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

DOSAGE AND ADMINISTRATION

The usual adult dosage is 1 or 2 mg 2 times a day. 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 3 times a day.

Cesamet may be administered 2 or 3 times a day 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 (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Rx Only

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

IN-012250-01 Rev 9/2013 Part No. 22101757

F50104597A

Manufactured by: Valeant Canada LP, Quebec, Canada for:
Meda Pharmaceuticals®
Somerset, New Jersey 08873-4120

MEDA PHARMACEUTICALS is a registered trademark of Meda AB.

©2013 Meda Pharmaceuticals Inc.

Made in Canada

CESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.

Package Label — Principal Display Panel – 50-Count Bottle Label

NDC 0037-1221-50
Rx Only
Cesamet® CII
(Nabilone Capsules)
1 mg
Each capsule contains 1 mg nabilone
50 Capsules
Meda
Pharmaceuticals®

50-Count Bottle Label
(click image for full-size original)
CESAMET nabilone capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0037-1221
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NABILONE (NABILONE) NABILONE 1 mg
Product Characteristics
Color BLUE (Imprint is MEDA on blue side of capsule) , WHITE (Imprint is 1221 on white side of capsule) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code MEDA;1221
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0037-1221-50 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 CAPSULE in 1 BOTTLE This package is contained within the CARTON (0037-1221-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018677 03/01/2010
Labeler — Meda Pharmaceuticals Inc. (051229602)

Revised: 05/2015 Meda Pharmaceuticals Inc.

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