Universal reference book for medicines
Product name: CARDIOXANE

Active substance: dexrazoxane

Type: Complexing drug.
Cardioprotector with anthracycline therapy
Manufacturer: NOVARTIS PHARMA (Switzerland) manufactured by NOVARTIS PHARMACEUTICALS UK (United Kingdom)
Composition, form of production and packaging
Liofilizate for the preparation of a solution for infusions of
white or almost white with a yellowish tint of color.

1 f.

dexrazoxane hydrochloride 598 mg,

which corresponds to the content of dexrazoxane 500 mg

Excipients: hydrochloric acid 0.1N.

Vials of dark glass (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Complexing agent.
Cardioprotector with anthracycline therapy.
Dexrazoxane is an analogue of ethylenediaminetetraacetic acid (EDTA).
In the myocardium it undergoes hydrolysis, forms chelate compounds with iron and copper, reduces the formation of doxorubicin-iron complex and free oxygen radicals. It breaks the formation of the anthracycline-iron complex and prevents the appearance of iron-containing free radicals that mediate the cardiotoxic effect of anthracyclines. Protects the structural components of cardiomyocytes. The selectivity of action is due to the difference in the mechanisms of intracellular metabolism of the active substance in tumor cells and myocardial cells.
PHARMACOKINETICS

After intravenous administration, it is rapidly distributed among the tissues with the highest concentration of unchanged drug (ICRF-187) and the hydrolyzed active metabolite (CRF-198) in the liver and kidneys.
Through the BBB does not penetrate. Binding to plasma proteins is low - less than 2%.
The kinetics of dexrazoxane corresponds to a two-phase pharmacokinetic model with T 1/2 15 min and 140 min, respectively.
About 40% of the unchanged drug is excreted in the urine. In chronic renal failure, dexrazoxane withdrawal decreases.
INDICATIONS

- prophylaxis of cardiotoxicity in the application of antitumor therapy with the inclusion of doxorubicin.

DOSING MODE

Cardioksan is administered iv in the form of a 15-minute infusion, approximately 30 minutes before the introduction of anthracycline, at a dose exceeding 20 times the dose of doxorubicin administered.
For example: it is recommended to administer Cardioksan at a dosage of 1000 mg / m 2 with a usual dosage of doxorubicin 50 mg / m 2 every 21 days.
The use of Cardioksan should be started simultaneously with the first dose of doxorubicin and repeated at the same frequency as doxorubicin.
For elderly patients there is no special dose. The tolerability and efficacy of Cardioksan in patients of childhood is not fully understood.
Preparation of the solution

To obtain a reconstituted solution of Cardioksan, the contents of one vial must be dissolved in 25 ml of sterile water for injection.
The contents of the vial dissolve within a few minutes with gentle shaking. To avoid the risk of formation of a thrombus at the injection site, Cardiocyan should not be administered without dilution with one of the solutions listed in the table below.
It is preferable to use a solution with a higher pH (including Ringer's lactate, Hartmann's solution or phosphate buffer).
The final volume is proportional to the number of used Cardioksan bottles and the amount of dilution liquid, the volume of which can be from 25 ml to 100 ml per vial.
The table provides an overview of the final volumes and the approximate pH level after diluting 1 vial of Cardioksan or after diluting 4 flasks of Cardioksan with the recommended liquid.

Dilution liquid Dilution liquid volume 1 fl.
(25 ml) / reduced cardiocyanate The final volume for 1 fl. The final volume for 4fl. pH (approximately)
Ringer lactate 25 ml / 100 ml 50 ml / 125 ml 200 ml / 500 ml 2.2 / 3.3

0.16 M sodium lactate 25 ml / 100 ml 50 ml / 125 ml 200 ml / 500 ml 2.9 / 4.2

0.9% sodium chloride solution 25 ml / 100 ml 50 ml / 125 ml 200 ml / 500 ml 2.0 / 2.3

5% dextrose solution 25 ml / 100 ml 50 ml / 125 ml 200 ml / 500 ml 1.9 / 2.2

Saline rp buffered with phosphate pH 7.4 25 ml / 100 ml 50 ml / 125 ml 200 ml / 500 ml 2.1 / 2.7

Phosphate buffer pH 9.1 * 10 ml + 15 ml water for injection 50 ml 200 ml 6.7

* This solution should be prepared by mixing 1 vial of reconstituted Cardioksan solution, 15 ml of water for injection and 10 ml of phosphate buffer (0.448 M, pH 9.1)

Using large volumes of dilution (maximum 100 ml per vial) is usually recommended to increase the pH of the solution.
Smaller volumes of dilution (minimum 25 ml per vial) can be used if necessary on the basis of the hemodynamic status of the patient.
The initial preparation should be visually inspected for presence of particles and discoloration before administration.

