Doxorubicin Ebewe 10mg/5ml treatment of hard tumor, hematuria and lymphoma (5ml)

Dosage form Box x 5ml
Specifications Doxorubicin
Ingredient EBewe

Ingredient

Composition informationContent
Doxorubicin2mg/ml

Uses

Indications

Concentrated tumors, hematuria and lymphatic systems, including:

Granulocytes and lymphocytes, such as Hodgkin lymphoma and no Hodgkin.

Carcinome (carcinome) of the breast, bladder, bronchial, uterus, cervix, ovaries, prostate, pancreas, stomach, thyroid, testicular, liver; Neuromuscular tumor;

Soft tissue tissue, bone (Ewing Sarcoma); Wilms tumor, head-head, bone marrow tumor.

Doxorubicin can be pumped directly into the bladder in the case of patients with non -invasive shallow bladder cancer - after endoscopic cutting procedure (Tur) and to prevent cancer tissue.

Pharmacokology

mǎ ATC: L01D B01

Doxorubicin has shown anti -alien activity in some animals and are effective in humans but there is no agreement on how doxorubicin and other anthracycline have anti -cancer effects. There are 3 main biochemical mechanisms given: impact on DNA, attaching to cell membranes and activating metabolism through Christmas.

An important cause of treatment failure with doxorubicin and other anthracycline is the development of drug resistance. To overcome cell resistance with doxorubicin, the use of calcium antagonists such as Verapamil is considered for the main target of cell membranes; Verapamil inhibits slow -channel calcium transport and can increase the cells to increase the absorption of Doxorubicin. Chang et al, 1989 shows that the cytotoxic effect of doxorubicin increases by verapamil on in vitro when used for 3 lines of pancreatic cancer cells.

It has also surveyed the role that may be in Doxorubicinol's plasma plasma, the mainstream metabolites of Doxorubicin, but concluded that it is not related to the accumulation of Doxorubicin in the cell. It should be noted that the coordination of doxorubicin and verapamil has shown that it is combined with heavy toxic effects in animals (Sridhar et al, 1992).

Dynamic pharmacokinetics

After using the Doxorubicin intravenously, there is rapid plasma clearance (t)/2 = 10 minutes) and highly attached to tissue. The last waste sale time is about 30 hours. Doxorubicin is partially metabolized, mainly into doxorubicinol and a smaller amount into Aglycon, and linked to glucuronide and sulfate. Elimination mainly through bile and fertilizer. About 10% of the dose is eliminated through the kidneys. Doxorubicin attached to plasma protein is about 50-85%. The distribution volume is 800-3,500 l/m2.

doxorubicin is not absorbed by oral; The drug does not pass the bloodstream barrier.

In patients with impaired liver function of doxorubicin and metabolites may decrease.

Before taking Doxorubicin Ebewe 10mg/5ml treatment of hard tumor, hematuria and lymphoma (5ml)

How to use

doxorubicin can be used intravenously, artery, intravenous infusion for 48-96 hours or pump into the bladder. The drug is not allowed to be taken into the spinal cord, intramuscularly, injected subcutaneously or drink. Absolutely should be avoided from blood vessels because it can cause vascular inflammation and necrosis.

Prolonged drug transmission should only be indicated for special cases.

Aortic injection achieved the high level of medication. Wide necrosis can occur in the tissue spread. Because this injection is dangerous, it is necessary to consider carefully. There should be accurate operation when injected directly (Bolus injection) and/ or injecting in a short time. It is necessary to make sure the needle has entered the right position by testing about 5ml of standard transmission solution (isotonic saline solution) before transmitting medicine. Should clamp the transmission lock above the end of the line of the line, then pump Doxorubicin into the line at the position below the lock to avoid Doxorubicin from the upstream transmission in the infusion cord. Slowly inject the entire amount of Doxorubicin solution into the vein (10-20 minutes). Then unlock the infusion cord to transmit the drug to push the drug into the vein to avoid the risk of embolism.

