Doxorubicin Bidiphar 10 Treatment of breast cancer, hard tumors, hematopoietic cancer, bladder cancer (5ml)

Dosage form Box x 5ml
Specifications Doxorubicin
Ingredient The company tried to pharmaceutical parts - Binh Dinh medical equipment (bidiphar)

Ingredient

Composition informationContent
Doxorubicin10mg

Uses

indication

doxorubicin is indicated for the following cancers:

  • Small cell lung cancer (SCLC). Ewing. Armor (cysts, papillae) progress.

    Pharmacological

    No data.

    pharmacokinetics

    No data.

    • Before taking Doxorubicin Bidiphar 10 Treatment of breast cancer, hard tumors, hematopoietic cancer, bladder cancer (5ml)

    How to use

    doxorubicin injection should be used under the supervision of a qualified and experienced doctor in the treatment of cytotoxic toxicity. In addition, patients must be monitored carefully and regularly during treatment.

    Due to the risk of cardiac disease, the risk and benefits of patients should be considered before treatment.

    doxorubicin is used by intravenous lines and transmitted into the bladder; Do not use oral, subcutaneous injection, intramuscularly or internal injection. Doxorubicin can be fast intravenous (bolus) for a few minutes or intravenously for up to 1 hour or intravenously continuously up to 96 hours.

    The drug solution is put into the melted intravenous line of 0.9% NaCl solution or 5% Dextrose solution for about 2-15 minutes. This technique helps minimize the risk of intravenous inflammation and escape vessels out of the vein, which can lead to "orange peel", skin blistering, severe local tissue necrosis. Direct intravenous injection technique is not recommended due to the risk of vascular escape.

    Safe user manual and removal:

    Doxorubicin is a strong cytotoxic agent and should only be indicated, prepared and used by experts who have been trained in the safe use of this product. It is necessary to follow the following instructions when processing, preparing and eliminating doxorubicin.

    Preparation:

  • Employees must be trained with good techniques for processing. dangerous waste bags to burn at high temperatures (7000C).
  • All cleaning materials must be treated as described above.
  • In case of contact with the skin or mucous membrane, it must be carefully washed the exposed area with soap and water or sodium bicarbonate solution. However, it is necessary to avoid scrubbing the skin with a brush. A soothing cream can be used to reduce the feeling of pain in the skin. Then take the doctor for medical evaluation. Use a water towel/fabric to keep in the affected area. Wash 2 times with water. Place all the towels in a plastic bag and sealed to burn.

    • Use:

    The rest of the drug as well as all items that have been used for dilution and infusion must be destroyed according to the standard process of the hospital applied to cytotoxic agents in accordance with the current regulations related to hazardous waste treatment.

    Processing:

    Use only 1 time. Any unused drug or waste should be treated as required at the hospital. Comply with guidelines for handling of cytotoxic drugs.

    Dosage

    Intravenous injection: Dosage of doxorubicin depends on the treatment regimen, general condition and previous treatment of the patient. The dose mode of doxorubicin hydrochloride may vary depending on the indications (solid tumors or acute leukemia) and depending on specific treatment regimens (such as single dose or combined with other cytotoxic drugs or partly in the tricks combined with many methods include: combining chemotherapy, surgery, radiation and hormonal treatment).

    Single therapy: Dosage is calculated on the basis of body surface area (mg/m2). The recommended dose is 60 - 75 mg/m2 of the body surface area every 3 weeks.

    combined regimen:

  • When doxorubicin is used in combination with other anti -cancer drugs with overlapping toxicity, such as cyclophosphamide high -dose intravenous injection or anthracyclin compounds (such as: daunorubicin, idarubicin and/or epirubicin), dose of doxorubicin should be reduced to 30 - 60 mg/m2 every 3 weeks. The nucleus cannot treat enough doses (such as a person with immunodeficiency, the elderly), the replacement dose is 15-20 mg/m2 of the body surface per week. The recommended dose for the treatment of bladder surface is a drip transmission into the bladder dose of 30 - 50 mg in 25 - 50 ml of 0.9%NaCl solution. The optimal concentration is about 1 mg/ml. Typically, this solution should be stored in the bladder for 1-2 hours. During this period, patients should be rotated 900 every 15 minutes. Patients should not take any liquid for 12 hours before treatment to avoid unwanted dilution with urine. This can reduce the amount of urine by about 50 ml/hour. Drip transmission can be repeated for about 1 week to 1 month depending on the purpose of treatment is prevention or treatment.

