opaque white bodies with yellow 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:
5-count - NDC 0085-1519-02
14-count - NDC 0085-1519-01
TEMODAR Capsules 100 mg: have opaque white bodies with pink 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:
5-count - NDC 0085-1366-02
14-count - NDC 0085-1366-01
TEMODAR Capsules 140 mg: have opaque white bodies with blue 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:
5-count - NDC 0085-1425-01
14-count - NDC 0085-1425-02
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:
5-count - NDC 0085-1430-01
14-count - NDC 0085-1430-02
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:
5-count - NDC 0085-1417-01
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 Storage
Store 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 INFORMATION
17.1 Information for the Patient
Physicians 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.
17.2 FDA-approved Patient Labeling
TEMODAR Capsules
Manufactured by: Schering Corporation, a subsidiary of {corporate logo}MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
TEMODAR for Injection
Manufactured by: Baxter Oncology GmbH, Halle/Westfalen, Germany
Distributed by: Schering Corporation, a subsidiary of {corporate logo}MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Copyright© 1999, 2008 Schering Corporation, a subsidiary of Merck & Co., Inc. All rights reserved.
U.S. Patent Nos. 5,260,291 and 6,987,108.
Rev 11/10
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