0 0 1
300 0 0 0 3 0 0
315 0 0 0 3 0 3
320 0 1 1 0 0 0
330 0 1 1 0 0 2
340 0 1 1 0 1 0
345 0 1 1 0 1 1
360 0 2 0 0 0 0
375 0 2 0 0 0 3
380 0 1 0 2 0 0
400 0 0 0 4 0 0
420 0 0 3 0 0 0
440 0 0 3 0 1 0
460 0 2 0 1 0 0
480 0 1 0 3 0 0
500 2 0 0 0 0 0
2.2 Preparation and Administration
TEMODAR Capsules:
In clinial trials, TEMODAR was administered under both fasting and nonfasting conditions; however, absorption is affected by food [see Clinical Pharmacology (12)], and consistency of administration with respect to food is recommended. There are no dietary restrictions with TEMODAR. To reduce nausea and vomiting, TEMODAR should be taken on an empty stomach. Bedtime administration may be advised. Antiemetic therapy may be administered prior to and/or following administration of TEMODAR.
TEMODAR (temozolomide) Capsules should not be opened or chewed. They should be swallowed whole with a glass of water.
If capsules are accidentally opened or damaged, precautions should be taken to avoid inhalation or contact with the skin or mucous membranes [see How Supplied/Storage and Handling (16.1)].
TEMODAR for Injection:
Each vial of TEMODAR for Injection contains sterile and pyrogen-free temozolomide lyophilized powder. When reconstituted with 41 mL Sterile Water for Injection, the resulting solution will contain 2.5 mg/mL temozolomide. Bring the vial to room temperature prior to reconstitution with Sterile Water for Injection. The vials should be gently swirled and not shaken. Vials should be inspected, and any vial containing visible particulate matter should not be used. Do not further dilute the reconstituted solution. After reconstitution, store at room temperature (25°C [77°F]). Reconstituted product must be used within 14 hours, including infusion time.
Using aseptic technique, withdraw up to 40 mL from each vial to make up the total dose based on Table 5 above and transfer into an empty 250 mL PVC infusion bag.2 Compatibility studies with non-PVC bags have not been conducted. TEMODAR for Injection should be infused intravenously using a pump over a period of 90 minutes. TEMODAR for Injection should be administered only by intravenous infusion. Flush the lines before and after each TEMODAR infusion.
Because no data are available on the compatibility of TEMODAR for Injection with other intravenous substances or additives, other medications should not be infused simultaneously through the same intravenous line.
3 DOSAGE FORMS AND STRENGTHS
TEMODAR (temozolomide) Capsules for oral administration
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5-mg capsules have opaque white bodies with green caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR."
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20-mg capsules have 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."
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100-mg capsules 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."
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140-mg capsules 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."
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180-mg capsules have opaque white bodies with orange caps. The capsule body is imprint