    Adjust the dose on special objects:

    Patients with impaired liver function: Doxorubicin is eliminated mainly through the liver and bile, so the elimination of the drug may be reduced in patients with impaired liver function or bile secretion and this can cause serious secondary effects. Dosage adjustment recommendations in patients with liver function decline based on serum bilirubin concentration:

    Bilirubin concentration recommended dose µmol/l ¼ of the normal dose

    Patients with impaired renal function:

  • In patients with renal failure (GFR 5 years, heart muscle damage, heart valve or before rim, over 70 years old), a maximum dose of maximum 400 mg/m2 should not be exceeded and heart function of these patients should be monitored. In patients with signs or symptoms of myocardial disease.

    Dosage in children: Dosage in children should be reduced because children are at higher risk for heart toxicity, especially late toxicity. Bone marrow disease should be predicted for a minimum of 10 to 14 days after the beginning of treatment. The maximum cumulative dose in children is 400 mg/m2.

    Obesity patients: Reducing the starting dose or extending the drug cycle to be considered in obesity patients.

    What to do when overdose?

    • Side Effects

    Notify the physician the unwanted effects when using the drug.

    Warnings

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

    Contraindicated

    Ibran125mg drug contraindicated in the following cases:

  • There is a history of hypersensitivity to any ingredients of the drug.

    • Be cautious when used

    Doxorubicin injection is only used under the supervision of a doctor who has sufficient experience in the treatment of cytotoxic toxicity using intravenous or bladder glands. Doxorubicin may increase the toxicity of other anti -cancer therapies. Caution control of clinical complications should be performed, especially in elderly patients, patients with a history of heart disease or bone marrow inhibitor or previously treated patients with anthracyclin or radiation treatment in the mediastinum.

    Need to closely observe the patient condition and monitor general trials during the initial treatment. Therefore, it is recommended that patients need to be hospitalized at least in the early stages of treatment. Doxorubicin can cause infertility during medication.

    Patients should recover from previous acute toxicity (such as stomatitis, neutropenia, thrombocytopenia and systemic infections) before starting treatment with doxorubicin.

    Before or during treatment with doxorubicin, the tests below are recommended (the frequency of tests depends on the general condition, the dose and simultaneous use):

    Lung and chest X -ray, ECG (ECG).

    Regularly monitor cardiac function: LVEF's left ventricular blood emulsion (LVEF) with ECG, UCG and Muga scan.

    Daily checks for oral cavity and throat to view mucosa changes.

    Blood test: hematocrit, platelets, leukocytes, SGPT, SGOT, LDH, Bilirubin, uric acid.

    Control treatment: Before treatment, it is necessary to measure liver function with conventional tests such as AST, ALT, ALP and Bilirubin as well as renal function.

    Control left ventricular function: LVEF analysis with ultrasound or cardiomyopathy should be performed to assess the patient's heart condition. This control should be done before the beginning of treatment and after each cumulative dose (about 100 mg/m2).

    Heart function: Heart poisoning is a risk of anthracyclin treatment and may manifest early (acute) or late events (slow appearance).

    Early (acute) Early (Early) Early Early Dharma events include the main manifestations of sinus tachycardia and/or electrocardiogram abnormalities such as non-typical ST-T wave changes. A tachycardia, including early ventricle, ventricular tachycardia, slow heartbeat as well as atrioventricular and branch blocks have been reported. These symptoms are usually transient acute toxicity. These symptoms often do not predict the next progression of late heart poisoning and often do not need to stop the drug. Expanding and flattening the QRS wave complex that exceeds normal limits can be a sign of DOXORUBICIN. In principle, patients with normal LVEF values ​​(= 50%), reduced 10% of the absolute value or decreased to below the threshold of 50% indicating the condition of heart dysfunction and in this condition, the treatment with doxorubicin should be carefully considered.

