Brand names: Marinol, Syndros
Drug class: GI Drugs, Miscellaneous

Medically reviewed by Drugs.com on Nov 10, 2024. Written by ASHP.

Introduction

Antiemetic and appetite stimulant; a synthetic cannabinoid.

Uses for Dronabinol

Anorexia Associated with Weight Loss in Patients with AIDS

Treatment of anorexia associated with weight loss in adult patients with acquired immunodeficiency syndrome (AIDS) (has been designated an orphan drug by FDA for this use).

Efficacy of dronabinol oral solution (e.g., Syndros) for this use based on clinical studies of dronabinol capsules.

Cancer Chemotherapy-induced Nausea and Vomiting

Treatment of nausea and vomiting associated with cancer chemotherapy in adult patients who have failed to respond adequately to conventional antiemetic therapy.

Efficacy of dronabinol oral solution (e.g., Syndros) for this use based on clinical studies of dronabinol capsules.

ASCO does not consider cannabinoids (e.g., dronabinol, nabilone) appropriate first-line antiemetics for patients receiving chemotherapy of low, moderate, or high emetic risk; however, cannabinoids may be used in addition to first-line antiemetic therapies for patients experiencing refractory nausea and vomiting despite optimal antiemetic therapy. For patients in whom a cannabinoid is chosen for treatment of nausea and vomiting caused by chemotherapy or radiation therapy, ASCO recommends dronabinol or nabilone over medical marijuana.

Dronabinol Dosage and Administration

General

Pretreatment Screening

• Ensure patient is not allergic to sesame oil (if using Marinol capsules).

• Ensure patient is not allergic to alcohol (if using Syndros oral solution).

• Ensure patient is not receiving or has not received disulfiram or metronidazole-containing products in the previous 14 days (if using Syndros oral solution).

• Screen patients for a history of mania, depression, or schizophrenia prior to initiating dronabinol; generally avoid use in patients with a history of psychiatric disorders.

• Assess risk for substance abuse or misuse in patients with a history of substance abuse or dependence prior to prescribing dronabinol.

• If initiating dronabinol in elderly patients with dementia, place these patients on fall precautions prior to treatment initiation.

Patient Monitoring

• Monitor for new or worsening psychiatric symptoms during treatment with dronabinol, particularly in patients with a history of psychiatric disorders.

• Monitor for changes in blood pressure, heart rate, and occurrence of syncope after initiation and dosage increases.

• Monitor patients for adverse CNS reactions (e.g., feeling high, dizziness, confusion, somnolence).

• Monitor for worsened seizure control in patients with a history of seizure disorders during treatment with dronabinol.

• Monitor for abuse or misuse in patients with a history of substance abuse during treatment with dronabinol.

Administration

Oral Administration

Administer orally. Available as capsules (e.g., Marinol) or oral solution (Syndros).

For the management of anorexia in adults with AIDS, initially administer dronabinol capsules or oral solution twice daily, 1 hour before lunch and dinner. In geriatric patients or patients unable to tolerate the recommended twice daily dosage, give dronabinol capsules or oral solution once daily, 1 hour before dinner or at bedtime. Administering dronabinol later in the day may help reduce frequency of adverse CNS effects.

For the management of cancer chemotherapy-induced nausea and vomiting in adults who have failed conventional antiemetics, administer dronabinol capsules or oral solution 1–3 hours prior to chemotherapy and then every 2–4 hours after chemotherapy totaling 4-6 doses per day. In geriatric patients, consider initiating dronabinol capsules or oral solution at a lower dosage 1–3 hours prior to chemotherapy once daily.

Administer first dose of dronabinol capsules or oral solution on an empty stomach, ≥30 minutes before eating. May administer subsequent doses without regard to meals, but administer in a consistent manner relative to meals for each chemotherapy cycle once the dosage has been determined from the titration process.

