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Totect

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Totect

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

Totect

DRUG DESCRIPTION

Totect® (dexrazoxane for injection) is a sterile, pyrogen-free lyophilizate intended for intravenous (IV) administration. Totect® is packaged as an urgent treatment kit for single patient use. Each kit contains 1 or 4 vials of Totect® (dexrazoxane for injection) 500 mg and 1 or 4 vials of 50 mL diluent. Up to 10 vials each may be needed to complete three days of 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® Kit (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 2 or 8 50 mL Type I glass vials. One or 4 vials each contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane and 1 or 4 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, sores in your mouth and throat;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
  • bruising, swelling, warmth, redness, oozing, or bleeding of any surgical incision.

Less serious side effects may...

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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, because this drug may...

Read All Potential Precautions of Totect »

Last reviewed on RxList: 5/14/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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