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CESAMET is a brand name for Nabilone, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
NCESAMET® (nabilone) is contraindicated in patients with known sensitivity to marijuana or other cannabinoid agents, and in those with a history of psychotic reactions. WARNINGS NCESAMET® (nabilone) should be used with extreme caution in patients with severe liver dysfunction and in those with a history of non-psychotic emotional disorders.
NCESAMET® should not be taken with alcohol, sedatives, hypnotics, or other psychotomimetic substances. NCESAMET® should not be used during pregnancy, in nursing mothers, or pediatric patients since its safety under these conditions has not been established.
PRECAUTIONS Since NCESAMET® (nabilone) will often impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car and operating machinery, the patient should be warned accordingly and should not be permitted to drive or engage in dangerous tasks until the effects of nabilone are no longer present.
Adverse psychotropic reactions can persist for 48 to 72 hours following cessation of treatment. Since NCESAMET® elevates supine and standing heart rates and causes postural hypotension, it should be used with caution in the elderly and in patients with hypertension or heart disease.
Drug Interactions Potential interactions between NCESAMET®, and diazepam; sodium secobarbital; alcohol; or codeine, were evaluated. The depressant effects of the combinations were additive. Psychomotor function was particularly impaired with concurrent use of diazepam.
Pediatric Use The safety and efficacy in children under the age of 18 has not been established. Therefore, the use of NCESAMET® in this patient population is not recommended. 0%). The following adverse reactions were observed in less than 1% of the patients who were administered nabilone in the course of the clinical trials: tachycardia, tremors, syncope, nightmares, distortion in the perception of time, confusion, dissociation, dysphoria, psychotic reactions and seizures.
Spontaneously Reported Adverse Reactions The following adverse reactions listed in order of decreasing frequency by body system have been reported since NCESAMET® has been marketed. All events are listed regardless of causality assessment.
Blood and Hematopoietic:
Leukopenia Cardiovascular: Hypotension and tachycardia Eye and Ear: Visual disturbances Gastrointestinal: Dry mouth, nausea, vomiting, and constipation Nervous System: Hallucinations, CNS depression, CNS stimulation, ataxia, stupor, vertigo, convulsion, and circumoral paresthesia Psychiatric: Somnolence, confusion, euphoria, depression, dysphoria, depersonalization, anxiety, psychosis, and emotional lability Miscellaneous and Ill-Defined Conditions: Dizziness, headache, insomnia, abnormal thinking, chest pain, lack of effect, and face edema SYMPTOMS AND TREATMENT OF OVERDOSE Signs and Symptoms Signs and symptoms which might be expected to occur are psychotic episodes including hallucinations, anxiety reactions, respiratory depression and coma (experience with cases of overdosage of more than 10 mg/day has not yet been reported).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nabilone in Canada.
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Treatment Overdosage may be considered to have occurred, even at prescribed dosages, if disturbing psychiatric symptoms are present. In these cases, the patient should be observed in a quiet environment and supportive measures, including reassurance, should be used.
Subsequent doses should be withheld until patients have returned to their baseline mental status; routine dosing may then be resumed if clinically indicated. In such instances, a lower initiating dose is suggested. NCESAMET® Product Monograph Page 5 of 16 If psychotic episodes occur, the patient should be managed conservatively, if possible.
For moderate psychotic episodes and anxiety reactions, verbal support and comforting may be sufficient. In more severe cases, antipsychotic drugs may be useful; however, the utility of antipsychotic drugs in cannabinoid psychosis has not been systematically evaluated.
Support for their use is drawn from limited experience using antipsychotic agents to manage cannabis overdoses. , additive CNS depressant effects due to nabilone and chlorpromazine), such patients should be closely monitored. Protect the patient's airway and support ventilation and perfusion.
Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying.
Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal. The use of forced diuresis, peritoneal dialysis, hemodialysis, charcoal hemoperfusion, or cholestyramine has not been reported.
In the presence of normal renal function, most of a dose of nabilone is eliminated through the biliary system. Treatment for respiratory depression and comatose state consists in symptomatic and supportive therapy. Particular attention should be paid to the occurrence of hypothermia.
If the patient becomes hypotensive, consider fluids, inotropes, and/or vasopressors. DOSAGE AND ADMINISTRATION Adults The usual dosage of NCESAMET® (nabilone) is 1 mg or 2 mg twice a day. The first dose should be given the night […]