DOXORUBICIN-TEVA
Active material: Doxorubicin
When ATH: L01DB01
CCF: Antitumor antibiotic
When CSF: 22.04.03
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)
Pharmaceutical form, composition and packaging
Freeze dried powder for injection solution in the form of powder or mass from orange-red to red.
| 1 fl. | |
| doxorubicin hydrochloride | 10 mg |
Excipients: lactose monohydrate.
Bottles (1) – packs cardboard.
Bottles (10) – styrofoam boxes.
Liofilizirovanny powder for injection preparation solution in the form of powder or mass from orange-red to red.
| 1 fl. | |
| doxorubicin hydrochloride | 50 mg |
Excipients: lactose monohydrate.
Bottles (1) – packs cardboard.
Bottles (10) – styrofoam boxes.
DESCRIPTION OF ACTIVE SUBSTANCES.
Pharmacological action
Antitumor agent from the group of anthracycline antibiotics. The mechanism of action is to bind DNA and inhibit the synthesis of nucleic acids..
Pharmacokinetics
Vd is 20-30 l / kg. Do not cross the BBB. Biotransformation occurs in the liver with the formation of an active metabolite. T1/2 for doxorubicin and doxorubicinol varies from 20 to 48 no. Excreted in bile unchanged (about 40% during 5 days) and kidneys in unchanged form and in the form of metabolites (about 5-12% during 5 days).
Testimony
Lymfoblastnыy leukemia, soft tissue sarcoma, osteosarcoma, sarkoma Juinga, mammary cancer, thyroid cancer, Wilms' tumor, sympathicoblastoma, bladder cancer, stomach cancer, ovarian cancer, limfogranulematoz, non-Hodgkin's lymphoma, trophoblastic tumors.
Dosage regimen
The mode set individually, depending on the evidence, the patient's condition and the cytotoxic therapy regimen used.
Depending on the dosage form used, it is intended for intravenous or intravesical administration..
Side effect
From the hematopoietic system: thrombocytopenia, leukopenia, anemia.
Cardio-vascular system: cardiomyopathy, heart failure, Arrhythmia.
From the digestive system: stomatitis, esophagitis, stomach ache; nausea, vomiting, diarrhea.
Reproductive system: azoospermia, amenorrhea.
Allergic reactions: hives, fever, anaphylactoid reactions.
Other: alopecia, hyperuricemia, nephropathy.
Local reactions: when injected into small diameter veins or when repeatedly injected into the same vein – vessel sclerosis; when extravasation – necrosis.
Contraindications
Severe leukopenia, anemia, thrombocytopenia; severe diseases of the cardiovascular system; acute hepatitis; pregnancy. Doxorubicin is not used in patients, who received the full cumulative dose of daunorubicin, idarubicin and/or other anthracyclines and anthracenes.
Pregnancy and lactation
Doxorubicin is contraindicated in pregnancy. If necessary, use during lactation should stop breastfeeding.
Women of childbearing age should use reliable methods of contraception while using doxorubicin.
IN experimental studies teratogenic and embryotoxic effects of doxorubicin have been established.
Cautions
Use with caution in patients with heart disease (incl. history), chicken pox (incl. recently transferred or after contact with sick), Herpes Zoster, other acute infectious diseases, gout or nephrolithiasis (incl. history), as well as patients who have undergone mediastinal radiation therapy or are receiving concomitant cyclophosphamide.
During the period of treatment, regular monitoring of the picture of peripheral blood is necessary., laboratory parameters of liver function, ECG and ultrasound of the heart (with the determination of the ejection fraction of the left ventricle). When the number of leukocytes is less than 3500 / μl and platelets are less than 100 000/µl dose of doxorubicin is reduced by 50%.
Severe cases have been described, life-threatening arrhythmias immediately or within hours after administration of doxorubicin.
It is not recommended to vaccinate patients and their families.
Doxorubicin can cause urine to turn red for a 1-2 days after administration.
IN experimental studies found carcinogenic and mutagenic effects of doxorubicin.
Drug Interactions
Preparations, depressing hematopoiesis exacerbate thrombocytopenia and leukopenia, due to the action of doxorubicin.
With simultaneous use with hepatotoxic drugs (incl. with methotrexate) increased hepatotoxic effect.
Doxorubicin can cause an increase in the concentration of uric acid in the blood, which reduces the effectiveness of anti-inflammatory drugs (incl. allopurinola, colchicine).
With simultaneous use with clindamycin, the risk of developing allergic reactions increases..
Doxorubicin may potentiate the hepatotoxic effect of mercaptopurine.
Streptozocin and methotrexate cause increased toxicity of doxorubicin, due to decreased hepatic clearance.
When using paclitaxel simultaneously or after doxorubicin, increased cardiotoxicity is possible..
Propranolol inhibits the activity of coenzyme Q10 hearts, therefore, with simultaneous use, it is possible to increase the cardiotoxicity of doxorubicin.
Cardiotoxicity may be increased when trastuzumab is used concomitantly or after doxorubicin..
With simultaneous use with cyclosporine, an increase in the concentration of doxorubicin in plasma and an increase in myelotoxic effect are observed.; with cyclophosphamide, mitomycin, dactinomycin – may increase the cardiotoxic effect of doxorubicin.
When using doxorubicin (in / in during 3 d) in combination with cytarabine (by infusion over 7 days) cases of necrotizing colitis and severe infectious complications are described.
Against the background of the use of doxorubicin, the formation of antibodies is inhibited and / or adverse reactions are increased with the introduction of live vaccines., due to immune suppression. This effect may persist from 3 Months before 1 year.
