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Totect

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Overview

What is Totect?

Totect (dexrazoxane for injection) is a sterile, pyrogen-free lyophilized powder intended for intravenous (IV) administration. Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg.

Chemically, dexrazoxane a cytoprotective agent, is 2,6-piperazinedione,4,4'-(1-methyl-1,2-ethanediyl)bis-,(S)- or (S)-(+)-1,2-bis(3,5-dioxopiperazin-1-yl)propane. The following diagram shows the chemical structure:

The molecular formula is CHNO; the molecular weight is 268.3. Dexrazoxane is a white to off-white powder, with a melting point of 194 ± 3 °C. It is soluble in dioxane and 0.1 N HCl, sparingly soluble in water, tetrahydrofuran, citrate buffer at pH 4.0, phosphate buffer at pH 7.0, and borate-potassium chloride sodium hydroxide buffer at pH 9.0. The acid dissociation constants, pKa, are 2.5 (for the tertiary piperazine nitrogen) and 9.7 (for the nitrogen imide). Log P is -2.135.

The finished product is supplied in a sterile form for intravenous infusion only following mixing and diluting.

Each carton contains one 50 mL Type I glass vial. Each vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane (free base). Each vial of dexrazoxane for injection is closed with an aluminum flip-off cap covered with a dark red overcap.

When reconstituted as directed with 50 mL of sodium lactate injection solution (0.167 M), the admixture contains dexrazoxane (10 mg/mL) and the following excipients: hydrochloric acid, sodium lactate, water for injection, sodium hydroxide and lactic acid . The admixture should be further diluted in 0.9 % NaCl prior to administration to patients.



What does Totect look like?



What are the available doses of Totect?

For Injection: 500 mg as a sterile, pyrogen-free lyophilized powder in a single dose vial for reconstitution.

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

How should I use Totect?

Totect is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.


What interacts with Totect?

Sorry No Records found


What are the warnings of Totect?

Sorry No Records found


What are the precautions of Totect?

Sorry No Records found


What are the side effects of Totect?

Sorry No records found


What should I look out for while using Totect?

None.


What might happen if I take too much Totect?

Overdose with dexrazoxane can lead to signs of bone marrow failure. Treatment should be symptomatic. There is no known antidote for dexrazoxane.


How should I store and handle Totect?

StorageStore bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).StorageStore bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder.NDC 66220-110-01: Carton of 1 vial of TotectStore at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep vial in carton until ready for use.Follow special handling and disposal procedures. Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder.NDC 66220-110-01: Carton of 1 vial of TotectStore at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep vial in carton until ready for use.Follow special handling and disposal procedures. Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder.NDC 66220-110-01: Carton of 1 vial of TotectStore at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep vial in carton until ready for use.Follow special handling and disposal procedures. Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder.NDC 66220-110-01: Carton of 1 vial of TotectStore at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep vial in carton until ready for use.Follow special handling and disposal procedures.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism by which Totect diminishes tissue damage resulting from the extravasation of anthracycline drugs is unknown. Some evidence suggests that dexrazoxane inhibits topoisomerase II reversibly.

Non-Clinical Toxicology
None.

Treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Grade 2-4 decreased white blood cells (73%), decreased neutrophils (61%), and decreased platelets (26%) occurred in patients treated with Totect and cytotoxic chemotherapy in clinical trials. Febrile neutropenia occurred in 2.5% of patients .

Monitor complete blood counts during treatment with Totect and cytotoxic chemotherapy. The myelosuppression and cytotoxic potential of Totect and cytotoxic chemotherapy (with a nadir occurring on days 10-12) may be additive to that of the chemotherapy administered alone.

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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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