temozolomide 5 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 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.

Zydus Pharmaceuticals (USA) Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] nausea` `[5] pain` `[6] diarrhoea` `[7] dyspnoea` `[8] headache` `[9] vomiting` `[10] dizziness`

4 years ago

CAPSULE GREEN 751

16 HOW SUPPLIED/STORAGE AND HANDLING

TEMOZOLOMIDE is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

TEMOZOLOMIDE capsules are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths:

TEMOZOLOMIDE capsules, 5 mg have white to off-white to light-pink/light-tan granular powder filled in size '5' hard gelatin capsules with green colored cap and white colored body. The capsule bodies are imprinted with "751" in black and are supplied as follows: NDC 68382-751-96 in bottle of 5 capsules with child-resistant closure NDC 68382-751-67 in bottle of 14 capsules with child-resistant closure

TEMOZOLOMIDE capsules, 20 mg have white to off-white to light-pink/light-tan granular powder filled in size '5' hard gelatin capsules with yellow colored cap and white colored body. The capsule bodies are imprinted with "752" in black and are supplied as follows: NDC 68382-752-96 in bottle of 5 capsules with child-resistant closure NDC 68382-752-67 in bottle of 14 capsules with child-resistant closure

TEMOZOLOMIDE capsules, 100 mg have white to off-white to light-pink/light-tan granular powder filled in size '3' hard gelatin capsules with pink colored cap and white colored body. The capsule bodies are imprinted with "753" in black and are supplied as follows: NDC 68382-753-96 in bottle of 5 capsules with child-resistant closure NDC 68382-753-67 in bottle of 14 capsules with child-resistant closure

TEMOZOLOMIDE capsules, 140 mg have white to off-white to light-pink/light-tan granular powder filled in size '2' hard gelatin capsules with blue colored cap and white colored body. The capsule bodies are imprinted with "754" in black and are supplied as follows: NDC 68382-754-96 in bottle of 5 capsules with child-resistant closure NDC 68382-754-67 in bottle of 14 capsules with child-resistant closure

TEMOZOLOMIDE capsules, 180 mg have white to off-white to light-pink/light-tan granular powder filled in Size '0' hard gelatin capsules with orange colored cap and white colored body. The capsule bodies are imprinted with "755" in black and are supplied as follows: NDC 68382-755-96 in bottle of 5 capsules with child-resistant closure NDC 68382-755-67 in bottle of 14 capsules with child-resistant closure

TEMOZOLOMIDE capsules, 250 mg capsules have white to off-white to light-pink/light-tan granular powder filled in Size '00' hard gelatin capsules with white colored cap and white colored body. The capsule bodies are imprinted with "756" in black and are supplied as follows: NDC 68382-756-96 in bottle of 5 capsules with child-resistant closure NDC 68382-756-67 in bottle of 14 capsules with child-resistant closure Store

TEMOZOLOMIDE capsules at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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