temozolomide 250 MG Oral Capsule
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 is 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 is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
Sandoz Inc.
CAPSULE WHITE Temozolomide 250 mg
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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 Temozolomide capsules are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths: 5 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 5-count – NDC 0781-2691-75 14-count – NDC 0781-2691-44 20 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 5-count – NDC 0781-2692-75 14-count – NDC 0781-2692-44 100 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 5-count – NDC 0781-2693-75 14-count – NDC 0781-2693-44 140 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 5-count – NDC 0781-2694-75 14-count – NDC 0781-2694-44 180 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 5-count – NDC 0781-2695-75 14-count – NDC 0781-2695-44 250 mg: opaque white bodies with opaque white caps. The capsule is imprinted with the dosage strength and "Temozolomide". They are supplied as follows: 5-count – NDC 0781-2696-75 Store temozolomide capsules at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store temozolomide for injection refrigerated at 2°C to 8°C (36°F to 46°F).
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