Administer dronabinol oral solution using calibrated dosing syringe supplied by manufacturer. Oral syringe measures a maximum dose of 5 mg (i.e., 1 mL of the oral solution); if prescribed dose is >5 mg, divide dose into 2 or more portions and administer total dose using oral syringe. When preparing oral solution, firmly insert bottle adapter provided by the manufacturer into neck of bottle before first use; keep adaptor in place for duration of bottle usage. To dispense dose, firmly insert oral dosing syringe into adapter, then carefully invert bottle and withdraw appropriate dose into syringe. Lastly, while the oral syringe and adapter are connected, turn the bottle upright and remove the oral syringe from the adapter by gently pulling up. Administer dose slowly into the back of mouth on top of the tongue. Administer full glass of water (180–240 mL [6–8 ounces]) after each dose. For complete instructions on how to prepare and administer dronabinol oral solution, refer to full prescribing information.

Dronabinol oral solution can be administered via enteral feeding tubes that are manufactured with silicone and of a size greater than or equal to 14 French (e.g., nasogastric, gastrostomy, percutaneous endoscopic gastrostomy, and gastro-jejunostomy tubes). Do not use with polyurethane tubes. To prepare oral solution via feeding tube, first draw up prescribed dose with calibrated dosing syringe. If prescribed dose is >5 mg, divide total dose and draw up in 2 or more portions using oral syringe. Administer dose via the feeding tube using the calibrated dosing syringe. Flush feeding tube with 30 mL of water using a catheter-tip syringe. For complete instructions on how to prepare and administer dronabinol solution via a feeding tube, refer to full prescribing information.

Dosage

A 4.2-mg dose of dronabinol oral solution appears to provide comparable systemic exposure to a 5-mg oral dose given as dronabinol capsules under fasted conditions.

Adults

Anorexia Associated with Weight Loss in Patients with AIDS

Adverse CNS effects (e.g., feeling “high,” dizziness, confusion, somnolence) are dose-related and generally resolve within 1–3 days with continued therapy at the same dosage.

Oral (Capsules)

Initially, 2.5 mg twice daily, given 1 hour before lunch and dinner.

If unable to tolerate this dosage, consider initiating therapy at a dosage of 2.5 mg once daily, given 1 hour before dinner or at bedtime to reduce the risk of CNS symptoms.

If tolerated and additional therapeutic effect is desired, gradually increase dosage to 2.5 mg one hour before lunch and 5 mg one hour before dinner; most patients respond to 2.5 mg twice daily, but dosage may be further increased to 5 mg one hour before lunch and 5 mg one hour before dinner as tolerated, up to a maximum of 10 mg twice daily. If adverse CNS effects are severe or persistent, reduce dosage to 2.5 mg once daily given in the evening or at bedtime.

Oral (Solution)

Initially, 2.1 mg twice daily, given 1 hour before lunch and dinner.

If unable to tolerate this dosage, consider initiating therapy at a dosage of 2.1 mg once daily, given 1 hour before dinner or at bedtime to reduce the risk of CNS symptoms.

If tolerated and additional therapeutic effect desired, gradually increase dosage to 2.1 mg one hour before lunch and 4.2 mg one hour before dinner; most patients respond to 2.1 mg twice daily, but dosage may be further increased to 4.2 mg one hour before lunch and 4.2 mg one hour before dinner as tolerated, up to a maximum of 8.4 mg twice daily. If adverse CNS effects are severe or persistent, reduce dosage to 2.1 mg once daily, given 1 hour before dinner or at bedtime.

Cancer Chemotherapy-induced Nausea and Vomiting

Adverse effects are dose-related and incidence of adverse psychiatric effects increases substantially at the maximum dosage; monitor patients for adverse effects during dosage escalation.

Oral (Capsules)

Initially, 5 mg/m² given 1–3 hours before chemotherapy; repeat every 2–4 hours after chemotherapy up to a total of 4–6 doses daily.

