol. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. - sulfadiazine
sulfadiazine will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- sulfamethoxazole
sulfamethoxazole will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- tacrolimus
dronabinol increases levels of tacrolimus by plasma protein binding competition. Modify Therapy/Monitor Closely. Dronabinol is highly bound to plasma proteins and may displace and increase the free fraction of other concomitantly administered highly protein-bound drugs. This has not been confirmed in vivo. Caution with narrow therapeutic index drugs that are highly protein bound when initiating or increasing the dose of dronabinol.
- tazemetostat
tazemetostat will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- tipranavir
tipranavir will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate.
- tolbutamide
tolbutamide will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
- valproic acid
dronabinol increases levels of valproic acid by plasma protein binding competition. Modify Therapy/Monitor Closely. Dronabinol is highly bound to plasma proteins and may displace and increase the free fraction of other concomitantly administered highly protein-bound drugs. This has not been confirmed in vivo. Caution with narrow therapeutic index drugs that are highly protein bound when initiating or increasing the dose of dronabinol.
- voriconazole
voriconazole will increase the level or effect of dronabinol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Dronabinol is a CYP2C9 substrate.
voriconazole will increase the level or effect of dronabinol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dronabinol is a CYP3A4 substrate. - warfarin
dronabinol increases levels of warfarin by plasma protein binding competition. Modify Therapy/Monitor Closely. Dronabinol is highly bound to plasma proteins and may displace and increase the free fraction of other concomitantly administered highly protein-bound drugs. This has not been confirmed in vivo. Caution with narrow therapeutic index drugs that are highly protein bound when initiating or increasing the dose of dronabinol.
Minor (0)
Adverse Effects
1-10%
Dizziness
Euphoria
Paranoid reaction
Somnolence
Abnormal thinking
Abdominal pain
Nausea
Vomiting
<1%
Depression
Nightmares
Speech difficulties
Emotional lability
Hypotension
Tremors
Flushing
Sweating
Anorexia
Hepatic enzyme elevation
Tinnitus
Frequency Not Defined
Amnesia
Anxiety/nervousness
Hallucination
Ataxia
Confusion
Depersonalization
Asthenia
Palpitations
Tachycardia
Warnings
Contraindications
Hypersensitivity to dronabinol
Capsule: Hypersensitivity to sesame seed oil
Oral solution
- History of hypersensitivity reaction to alcohol
- Patients who are receiving, or have received, disulfiram- or metronidazole-containing products within the past 14 days
Cautions
Neurologic effects
- May cause psychiatric and cognitive effects and impair mental and/or physical abilities
- Monitor patients with mania, depression, or schizophrenia; dronabinol may exacerbate these illnesses
- Avoid in patients with a psychiatric history
- Monitor for symptoms and avoid concomitant use of drugs with similar effects; reduce the dose or discontinue use if signs or symptoms of cognitive impairment develop
- Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol does not affect them adversely
- Abrupt discontinuation may cause withdrawal symptoms
Hemodynamic instability
- Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia
- Avoid concomitant use of drugs with similar effects and monitor for hemodynamic changes; monitor patients for changes in blood pressure, heart rate, and syncope after initiating or increasing the dosage
- Caution when initiating or increasing the dosage
- Caution in elderly patients; may be more sensitive to neurological, psychoactive, and postural hypotensive effects of drug
Seizures
- Seizures and seizure-like activity reported
- Weigh potential risk before prescribing to patients with a history of seizures, including those with factors that can lower seizure threshold
- If a seizure occurs, discontinue dronabinol immediately
Multiple substance abuse
- Patients with a history of substance abuse or dependence, including marijuana or alcohol, may be more likely to abuse dronabinol
- Assess risk for abuse or misuse before prescribing
Paradoxical nausea, vomiting, or abdominal pain
- New or worsening nausea, vomiting, or abdominal pain can occur during treatment with synthetic delta-9 tetrahydrocannabinol (delta-9-THC), the active ingredient in dronabinol
- In some cases, these adverse reactions were severe (eg, dehydration, electrolyte abnormalities) and required dose reduction or drug discontinuation
- Symptoms are similar to cannabinoid hyperemesis syndrome (CHS), which is described as cyclical events of abdominal pain, nausea, and vomiting in chronic, long-term users of delta-9-THC products