In case of bladder injection, avoid the condition in urine. To reduce the amount of urine to approximately 50ml/hour, patients should not drink liquid 12 hours before the treatment procedure is conducted. Patients should change the position lying every 15 minutes while transmitting dripping into the bladder. Usually the transmission time is 1 hour.

Next, patients should urinate.

Before pulling out the drug from the vial and injecting the drug, Doxorubicin should be stored at room temperature. To dilute Doxorubicin solution should use physiological saline.

Dissolve 50ml doxorubicin with 30-50 ml of physiological saline solution to transmit bladder drip.

If Doxorubicin is exposed to the skin, mucosa, you should wash the contact with water, soap immediately.

Dosage

doxorubicin dose depends on the corresponding treatment cycle, the patient's general condition and the patient's previous treatment. So the following data is just instructions.

Treatment of distance with a dose of 75 mg/m2 body skin every 3 weeks taking a single dose or divided into several doses smaller than injected for 2-3 consecutive days.

Treatment of distance with a dose of 60 mg/m body skin every 3 weeks in patients with impaired bone marrow function due to age or a history of bone marrow failure or newly invaded bone marrow

Treatment of 25 mg/m2 of body skin per day (equivalent to 0.6mg/kg of body weight) within 3 days or 35 mg/m body skin (equivalent to 0.8 mg/kg body weight) within 2 days for cancer treatment of hematopathy, should not stop the drug less than 10 days.

In children: 10-20 mg/m2 body skin, once a week or every 2 weeks, total dose not exceeding 500 mg/m2 body skin.

For patients who cannot treat enough dose of some reasons (age, bone marrow inhibitor, immunosuppressive inhibition, relative contraindications) The following treatment cycle is recommended for monomers or multi -chemotherapy).

transmitted for a long period of 60 mg/m within 48-96 hours.

20 mg/m2 The body skin used for 3 consecutive days, every 3 weeks.

20 mg/m2 body skin once a week, replacing treatment at a dose of 60 mg/m2 body skin every 3 weeks.

Because there may be unwanted side effects on the heart, the total accumulation dose must not exceed 500-550 mg/m2 of the body.

The total dose should be reduced to 400 mg/m2 of the body skin in the following cases:

Patients who have been far away from the previous mediastinum, have been used before or are taking simultaneously toxic drugs (such as cyclophosphamide, mitoxantron) or related substances (daughterubicin).

In the case of stomatitis or mucositis, therapy should only continue when the lesions have healed at a decrease to about 50%.

In case of changes in blood formula, with liver and kidney dosage disorders, the dose should be reduced corresponding to the following test results:

The number of white blood cells 4000/mm³ ≥100,000/mm³ D> 50% leukocytes less than 2000 and platelets less than 50,000/mm3 stop using doxorubicin.
  • Bilirubin 1.2-3 mg/100 ml: 50%dose
  • bilirubin> 3 mg/100 ml: 25%dose
  • Creatinin serum 1,2-2 mg/100 ml: 50%dose
  • What to do when overdose? 24 -hour round) as well as inhibition of bone marrow that peaks within 14 days. Treatment recommends is the treatment of mucositis symptoms.

    Heart symptoms due to toxicity are largely recovered and temporarily and can lead to nonspecific changes on the center of electrocardiogram (reducing the difference of ST, sinus tachycardia, extracellular fall).

    may need infection reserve (including antibiotics) as well as supplements to replace the affected urine ingredients in cases of bone marrow failure.

    Chronic poisoning occurs as a myocardial disease (left heart failure) especially when accumulating more than 500 mg/m2 of body skin, and need symptom treatment.

    It is necessary to perform an echocardiogram, measure the systolic time and nuclear arterial angiography to diagnose myocardial toxicity due to accumulation.

