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Marinol 5 mg Dronabinol capsules

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Marinol 5 mg Dronabinol capsules

Capsules for oral administration: Marinol 5 mg Dronabinol is supplied as round, soft gelatin capsules containing either 2.5 mg, 5 mg, or 10 mg dronabinol. Each MARINOL Capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.

INDIVIDUALIZATION OF DOSAGES

The pharmacologic effects of MARINOL Capsules are dose-related and subject to considerable interpatient variability. Therefore, dosage individualization is critical in achieving the maximum benefit of MARINOL Capsules treatment. Appetite Stimulation: In the clinical trials, the majority of patients were treated with 5 mg/day MARINOL Capsules, although the dosages ranged from 2.5 to 20 mg/day.

Antiemetic:

Most patients respond to 5 mg three or four times daily. Dosage may be escalated during a chemotherapy cycle or at subsequent cycles, based upon initial results. Therapy should be initiated at the lowest recommended dosage and titrated to clinical response. Administration of MARINOL Capsules with phenothiazines, such as prochlorperazine, has resulted in improved efficacy as compared to either drug alone, without additional toxicity.

Pediatrics:

MARINOL Capsules is not recommended for AIDS-related anorexia in pediatric patients because it has not been studied in this population. The pediatric dosage for the treatment of chemotherapy-induced emesis is the same as in adults. Caution is recommended in prescribing MARINOL Capsules for children because of the psychoactive effects.

Geriatrics:

Caution is advised in prescribing MARINOL Capsules in elderly patients because they may be more sensitive to the neurological, psychoactive and postural hypotensive effects of the drug. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (See PRECAUTIONS.)

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.

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