dronabinol (Rx)

Brand and Other Names:Marinol, Syndros
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Dosing & Uses

AdultPediatricGeriatric

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

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Interactions

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            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)

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              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

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              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

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              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.

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              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

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              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
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              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.

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              Patient Handout

              Patient Education
              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.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.