    Side Effects

    Severe bone marrow failure is usually recovery that may occur after 10-14 days of treatment. The proportion of patients with anemia, thrombocytopenia, leukopenia depends on the dose increased later. The activity of bone marrow failure increases when combined with other anti -cancer drugs (cytostatic) or with radiation, especially if the larger dose is 550 mg/ m2 of the body and 400 mg/ m2 of the body. Therefore, it is necessary to strictly control the white blood cell formula, red blood cells. With the mentioned doses, leukopenia occurs and the most severe after 10-14 days. In general, this condition recovers until the 21st day.

    As well as other Anthracycline drugs, treatment with doxorubicin can cause heart lesions. The risk of myocardial toxicity increases when the total accumulation dose exceeds 500 mg/m2 of the body in adults and 400 mg/m2 of the body's skin in children. Avoid high levels of drugs that often occur after high -dose intravenous infusion can reduce the toxicity on the heart.

    The stage of acute: Most within 24 hours after the beginning of treatment, the first is the electrocardiogram changes that do not depend on the dose such as reducing the length of the St, sinus tachycardia, ventricular tachycardia and ventricular tachycardia. Most of the symptoms on the heart can recover or can be treated with anti -arrhyths. There have been reports of rare cases of patients suffering from life -threatening heart arrhythmia within a few minutes. After the patient has gone over the arrhythmia can be continued.

    Late phase: heart poisoning due to drug accumulation and dosage dependent. Late complications are usually congestive heart failure (left heart failure) during treatment or maybe after months or noise after treatment has ended (shortness of breath, hands and legs).

    Anthracyclin caused by anthracyclin combined with a decrease in QRS, extending the centrifugal time and reducing the total sample fiber of the left ventricle. These manifestations can grow fast and difficult to detect through regular electrocardiograms. Myocardial disease responds well to treatment but may not recover and cause death if not detected early. Difficulty breathing, arms and legs can lead to anthracyclin heart muscle disease. Before treatment with doxorubicin should do electrocardiogram tests, echocardiograms and determine the left ventricular blood emulsion. The heart function must be monitored regularly during and after treatment.

    Hair loss has a recovery of about 85% of patients.

    Nausea, anorexia, gastric contractions, diarrhea are unwanted side effects but are easy to recover.

    Gastritis and esophagitis are usually average for 5-10 days and rarely lead to ulcers. Gastrointestinal inflammation lesions (rarely leading to ulcers).

    The patient's urine is red at the beginning of the treatment but returns to normal after 48 hours and has no important symptoms.

    Rarely cases of hyperuricemia, kidney disease due to drugs that most occur at the beginning of treatment in patients with leukemia or malignant lymphoma due to rapid destruction of a large number of cells leading to increased serum uric acid.

    Red rash, itching, urticaria, fever, tremor, rarely shocked anaphylaxis. Rarely cases of patients with nail loss, hyperpigmentation, venous inflammation due to thrombosis, epidermal glass, joint pain, immunodeficiency.

    Observed with hyperuricemia in diseases with leukemia and needed treatment with xanthinoxidase inhibitors.

    Patients who have been or radioactive treatment may have an increased risk of local reactions in the irradiation area (regression phenomenon): Again the previous radiation lesions have been healed earlier when using doxorubicin.

    Collaborative treatment with cytarabine can cause colitis of colitis sometimes with severe infections.

    Observed the menstruality and sperm in combination with other cell drugs.

    Radiotherapy combination can cause dermatitis and mucositis on radiation areas. It is also not excluded for secondary tumors caused by drugs.

    Unwanted side effects related to drug use: After the infusion in small veins or the injection is repeated in a vein that can cause sclerosis. If the doxorubicin injection is left out of the medication, it will cause severe local tissue necrosis at the injection site. The risk of thrombosis can be reduced at the injection site when the medical routes of the drug are followed.

    * Rarely rarely appears along the intravenous injection (when intravenous injection too fast).

    Notice to the doctor for unwanted effects on treatment.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    allergies to an ingredient of the drug.

    doxorubicin is not used for patients with severe bone marrow failure.

    doxorubicin is not used for patients with a history of heart disease (unstable angina, progressive heart failure, IV stage heart failure, transmission disorders and severe heart arrhythmia, myocardial infarction for 6 months before, myocardial disease).

