Temozar
Generic Name
Temozolomide
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| temozar 100 mg capsule | ৳ 600.00 | ৳ 4,200.00 |
Description
Overview of the medicine
Temozar 100 mg Capsule is an oral chemotherapy medication containing Temozolomide. It is primarily used to treat certain types of brain tumors by interfering with the growth of cancer cells.
Uses & Indications
Dosage
Adults
Dosage is highly individualized based on body surface area (BSA), concomitant radiotherapy, and prior chemotherapy. For newly diagnosed GBM: 75 mg/m² orally once daily for 42 days (with radiotherapy), followed by 150-200 mg/m² orally once daily for 5 days every 28 days for up to 6 cycles (adjuvant). For refractory anaplastic astrocytoma: Initial dose 150 mg/m² orally once daily for 5 days every 28 days, increasing to 200 mg/m² if tolerated.
Elderly
Similar dosage to adults, but increased monitoring for myelosuppression is recommended, especially in patients over 70 years.
Renal_impairment
No specific dose adjustments are typically required for mild to moderate renal impairment. Use with caution in severe renal impairment as data are limited.
How to Take
Take Temozar capsules orally once daily, on an empty stomach (at least one hour before or two hours after food). Capsules should be swallowed whole with a glass of water and not opened, chewed, or crushed. Taking the dose at bedtime may help reduce nausea and vomiting.
Mechanism of Action
Temozolomide is an imidazotetrazine derivative which undergoes rapid chemical conversion at physiological pH to the active compound monomethyl triazenoimidazole carboxamide (MTIC). MTIC alkylates DNA, primarily at the N7-guanine and O6-guanine positions, leading to DNA damage, cell cycle arrest, and apoptosis in rapidly dividing cancer cells.
Pharmacokinetics
Onset
Peak plasma levels reached within 0.5-1.5 hours.
Excretion
Mainly excreted renally (approximately 38% of the dose within 24 hours, with 5-10% as unchanged drug).
Half life
Approximately 1.8 hours.
Absorption
Rapid and almost complete absorption after oral administration; peak plasma concentrations achieved in 0.5-1.5 hours.
Metabolism
Primarily undergoes non-enzymatic hydrolysis to the active metabolite MTIC. Hepatic metabolism is minimal.
Side Effects
Contraindications
- Hypersensitivity to temozolomide or dacarbazine (since MTIC is the active metabolite of dacarbazine).
- Severe myelosuppression (e.g., severe thrombocytopenia, leukopenia) before starting treatment.
Drug Interactions
Valproic acid
Co-administration with valproic acid may lead to a small but statistically significant decrease in temozolomide clearance, which may be clinically relevant in some patients.
Other myelosuppressive agents
Increased risk of myelosuppression when co-administered with other agents that cause bone marrow suppression.
Storage
Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.
Overdose
Overdose is likely to result in increased myelosuppression. Treatment for overdose should consist of symptomatic and supportive therapy, including regular monitoring of blood counts and appropriate interventions if severe myelosuppression occurs.
Pregnancy & Lactation
Pregnancy Category D: Temozolomide can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant. Lactation: It is unknown whether temozolomide is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment.
Side Effects
Contraindications
- Hypersensitivity to temozolomide or dacarbazine (since MTIC is the active metabolite of dacarbazine).
- Severe myelosuppression (e.g., severe thrombocytopenia, leukopenia) before starting treatment.
Drug Interactions
Valproic acid
Co-administration with valproic acid may lead to a small but statistically significant decrease in temozolomide clearance, which may be clinically relevant in some patients.
Other myelosuppressive agents
Increased risk of myelosuppression when co-administered with other agents that cause bone marrow suppression.
Storage
Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.
Overdose
Overdose is likely to result in increased myelosuppression. Treatment for overdose should consist of symptomatic and supportive therapy, including regular monitoring of blood counts and appropriate interventions if severe myelosuppression occurs.
Pregnancy & Lactation
Pregnancy Category D: Temozolomide can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant. Lactation: It is unknown whether temozolomide is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture, specific details on packaging.
Availability
Available in hospital pharmacies and specialized oncology centers
Approval Status
Approved by regulatory authorities for oncology indications
Patent Status
Generic versions available, active ingredient likely off-patent
WHO Essential Medicine
YesClinical Trials
Temozolomide has been extensively studied in clinical trials, particularly for glioblastoma multiforme. Key trials demonstrated improved overall survival when used concomitantly with radiotherapy and subsequently as adjuvant therapy for newly diagnosed GBM.
Lab Monitoring
- Complete Blood Count (CBC) with differential and platelet count: weekly during concomitant phase, and on Day 22 (21 days after the first dose) of each 28-day cycle for the adjuvant phase, or as clinically indicated.
- Liver Function Tests (LFTs): Periodically during treatment.
Doctor Notes
- Rigorous hematological monitoring (CBC with platelets) is essential before, during, and after temozolomide therapy due to the risk of severe myelosuppression.
- Dose adjustments or interruptions may be required based on nadir blood counts and patient tolerance.
- Consider antiemetic prophylaxis for all patients, especially during the concomitant phase with radiotherapy.
Patient Guidelines
- Take Temozar exactly as prescribed by your doctor.
- Swallow capsules whole with water; do not open, chew, or crush them.
- Take on an empty stomach to improve absorption.
- Report any unusual bleeding, bruising, fever, or signs of infection immediately.
- Use effective contraception during and for at least 6 months after treatment for both male and female patients.
Missed Dose Advice
If you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Temozolomide may cause fatigue or dizziness. Patients should be cautioned against driving or operating machinery if they experience these symptoms.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids.
- Manage nausea and vomiting with antiemetic medications as prescribed.
- Avoid contact with the powder inside the capsule if it breaks, and wash hands thoroughly.
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