Totect (Dexrazoxane for Injection, Intravenous Infusion Only) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

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Totect

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Totect® Kit
(dexrazoxane) for Injection, for Intravenous Infusion Only

DRUG DESCRIPTION

Totect® (dexrazoxane) for injection is a sterile, pyrogen-free lyophilizate intended for intravenous (IV) administration. Totect (dexrazoxane for injection, intravenous infusion only ) ® is packaged as a kit for single patient use. Each kit contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent, which provides a complete three day treatment

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

Totect (dexrazoxane) Structural Formula Illustration

The molecular formula is C₁₁H₁₆N₄O₄; 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 kit contains twenty 50 mL Type I glass vials. Ten vials each contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane and 10 vials each contains diluent (0.167M Sodium Lactate Injection, USP). Each vial of dexrazoxane for injection is closed with an aluminum flip-off cap covered with a dark red overcap. Each vial of diluent is closed with an aluminum flip-off cap covered with a white overcap.

When reconstituted as directed, the admixture contains dexrazoxane and the following excipients: hydrochloric acid, sodium lactate, water for injection, sodium hydroxide and lactic acid [see DOSAGE AND ADMINISTRATION]. The admixture should be further diluted in 0.9 % NaCl prior to administration to patients.

What are the possible side effects of dexrazoxane (Totect, Zinecard)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms;
easy bruising or bleeding, weakness; or
white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

hair loss;
nausea, vomiting, diarrhea, loss...

Read All Potential Side Effects and See Pictures of Totect »

What are the precautions when taking dexrazoxane for injection, intravenous infusion only (Totect)?

Before using dexrazoxane, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before...

Read All Potential Precautions of Totect »

Last reviewed on RxList: 9/30/2009
This monograph has been modified to include the generic and brand name in many instances.