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.

Appetite Stimulation: Initially, 2.5 mg MARINOL Capsules should be administered orally twice daily (b.i.d.), before lunch and supper. For patients unable to tolerate this 5 mg/day dosage of MARINOL Capsules, the dosage can be reduced to 2.5 mg/day, administered as a single dose in the evening or at bedtime. If clinically indicated and in the absence of significant adverse effects, the dosage may be gradually increased to a maximum of 20 mg/day MARINOL Capsules, administered in divided oral doses. Caution should be exercised in escalating the dosage of MARINOL Capsules because of the increased frequency of dose-related adverse experiences at higher dosages. (See PRECAUTIONS.)

Antiemetic: MARINOL Capsules is best administered at an initial dose of 5 mg/m², given 1 to 3 hours prior to the administration of chemotherapy, then every 2 to 4 hours after chemotherapy is given, for a total of 4 to 6 doses/day. Should the 5 mg/m² dose prove to be ineffective, and in the absence of significant side effects, the dose may be escalated by 2.5 mg/m² increments to a maximum of 15 mg/m² per dose. Caution should be exercised in dose escalation, however, as the incidence of disturbing psychiatric symptoms increases significantly at maximum dose. (See PRECAUTIONS.)

Storage Conditions

MARINOL Capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.

MARINOL Capsules (dronabinol solution in sesame oil in soft gelatin capsules)

2.5 mg white capsules (Identified UM).

NDC 0051-0021-21 (Bottle of 60 capsules).

5 mg dark brown capsules (Identified UM).

NDC 0051-0022-21 (Bottle of 60 capsules).

10 mg orange capsules (Identified UM).

NDC 0051-0023-21 (Bottle of 60 capsules).

MARINOL is a registered trademark of Unimed Pharmaceuticals, Inc. and is Manufactured by Banner Pharmacaps, Inc. High Point, NC 27265. For: Unimed Pharmaceuticals, Inc. A Solvay Pharmaceuticals, Inc. Company, Marietta, GA 30062-2224, USA. Rev Jul 2006. FDA Rev date: 6/21/2006

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