A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Marinol Indications, Dosage, Storage, Stability - Dronabinol
Marinol Indications, Dosage, Storage, Stability - Dronabinol
INDICATIONS AND USAGE
MARINOL® (Dronabinol) 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.
DOSAGE AND ADMINISTRATION
Appetite Stimulation
Initially,2.5 mg MARINOL® (Dronabinol) 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 4to 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® (Dronabinol) 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.
HOW SUPPLIED
MARINOL® Capsules (dronabinol solution in sesame
oil in soft gelatin capsules) 2.5 mg white capsules (Identified UM or RL).
NDC 0051-0021-21 (Bottle of 60 capsules).
5 mg dark brown capsules (Identified UM or RL).
NDC 0051-0022-11 (Bottle of 25 capsules).
10 mg orange capsules (Identified UM or RL).
NDC 0051-0023-21 (Bottle of 60 capsules).
MARINOL® is a registered trademark
of Unimed Pharmaceuticals, Inc. and is Manufactured by Banner Pharmacaps, Inc.
M High Point, NC 27265, 500012 4E Rev 5/2003, Marietta, GA 30062 © UPI,2003
top
