Idarubicin Hydrochloride Capsules

Idarubicin is a DNA intercalator that acts on topoisomerase II, thereby inhibiting nucleic acid synthesis. The compound is highly lipophilic and has increased cellular uptake of the drug compared to doxorubicin and daunorubicin. Compared to daunorubicin, idarubicin has a broader antitumor spectrum and is more effective against murine leukemia and lymphoma when administered intravenously or orally. In vitro experiments in humans and mice showed that anthracycline-resistant cells showed a lower degree of cross-resistance to idarubicin than doxorubicin and daunorubicin. Animal cardiotoxicity studies suggest that idarubicin has a higher therapeutic index than doxorubicin and daunorubicin. Its main metabolite, idarubicinol, has shown good antitumor activity in both in vivo and in vitro experimental animal models. In rat experiments, the cardiotoxicity of idarubicinol was significantly lower than that of idarubicin at the same dose. Oral administration is nearly 3 times less toxic than intravenous administration, and gastrointestinal toxicity does not increase when administered orally. The target organs of toxicity when administered orally are the same as those when administered intravenously or with other anthracyclines: blood lymphatic system and immune system, gastrointestinal tract, heart, liver, kidney, testis. When administered intravenously, the liver and kidney have been shown to be more sensitive to toxicity, while the gastrointestinal tract and testis are equally toxic. Like other anthracyclines, idarubicin hydrochloride is still considered mutagenic, teratogenic, and potentially carcinogenic even when administered orally.

Idarubicin hydrochloride. Chemical name: 4-demethoxydaunorubicin hydrochloride Molecular weight: C26H27NO9.HCL

This product is orange-red mass and powder.

Acute non-lymphocytic leukemia is used for the first-line treatment of adult acute non-lymphocytic leukemia and the treatment of patients with relapsed or refractory acute non-lymphocytic leukemia who cannot be given idarubicin intravenously. Idarubicin hydrochloride capsules can be combined with other cytotoxic drugs to form a combined chemotherapy regimen.

The dose is usually calculated based on body surface area. (1) The recommended dosing regimen for adult acute non-lymphocytic leukemia is: alone, 30 mg/m2 per day for 3 days; or in combination with other anti-leukemia drugs, 15-0 mg/m2 per day orally for 3 days. (2) The recommended dosing regimen for advanced breast cancer is: alone, 45 mg/m2 per day, or divided into 3 consecutive days (15 mg/m2 per day, repeated every 3-4 weeks depending on the recovery of blood count). (3) The maximum cumulative dose recommended is 400 mg/m2. When adopting the above dosage regimen, the patient's blood count condition and the dose of other cytotoxic drugs used in combination should be taken into consideration. For patients with liver damage, Sanveda should be used at a reduced dose (see Warnings). During use

Not yet clear.

1. Idarubicin hydrochloride should not be used for patients who are allergic to idarubicin and/or other anthracyclines. 2. Patients with severe renal and liver damage, or patients with uncontrolled infections should not receive treatment with idarubicin hydrochloride. 3. Patients need to be closely observed and laboratory monitoring should be performed during treatment with idarubicin hydrochloride capsules. 4. The rapid dissolution of leukemia cells can cause secondary hyperuricemia. 5. Blood uric acid levels should be monitored, and appropriate treatment should be given if hyperuricemia occurs. 6. Appropriate measures must be taken to control any existing systemic infection before starting treatment. 7. Intravenous extravasation can cause severe local tissue necrosis. If there is a stinging or burning sensation at the injection site, stop immediately and choose another intravenous injection. 8. Effects on the ability to drive and use machines If the patient must during treatment

Precautions for children: No relevant reports have been found. Precautions for pregnancy and lactation: There is currently no data to indicate whether idarubicin has a negative impact on human fertility or is teratogenic. However, it is teratogenic and embryotoxic to rats (but not rabbits). Women of childbearing age should be advised to avoid pregnancy. If idarubicin is used during pregnancy or the patient becomes pregnant during treatment, the patient should be informed of the potential risk of the drug to the fetus. The use of Sanvida under the above conditions should rely on the joint decision of the doctor and the patient. Mothers should be warned not to breastfeed during chemotherapy with idarubicin. Precautions for the elderly: Elderly patients over the age of 60 are more likely to develop heart failure and arrhythmias in the case of sepsis, anemia and excessive infusion speed, but the above symptoms are usually reversible.

Idarubicin is a strong bone marrow suppressant. When combined with other drugs with similar effects in chemotherapy regimens, it may produce additive bone marrow suppression. Radiotherapy of metastatic lesions 2-3 weeks before or at the same time as idarubicin hydrochloride treatment will also produce the same predictable bone marrow suppression reaction. Capsule food does not seem to reduce the absorption of idarubicin, so idarubicin hydrochloride capsules can be taken with a light meal. The injection will degrade when mixed with alkaline solution. It will produce precipitation when used in combination with heparin, so do not mix it with other drugs.

Sealed in a cool, dry place.

10 mg

36 months