- Patients may not recognize these symptoms as abnormal; specifically monitor for development of worsening nausea, vomiting, or abdominal pain
Toxicities related to propylene glycol in preterm neonates
- Contains the excipients dehydrated alcohol (50%, w/w) and propylene glycol (5.5%, w/w)
- Large amounts of propylene glycol are potentially toxic and have been associated with seizures, lactic acidosis, respiratory depression, and respiratory depression
- When administered concomitantly with propylene glycol, ethanol competitively inhibits the metabolism of propylene glycol, which may lead to elevated concentrations of propylene glycol
- Preterm neonates may be at increased risk of propylene glycol-associated adverse reactions due to a diminished ability to metabolize propylene glycol, thereby, leading to accumulation
- The safety and effectiveness of dronabinol have not been established in pediatric patients
Drug interaction overview
- Coadministration with disulfiram or metronidazole may cause a disulfiramlike reactions (eg, abdominal cramps, nausea, vomiting, headaches, and flushing); discontinue disulfiram or metronidazole at least 14 days before initiating dronabinol and do not administer these products within 7 days of completing treatment with dronabinol
- Inhibitors and inducers of CYP2C9 and CYP3A4: May alter dronabinol systemic exposure; monitor for dronabinol-related adverse reactions or loss of efficacy
- Highly protein-bound drugs: Potential for displacement of other drugs from plasma proteins; monitor for adverse reactions to concomitant narrow therapeutic index drugs (eg, warfarin, cyclosporine, or amphotericin B) when initiating dronabinol or increasing the dosage
- Caution in patients receiving concomitant therapy with sedatives, hypnotics or other psychoactive drugs because of potential for additive or synergistic CNS effects
Caution in pregnant patients, nursing mothers, or pediatric patients; not studied
Pregnancy & Lactation
Pregnancy
May cause fetal harm; avoid use during pregnancy
Published studies suggest that during pregnancy, the use of cannabis, which includes THC, whether for recreational or medicinal purposes, may increase the risk of adverse fetal/neonatal outcomes including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, admission to the NICU, and stillbirth
Contains alcohol; alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development
Delta-9-THC has been measured in the cord blood of some infants whose mothers reported prenatal use of cannabis, suggesting that dronabinol may cross the placenta to the fetus during pregnancy
Effects of delta-9-THC on the fetus are not known
Lactation
Women with HIF: Advise HIV infected women not to breastfeed
Women with CINV: Do not breastfeed during treatment with dronabinol and for 9 days after the last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Dronabinol is an orally active cannabinoid which has complex effects on the CNS, including central sympathomimetic activity
Cannabinoid receptors have been discovered in neural tissues; these receptors may play a role in mediating the effects of dronabinol
Has appetite stimulant effect
Antiemetic mechanism unknown but probably involves inhibition of vomiting center in medulla oblongata
Absorption
Bioavailability: 90-95%, but due to combined effects of first-pass metabolism and high lipid solubility, only 10-20% of the administered dose reaches systemic circulation
Peak plasma time: 0.5-4 hr (dronabinol and major active metabolite: 11-hydroxy-delta-9-THC)
Peak plasma concentration: 1.9 ng/mL
AUC: 3.8 ng·hr/mL
Distribution
Protein bound: ~97%
Vd: 10 L/kg
Metabolism
Extensive first-pass hepatic metabolism
Metabolites: 11-hydroxy-delta-9-tetrahydrocannabinol (active)
Elimination
Half-life: 5.6 hr (parent drug); 44-59 hr (metabolites)
Renal clearance: 18-20 mL/min
Total body clearance: 0.2 L/kg/hr
Excretion: 50% feces; 15% urine
Pharmacogenomics
Systemic clearance may be reduced and concentrations may be increased in presence of CYP2C9 genetic polymorphism 2- to 3-fold higher dronabinol exposure in individuals carrying genetic variants associated with diminished CYP2C9 function
Monitoring for increased adverse reactions is recommended in patients known to carry genetic variants associated with diminished CYP2C9 function
Administration
Oral Administration
Oral solution
- Always use the enclosed calibrated oral dosing syringe when administering to ensure the dose is measured and administered accurately
- The calibrated oral syringe measures a maximum dronabinol dose of 5 mg; if the prescribed dose exceeds 5 mg, the total dose will need to be divided and drawn up in 2 or more portions using the oral syringe
- Take each dose with a full glass of water (6-8 oz)
Meals
- CINV: Take first dose on an empty stomach at least 30 minutes before eating; subsequent doses can be taken without regard to meals
- Anorexia: Take BID 1 hr before lunch and dinner
Storage
Oral capsules