Based on clinical response and tolerability, may increase dosage in 2.5 mg/m² increments during a chemotherapy cycle or at subsequent cycles up to a maximum of 15 mg/m² for each dose for a total of 4–6 doses each day.

To reduce the risk of adverse CNS effects, consider reducing dosage to 2.5 mg once daily given 1–3 hours before chemotherapy.

Oral (Solution)

Initially, 4.2 mg/m² given 1–3 hours before chemotherapy; repeat every 2–4 hours after chemotherapy up to a total of 4–6 doses daily.

To calculate the starting dose, multiply patient body surface area (BSA) in m² by 4.2 mg/m². Round calculated doses to the nearest 0.1-mg increment.

Convert from mg to mL by dividing starting dose (rounded to the nearest 0.1-mg increment) by 5 to obtain starting dose in mL. To correspond with the calibrated oral dosing syringe, may need to round the dose to the nearest 0.1-mL increment.

Based on clinical response and tolerability, may increase dosage in 2.1 mg/m² increments during a chemotherapy cycle or at subsequent cycles up to a maximum of 12.6 mg/m² for each dose for a total of 4–6 doses each day.

To reduce the risk of adverse CNS effects, consider reducing dosage to 2.1 mg once daily given 1–3 hours before chemotherapy.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

Select dosage with caution, usually starting at low end of recommended dosage range because these patients have a greater frequency of falls; decreased hepatic, renal, or cardiac function; increased sensitivity to psychoactive effects; and of concomitant illnesses and medication. To reduce the risk of CNS symptoms in elderly patients, consider initiating at a lower dose as described below.

Anorexia Associated with Weight Loss in Patients with AIDS: Capsules: Initially, 2.5 mg once daily given 1 hour before dinner or at bedtime. Solution: Initially, 2.1 mg once daily given 1 hour before dinner or at bedtime.

Chemotherapy-induced Nausea and Vomiting: Capsules: Initially, 2.5 mg/m² once daily, given 1–3 hours before chemotherapy. Solution: Initially, 2.1 mg/m² once daily, given 1–3 hours before chemotherapy.

Cautions for Dronabinol

Contraindications

• History of hypersensitivity to dronabinol or any ingredient in the formulation. Hypersensitivity reactions reported with dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, and throat tightness.

• Capsules (e.g., Marinol): Hypersensitivity to sesame oil.

• Oral solution (Syndros): Hypersensitivity to alcohol; current or recent (i.e., within 14 days) therapy with disulfiram- or metronidazole-containing products.

Warnings/Precautions

Neuropsychiatric Adverse Effects

May cause adverse psychiatric effects, including exacerbation of mania, depression, or schizophrenia, Prior to initiating dronabinol therapy, screen patients for a history of these psychiatric conditions. Avoid dronabinol therapy in patients with a history of psychiatric disorders; if therapy cannot be avoided, monitor for new or worsening psychiatric symptoms during therapy. Avoid concomitant use of other drugs associated with similar psychiatric adverse effects.

May cause cognitive impairment and altered mental state. Geriatric and pediatric patients may be more sensitive to neurologic and psychoactive effects. If signs or symptoms of cognitive impairment develop during therapy, reduce dosage or discontinue dronabinol.

May impair cognitive and/or physical abilities required to perform hazardous tasks (e.g., operating a motor vehicle or other dangerous machinery). Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants (e.g., barbiturates, benzodiazepines, alcohol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants) may increase this effect. Inform patients not to operate motor vehicles or other dangerous machinery until certain that dronabinol does not affect them adversely.

Hemodynamic Instability

Occasional hypotension, hypertension, syncope, or tachycardia may occur. Patients with cardiac disorders may be at increased risk.

Monitor for changes in BP, heart rate, and syncope following initiation of therapy or increases in dosage.

