"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
- The effects of Cesamet (nabilone capsules) 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 (nabilone capsules) has the potential to affect the CNS, which might manifest itself in dizziness, drowsiness, euphoria “high”, ataxia, anxiety, disorientation, depression, hallucinations and psychosis.
- Cesamet (nabilone capsules) can cause tachycardia and orthostatic hypotension.
- Because of individual variation in response and tolerance to the effects of Cesamet (nabilone capsules) , patients should remain under supervision of a responsible adult especially during initial use of Cesamet (nabilone capsules) and during dose adjustments.
- Patients receiving treatment with Cesamet (nabilone capsules) should be specifically warned not to drive, operate machinery, or engage in any hazardous activity while receiving Cesamet (nabilone capsules) .
- Cesamet (nabilone capsules) should not be taken with alcohol, sedatives, hypnotics, or other psychoactive substances because these substances can potentiate the central nervous system effects of nabilone.
The benefit/risk ratio of Cesamet (nabilone capsules) use should be carefully evaluated in patients with the following medical conditions because of individual variation in response and tolerance to the effects of Cesamet (nabilone capsules) .
- Since Cesamet (nabilone capsules) can elevate supine and standing heart rates and cause postural hypotension, it should be used with caution in the elderly, and in patients with hypertension or heart disease.
- Cesamet (nabilone capsules) 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 (nabilone capsules) should be used with caution in individuals receiving concomitant therapy with sedatives, hypnotics, or other psychoactive drugs because of the potential for additive or synergistic CNS effects.
- Cesamet (nabilone capsules) should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since Cesamet (nabilone capsules) contains a similar active compound to marijuana.
- The safety aspects of the effects of hepatic and renal impairment have not been investigated.
- Nabilone is purportedly highly bound to plasma proteins and undergoes extensive first pass hepatic metabolism. Those properties have the potential to lead to drug-drug interactions affecting the pharmacokinetics of similar behaving co-administered drugs or of Cesamet (nabilone capsules) itself.
- The effects of QT prolongation potential by Cesamet (nabilone capsules) have not been determined.
- Cesamet (nabilone capsules) should be used with caution in pregnant patients, nursing mothers, or pediatric patients because it has not been studied in these patient populations.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been performed to evaluate the carcinogenic potential of nabilone.
Nabilone was not genotoxic in the Ames test, the rat hepatocyte unscheduled DNA synthesis (UDS) test, the Chinese hamster bone marrow cell sister chromatid exchange (SCE) test, the male rat dominant lethal tests nor the rat micronucleus test. Dietary administration of nabilone up to 4 mg/kg/day (about 6 times the recommended maximum human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male and female rats.
Pregnancy: Teratogenic Effects. Pregnancy Category C
Teratology studies conducted in pregnant rats at doses up to 12 mg/kg/day (about 16 times the human dose on a body surface area basis) and in pregnant rabbits at doses up to 3.3 mg/kg/day (about 9 times the human dose on a body surface area basis) did not disclose any evidence for a teratogenic potential of nabilone. However, there was dose related developmental toxicity in both species as evidenced by increases in embryo lethality, fetal resorptions, decreased fetal weights and pregnancy disruptions. In rats, postnatal developmental toxicity was also observed. There are no adequate and well-controlled studies in pregnant women. Because animal studies cannot rule out the possibility of harm, Cesamet (nabilone capsules) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in breast milk. Because many drugs including some cannabinoids are excreted in breast milk it is not recommended that Cesamet (nabilone capsules) be given to nursing mothers.
Safety and effectiveness have not been established in patients younger than 18 years of age. Caution is recommended in prescribing Cesamet (nabilone capsules) to children because of psychoactive effects.
Clinical studies of Cesamet (nabilone capsules) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Cesamet (nabilone capsules) should be used with caution in elderly patients aged 65 and over because they are generally more sensitive to the psychoactive effects of drugs and Cesamet (nabilone capsules) can elevate supine and standing heart rates and cause postural hypotension.
Last reviewed on RxList: 2/26/2009
This monograph has been modified to include the generic and brand name in many instances.
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