Doxorubicine

Доксорубицин Drug photo

The description is actual on 17.01.2015

  • Latin name: Doxorubicin
  • ATH code: L01DB01
  • Active ingredient: Doxorubicine (Doxorubicin)
  • Producer: Pharmstandard Biolik of PAO (Ukraine), LLC Lens-Farm, Pharmstandard of joint stock company, St. Petersburg NIIVS (Russia)

Structure

  • 1 bottle with lyophilisate for production of solution for intravesical and intravascular injections contains 10 mg of a hydrochloride of doxorubicine. Additional substances: Mannitolum.
  • 1 ml of a concentrate for production of solution for intravesical and intravascular injections contains 2 mg of a hydrochloride of doxorubicine.

Release form

Lyophilisate represents the yellow-red porous weight, possible forms of release:

  • 10 mg of such weight in a bottle; ten bottles in a box from a cardboard.

The concentrate represents transparent liquid of red color, possible forms of release:

  • 5 ml of such solution in a glass bottle; one or ten bottles in a box from a cardboard;
  • 25 ml of such solution in a glass bottle; one bottle in a box from a cardboard;
  • 50 ml of such solution in a glass bottle; one bottle in a box from a cardboard.

Pharmacological action

Possesses antineoplastic and antibacterial action.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

The anthracycline antineoplastic antibiotic allocated from culture of a fungus of Streptomyces peucetius. Has anti-proliferative and antimitotic effect. Interacts with DNA, suppresses topoisomerase of the second type, a DNA polymerase and a RNA polymerase, activates products of free radicals and directly influences walls of cells owing to what DNA replication and biosynthesis of nucleic acids is slowed down. Has also direct cytotoxic effect. Cells show sensitivity to means in a S-phase and G2 phase of life of a cell.

Pharmacokinetics

After an intravenous injection Doxorubicine always shows multiphase distribution: in the first phase within the first 5 minutes drug is quickly taken fabrics, and its concentration in plasma actively decreases; in the second phase there is slow exit of molecules of drug from fabrics.

Concentrates mainly in kidneys, a liver, a spleen, a myocardium, lungs. Gets through a placenta and it is excreted with breast milk, but does not get through a blood-brain barrier.

Reacts with proteins of plasma to 75%. It is metabolized in a liver with products of one active derivative – a doksorubitsinola.

Synthesis of free radicals in the course of enzymatic recovery can promote development of cardiotoxic action. Elimination half-lives of a doksorubitsinol and Doxorubicine are similar and average 20-48 h. About 40% of a dose are allocated with bile and only 6-11% of doxorubicine and its proizodny it is found in urine within five days.

Indications to use

Cancer of a thyroid gland, Vilms's tumor, small-celled form of cancer of lung, Kaposha's sarcoma, breast cancer, bladder cancer, gullet cancer, neuroblastoma, mesothelioma, Ewing's sarcoma, carcinoma of the stomach, insulinoma, primary hepatocellular cancer, nekhodzhkinsky lymphoma, carcinoid, osteosarcoma, oncological diseases of area of the head and neck, malignant thymoma, some types of a tumor of a small egg, prostate cancer, endometria cancer, uterus sarcoma, cancer of a neck of uterus, rhabdomyosarcoma, acute leukosis, Hodzhkin's illness, chronic lymphoid leukosis, multiple myeloma.

Contraindications

  • sensitization to Doxorubicine or other components of drug; to other representatives of anthracyclines and antratsendion.
  • Introduction is intravenously contraindicated at: the previous treatment by other representatives of an antratsendionama or anthracyclines in limit doses; the heavy liver failure, arrhythmias, a myocardial infarction expressed to heart failure, acute viral infections.
  • Introduction is vnutripuzyrno contraindicated at: malignant tumors which burgeon in a bladder wall, cystitis, infectious diseases of uric ways.

With care to use drug the patient receiving intensive chemotherapy with risk factors of emergence of cardiotoxicity, obesity, an infiltration with oncological cells of marrow, disturbance of work of a liver, at persons of children's and advanced age, at use as a part of multicomponent and multispecific antineoplastic therapy.

Side effects of Doxorubicine

  • Side effects from system of a hemopoiesis: reversible dozozavisimy leukopenia, anemia, neutropenia, thrombocytopenia. The leukopenia, as a rule, reaches the most expressed value in a half-month after drug use, and recovery of normal indicators of blood is observed in three weeks after drug use.
  • Reactions from system of digestion: vomiting, nausea, stomatitis, an esophagitis, anorexia, hyperpegmentation of a mucous oral cavity, abdominal pains, diarrhea, gastrointestinal bleedings, colitis, increase in concentration of bilirubin and hepatic transaminases in blood.
  • Reactions from the blood circulatory system: sinus tachycardia, tachyarrhythmias, bradycardia, a ventricular ekstrasistoliya, anomalies on an ECG, an atrioventricular block, blockade of branches of a ventriculonector, congestive type of heart failure, phlebitis, tromboembolic episodes, thrombophlebitis, an embolism of a pulmonary artery.
  • Reactions from sight: keratitis, conjunctivitis, dacryagogue.
  • Reactions from urinogenital system: oligospermatism, red coloring of urine, hyperuricemia, amenorrhea, azoospermism.
  • Reactions from skin: the reversible alopecia, hyperpegmentation of skin, photosensitivity, rash, urticaria, an itch, an erythema, severe pain, hypostasis, wet epidermit.
  • Reactions from a nervous system: epileptic seizures, peripheral neurotoxicity, coma.
  • Local reactions: local phlebitis, a phlebosclerosis, the expressed inflammation, local morbidity, thrombophlebitis, a necrosis of fabrics; erythematic striation in the place of a projection of the saphena used for introduction.
  • Allergic reactions: dermatitis, bronchospasm, skin rash, dermahemia, small tortoiseshell, anaphylaxis.
  • Intravesical administration of drug can lead to development of signs of a konstriktion of a bladder and chemical cystitis: polyuria, dysuria, nocturia, hamaturia, urodynia, discomfort, necrosis of covers of a bladder.
  • Intra arterial administration of drug can cause ulcers of a 12-perstny gut or a stomach, a sclerosis of bilious channels.
  • Other reactions: adynamy, fever, indisposition, fever, inflow, hyperuricemia, nephropathy, development of an acute miyelotsitarny or lymphocytic leukosis.

