Major Ingredients

Each capsule contains Temozolomide USP 100 mg.

Major Functionality

Newly Diagnosed Glioblastoma Multiforme Temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Refractory Anaplastic Astrocytoma Temozolomide is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. DOSAGE AND ADMINISTRATION Newly Diagnosed GBM: 75 mg/m2 for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m2 once daily for Days 1-5 of a 28-day cycle of Temozolomide for 6 cycles. Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category D. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Temozolomide.

Manufacture Information

Drug International Limited was incorporated under the Registrar of Joint Stock Companies in 1974 as a Private Limited Company. The company commenced formulation and production in 1983 and emerged as a pioneer in Bangladesh for adding a state of the art oral solid dosage plant. Since inception, Drug International Limited's primary objective has been to meet guidelines provided by major global regulatory bodies such as the World Health Organization Good Manufacturing Practices (WHO cGMP) guidelines.