Avoid concomitant use of dronabinol and other drugs associated with similar cardiac effects (e.g., amphetamines or other sympathomimetic agents; antihistamines, atropine, scopolamine, or other anticholinergic agents; amitriptyline, amoxapine, desipramine, or other tricyclic antidepressants).

Interaction with Disulfiram and Metronidazole

Dronabinol oral solution (Syndros) contains 50% dehydrated alcohol and 5.5% propylene glycol; therefore, disulfiram-like reactions (e.g., abdominal cramps, nausea, vomiting, headaches, flushing) can occur in patients concurrently receiving disulfiram, metronidazole, or other drugs associated with such reactions.

Concomitant use of dronabinol oral solution and disulfiram- or metronidazole-containing preparations contraindicated. Allow ≥14 days to elapse between discontinuance of disulfiram- or metronidazole-containing preparations and initiation of dronabinol oral solution and ≥7 days between discontinuance of dronabinol oral solution and initiation of such preparations.

Seizures

Seizures and seizure-like activity reported. Weigh potential risk of seizures against potential benefits of dronabinol before initiating therapy in patients with a history of seizures, including those receiving anticonvulsants or with other factors that can lower the seizure threshold.

Monitor patients with a history of seizure disorders for worsening seizure control. If seizures occur, discontinue dronabinol and contact a clinician immediately.

Potential for Drug Abuse and Dependence

Patients with a history of substance abuse or dependence, including marijuana or alcohol, may be more likely to abuse dronabinol as well. Commercially available dronabinol formulations (e.g., Marinol, Syndros) contain the main psychoactive component in marijuana. Ingestion of high doses of dronabinol increases the risk of adverse psychiatric effects (e.g., psychosis, hallucinations, depersonalization, mood alteration, paranoia) if drug abused or misused; continued administration can lead to addiction. Physical dependence can develop during chronic therapy with dronabinol. Instruct patients to keep dronabinol in a secure place out of reach of others for whom the medication has not been prescribed.

Before prescribing dronabinol therapy, assess each patient's risk for abuse or misuse. Monitor patients with a history of substance abuse for the development of behaviors or conditions associated with substance abuse.

Paradoxical Nausea, Vomiting, or Abdominal Pain

May cause new or worsening nausea, vomiting, or abdominal pain; can be severe (e.g., leading to dehydration or electrolyte abnormalities) and require dosage reduction or drug discontinuance. These symptoms are similar to cannabinoid hyperemesis syndrome, which has been described as cyclical events of abdominal pain, nausea, and vomiting in chronic users of products containing delta-9-tetrahydrocannabinol (delta-9-THC).

Because patients may not recognize these symptoms as abnormal, clinicians should ask patients or their caregivers about development of worsening nausea, vomiting, or abdominal pain during dronabinol therapy. Consider dosage reduction or drug discontinuance if a patient develops such symptoms during therapy.

Toxicity in Preterm Neonates Associated with Alcohol and Propylene Glycol in the Oral Solution

Dronabinol oral solution contains 50% dehydrated alcohol and 5.5% propylene glycol. Alcohol competitively inhibits metabolism of propylene glycol, which may lead to elevated propylene glycol concentrations.

Preterm neonates have a decreased ability to metabolize propylene glycol and may be at increased risk of accumulation and propylene glycol-associated toxicities (e.g., hyperosmolarity, with or without lactic acidosis; renal toxicity; CNS depression, including stupor, coma, and apnea; seizures; hypotonia; cardiac arrhythmias; ECG changes; hemolysis).

Safety and efficacy of dronabinol oral solution not established in pediatric patients. Avoid use in preterm neonates during the immediate postnatal period.

Specific Populations

Pregnancy

May cause fetal harm. Limited data regarding use of synthetic cannabinoids during pregnancy.

Cannabis use during pregnancy associated with adverse fetal/neonatal outcomes (e.g., fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, admission to neonatal intensive care, stillbirth).

