MARINOL® (dronabinol) CIII Capsules  Clinical Information MARINOL® is indicated for the treatment of anorexia associated with weight loss in patients with AIDS and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.  In a randomized, double-blind, placebo-controlled, 6-week study involving 139 AIDS patients, MARINOL® provided: Statistically significant improvement in appetite Reduction in nausea Trends toward improved body weight and mood   Click to enlarge   Click to enlarge In well-controlled clinical trials involving patients with AIDS, the most frequently reported adverse experiences involved the CNS and were reported by 33% of MARINOL® patients. About 25% of patients reported a minor CNS adverse event during the first 2 weeks and about 4% reported such an event each week for the next 6 weeks. After completing the 6-week study, patients were allowed to continue treatment with MARINOL® in an open-label study in which there was sustained improvement in appetite. In clinical studies conducted by the National Cancer Institute, 454 patients with cancer received a total of 750 courses of treatment for various malignancies.  MARINOL® Capsules provided complete or partial emesis reduction in > 2/3 of treatment courses at a dose of < 7 mg/m2. Click to enlarge In a randomized, double-blind, parallel-group study of 54 evaluable cancer chemotherapy patients, MARINOL® in combination with prochlorperazine resulted in additive/synergistic anti-emetic effects. Click to enlarge MARINOL® is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid or sesame oil. Warn patients not to drive, operate machinery, or engage in hazardous activity until they establish they can tolerate MARINOL®  and perform such tasks safely. A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving MARINOL® in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%) Other frequently reported adverse events in MARINOL® clinical trials included abdominal pain, nausea, vomiting, dizziness, euphoria, paranoid reaction, somnolence, and thinking abnormal.  Please see link below for complete safety and prescribing information.      MARINOL® Prescribing and Safety Information