    Late events (slow appearing): Late heart poisoning usually appears at the end of the doxorubicin treatment or within 2-3 months after stopping the drug. Some events appear slower (several months to several years) have been reported. Late myocardial disease is manifested by reducing left ventricular blood emulsion (LVEF) and/or signs and symptoms of congestive heart failure (CHF) such as shortness of breath, pulmonary edema, enlarged and enlarged heart, urinary tract, ascites, pleural effusion and gallop rhythm. Semi -acute manifestations such as pericarditis/myocarditis have also been reported. Set endemic heart failure is the most serious form of myocardial disease due to the use of anthracycline and represent the cumulative limit of the drug.

    It is necessary to assess the heart function before the patient starts to treat with Doxorubicin and must monitor the heart function during the treatment process to minimize the risk of severe heart failure. The risk of heart failure may be reduced when regularly monitoring LVEF during treatment and stop using doxorubicin as soon as the first symptom of heart failure. The appropriate quantitative method to evaluate cardiac function (LVEF assessment) is a multi -port -shaped bandage (MUGA) or an echocardiography (Echo). The initial recommendation of the heart function by electrocardiogram and muga or echo, especially in patients with risk factors that increase the risk of myocardial toxicity. It is necessary to re -evaluate LVEF with Muga or echo, especially when using high -dose and accumulated anthracyclin derivatives. The method used to evaluate the heart function must be homogeneous during monitoring.

    The probability of congestive heart failure, estimated at 1-2% at the cumulative dose of 300 mg/m2, increasing slowly to a total accumulation of 450 - 550 mg/m2. After that, the risk of congestive heart failure increased rapidly and recommended not to exceed the maximum accumulation of 550 mg/m2. If the patient has other potential risk factors for heart poisoning (a history of cardiovascular disease, previous treatment with other anthracyclin or anthracendion, previous radiation therapy or at the same time in the mediastinum/pericardium and simultaneous use of drugs that can reduce the ability to contraction of the heart muscle including: cyclophosphamide and 5 - fluoracil) Out at lower doses and heart function should be carefully monitored.

    Children and adolescents are at high risk for the progression of late heart poisoning after using Doxorubicin. Women are at higher risk than men. Demolable heart function assessment is recommended to monitor this effect.

    toxicity of doxorubicin and other alternyclin or other anthracenedion derivatives are of synergistic properties.

    Liver function: The main elimination line of doxorubicin is through the liver system. It is necessary to evaluate the total level of bilirubin before and during treatment with doxorubicin. Patients with increased bilirubin may have a slower clearance rate, accompanied by an increased risk of poisoning. Recommendations for low doses for these patients. Patients with severe liver failure should not use doxorubicin.

    Hematology: Doxorubicin can cause marrow failure. It is necessary to check the hematological parameters before and in each doxorubicin treatment cycle, including different types of leukemia. Reducing leukopenia and/or granular leukemia (neutropenia) depends on the dose and recovery is the main manifestation of hematopology caused by doxorubicin and is the most acute toxicity that limits the dose when using this drug. Neutrophilia and neutropenia reduced the lowest decrease between the 10th and 14th days after the drug. The number of neutrophils/neutrophils returns to normal on the 21st in most patients. It is necessary to consider reducing the dose or increasing the duration of the drug if abnormal hematological values. Reducing bridges and anemia can also occur. The clinical consequences of severe marrow failure include: fever, bacterial infection, bacterial infection, bacterial shock, hemorrhage, lack of tissue oxygen or death.

    Secondary leukemia: Secondary or without periodic leukemia has been recorded in patients treated with anthracycline derivatives including doxorubicin. Secondary leukemia is more common when used in combination with anti -cancer drugs that cause DNA destruction, when the patient has been treated with high doses earlier, cytotoxic drugs or when anthracycline dose increases rapidly. Leukemia can incubate for 1 to 3 years.

    transmitted into the bladder:

  • Doxorubicin can cause symptoms of cystitis due to drugs (difficulty urination, many times, night urination, urinating, bloody urine, necrosis into bladder). Special attention should be paid to cases related to urinary tract catheter (such as the urethra due to the large tumor inside the bladder). The transmission into the bladder is contraindicated for the blocks that have entered the bladder.

    Control of serum uric acid: During treatment, uric acid may increase. In this case, uric acid lowering therapy should be done.

    In patients with severe renal function, the dose reduction is necessary.

