Temozar

Temozolomide USP

COMPOSITION:

Temozar: Each capsule contains Temozolomide USP 100 mg.

INDICATIONS:

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.

ADVERSE EFFECTS:

The most common adverse reactions (> _10% incidence) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, convulsions, rash, hemiparesis, diarrhea, asthenia, fever, dizziness, coordination abnormal, viral infection, amnesia, and insomnia. The most common Grade 3 to 4 hematologic labcratory abnormalities (> _ 10% incidence) that have developed during treatment with Temozolomide are: lymphopenia, thrombocytopenia, neutropenia, and leukopenia. Allergic reactions have also been reported. DRUG INTERACTIONS Valproic Acid: Administration of valproic acid decreases oral clearance of temozolomide by about 5%. The clinical implication of this effect is not known.

Storage: Store below 30o C in a dry place.

Packaging: Temozar: Each box contains 7 Capsules in Alu-Alu blister pack.

Prescribing Description

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