Class: Antiemetic, Antivertigo
- Capsules 1 mg
Has complex effects on the CNS; interacts with the cannabinoid receptor system in neural tissue.
Completely absorbed following oral ingestion. C max occurs within 2 h.
Vd is approximately 12.5 L/kg.
Extensively metabolized; however, information about the metabolites and their activities is not available.
Nabilone t ½ is approximately 2 h. Approximately 60% is excreted in the feces via the biliary system and 24% in urine.
Special PopulationsHepatic and Renal Function Impairment
Effects have not been determined.
Indications and Usage
Treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
Dosage and AdministrationAdults
PO 1 or 2 mg twice daily. On the day of chemotherapy, administer the initial dose 1 to 3 h before giving the chemotherapeutic agent. May be administered during the entire chemotherapy cycle and for 48 h after the last dose of each chemotherapy cycle. Max dose: 2 mg 3 times daily.
- Food does not affect absorption of the drug.
Store at 59° to 86°F.
Drug InteractionsAnticholinergic agents (eg, atropine, scopolamine), tricyclic antidepressants (eg, amitriptyline)
Additive or potentiation of tachycardia and drowsiness.Barbiturates
Cl may be decreased by nabilone, increasing the risk of adverse reactions.CNS depressants (eg, alcohol, barbiturates, benzodiazepines, buspirone, codeine, muscle relaxants)
Additive depressant effects. Psychomotor function is particularly impaired when coadministered with diazepam.Disulfiram, fluoxetine
Risk of hypomania may be increased.Highly protein-bound drugs
May be displaced, leading to transient increases in pharmacologic activity.Naltrexone
Opioid blockade may enhance effects of nabilone.Opioids
Cross-tolerance and mutual potentiation may occur.Sympathomimetic agents (eg, amphetamines)
Additive hypertension and tachycardia, possible cardiotoxicity.Theophylline
Metabolism of theophylline may be increased, reducing the therapeutic effect.
Laboratory Test Interactions
None well documented.
Hypotension (8%); arrhythmia; cerebral vascular accident; flushing; hypertension; orthostatic hypotension; palpitation; syncope; tachycardia.
Drowsiness (66%); dizziness/vertigo (59%); euphoria (38%); ataxia, depression (14%); difficulty concentrating (12%); sleep disturbance (11%); dysphoria (9%); asthenia (8%); headache (7%); sedation (3%); depersonalization, disorientation (2%); abnormal dreams, abnormal thinking, akathisia, anxiety, apathy, CNS stimulation, circumoral paresthesia, confusion, convulsions, disorientation, disturbed coordination, disturbed perception, dystonia, emotional disorder, emotional lability, fatigue, hallucinations, hyperactivity, inebriated feeling, insomnia, irritability, light-headedness, malaise, mood swings, nervousness, numbness, paranoia, paresthesia, phobic neurosis, somnolence, speech disorder, stupor, taste change, thought disorder, toxic psychosis, tremor, twitching, unconsciousness, withdrawal panic disorder (postmarketing).
Allergic reactions; anhidrosis; excessive sweating; photosensitivity; pruritus; rash.
Visual disturbances (13%); amblyopia; dry nose; dry throat; ear tightness; equilibrium dysfunction; eye disorder; eye irritation; eye swelling; eyelid disease; nasal congestion; nosebleed; pharyngitis; photophobia; pupil dilation; tinnitus; visual field defect; voice change.
Dry mouth (36%); anorexia (8%); nausea (4%); abdominal pain; aphthous ulcer; constipation; diarrhea; dyspepsia; gastritis; mouth irritation; thick tongue; vomiting.
Decreased urination; frequency of micturition; increased urination; urinary retention.
Anemia, leukopenia (postmarketing).
Back pain; joint pain; muscle pain; neck pain; unspecified pain.
Cough; dyspnea; sinus headache; wheezing.
Increased appetite (2%); bacterial infection, chest pain, chills, face edema, fever, inhibited walking (postmarketing).
Category C .
Safety and efficacy not established.
Use with caution, usually starting at the low end of the dosage range because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Special Risk Patients
Use with caution in patients with hypertension or heart disease.
Adverse psychiatric reactions may persist for 72 h following cessation of therapy.
Because of the high abuse potential, limit prescriptions to the amount necessary for a single cycle of chemotherapy (a few days).
Previous psychiatric disorders
Use with caution in patients with history of psychiatric disorders (eg, depression, manic depressive illness, schizophrenia) because symptoms of these disorders may be unmasked.
Anxiety reactions; coma; hypertension; hypotension; orthostatic hypotension; psychotic episodes, including hallucinations; respiratory depression; tachycardia.
- Caution patient not to drive, operate machinery, or engage in hazardous activities.
- Advise patient of possible changes in mood and other adverse behavioral effects of nabilone.
- Caution patient to remain under supervision of a responsible adult while taking nabilone.
- Alert patient to the potential for additive CNS depression with concurrent use of alcohol or other depressants.
Copyright © 2009 Wolters Kluwer Health.
More about nabilone
- Other brands: Cesamet