Doxorubicin Hydrochloride for Injection

The drug can penetrate into cells and bind to chromosomes. Experiments have shown that the planar ring of doxorubicin inserts between base pairs to form a complex with DNA, which severely interferes with DNA synthesis, DNA-dependent RNA synthesis and protein synthesis. However, the concentration of doxorubicin required to produce antiproliferative effects through this mechanism is higher than the drug concentration at the tumor site during clinical treatment. Recent experiments have shown that drug insertion into DNA triggers topoisomerase II to cleave DNA, thereby destroying the tertiary structure of DNA. This effect can be seen at the drug concentration used in clinical treatment. Doxorubicin is also associated with oxidation/reduction: a series of NADPH-dependent cellular reductases can reduce doxorubicin to semiquinone free radicals, which then react with molecular oxygen to produce highly reactive cytotoxic compounds such as peroxides, active hydroxyl radicals and hydrogen peroxide. Free radical formation is associated with the cytotoxic effect of doxorubicin. Further sites of action of doxorubicin may be on the cell membrane: binding to lipids on the cell membrane affects a variety of different functions. The cytotoxic and/or antiproliferative effects of doxorubicin may be the result of any of the above mechanisms, and there may be other mechanisms of action. Studies have shown that doxorubicin is active throughout the cell cycle, including in the interphase, so rapidly proliferating tissues such as tumor tissue (but also bone marrow, gastrointestinal tract and mucosa, hair follicles) are most sensitive to the antiproliferative effects of doxorubicin.

The main ingredients and chemical names of this product are: (8S,10S)-10-(3-amino-2,3,6-tridehydroxy-*-L-lyso-hexopyranoside)-8-ethanolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthalenedione hydrochloride. Each bottle contains 10mg doxorubicin hydrochloride and appropriate amount of lactose and methyl parahydroxybenzoate.

This product is an orange-red freeze-dried powder.

Antimitotic and cytotoxic drugs. Doxorubicin can successfully induce remission in a variety of malignancies, including acute leukemias, lymphomas, soft tissue and bone sarcomas, childhood malignancies, and adult solid tumors, especially breast and lung cancer.

When preparing the solution, dissolve the contents of each vial with 5 ml of water for injection or sodium chloride injection. After adding the dissolving solution, shake the vial gently for half a minute to dissolve the contents, but do not invert the vial. Adults and children [intravenous administration]: This is the most commonly used route of administration. The prepared solution is infused intravenously through an unobstructed infusion tube for about 2-3 minutes. This can reduce the risk of thrombosis and cellulitis and blisters caused by drug spillage. Commonly used solutions are sodium chloride injection, 5% glucose injection, or sodium chloride glucose injection. The dosage is usually calculated based on body surface area. Usually when doxorubicin is used alone, it is administered once every three weeks at 60-75 mg/m2. When used in combination with other anti-tumor agents with repeated toxicity, the dose of doxorubicin must be reduced.

1. Bone marrow suppression and oral ulcers. Do not reuse this product when bone marrow suppression and oral ulcers exist. The latter may have precursor symptoms of oral burning sensation and should not be used again when symptoms occur. Obvious bone marrow suppression may occur about 10 days after the use of doxorubicin, so blood counts should be routinely monitored regardless of whether the patient has blood or non-blood disease. 2. Cardiac toxicity. Cardiac toxicity can manifest as bradycardia, including supraventricular bradycardia and electrocardiogram changes. Routine monitoring of electrocardiograms is recommended. Patients with existing cardiac impairment should be particularly careful. When the cumulative dose exceeds 450-500 mg/m2, special care should be taken. When this dose level is exceeded, the risk of irreversible congestive heart failure is greatly increased. When considering the total amount of doxorubicin used, the patient's previous or concurrent use of other drugs should be monitored.

Patients with severe organic heart disease and abnormal heart function and those who are allergic to this product and anthracyclines are contraindicated. 1. Contraindications to intravenous administration: due to previous cytotoxic drug treatment, persistent bone marrow suppression or severe oral ulcers, systemic infection, obvious liver damage, severe arrhythmia, myocardial insufficiency, previous myocardial infarction, and the maximum cumulative dose of the drug has been used in previous anthracycline treatment. 2. Contraindications to intravesical instillation: invasive tumors have penetrated the bladder wall, urinary tract infection, bladder inflammation, difficulty in catheter insertion (such as due to huge intravesical tumors)

1 Doxorubicin is usually used in combination with other cytotoxic drugs, so toxic effects may occur, especially the superposition of bone marrow, hematological and gastrointestinal toxic effects. In addition, if doxorubicin is used concomitantly with other anti-tumor drugs that have been reported to have potential cardiotoxic effects (such as 5-Fu, cyclophosphamide, cisplatin, etc.) or other drugs with cardioactive effects (such as calcium channel antagonists), cardiac function needs to be closely monitored throughout the treatment period. 2 Doxorubicin is mainly metabolized in the liver, and changes in liver function caused by other concomitant treatments can affect the metabolism, pharmacokinetics, efficacy and/or toxicity of doxorubicin. 3 This product should avoid long-term contact with alkaline solutions. 4 Because of precipitation, fast-dissolving doxorubicin cannot be mixed with heparin, and it is not recommended to mix fast-dissolving doxorubicin with other drugs.

The prepared solution can be stored at room temperature for 24 hours and in a refrigerator (4-10°C) for 48 hours. Keep away from light.

10mg (calculated as C27H29NO11.HCL)

Pfizer Pharmaceutical Wuxi Co., Ltd.

• Founded in:

  1995-09-19

• Address:

  No. 7 Mashan Bridge, Binhu District, Wuxi City

• Tax NO.:

  913202006079219223

• Registered Funds:

  $36 million

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