Dronabinol - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Reactions : May cause psychiatric and cognitive effects and impair mental and/or physical abilities.

Avoid use in patients with a psychiatric history.

Monitor for symptoms and avoid concomitant use of drugs with similar effects.

Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol capsules do not affect them adversely.

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 after initiating or increasing the dosage of dronabinol capsules.

Seizures and Seizure-like Activity : Weigh the potential risk versus benefits before prescribing dronabinol capsules to patients with a history of seizures, including those requiring anti-epileptic medication or with other factors that lower the seizure threshold.

Monitor patients and discontinue if seizures occur.

Multiple Substance Abuse : Assess risk for abuse or misuse in patients with a history of substance abuse or dependence, prior to prescribing dronabinol capsules and monitor for the development of associated behaviors or conditions.

Paradoxical Nausea, Vomiting, or Abdominal Pain : Consider dose reduction or discontinuation, if worsening of symptoms while on treatment.

5.1 Neuropsychiatric Adverse Reactions Psychiatric Adverse Reactions Dronabinol has been reported to exacerbate mania, depression, or schizophrenia.

Significant CNS symptoms followed oral doses of 0.4 mg/kg (28 mg per 70 kg patient) of dronabinol capsules in antiemetic studies.

Prior to initiating treatment with dronabinol capsules, screen patients for a history of these illnesses.

Avoid use in patients with a psychiatric history or, if the drug cannot be avoided, monitor patients for new or worsening psychiatric symptoms during treatment.

Also, avoid concomitant use with other drugs that are associated with similar psychiatric effects.

Cognitive Adverse Reactions Use of dronabinol capsules has been associated with cognitive impairment and altered mental state.

Reduce the dose of dronabinol capsules or discontinue use of dronabinol capsules if signs or symptoms of cognitive impairment develop.

Elderly patients may be more sensitive to the neurological and psychoactive effects of dronabinol capsules [see Use in Specific Populations (8.4 , 8.5) ] .

Hazardous Activities Dronabinol capsules can cause and may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle or operating machinery.

Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants may increase this effect (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants).

Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol capsules do not affect them adversely.

5.2 Hemodynamic Instability Patients may experience occasional hypotension, possible hypertension, syncope, or tachycardia while taking dronabinol capsules [see Clinical Pharmacology ] .

Patients with cardiac disorders may be at higher risk.

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

Monitor patients for changes in blood pressure, heart rate, and syncope after initiating or increasing the dosage of dronabinol capsules.