Cannabinoids found in umbilical cord blood from pregnant women who reported prenatal use of cannabis, suggesting dronabinol may cross placenta.

Dronabinol oral solution (Syndros) contains alcohol, which is associated with fetal harm.

In animal reproduction studies, dronabinol was not teratogenic. However, decreased maternal weight gain and number of viable pups and increased fetal mortality and early resorptions observed. Prenatal exposure to delta-9-THC in animals has resulted in neurotoxicity with adverse effects on brain development, including abnormal neuronal connectivity and impairments in cognitive and motor function.

Avoid use of cannabis and dronabinol in pregnant women.

Lactation

Limited data available on presence of dronabinol in human milk, effects of the drug on the breast-fed infant, and its effects on milk production. Reported effects of inhaled cannabis on breast-fed infants inconsistent and insufficient to establish causality.

Because of the risk of serious adverse effects in the infant and the risk of HIV transmission, HIV-infected women should not breast-feed infants.

Monitor weight in breast-feeding infants of mothers with nausea and vomiting associated with cancer chemotherapy who are receiving dronabinol capsules and in whom breast-feeding is appropriate.

Consider developmental and health benefits of breast-feeding along with mother’s clinical need for dronabinol and any potential adverse effects on breast-fed infant from dronabinol or from underlying maternal condition.

Pediatric Use

Safety and efficacy not established. Pediatric patients may be more sensitive to neurologic and psychoactive effects.

Because of potential propylene glycol-associated toxicity, avoid use of dronabinol oral solution (Syndros) in preterm neonates during the immediate postnatal period.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults. In antiemetic studies, no difference in efficacy observed in patients >55 years of age compared to younger patients. Geriatric patients may be more sensitive to neuropsychiatric and postural hypotensive effects.

Use with caution in geriatric patients with dementia; risk of falls as a result of their underlying disease may be exacerbated by adverse CNS effects (e.g., somnolence, dizziness) of dronabinol. Initiate precautions to prevent falls before starting drug and closely monitor such patients during therapy.

Hepatic Impairment

The manufacturers make no specific safety warnings for patients with hepatic impairment.

Renal Impairment

The manufacturers make no specific safety warnings for patients with renal impairment.

Pharmacogenomics and Effect of CYP2C9 Polymorphism

Reduced dronabinol clearance and increased exposure (twofold to threefold higher exposure) reported in individuals carrying genetic variants associated with diminished CYP2C9 function (i.e., poor CYP2C9 metabolizers).

Monitor such patients for possibly increased adverse effects.

Common Adverse Effects

Most common adverse reactions (≥3%): abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, abnormal thinking, vomiting.

Drug Interactions

No formal drug interaction studies to date. Enzyme inhibition and induction potential of dronabinol and its active metabolite have not been fully elucidated.

Metabolized principally by CYP2C9 and CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

CYP2C9 or CYP3A4 inhibitors: Potential increased systemic exposure to dronabinol and/or its active metabolite; monitor for adverse effects.

CYP2C9 or CYP3A4 inducers: Potential decreased systemic exposure to dronabinol and/or its active metabolite; monitor for reduced efficacy.

CNS Depressants

Additive CNS effects (e.g., dizziness, confusion, sedation, somnolence) possible with concomitant use of drugs with similar effects on the CNS, such as CNS depressants (e.g., barbiturates, benzodiazepines, alcohol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants).

Drugs with Additive Cardiac Effects

Additive cardiac effects (e.g., hypotension, hypertension, syncope, tachycardia) possible with concomitant use of drugs with similar effects on cardiovascular system (e.g., amphetamines or other sympathomimetic agents; atropine, scopolamine, antihistamines, or other anticholinergic agents; amitriptyline, desipramine, amoxapine, or other tricyclic antidepressants).

Avoid concomitant use of dronabinol and other drugs associated with similar cardiac effects.

