CapsulesCapsules
Schedule H (Prescription Required)Cytotoxic Chemotherapy FormulationsCode: 1218

Temozolomide Capsules 250 mg

Generic Formulation:Temozolomide Capsules IP 250 mg
Pack Size:5's
Common Commercial Brand Equivalents:Market reference only
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Clinical Overview

Temozolomide Capsules (20mg, 100mg, 250mg) is an oral imidazotetrazine alkylating prodrug on the WHO Model List of Essential Medicines. Unlike dacarbazine, it does not require hepatic enzymatic activation; at physiological systemic pH (7.4), it undergoes spontaneous non-enzymatic conversion to active MTIC, which methylates DNA at the O-6 and N-7 positions of guanine. O-6 methylguanine mispairs with thymine during replication, triggering repetitive futile mismatch repair cycles that culminate in lethal double-strand DNA breaks. Excellent blood-brain barrier penetration. Indicated for newly diagnosed Glioblastoma Multiforme (concomitant with radiotherapy and adjuvant maintenance, the Stupp protocol) and refractory anaplastic astrocytoma.

Active Pharmaceutical Ingredients

AI-assistedClinical summary synthesized from pharmacopoeial references (CDSCO, WHO EML, IP/BP/USP). Not clinician-reviewed. Drug code 1218.Report inaccuracy

Usage Guidelines

Take orally once daily on an empty stomach (at least 1 hour before or 2 hours after meals) at bedtime with a full glass of water. Swallow capsules whole; do NOT open, chew, or dissolve. During concomitant radiotherapy, take 75 mg/m² daily for 42 consecutive days with mandatory Pneumocystis jirovecii pneumonia (PCP) prophylaxis (e.g., co-trimoxazole).

General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.

Possible Side Effects

Common: Nausea, vomiting (routine prophylactic antiemetics advised), fatigue, headache, constipation, dose-limiting myelosuppression (thrombocytopenia, neutropenia). Rare/Severe: Prolonged pancytopenia, aplastic anemia, opportunistic infections (PCP pneumonia), and hepatic injury.

*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.

Precautions & Warnings

Black Box Warning: Myelosuppression; monitor absolute neutrophil count (ANC) and platelets prior to each cycle. Mandatory PCP prophylaxis during concomitant radiotherapy phase due to severe lymphopenia. Patients with unmethylated MGMT gene promoters demonstrate lower clinical sensitivity. Teratogenic (Category D).

Schedule H (Prescription Required)

This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.

Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, oncological diagnosis, or chemotherapy protocol guidance. Cancer therapies require specialized administration under the direct supervision of a registered medical oncologist in an accredited healthcare facility.