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TEMODAR

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Overview

What is TEMODAR?

TEMODAR contains temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]--tetrazine-8-carboxamide. The structural formula is:

The material is a white to light tan/light pink powder with a molecular formula of CHNO and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH.



What does TEMODAR look like?



What are the available doses of TEMODAR?

What should I talk to my health care provider before I take TEMODAR?

How should I use TEMODAR?

TEMODAR (temozolomide) is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

The recommended dose for TEMODAR as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when TEMODAR for Injection was given over 90 minutes Dosage of TEMODAR must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For TEMODAR dosage calculations based on body surface area (BSA) see . For suggested capsule combinations on a daily dose see .


What interacts with TEMODAR?

Sorry No Records found


What are the warnings of TEMODAR?

Sorry No Records found


What are the precautions of TEMODAR?

Sorry No Records found


What are the side effects of TEMODAR?

Sorry No records found


What should I look out for while using TEMODAR?

Known hypersensitivity to any TEMODAR component or to dacarbazine (DTIC). ()


What might happen if I take too much TEMODAR?

Doses of 500, 750, 1000, and 1250 mg/m(total dose per cycle over 5 days) have been evaluated clinically in patients. Dose-limiting toxicity was hematologic and was reported with any dose but is expected to be more severe at higher doses. An overdose of 2000 mg per day for 5 days was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure, and death. There are reports of patients who have taken more than 5 days of treatment (up to 64 days), with adverse reactions reported including bone marrow suppression, which in some cases was severe and prolonged, and infections and resulted in death. In the event of an overdose, hematologic evaluation is needed. Supportive measures should be provided as necessary.


How should I store and handle TEMODAR?

Store TEMODAR Capsules at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].Store TEMODAR for Injection refrigerated at 2–8°C (36–46°F). After reconstitution, store reconstituted product at room temperature (25°C [77°F]). Reconstituted product must be used within 14 hours, including infusion time.Store TEMODAR Capsules at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].Store TEMODAR for Injection refrigerated at 2–8°C (36–46°F). After reconstitution, store reconstituted product at room temperature (25°C [77°F]). Reconstituted product must be used within 14 hours, including infusion time.Minoxidil tablets are available as follows:Minoxidil tablets 2.5 mg are round, scored, white and debossed on one side and on the reverse side.Minoxidil tablets 10 mg are round, scored, white and debossed on one side and on the reverse side.Minoxidil tablets are available as follows:Minoxidil tablets 2.5 mg are round, scored, white and debossed on one side and on the reverse side.Minoxidil tablets 10 mg are round, scored, white and debossed on one side and on the reverse side.Minoxidil tablets are available as follows:Minoxidil tablets 2.5 mg are round, scored, white and debossed on one side and on the reverse side.Minoxidil tablets 10 mg are round, scored, white and debossed on one side and on the reverse side.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA. Alkylation (methylation) occurs mainly at the O and N positions of guanine.

Non-Clinical Toxicology
Known hypersensitivity to any TEMODAR component or to dacarbazine (DTIC). ()

See "" under .

Patients treated with TEMODAR may experience myelosuppression, including prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome. In some cases, exposure to concomitant medications associated with aplastic anemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment. Prior to dosing, patients must have an absolute neutrophil count (ANC) greater than or equal to 1.5 × 10/L and a platelet count greater than or equal to 100 × 10/L. A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 10/L and platelet count exceeds 100 × 10/L. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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