    Patients were treated by drugs of anthracyclin group (epirubicin, idarubicin, daunorubicin) to the maximum cumulative dose corresponding to doxorubicin.

    No treatment with doxorubicin in case of severe renal failure, severe liver failure, uncontrolled infection and hemorrhage.

    Contraindicated use doxorubicin directly in the bladder if there is cystitis.

    Do not use doxorubicin injected directly in the bladder if the tumor has invaded the wall of the bladder. Caution should be cautious in the case of patients who have or are irradiating the mediastinum, pericardial or post -treatment patients with toxic pills for the heart as well as patients with special clinical conditions due to disease such as anemia, pericarditis and/or myocarditis. There is an increase in the risk of toxicity on the heart when using doxorubicin in these cases.

    Do not indicate doxorubicin for pregnant and lactating women.

    Be cautious when used

    The treatment of drugs in the Anthracycline group is only performed by experienced cancer specialists. Aortic injection is only done by a doctor with specific experience. Essential conditions/medical conditions or medical conditions must be provided for unwanted effects. It is necessary to ensure safe intravenous infusion, otherwise it may occur necrotic and thrombosis. The patient must be closely monitored before, during and after treatment. Monitor hematology parameters: blood formula, granulocytes, red blood cells and platelets. Early treatment of severe bleeding and/or infection also contributes to successful treatment.

    Check the liver and kidney function such as bilirubin, serum creatinine and dose adjustment are essential.

    Hemorrhagic concentration: The corresponding treatment is required for cases of hyper urea.

    Monitor the heart parameters: ECG, echocardiography, Left ventricular sense. Early diagnosis and fast treatment is necessary for successful treatment.

    Infection control: Systemic infections must be controlled before starting treatment.

    Pre -heart disease, previous treatment with heart poisoning such as anthracycline with high cumulative doses increases the risk of toxicity on the heart. The ratio of benefits/risks must be considered when taking drugs for patients of this group.

    Should consult genetic experts if the patient wants to get pregnant after stopping treatment.

    Note: Doxorubicin cannot be appraised.

    Safety manipulation guide for health workers. Like other anti -cancer chemicals, be careful when working with doxorubicin. If the drug is spilled out, wash immediately with soap and water. Do not let pregnant women come into contact with doxorubicin.

    doxorubicin is inactive:

  • 700 degrees C
  • dilute sodium solution of the sodium hypochlorosi with 10 parts of water.

    The effect of the drug on the ability to drive and operate machinery

    doxorubicin can reduce the ability to drive and operate machinery, so it must be cautious if performing these activities while taking the drug.

    Use drugs for women during pregnancy and lactation

    do not indicate Doxorubicin for pregnant and lactating women. Doxorubicin has manifested toxic to the poisoning, causing teratogen on experimental animals, so it is not used for pregnant women. It is necessary to ensure strict contraception for both patients as well as women in the previous time and at least 3 months after therapeutic with doxorubicin. Because doxorubicin is secreted into breast milk, the patient is breastfeeding must be stopped without breastfeeding.

    Interactive drug

    Interactive drugs occur with all drugs that cause bone marrow inhibitors, toxic pills with heart, poison with the liver. Because doxorubicin can cause increased uric acid levels and therefore may need to be responded by adjusting the dose during combination time to treat gout. Coordinating with cyclosporin can cause neuropathy or chaos. Doxorubicin is similar to heparin and alkalin solutions. In general, doxorubicin should not mix with other transmission solutions. Phenobarbital may cause increased doxorubicin clearance. Doxorubicin can reduce the bioavailability of Digoxine (oral).

    During the treatment of doxorubicin, do not use vaccine to calculate patients (patients should avoid contact with people who have just been paralyzed vaccine). Cross resistance occurs with Doxorubicin and Daunorubicin.

  • Storage

    Leave a cool place, avoid light, temperature below 30⁰C.

    To be out of reach of children, read the user manual carefully before use.

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