temozolomide 140 mg
1 INDICATIONS AND USAGE Temozolomide is an alkylating drug indicated for the treatment of adult patients with: • Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) • Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 1.2 Refractory Anaplastic Astrocytoma Temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
ani pharmaceuticals, inc.
CAPSULE BLUE AMG 255
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16 HOW SUPPLIED/STORAGE AND HANDLING Temozolomide is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Temozolomide capsules USP are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths: Temozolomide capsules USP 5 mg have a green opaque cap and white opaque body. The capsule is imprinted with “AMG†on the cap and “252†on the body in black ink. They are supplied as follows: 5-count – NDC 62559-920-51 14-count – NDC 62559-920-14 Temozolomide capsules USP 20 mg have a gold cap and white opaque body. The capsule is imprinted with “AMG†on the cap and “253†on the body in black ink. They are supplied as follows: 5-count – NDC 62559-921-51 14-count – NDC 62559-921-14 Temozolomide capsules USP 100 mg have a pink opaque cap and white opaque body. The capsule is imprinted with “AMG†on the cap and “254†on the body in black ink. They are supplied as follows: 5-count – NDC 62559-922-51 14-count – NDC 62559-922-14 Temozolomide capsules USP 140 mg have a blue cap and white opaque body. The capsule is imprinted with “AMG†on the cap and “255†on the body in black ink. They are supplied as follows: 5-count – NDC 62559-923-51 14-count – NDC 62559-923-14 Temozolomide capsules USP 180 mg have a dark orange opaque cap and white opaque body. The capsule is imprinted with “AMG†on the cap and “256†on the body in black ink. They are supplied as follows: 5-count – NDC 62559-924-51 14-count – NDC 62559-924-14 Temozolomide capsules USP 250 mg have a white opaque cap and body. The capsule is imprinted with “AMG†on the cap and “257†on the body in black ink. They are supplied as follows: 5-count – NDC 62559-925-51 Store temozolomide capsules at 20° to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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