- Store in well-closed container in a cool environment at 8-15°C (46-59°F); alternatively could be stored in a refrigerator
- Protect from freezing
Oral solution
- Store refrigerated at 2-8°C (36-46°F); excursions permitted to 15-25°C (59-77°F)
- The opened bottle can be stored at 25°C (77°F)
- Discard unused portion 28 days after first opening
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| dronabinol oral - | 2.5 mg capsule |  | |
| dronabinol oral - | 2.5 mg capsule |  | |
| dronabinol oral - | 2.5 mg capsule |  | |
| dronabinol oral - | 10 mg capsule |  | |
| dronabinol oral - | 2.5 mg capsule |  | |
| dronabinol oral - | 5 mg capsule |  | |
| dronabinol oral - | 10 mg capsule |  | |
| dronabinol oral - | 10 mg capsule |  | |
| dronabinol oral - | 5 mg capsule |  | |
| dronabinol oral - | 10 mg capsule |  | |
| dronabinol oral - | 5 mg capsule |  | |
| dronabinol oral - | 10 mg capsule |  | |
| dronabinol oral - | 5 mg capsule |  | |
| dronabinol oral - | 2.5 mg capsule |  | |
| dronabinol oral - | 5 mg capsule |  | |
| Marinol oral - | 5 mg capsule | | |
| Marinol oral - | 10 mg capsule | | |
| Marinol oral - | 2.5 mg capsule | | |
| Syndros oral - | 5 mg/mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
dronabinol oral
DRONABINOL SOLUTION - ORAL
(droe-NAB-i-nol)
COMMON BRAND NAME(S): Syndros
USES: Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is used when other drugs usually used to control nausea and vomiting have not worked well. Dronabinol is also used to treat loss of appetite and weight loss in people with HIV infection. Dronabinol (also called THC) is a man-made form of a natural substance in marijuana (cannabis).
HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking dronabinol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually up to 4 to 6 times daily if you are taking it to control nausea and vomiting, or twice daily (1 hour before lunch and 1 hour before dinner) if you are taking it to treat loss of appetite. Drink a full glass of water (8 ounces/240 milliliters) right after taking each dose. Follow your doctor's instructions carefully.Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.The dosage is based on your medical condition and response to treatment. If you are taking this medication to control nausea and vomiting, your dosage may also be based on your body size.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.If you suddenly stop using this medication, you may have withdrawal symptoms (such as irritability, trouble sleeping, restlessness, hot flashes, diarrhea). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used dronabinol for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.Tell your doctor if your condition does not get better or if it gets worse.
SIDE EFFECTS: Dizziness, drowsiness, confusion, feeling "high," an exaggerated sense of well-being, lightheadedness, nausea, vomiting, or stomach/abdominal pain may occur as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: fainting, fast/pounding heartbeat, mental/mood changes (such as anxiety, nervousness, hallucinations, abnormal thoughts, paranoia).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana (cannabis); or if you have any other allergies. This product may contain inactive ingredients (such as alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), heart disease, high blood pressure, mental/mood disorders (such as mania, depression, schizophrenia), seizures.This drug may make you dizzy or drowsy or may affect your judgment. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children may be more sensitive to the side effects of this drug, especially drowsiness and mental/mood changes.Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and mental/mood changes.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Dronabinol solution contains alcohol. Certain medications (such as disulfiram, metronidazole) should not be taken within 2 weeks before, during, or 7 days after taking dronabinol solution. Doing so can lead to a reaction that may include flushing, throbbing headache, breathing problems (such as shortness of breath, fast breathing), nausea, vomiting, dizziness, extreme tiredness, fainting, fast/irregular heartbeat, or blurred vision. Consult your doctor or pharmacist for details.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, fast heartbeat, mental/mood changes, seizures.
NOTES: Do not share this medication with others. Sharing it is against the law.Keep this medication in a safe place to prevent theft, misuse, or abuse.Keep all medical and lab appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store the unopened bottle in the refrigerator away from light or moisture. After opening, store in the refrigerator or at room temperature and discard any unused portion after 28 days. Do not freeze this medication or store it in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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