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Cesamet Indication

Cesamet^® (nabilone) capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
This restriction in use is required because a substantial proportion of any group of patients treated with Cesamet^® can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.
Because of its potential to alter the mental state, Cesamet^® is intended for use under circumstances that permit close supervision of the patient by a responsible individual, particularly during initial use and during dose adjustments.
Cesamet^® contains nabilone, which is a Schedule II controlled substance and has a high potential for abuse. Prescriptions for Cesamet^® should be limited to the amount necessary for a single cycle of chemotherapy (ie, a few days).
Prescribers should monitor patients receiving nabilone for signs of excessive use, abuse, and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse or mental illness.
Cesamet^® capsules are not intended to be used on an as-needed basis or as a first antiemetic product prescribed for a patient.

Important Safety Information

Cesamet^® (nabilone) is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid.
The effects of Cesamet^® may persist for a variable and unpredictable period of time following its oral administration. Adverse psychiatric reactions can persist for 48 to 72 hours following cessation of treatment.
Cesamet^® has the potential to affect the CNS, which might manifest itself in dizziness, drowsiness, euphoria “high”, ataxia, anxiety, disorientation, depression, hallucinations, and psychosis.
Since Cesamet^® can cause tachycardia and orthostatic hypotension, it should be used with caution in the elderly and in patients with hypertension or heart disease.
Because of individual variation in response and tolerance to the effects of Cesamet^®, patients should remain under supervision of a responsible adult, especially during initial use of Cesamet^® and during dose adjustments.
Patients receiving treatment with Cesamet^® should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet^®.
Cesamet^® should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone.
Cesamet^® should also be used with caution in patients with current or previous psychiatric disorders (including manic depressive illness, depression, and schizophrenia), as the symptoms of these disease states may be unmasked by the use of cannabinoids.
Cesamet^® is a Schedule II controlled substance and should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since Cesamet contains a similar active compound to marijuana.
Cesamet^® has not been studied in pregnant patients, nursing mothers, or pediatric patients and, therefore, if used at all in those populations, it should be used with caution.
The effects of QT prolongation potential by Cesamet^® have not been determined.
During controlled clinical trials, virtually all patients experienced at least one adverse reaction. The most commonly encountered events were drowsiness, vertigo, dry mouth, euphoria, ataxia, headache, and concentration difficulties.