Highly Protein-bound Drugs

Dronabinol is highly bound to plasma proteins. Potential for displacement of other protein-bound drugs and increased adverse effects. Monitor for possible increased adverse effects, particularly with drugs that have a narrow therapeutic index and during initiation or dosage increases of dronabinol.

Specific Drugs and Foods

Dronabinol Pharmacokinetics

Absorption

Bioavailability

About 90–95% absorbed after oral administration; only 10–20% of administered dose reaches systemic circulation because of first-pass hepatic metabolism and high lipid solubility.

Bioequivalence demonstrated between a single 4.25-mg dose given as oral solution and a single 5-mg dose given as capsules under fasting conditions.

Absorption from oral solution appears to be more rapid than from capsule. In a pharmacokinetic study, plasma concentrations detected within 15 minutes in all individuals following administration of oral solution compared with about 17% of individuals following administration of capsules.

Peak plasma concentrations of dronabinol and its major active metabolite occur approximately 0.5–4 hours following oral administration of capsules or solution.

Steady-state cannabinoid concentrations achieved within about 2 weeks following chronic oral administration.

Onset

Approximately 0.5–1 hour after oral administration.

Peak effect occurs 2–4 hours after oral administration.

Duration

Appetite stimulant effect may persist ≥24 hours after oral administration.

Psychoactive effects continue 4–6 hours after oral administration.

Food

Administration of capsules with a high-fat, high-calorie meal delayed time to peak plasma concentrations by 4 hours and increased total exposure 2.9-fold; peak plasma concentration unchanged.

Administration of oral solution with a high-fat, high-calorie meal delayed time to peak plasma concentration by approximately 5 hours, decreased peak plasma concentration by approximately 20%, and increased total exposure approximately 2.5-fold.

Special Populations

Twofold to threefold higher dronabinol exposures reported in poor CYP2C9 metabolizers.

Distribution

Extent

High lipid solubility.

May cross placenta; cannabinoids detected in umbilical cord blood in pregnant women who reported prenatal use of cannabis (e.g., marijuana).

Unknown if distributed into human milk.

Plasma Protein Binding

Approximately 97% for dronabinol and its metabolites.

Elimination

Metabolism

Undergoes extensive first-pass hepatic metabolism, principally by hydroxylation, to active and inactive metabolites.

Metabolized principally by CYP2C9 and CYP3A4. Formation of the major active metabolite, 11-hydroxy-delta-9-THC, appears to be mediated primarily by CYP2C9.

Dronabinol and 11-hydroxy-delta-9-THC present in plasma in approximately equal concentrations.

Elimination Route

Dronabinol and its metabolites eliminated principally in feces (approximately 50%) and to a lesser extent in urine (approximately 10–15%) within 72 hours; <5% of an oral dose is recovered unchanged in feces.

Principal excretory pathway appears to be biliary system.

Half-life

Biphasic; initial elimination half-life is about 4 hours, and terminal elimination half-life is 25–36 hours.

Because of redistribution, dronabinol and its metabolites may be excreted at low concentrations for extended periods; dronabinol metabolites detected in urine and feces >5 weeks following single doses.

Stability

Storage

Oral

Capsules

8–15ºC in tightly closed container; alternatively, may refrigerate, but protect from freezing.

Solution

2–8°C in a refrigerator (excursions permitted up to 25°C). Can store at 25°C after opening. Discard unused portion 42 days after first opening. Keep oral solution and oral syringe in supplied carton.

Actions

• Synthetic cannabinoid; antiemetic and appetite stimulant.

• Synthetic delta-9-tetrahydrocannabinol (active ingredient) also is a naturally occurring component of Cannabis sativa (marijuana).

• Exerts complex effects on CNS, including central sympathomimetic activity; cannabinoid receptors may play role in mediating effects.

• May produce alterations in mental state (e.g., dysphoria, euphoria, anxiety, or panic reactions in some individuals) and psychotomimetic reactions.

