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Dronabinol

Pronunciation

Pronunciation

(droe NAB i nol)

Index Terms

  • Delta-9 THC
  • Delta-9-tetrahydro-cannabinol
  • Tetrahydrocannabinol
  • THC

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Marinol: 2.5 mg, 5 mg, 10 mg [contains sesame oil]

Generic: 2.5 mg, 5 mg, 10 mg

Brand Names: U.S.

  • Marinol

Pharmacologic Category

  • Antiemetic
  • Appetite Stimulant

Pharmacology

Dronabinol (synthetic delta-9-tetrahydrocannabinol [delta-9-THC]), an active cannabinoid and natural occurring component of Cannabis sativa L. (marijuana), activates cannabinoid receptors CB1 and CB2. Activation of the CB1 receptor produces marijuana-like effects on psyche and circulation, whereas activation of the CB2 receptor does not. Dronabinol has approximately equal affinity for the CB1 and CB2 receptors; however, efficacy is less at CB2 receptors. Activation of the cannabinoid system with dronabinol causes psychological effects that can be divided into 4 groups: affective (euphoria and easy laughter); sensory (increased perception of external stimuli and of the person’s own body); somatic (feeling of the body floating or sinking in the bed); and cognitive (distortion of time perception, memory lapses, difficulty in concentration). Most effects (eg, analgesia, appetite enhancement, muscle relaxation, hormonal actions) are mediated by central cannabinoid receptors (CB1), their distribution reflecting many of the medicinal benefits and adverse effects (Grotenhermen 2003).

Absorption

Oral: 90% to 95%; 10% to 20% of dose gets into systemic circulation

Distribution

Vd: ~10 L/kg; dronabinol is highly lipophilic

Metabolism

Extensive first-pass hepatic primarily via microsomal hydroxylation to metabolites, some of which are active; 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-THC) is the major active metabolite

Excretion

Feces (50%, 5% as unchanged drug); urine (10% to 15%)

Onset of Action

~0.5 to 1 hour; Peak effect: 2 to 4 hours

Time to Peak

Serum: 0.5 to 4 hours

Duration of Action

4 to 6 hours (psychoactive effects); ≥24 hours (appetite stimulation)

Half-Life Elimination

Biphaisc: Alpha: 4 hours; Terminal: 25 to 36 hours

Protein Binding

~97%

Use: Labeled Indications

Appetite stimulation in AIDS patients: Treatment of anorexia associated with weight loss in patients with AIDS.

Chemotherapy-induced nausea and vomiting: Treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Use: Unlabeled

Cancer-related anorexia

Contraindications

Hypersensitivity to dronabinol, cannabinoids, sesame oil, or any component of the formulation.

Dosing: Adult

Note: Use caution when increasing the dose of dronabinol because of the increased frequency of dose-related adverse reactions at higher dosages.

Appetite stimulation in AIDS patients: Oral: Initial: 2.5 mg twice daily (before lunch and dinner); for patients unable to tolerate this dosage, may reduce to 2.5 mg once daily (in the evening or at bedtime). May increase dose gradually based on response and tolerability (maximum: 20 mg per day [in divided doses]).

Chemotherapy-induced nausea and vomiting (manufacturer’s labeling): Oral: 5 mg/m2 administered 1 to 3 hours before chemotherapy, then give 5 mg/m2/dose every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses/day; increase doses in increments of 2.5 mg/m2 based on response and tolerability (maximum: 15 mg/m2/dose). Note: Initiate with the lowest recommended dose and titrate to response; most patients respond to 5 mg 3 to 4 times daily; based on initial results, the dose may be escalated during a chemotherapy cycle or with subsequent cycles.

Chemotherapy-induced nausea and vomiting, refractory (off-label dosing): Oral: 2.5 to 10 mg 3 or 4 times daily (Lohr 2008)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Chemotherapy-induced nausea and vomiting: Oral: Refer to adult dosing. Use caution when increasing the dose because of the increased frequency of dose-related adverse reactions at higher dosages.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

Oral: For appetite stimulation, administer twice-daily doses before lunch and dinner; administer single doses in the evening or at bedtime.

Dietary Considerations

Capsules contain sesame oil.

Storage

Store in a cool environment between 8°C and 15°C (46°F and 59°F) or refrigerated; protect from freezing.

Drug Interactions

Alcohol (Ethyl): Dronabinol may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Anticholinergic Agents: May enhance the tachycardic effect of Cannabinoid-Containing Products. Monitor therapy

CNS Depressants: Dronabinol may enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cocaine: May enhance the tachycardic effect of Cannabinoid-Containing Products. Monitor therapy

CYP2C9 Inhibitors (Moderate): May increase the serum concentration of Dronabinol. Monitor therapy

CYP2C9 Inhibitors (Strong): May increase the serum concentration of Dronabinol. Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Dronabinol. Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Dronabinol. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Dronabinol. Monitor therapy

Ritonavir: May increase the serum concentration of Dronabinol. Monitor therapy

Sympathomimetics: Cannabinoid-Containing Products may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Adverse Reactions

Frequency not always defined.

>1%:

Cardiovascular: Facial flushing, palpitations, tachycardia, vasodilatation

Central nervous system: Euphoria (8% to 24%; dose-related), abnormality in thinking (3% to 10%), dizziness (3% to 10%), drowsiness (3% to 10%), paranoia (3% to 10%), amnesia, anxiety, ataxia, confusion, depersonalization, hallucination

Gastrointestinal: Abdominal pain (3% to 10%), nausea (3% to 10%), vomiting (3% to 10%)

Neuromuscular & skeletal: Weakness

<1% (Limited to important or life-threatening): Conjunctivitis, depression, diarrhea, fatigue, fecal incontinence, flushing, hypotension, myalgia, nightmares, seizure, speech disturbance, tinnitus, visual disturbance

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: May cause occasional hypotension, possible hypertension, syncope, or tachycardia; use with caution in patients with cardiac disorders.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).

Disease-related concerns:

• Drug abuse: Use with caution in patients with a history of substance abuse, including alcohol abuse or dependence; potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use.

• Psychiatric disorders: Use with caution in patients with mania, depression, or schizophrenia; careful psychiatric monitoring is recommended because dronabinol may exacerbate these conditions.

• Seizure disorder: Use with caution in patients with a history of seizure disorder; may lower seizure threshold. Discontinue dronabinol immediately in patients who develop seizures.

Special populations:

• Elderly: Since the elderly are more sensitive to the neurological, psychoactive, and postural hypotensive effects of dronabinol, use with caution.

Other warnings/precautions:

• Appropriate use: Administration with phenothiazines (eg, prochlorperazine) for the management of chemotherapy-induced nausea and vomiting may result in improved efficacy (compared to either drug alone) without additional toxicity.

• Withdrawal: May cause withdrawal symptoms upon abrupt discontinuation.

Monitoring Parameters

CNS effects, heart rate, blood pressure, behavioral profile

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, abdominal pain, nausea, vomiting, or loss of strength and energy. Have patient report immediately to prescriber confusion, severe dizziness, passing out, severe headache, behavioral changes, mood changes, tachycardia, arrhythmia, hallucinations, memory impairment, seizures, vision changes, or change in balance (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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