SIDE EFFECT

In doses recommended for the cardioprotective effect, Cardioksan does not increase the incidence or degree of clinical manifestations of toxicity that occurs against the background of standard chemotherapeutic regimens including doxorubicin, with the exception of a small but marked increase in leukopenia and thrombocytopenia.

In addition, there are pain and irritation in the area of ​​administration of the drug.

When using the drug in significantly higher doses (4500 mg / m 2 , Maximum Tolerated Dose / MTD), the following side effects are observed:

On the part of the hematopoiesis system: a small (passing into the middle) leukopenia, a small (turning into an average) thrombocytopenia, anemia.

From the coagulation system: blood coagulability.

On the part of the digestive system: nausea, vomiting, a transient increase in the level of hepatic enzymes, a transient increase in the content of triglycerides and amylase.

From the side of the urinary system: an increase in the content of urine in the urine and zinc.

Other: malaise, a slight increase in body temperature, alopecia, a decrease in serum calcium levels.

CONTRAINDICATIONS

- hypersensitivity to dexrazoxane.

Caution should be applied to the drug
with violations of the liver and kidneys, in children of childhood.
PREGNANCY AND LACTATION

The use of the drug during pregnancy and during breastfeeding is contraindicated.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should apply the drug for violations of kidney function.
In connection with the fact that in the case of renal insufficiency dexrazoxane withdrawal can be reduced, it is recommended to closely monitor the possible development of hemotoxicity in patients with signs of impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should apply the drug for violations of liver function.
Given the observed signs of impaired liver function with high doses of dexrazoxane, patients with signs of impaired liver function are advised to regularly check for liver samples.
APPLICATION FOR CHILDREN

The tolerability and efficacy of Cardioksan in patients of childhood is not fully understood.

APPLICATION IN ELDERLY PATIENTS

For elderly patients there is no special dose.

SPECIAL INSTRUCTIONS

Cardioksan should be used only for patients undergoing chemotherapy with the inclusion of doxorubicin.
To achieve a complete cardioprotective potential, Cardioxan should be started concurrently with the first dose of doxorubicin.
When treating Cardioksan, regular monitoring of the peripheral blood pattern is necessary, especially during the first 2 cycles of therapy.

Given the observed signs of impaired liver function with high doses of dexrazoxane, patients with signs of impaired liver function are advised to regularly check for liver samples.

In connection with the fact that in the case of renal insufficiency dexrazoxane withdrawal can be reduced, it is recommended to closely monitor the possible development of hemotoxicity in patients with signs of impaired renal function.

When treating Cardioksan, reliable methods of contraception should be used.

Care should be taken when using lyophilizate and preparing the solution.
It is recommended to work in gloves. If you get Cardioksan on your skin or mucous membranes, they should be rinsed immediately with water.
OVERDOSE

Symptoms: leukopenia, thrombocytopenia, nausea, vomiting, diarrhea, skin reactions and alopecia.

Treatment: symptomatic.
There is no special antidote.
DRUG INTERACTION

The drug does not affect the antitumor activity of anthracyclines.

Cardioksan can enhance the myelosuppressive effect of antitumor drugs and radiation therapy.

Despite the fact that incompatibility with other drugs or materials has not been identified, Cardioksan should not be mixed with other drugs when administered.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children, protected from light and moisture, at a temperature of no higher than 25 В° C.
Shelf life - 3 years.
Storage conditions for reconstituted and diluted solution: out of reach of children, protected from light at a temperature of 2 В° to 8 В° C.
The reconstituted and diluted solutions must be used within 4 hours. The unused solution must be destroyed.
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