Universal reference book for medicines
Product name: IDALEK (IDALEK)

Active substance: idarubicin

Type: Antitumor antibiotic

Manufacturer: FARMATSEL (Russia) manufactured by Biolec - Kharkov enterprise for the production of immunobiological and medicinal products (Ukraine)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Antitumor agent from the group of anthracycline antibiotics.
The mechanism of action is associated with inducing DNA ruptures and interaction with topoisomerase II.
PHARMACOKINETICS
After intravenous administration, Cmax in blood cells containing nuclei and in bone marrow cells is reached within a few minutes.
Metabolized both in the liver and outside it with the formation of the main metabolite of idarubicinol, which does not differ in activity from idarubicin. The concentrations of idarubicin and idarubicinol in blood cells containing nuclei and in bone marrow cells, respectively, are 400 and 200 times higher than in plasma. The binding of idarubicin with plasma proteins is 97%, idarubicinol is 94%.
T ½ and idarubicinol an average of 22 h, and idarubicinol - 2 times more.
It is excreted by the kidneys - less than 5% and with bile in the form of idarubicinol.
INDICATIONS
Acute myeloblastic leukemia in adults.

DOSING MODE
Established individually, depending on the indications and stage of the disease, the state of the hematopoiesis system, the scheme of antitumor therapy.

SIDE EFFECT
On the part of the hematopoiesis system: leukopenia, thrombocytopenia, anemia.

From the cardiovascular system: cardiomyopathy, the development of heart failure, arrhythmias, myocardial infarction.

On the part of the digestive system: nausea, vomiting, mucositis, abdominal pain, diarrhea;
rarely - enterocolitis with perforation, impaired liver function.
On the part of the urinary system: nephropathy due to increased formation of uric acid.

Dermatological reactions: alopecia.

CONTRAINDICATIONS
Severe hematopoiesis, severe heart disease, pregnancy, hypersensitivity to idarubicin, severe liver dysfunction (bilirubin level above 85.5 μmol / ml).

PREGNANCY AND LACTATION
Idarubicin is contraindicated in pregnancy.
If it is necessary to use during lactation, the question of stopping breastfeeding should be resolved.
Women of childbearing age who are receiving idarubicin therapy should use reliable methods of contraception.

In experimental studies , teratogenic and embryotoxic effects of idarubicin have been established.

APPLICATION FOR FUNCTIONS OF THE LIVER
If the renal function is impaired, a correction of the dose of idarubicin, depending on the level of creatinine in the blood plasma, is necessary.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe violations of liver function (bilirubin level above 85.5 μmol / ml).
If there is a violation of the liver, correction of the dose of idarubicin is necessary, depending on the level of bilirubin in the blood plasma.
APPLICATION IN ELDERLY PATIENTS
The risk of developing a cardiotoxic effect is increased in patients older than 60 years.

SPECIAL INSTRUCTIONS
Do not recommend the use of idarubicin in patients with chickenpox (including recently transferred or after contact with the sick), with herpes zoster, other acute infectious diseases.

With caution use idarubicin in patients with gout or nephrolithiasis (including in the anamnesis).

If there is a violation of the liver or kidney function, a correction of the dose of idarubicin is necessary, depending on the level of bilirubin or creatinine in the blood plasma.

The risk of developing a cardiotoxic effect is increased in patients over 60 years of age and in patients with a history of cardiovascular disease, as well as in the case of previous anthracycline therapy at a high total dose.

Do not recommend the vaccination of patients and their families.

In the process of treatment, monitoring of the peripheral blood picture, concentration of uric acid in the blood plasma, laboratory indicators of liver and kidney function, regular ECG, ultrasound of the heart, radiography and determination of the stroke volume of the heart.

In case of extravasation, local necrosis of tissues at the site of administration is possible.

Against the background of the application of idarubicin, it is possible to stain urine red.

In experimental studies, a carcinogenic and mutagenic effect of idarubicin was established.

DRUG INTERACTION
With the simultaneous use of idarubicin with drugs that have a myelotoxic effect, it is possible to intensify toxic effects on the hematopoiesis.

When combined with uricosuric drugs, the risk of developing nephropathy increases.

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