Medical Marijuana - Marinol - 3-23-10

MARINOL® (dronabinol) Capsules
"CLINICAL PHARMACOLOGY
"Pharmacodynamics
"After oral administration, dronabinol has an onset of action of approximately 0.5 to 1 hours and peak effect at 2 to 4 hours. Duration of action for psychoactive effects is 4 to 6 hours, but the appetite stimulant effect of dronabinol may continue for 24 hours or longer after administration.
"INDICATIONS AND USAGE
"MARINOL Capsules is indicated for the treatment of:
"1. anorexia associated with weight loss in patients with AIDS; and
"2. nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
"ADVERSE REACTIONS"
"A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving MARINOL® Capsules in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%)
"DRUG ABUSE AND DEPENDENCE
"MARINOL Capsules is one of the psychoactive compounds present in cannabis, and is abusable and controlled [Schedule III (CIII)] under the Controlled Substances Act. Both psychological and physiological dependence have been noted in healthy individuals receiving dronabinol, but addiction is uncommon and has only been seen after prolonged high dose administration.
"Chronic abuse of cannabis has been associated with decrements in motivation, cognition, judgement, and perception. The etiology of these impairments is unknown, but may be associated with the complex process of addiction rather than an isolated effect of the drug. No such decrements in psychological, social or neurological status have been associated with the administration of MARINOL Capsules for therapeutic purposes.
"In an open-label study in patients with AIDS who received MARINOL Capsules for up to five months, no abuse, diversion or systematic change in personality or social functioning were observed despite the inclusion of a substantial number of patients with a past history of drug abuse.
"OVERDOSAGE
"Signs and symptoms following MILD MARINOL Capsules intoxication include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth and tachycardia; following MODERATE intoxication include memory impairment, depersonalization, mood alteration, urinary retention, and reduced bowel motility; and following SEVERE intoxication include decreased motor coordination, lethargy, slurred speech, and postural hypotension. Apprehensive patients may experience panic reactions and seizures may occur in patients with existing seizure disorders.
Note: Marinol® is now marketed by Abbott Laboratories.

Source: 

"MARINOL® (dronabinol) Capsules," (Abbott Laboratories: Abbott Park, IL, July 2006), pp. 1, 2, 6, 9, 10, 11, and 13.
http://global.abbottgrowth.com...
http://www.fda.gov/ohrms/docke...
Abbott Marinol® pricing as of 2/27/11:
http://mapinc.org/url/WQiRxgLB
http://www.accessdata.fda.gov/...