• Sympathomimetic activity may result in tachycardia and/or conjunctival injection. Effects on BP inconsistent; orthostatic hypotension and/or syncope upon abrupt standing occasionally occurs.

• Exerts reversible effects on appetite, mood, cognition, memory, and perception; these effects appear to be dose-related and exhibit considerable interpatient variability.

Advice to Patients

• Advise patients to read the patient information for dronabinol capsules (e.g., Marinol) or dronabinol oral solution (Syndros).

• Advise patients and/or caregivers to read the instructions for use for dronabinol oral solution before starting therapy with the drug. Instruct patients and/or caregivers regarding proper dosing and administration of dronabinol oral solution. Instruct patients to drink a full glass of water (180–240 mL) with each dose of dronabinol oral solution.

• Inform patients that accidental ingestion of dronabinol oral solution, which contains 50% dehydrated alcohol and 5.5% propylene glycol, may result in toxicity. Instruct patients that dronabinol capsules and oral solution should be stored in a secure place to prevent possible theft, misuse, or accidental ingestion. In case of accidental ingestion of dronabinol oral solution, advise patients to seek immediate medical attention.

• Inform patients that adverse psychiatric effects may occur, particularly in patients with a past psychiatric history or in those concurrently receiving other drugs that also are associated with psychiatric effects. Advise patients to contact their clinician if any new or worsening psychiatric symptoms develop during dronabinol therapy.

• Inform patients, particularly geriatric patients, that cognitive impairment or altered mental state may occur during dronabinol therapy, and to contact their clinician if any signs or symptoms of cognitive impairment develop during dronabinol therapy.

• Advise patients to avoid driving, operating other dangerous machinery, or performing hazardous tasks during dronabinol therapy until they are reasonably certain that dronabinol does not adversely affect them.

• Alert patients to the potential for additive CNS depression during concurrent use with alcohol or other CNS depressants, including benzodiazepines and barbiturates.

• Advise patients of the risk of hemodynamic instability, particularly in patients with cardiac disorders. Advise patients to inform their clinician if they experience any manifestations of hemodynamic instability, including hypotension, hypertension, syncope, or tachycardia, particularly following initiation or increasing the dosage of dronabinol.

• Inform patients that concurrent use of disulfiram- or metronidazole-containing products with dronabinol oral solution may cause a disulfiram-like reaction because of the alcohol content of the oral solution. Advise patients not to take disulfiram- or metronidazole-containing preparations during treatment with dronabinol oral solution and for up to 7 days following discontinuance of the oral solution.

• Advise patients to discontinue dronabinol therapy and to immediately contact a clinician if they experience a seizure.

• Inform patients with a history of substance abuse or dependence, including marijuana and alcohol, that they may be more likely to abuse dronabinol. Advise patients to inform their clinician if they develop substance abuse behaviors or conditions.

• Advise patients to report worsening nausea, vomiting, or abdominal pain to their clinician.

• Advise patients of the importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., disulfiram, metronidazole) and OTC drugs or herbal supplements, as well as concomitant illnesses (e.g., cardiovascular disease, seizures, psychiatric conditions, history of substance or alcohol abuse).

• Advise women of childbearing potential of the risk of fetal harm and to avoid use of dronabinol during pregnancy. Advise women to inform clinicians if they are or plan to become pregnant. If pregnancy occurs, advise the patient of potential risk to fetus.

• Advise women to inform clinicians if they plan to breast-feed. Advise HIV-infected women with anorexia associated with weight loss not to breast-feed to avoid transmission of HIV to the infant. Advise women with nausea and vomiting associated with cancer chemotherapy who are being treated with dronabinol capsules to monitor the weight of their breast-feeding infants.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Dronabinol preparations are subject to control under the Federal Controlled Substances Act of 1970.

Dronabinol capsules are subject to control as a schedule III (C-III) drug.

Dronabinol oral solution is subject to control as a schedule II (C-II) drug.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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