Cesamet: Package Insert and Label Information (Page 3 of 3)

DOSAGE AND ADMINISTRATION

The usual adult dosage is 1 or 2 mg b.i.d. On the day of chemotherapy, the initial dose should be given 1 to 3 hours before the chemotherapeutic agent is administered. To minimize side effects, it is recommended that the lower starting dose be used and that the dose be increased as necessary. A dose of 1 or 2 mg the night before may be useful. The maximum recommended daily dose is 6 mg given in divided doses t.i.d.

Cesamet may be administered 2 or 3 times daily during the entire course of each cycle of chemotherapy and, if needed, for 48 hours after the last dose of each cycle of chemotherapy.

HOW SUPPLIED

Cesamet capsules (purple and white): 1 mg (bottles of 20 capsules) NDC 0187-0247-01. Capsules will be imprinted with Valeant on the white body and a four-digit code (0247) on the purple cap. Store at controlled room temperature, 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

Rx only

Rev: July 2006
Part No. 12-1391

Valeant Pharmaceuticals International
3300 Hyland Avenue
Costa Mesa, CA 92626, USA
(877) 361-2719

CESAMET
nabilone capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0247
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nabilone (nabilone) nabilone 1 mg
Inactive Ingredients
Ingredient Name Strength
povidone
corn starch
FD & C Blue No. 1
Red D & C Nos. 28 and 33
gelatin
titanium dioxide
Product Characteristics
Color PURPLE, WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Valeant;0247
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-0247-01 20 CAPSULE (20 CAPSULE) in 1 BOTTLE None
Labeler — Valeant Pharmaceuticals International

Revised: 06/2007 Valeant Pharmaceuticals International

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