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 TEMODAL
 
ACTIVE INGREDIENTS: Temozolomide 5 mg, 20 mg, 100 mg, 250mg.

Package
(a):
CAPSULES: 5 x 5 mg.
Dosage(a):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² once daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle.
Children: 200 mg/m² once daily for 5 days per 28-day cycle. Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² once daily for 5 days with escalation to 200 mg/m² once daily at the next cycle if there is no haematological toxicity.

Prescribing Restrictions:  None

Package(b):
CAPSULES: 5 x 20 mg.
Dosage(b):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² once daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle.
Children: 200 mg/m² once daily for 5 days per 28-day cycle. Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² once daily for 5 days with escalation to 200 mg/m² once daily at the next cycle if there is no haematological toxicity.

Prescribing Restrictions:  None

Package(c):
CAPSULES: 5 x 100 mg.
Dosage(c):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² once daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle.
Children: 200 mg/m² once daily for 5 days per 28-day cycle. Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² once daily for 5 days with escalation to 200 mg/m² once daily at the next cycle if there is no haematological toxicity.

Prescribing Restrictions:  None

Package(d):
CAPSULES: 5 x 250 mg.
Dosage(d):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² once daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle.
Children: 200 mg/m² once daily for 5 days per 28-day cycle. Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² once daily for 5 days with escalation to 200 mg/m² once daily at the next cycle if there is no haematological toxicity.

Prescribing Restrictions:  None


Indications:
Malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment.
Contra-Indications:
Hypersensitivity to its components or to dacarbazine (DTIC), severe myelosuppression, pregnancy and lactation.
Special Precautions:
In patients with recurrent malignant glioma who are in a poor performance status or have other severely debilitating diseases or infection, administer after weighing the potential benefits and risks to the patient. Patients who have experienced severe (grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy. Elderly. Genotoxic effects.
Side Effects:
Gastrointestinal disturbances. Fatigue, constipation, headache. Anorexia, diarrhoea, rash, fever and somnolence.
Drug Interactions:
Valproic acid, other myelosuppressive agents.

Taken from MEDIC