5-1425-03
14-count – NDC 0085-1425-04
TEMODAR Capsules 180 mg: have opaque white bodies with orange caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR".
They are supplied as follows:
Bottles:
5-count – NDC 0085-1430-01
14-count – NDC 0085-1430-02
Sachets:
5-count – NDC 0085-1430-03
14-count – NDC 0085-1430-04
TEMODAR Capsules 250 mg: have opaque white bodies with white caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR".
They are supplied as follows:
Bottles:
5-count – NDC 0085-1417-01
Sachets:
5-count – NDC 0085-1417-02
TEMODAR for Injection:
TEMODAR (temozolomide) for Injection is supplied in single-use glass vials containing 100 mg temozolomide. The lyophilized powder is white to light tan/light pink.
TEMODAR for Injection 100 mg:
NDC 0085-1381-01
16.3 StorageStore TEMODAR Capsules at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Store TEMODAR for Injection refrigerated at 2–8°C (36–46°F). After reconstitution, store reconstituted product at room temperature (25°C [77°F]). Reconstituted product must be used within 14 hours, including infusion time.
17 PATIENT COUNSELING INFORMATIONSee FDA-Approved Patient Labeling (Patient Information).
17.1 Information for the PatientPhysicians should discuss the following with their patients:
◦Nausea and vomiting are the most frequently occurring adverse reactions. Nausea and vomiting are usually either self-limiting or readily controlled with standard antiemetic therapy.
◦Capsules should not be opened. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes.
◦The medication should be kept away from children and pets.
TEMODAR Capsules
Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
TEMODAR for Injection
Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Manufactured by:
Baxter Oncology GmbH, Halle 33790, Germany
For patent information: www.merck.com/product/patent/home.html
Copyright © 1999, 2008 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
Revised: 06/2013
uspi-mk7365-mtl-1306r015
Patient Information
TEMODAR® (tĕm-ō-dăr)
(temozolomide)
Capsules
TEMODAR® (tĕm-ō-dăr)
(temozolomide) for Injection
What is the most important information I should know about TEMODAR?
◦TEMODAR may cause birth defects. Male and female patients who take TEMODAR should use effective birth control. Female patients and female partners of male patients should avoid becoming pregnant while taking TEMODAR.
See the section "What are the possible side effects of TEMODAR?" for more information about side effects.
What is TEMODAR?
TEMODAR (temozolomide) is a prescription medicine used to treat adults with certain brain |