Application instruction (Way and dosage)

The instruction on Doxorubicine allows to administer the drug vnutripuzyrno, intravenously or vnutriarterialno; it can be applied odinochno, or in a combination with other cytostatics in different doses. The recovered solution of Doxorubicine ispolztsya right after production.

Intravenous administration

When carrying out monotherapy by Doxorubicine the recommended dosage on a cycle makes each three weeks at the rate of 60-75 mg/sq.m. Usually the soyedstvo is entered once for the period of all cycle; however, it is possible to enter this dose for several injections (on 25-30 mg/sq.m a day during the first three days of a cycle).

For the purpose of decrease in toxic effect of drug the weekly way of introduction on at the rate of 10-20 mg/sq.m weekly is applied.

With other antineoplastic means Doxorubicine is entered into combinations in a cyclic dose at the rate of 30-60 mg/sq.m each 3-4 weeks. Additional courses of administration of drug are conducted only after disappearance of all signs of toxicity.

The total dosage of drug should not be more than 550 mg/sq.m.

Introduction to a bladder

The Sovetuyemy dosage for intravesical introduction makes 35-50 mg for installation. Instillations are carried out by intervals from a week to four weeks, depending on the purpose (treatment or prevention). Concentration of solution has to be 1 mg / 1 in ml of physical solution or water. Instillation is carried out within one-two hours. At the end the patient has to devastate a bladder.

Intra arterial introduction

For ensuring local influence Doxorubicine can be vnutriarterialno delivered to patients with hepatocellular cancer in the general artery of a liver in a dose of 35-150 mg/sq.m with intervals between cycles from three weeks to three months.

Overdose

Overdose can lead to toxic symptoms from bodies of a digestive tract, to a heavy miyelosupressiya, cause acute heart diseases. The specific antidote to Doxorubicine does not exist. In case of overdose symptomatic therapy is appointed, the patient is hospitalized and administer the antibacterial drugs.

Interaction

When using drug in a combination with other cytotoxic means their additive toxicity is quite often shown.

At simultaneous use with other cytotoxic drugs possessing cardiotoxicity (ftoruratsit, cyclophosphamide) implementation of careful control of cardiac performance during a therapy course is required.

Against treatment by Doxorubicine emergence of signs of an exacerbation of hemorrhagic cystitis after therapy by cyclophosphamide and strengthening of the phenomena of a hepatotoxic the field of therapy of Mercaptopurinum is possible.

Streptozotsin extends a drug Doxorubicine elimination half-life.

Paklitaksel's introduction before administration of Doxorubicine can cause increase of plasma concentration of the last.

Drug is forbidden to be mixed with other means, it pharmaceutical is incompatible with dexamethasone, heparin, a hydrocortisone, Aminophyllinum, cefalotin, sodium succinate, ftoruratsily and other antineoplastic means.

When sharing with virus live vaccines activation of process of replication of a virus, strengthening of side effects and decrease in synthesis of antibodies in the patient's organism in response to use of a vaccine is possible.

Terms of sale

Strictly according to the recipe.

Storage conditions

To store in the dry dark place at a temperature up to 5 degrees. To protect from children.

Period of validity

Two years.

Special instructions

During treatment it is necessary to exercise a constant control of a picture of indicators of peripheral blood, function of a liver, ultrasonography and an ECG of heart.

Analogs

Doksorubitsin-Tev, Onkodoks 50, Doxorubicine of Lakhem, Onkodoks 10, Doksorubitsin-Ronts, Doksorubitsin-Ebev and others.

Zdravzona

  • Doksorubitsin-LENS lyophilisate for solution 50 of mg No. 1 flakonlens-Farm Ltd company
  • Doksorubitsin-LENS lyophilisate for solution 10 of mg No. 1 flakonlens-Farm Ltd company
  • Doksorubitsin-Tev lyophilisate for solution 10 of mg No. 1 flakonteva Pharmaceutical
  • Doksorubitsin-Tev lyophilisate for solution 50 of mg No. 1 flakonteva Pharmaceutical
  • Doksorubitsin-Ebev a concentrate for solution 2mgml 5 of ml No. 1 flakonebewe pharma
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Apteka24

  • Doksorubitsinpharmachemie (Netherlands)
Section: Antineoplastic
in more detail

Education: Graduated from the Vitebsk state medical university majoring in "Surgery". At university headed Council of students' scientific society. Professional development in 2010 - in "Oncology" and in 2011 - in "A mammology, visual forms of oncology".

Experience: Work in an all-medical network 3 years the surgeon (The Vitebsk hospital of an emergency medical service, Lioznensky TsRB) and in combination the regional oncologist and the traumatologist. Work farm the representative within a year in the Rubicon company.

Provided 3 improvement suggestions on the subject "Optimization of an Antibioticotherapia depending on Species Composition of Microflora", 2 works took prizes in a republican competition review of student's scientific works (1 and 3 categories).
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