    Effects of the digestive tract:

  • recommended anti -vomiting drug prevention.

    Escapes: The exit of Doxorubicin solution after transmission can cause local necrosis, thrombosis. The burning sensation at the infusion site is a sign of the exit. If the exit occurs, the injection should be stopped immediately, the needle should be kept in a short time, then it is drawn after a short time with a barrel. In the case of exit, starting to infect dexrazoxan intravenously, no more than 6 hours after the exit. In the case of dexrazoxan contraindicated, it is recommended to apply Dimethyl Sulfonid (DMSO) on the spot with double the area of ​​the area escaped and repeat 3 times daily for not less than 14 days. The surgery can be removed if necessary. Due to the antagonistic mechanism, the topical area should be cooled after applying DMSO to relieve pain. DMSO should not be used in patients who use dexrazoxan to treat vascular escape.

    Radiation therapy: Radioactive toxicity (for myocardial, mucosa, skin and liver) has also been reported. Especially cautious is mandatory for patients who have been radiotherapy before or are being radiotherapy simultaneously or have radiotherapy. These patients have a special risk of local reactions (repeat phenomena) if using doxorubicin hydrochloride. Serious liver toxicity (liver damage) is sometimes reported to be reported when using a combination. Radiation therapy earlier in ventricular increases heart poisoning caused by doxorubicin. The cumulative dose of 400 mg/m2 must not exceed this case.

    Infertility:

  • doxorubicin can be toxic to genes. Doxorubicin can cause infertility during medication. In women, doxorubicin can cause amenorrhea. Early menopause can occur, although ovulation and menstruation reappear after the end of treatment. Women should not be pregnant during treatment and 6 months after treatment. Reducing sperm or without sperm may occur permanently. However, in some cases, the number of sperm is reported back to the level of normal sperm. This effect may occur several years after the end of treatment. Men being treated with doxorubicin should be used effectively. At the same time, do not have children while taking the drug and up to 6 months after the end of the treatment. If possible, sperm should be kept due to patients at risk of infertility not recovered from drug use.

    • Anti -cancer therapy: Doxorubicin may increase the toxicity of other anti -cancer treatments. Exacration of cyclophosphamide hemorrhage and liver toxicity have been increased by 6-Mercaptopurin. As with other cytotoxic drugs, Doxorubicin has been reported that can cause thrombosis and turbulent thrombosis including pulmonary embolism (some deaths).

    vaccine - please: doxorubicin should be avoided in combination with vaccine preparations - please contain raw bacteria or reduce toxicity. The recent anti -polio vaccination should be avoided. Using vaccine products - please contain raw bacteria or reduce toxicity for patients with immunodeficiency due to chemotherapy drugs such as Doxorubicin can cause severe infections, even death. The vaccine preparations contain killed or inactivated bacteria can be used. However, the reactions to the vaccines can decrease slightly.

    Other: The clearance of doxorubicin is reduced in obesity patients (such as> 130% of the ideal weight).

    Tumor solving syndrome:

    Doxorubicin can cause hyperuricic acid in the blood due to strong cataltization and cause rapid cancer cells (tumor solving syndrome). It is necessary to check the concentration of uric, potassium, calcium phosphate and creatinine in the blood after the beginning of treatment. Supplementing water, alkalizing urine and preventing with Allopurinol may help minimize the risk of complications of tumor solving syndrome.

    The burning sensation or being lit at the injection site may manifest a small level of the vascular drainage. If suspected or exit occurs, the injection and injection should be stopped again in other blood vessels. The cooling of the circuit in 24 hours may reduce discomfort. Patients should be carefully monitored for a few weeks. If necessary, surgery.

    Doxorubicin can make the urine red. Patients should be warned that this does not cause any health dangers.

    Do not repeat the same dose when appearing or progress of bone marrow inhibition or mouth ulcer. The mouth ulcer may occur before with a burning feeling in the mouth and the reproduction of these symptoms is not recommended.

    The effect of the drug on driving and operating machinery

    No data.

    Use drugs for women during pregnancy and lactation

    No data.

    Drug interaction

    drug interactions can affect the activity of the drug or cause side effects.

    Patients should notify the doctor or pharmacist a list of the drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

    Storage

    Avoid light, temperature 2 - 80C, always in the paper box before use

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