Etoposid-Ebeve infusion solution 200mg 10ml N1
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Active ingredients
Etoposide
Release form
Solution
Composition
In 1 ml. . etoposide 20 mg. Excipients: macrogol 300, polysorbate 80, benzyl alcohol, citric acid, ethanol.
Pharmacological effect
Etoposide is a semi-synthetic derivative of podophyllotoxin. The mechanism of action is associated with inhibited topoisomerase II. Etoposide has a cytotoxic effect due to DNA damage. The drug blocks mitosis, causing cell death in the G-phase and late S-phase of the mitotic cycle. High concentrations of the drug cause lysis of cells in the premitotic phase. Etoposide also inhibits the penetration of nucleotides through the plasma membrane, which prevents the synthesis and repair of DNA.
Indications
Germ cell tumors of the testicles and ovaries. - lung cancer. There are reports on the effectiveness of Etoposide-Ebeve in the treatment of: - Bladder cancer. - Hodgkin's disease. - non-Hodgkin's lymphomas. - acute monoblastic and myeloblastic leukemia. - Ewing's sarcoma. - trophoblastic tumors. - stomach cancer. - Kaposi's sarcoma. - neuroblastomas.
Contraindications
Myelosuppression (neutrophil count below 1500 / μl and / or platelet count below 75000 / μl). - severe liver dysfunction. - acute infections. - pregnancy and lactation period. - Hypersensitivity to etoposide or excipients.
Use during pregnancy and lactation
Contraindicated
Dosage and administration
When choosing the route of administration, mode and doses in each individual case, you should be guided by the data of special literature. The dosage regimen is set individually, depending on the chemotherapy regimen used (when choosing a dose, the myelosuppressive effects of other drugs in combination, as well as the effects of previous radiation therapy and chemotherapy should be taken into account). In / in Etoposid-Ebeve is administered within 30-60 minutes, while doses of Etoposide-Ebeve are usually 50-100 mg / m2 / day for 4-5 days, with repeated cycles every 3-4 weeks. Etoposide-Ebeve administration is also often used every other day at 100-125 mg / m2 on days 1, 3, and 5. Repeated courses are held only after the normalization of peripheral blood.Before the on / in the introduction of Etoposid-Ebeve diluted in 250 ml of 0.9% sodium chloride solution or 5% dextrose solution to a final concentration of 0.2-0.4 mg / ml. Avoid contact with buffer aqueous solutions with a pH above 8.
Side effects
On the part of the blood-forming organs: a decrease in the number of leukocytes and granulocytes depends on the dose administered and is the main dose-limiting toxic manifestation of Etoposide-Ebeve. The maximum decrease in the number of granulocytes is usually observed at 7-14 days after drug administration. Thrombocytopenia occurs less frequently and the maximum decrease in platelets is observed 9–16 days after administration of etoposide. Recovery of blood parameters usually occurs on the 20th day after the introduction of the standard dose. Anemia is observed infrequently. On the part of the digestive system: nausea and vomiting occurs in about 30-40% of patients. Usually, these phenomena are moderate, and they rarely resort to cancellation of treatment because of them. Day control of these side effects are shown antiemetic drugs. In addition, diarrhea, abdominal pain, stomatitis, esophagitis, dysphagia, and anorexia were noted. Sometimes there is a temporary hyperbilirubinemia and an increase in the level of transamnesis. Most often this occurs when applying doses higher than recommended. Since the cardiovascular system: with rapid on / in the introduction of 1-2% of patients there was a temporary decrease in blood pressure, which is usually restored when the infusion is stopped and the introduction of fluids or other supportive therapy. If necessary, the resumption of the introduction of Etoposid-Ebeve the speed of administration should be reduced. Allergic reactions: symptoms that resemble anaphylactic, such as chills, fever, tachycardia, bronchospasm, shortness of breath and a decrease in blood pressure. These reactions are usually observed during or immediately after the administration of etoposide and stop when the infusion is stopped and the use of GCS or antihistamines. Dermatological reactions: reversible alopecia, sometimes resulting in complete hair loss, occurs in at least 66% of patients. Rarely observed the appearance of pigmentation, itching. In one case, a relapse of radiation dermatitis was observed. Other toxic manifestations: rarely there are peripheral neuropathy, drowsiness, fatigue, residual taste in the mouth, fever, and interstitial pneumonitis / pulmonary fibrosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, optic neuritis, transient blind cortex genesis, toxic neurosis, optic nerve neuritis, transient blindness, coronary genesis, optic nerve neurolitis, optic nerve neuritis, transient blindness, pulmonary fibrosis acidosis, hyperuricemia, phlebitis with a / in the introduction.If the drug gets under the skin - a pronounced local irritant effect up to necrosis of the surrounding tissues.
special instructions
On the part of the blood-forming organs: a decrease in the number of leukocytes and granulocytes depends on the dose administered and is the main dose-limiting toxic manifestation of Etoposide-Ebeve. The maximum decrease in the number of granulocytes is usually observed at 7-14 days after drug administration. Thrombocytopenia occurs less frequently and the maximum decrease in platelets is observed 9–16 days after administration of etoposide. Recovery of blood parameters usually occurs on the 20th day after the introduction of the standard dose. Anemia is observed infrequently. On the part of the digestive system: nausea and vomiting occurs in about 30-40% of patients. Usually, these phenomena are moderate, and they rarely resort to cancellation of treatment because of them. Day control of these side effects are shown antiemetic drugs. In addition, diarrhea, abdominal pain, stomatitis, esophagitis, dysphagia, and anorexia were noted. Sometimes there is a temporary hyperbilirubinemia and an increase in the level of transamnesis. Most often this occurs when applying doses higher than recommended. Since the cardiovascular system: with rapid on / in the introduction of 1-2% of patients there was a temporary decrease in blood pressure, which is usually restored when the infusion is stopped and the introduction of fluids or other supportive therapy. If necessary, the resumption of the introduction of Etoposid-Ebeve the speed of administration should be reduced. Allergic reactions: symptoms that resemble anaphylactic, such as chills, fever, tachycardia, bronchospasm, shortness of breath and a decrease in blood pressure. These reactions are usually observed during or immediately after the administration of etoposide and stop when the infusion is stopped and the use of GCS or antihistamines. Dermatological reactions: reversible alopecia, sometimes resulting in complete hair loss, occurs in at least 66% of patients. Rarely observed the appearance of pigmentation, itching. In one case, a relapse of radiation dermatitis was observed. Other toxic manifestations: rarely there are peripheral neuropathy, drowsiness, fatigue, residual taste in the mouth, fever, and interstitial pneumonitis / pulmonary fibrosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, optic neuritis, transient blind cortex genesis, toxic neurosis, optic nerve neuritis, transient blindness, coronary genesis, optic nerve neurolitis, optic nerve neuritis, transient blindness, pulmonary fibrosis acidosis, hyperuricemia, phlebitis with a / in the introduction.If the drug gets under the skin - a pronounced local irritant effect up to necrosis of the surrounding tissues.