ll 42- or 5-day cycle as prescribed by the physician. For example, in a 5-day cycle, 275 mg/day would be dispensed as five 250-mg capsules, five 20-mg capsules and five 5-mg capsules. Label each container with the appropriate number of capsules to be taken each day. Dispense to the patient, making sure each container lists the strength (mg) per capsule and that he or she understands to take the appropriate number of capsules of TEMODAR from each package or vial to equal the total daily dose prescribed by the physician.
How can TEMODAR be ordered?
TEMODAR can be ordered from your wholesaler. It is important to understand if TEMODAR is being used as part of a 42-day regimen or as part of a 5-day course. Remember to order enough TEMODAR for the appropriate cycle.
For example:
◦a 5-day course of 360 mg/day would require the following to be ordered: two 5-count packages of 180-mg capsules.
◦a 42-day course of 140 mg/day would require the following to be ordered: three 14-count packages of 140-mg capsules.
For examples of other dosing regimens, please refer to the full Prescribing Information (Table 6).
TEMODAR Product NDC Number
Bottles:
5-mg capsules (5 count) 0085-3004-02
5-mg capsules (14 count) 0085-3004-01
20-mg capsules (5 count) 0085-1519-02
20-mg capsules (14 count) 0085-1519-01
100-mg capsules (5 count) 0085-1366-02
100-mg capsules (14 count) 0085-1366-01
140-mg capsules (5 count) 0085-1425-01
140-mg capsules (14 count) 0085-1425-02
180-mg capsules (5 count) 0085-1430-01
180-mg capsules (14 count) 0085-1430-02
250-mg capsules (5 count) 0085-1417-01
Sachets:
5-mg capsules (5 count) 0085-3004-03
5-mg capsules (14 count) 0085-3004-04
20-mg capsules (5 count) 0085-1519-03
20-mg capsules (14 count) 0085-1519-04
100-mg capsules (5 count) 0085-1366-03
100-mg capsules (14 count) 0085-1366-04
140-mg capsules (5 count) 0085-1425-03
140-mg capsules (14 count) 0085-1425-04
180-mg capsules (5 count) 0085-1430-03
180-mg capsules (14 count) 0085-1430-04
250-mg capsules (5 count) 0085-1417-02
TEMODAR Capsules
Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright © 2005 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
Revised: 06/2013
phi-mk7365-cp-1306r009
PRINCIPAL DISPLAY PANEL -- 5 mg Capsule Bottle Carton
NDC 0085-3004 -02
5 mg
per capsule
Temodar®
(temozolomide)
Capsules
For Oral Administration
Rx only
THIS PACKAGE CONTAINS5 CAPSULES
(click image for full-size original) PRINCIPAL DISPLAY PANEL -- 20 mg Capsule Bottle Carton
NDC 0085-1519 -02
20 mg per capsule
Temdar®
(temozolomide)
Capsules
For Oral Administration
Rx only
THIS PACKAGE CONTAINS5 CAPSULES
(click image for full-size original) PRINCIPAL DISPLAY PANEL -- 100 mg Capsule Bottle Carton
NDC 0085-1366 -01
100 mg per capsule
Temodar®
(temozolomide)
Capsules
For Oral Administration
Rx only
THIS PACKAGE CONTAINS14 CAPSULES
(click image for full-size original) PRINCIPAL DISPLAY PANEL -- 140 mg Capsule Bottle Carton
NDC 0085-1425 -01
140 mg per capsule
Temodar®
(temozolomide)
Capsules
For Oral Administration
R |