Accord Healthcare


Concise Prescribing Info
Doxorubicin HCl
Small-cell lung cancer (SCLC); breast cancer; advanced ovarian carcinoma; intravesically for bladder cancer; neoadjuvant & adjuvant therapy of osteosarcoma; advanced soft-tissue sarcoma in adults; Ewing's sarcoma; Hodgkin's disease; non-Hodgkin's lymphoma; acute lymphatic leukaemia; acute myeloblastic leukaemia; advanced multiple myeloma; advanced or recurrent endometrial carcinoma; Wilms' tumour; advanced papillary/follicular thyroid cancer; anaplastic thyroid cancer; advanced neuroblastoma. In combination chemotherapy regimens w/ other cytotoxic drugs.
Dosage/Direction for Use
IV Monotherapy 60-75 mg/m2 every 3 wk. Combination regimen 30-60 mg/m2 every 3-4 wk in combination w/ other antitumour agents w/ overlapping toxicity eg, high-dose IV cyclophosphamide or related anthracycline compd eg, daunorubicin, idarubicin &/or epirubicin. Patient who cannot receive the full dose (eg, immunosuppression, old age) 15-20 mg/m2/wk. Intravesical Treatment of superficial bladder carcinoma or in prophylaxis of tumor recurrence after transurethral resection (TUR) 30-50 mg in 25-50 mL of NaCl 9 mg/mL (0.9%) soln for inj. Retain the soln intravesically for 1-2 hr. During this period the patient should be turned 90° every 15 min. The patient should not drink fluids for 12 hr prior to the treatment to avoid undesired dilution w/ urine. May repeat instillation w/ an interval of 1 wk to 1 mth dependent on whether the treatment is therapeutic or prophylactic.
Hypersensitivity. For IV administration: Hypersensitivity to anthracendiones or other anthracyclines. Marked persisting myelosuppression &/or severe stomatitis induced by previous treatment w/ other cytotoxic agents &/or radiation; previous treatment w/ maximum cumulative doses of doxorubicin &/or other anthracyclines (eg, daunorubicin, epirubicin, idarubicin) & anthracenediones; generalized infection, severe impaired liver function; severe arrhythmias, heart failure, previous MI, acute inflammatory heart disease; increased haemorrhagic tendency. Breast-feeding. For intravesical administration: Invasive tumors that have penetrated the bladder (beyond T1); bladder inflammation; haematuria; difficult urinary catheter introduction (eg, in large intravesical tumors); UTI. Pregnancy & lactation.
Special Precautions
May potentiate the toxicity of other anticancer therapies. Patients w/ history of heart disease, bone-marrow suppression or patients who previously have been treated w/ anthracyclines, or treated w/ radiation in the mediastinum. Patients should recover from the acute toxicities of prior cytotoxic treatment (eg, stomatitis, neutropenia, thrombocytopenia & generalized infections) before beginning treatment. Before or during treatment monitor radiographs of the lungs & chest & ECG; regular monitoring of heart function; daily inspection of the oral cavity & pharynx for mucosal changes; blood tests. Measure liver function prior to start of the treatment. Perform analysis of LVEF using ultrasound or heart scintigraphy. Cardiotoxicity. Assess cardiac function before patients undergo treatment & must be monitored throughout therapy to minimize the risk of incurring severe cardiac impairment. Potential risk factors of cardiotoxicity eg, history of CV disease, previous therapy w/ other anthracyclines or anthracenediones, prior or concomitant radiotherapy to the mediastinal/pericardial area & concomitant use of drugs w/ the ability to suppress cardiac contractility, including cyclophosphamide & 5-fluoruracil. Secondary leukaemia w/ or w/o a preleukaemic phase. Catheter problems (ie, urethral obstruction caused by invasion of intravesical tumour). Serum uric acid may increase. Do not use in the presence in inflammations, ulcerations or diarrhoea. Perivenous misinjection results in local necrosis & thrombophlebitis. Discontinue infusion or inj in case of extravasation & restart in a different blood vessel. Patients who have previously radiotherapy, having radiotherapy concurrently or are planning to have radiotherapy. Not recommended in combination w/ live, attenuated vaccines. Obese patients (>130% ideal body wt). May induce hyperuricaemia. Evaluate blood uric acid levels, K, Ca, phosphate & creatinine after initial treatment. May impart a red colour to the urine. Do not repeat dose in the presence or development of bone marrow depression or buccal ulceration. Men undergoing treatment should use effective contraceptive measures & advised not to father a child during & up to 6 mth after treatment. Patients w/ elevated bilirubin; severe hepatic impairment. May affect ability to drive or operate machinery. Childn & adolescents. Elderly.
Adverse Reactions
Sepsis, septicaemia; bone-marrow suppression, leucopenia & neutropenia; anorexia; cardiomyopathy; nausea, vomiting, mucositis/stomatitis, diarrhoea; alopecia; local reactions (chemical cystitis) might occur at intravesical treatment (ie, dysuria, urinary frequency, nocturia, stranguria, haematuria, necrosis of the bladder wall).
Drug Interactions
Enhanced cardiotoxicity w/ other anthracyclines or other potentially cardiotoxic drugs (eg, 5-fluorouracil, cyclophosphamide or paclitaxel) or drugs affecting cardiac function (eg, Ca antagonists). Enhanced hepatotoxicity w/ other hepatotoxic treatment modalities (eg, 6-mercaptopurine). Increased plasma conc & toxicity w/ CYP450 &/or Pgp inhibitors. Decreased plasma conc & reduced efficacy w/ CYP450 inducers eg, rifampicin & barbiturates. Increased AUC w/ ciclosporin. Reduced plasma clearance & increased AUC w/ cimetidine. Decreased clearance & increased plasma conc w/ paclitaxel. Accelerated plasma clearance w/ barbiturates. May lower plasma levels of phenytoin. Elevated serum conc w/ ritonavir. Increased toxic effects w/ cytostatics (eg, cytarabine, cisplatin & cyclophosphamide). Necroses of the large intestine w/ massive haemorrhage & severe infections w/ cytarabine. Increased risk & severity of the hematologic toxicity w/ clozapine. May cause marked nephrotoxicity of amphotericin B. Reduced hepatic clearance w/ hepatotoxic chemotherapeutic agents (eg, mercaptopurine, methotrexate, streptozocin). Increased cardiotoxicity or hepatotoxicity w/ concomitant or subsequent radiation therapy or cardiotoxic or hepatotoxic drugs. Exacerbated hemorrhagic cystitis w/ cyclophosphamide. May reduce oral bioavailability of digoxin. Patients should not be actively vaccinated & avoid contact w/ recently polio vaccinated persons. Increased AUC w/ sorafenib.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DB01 - doxorubicin ; Belongs to the class of cytotoxic antibiotics, anthracyclines and related substances. Used in the treatment of cancer.
Zodox-10 soln for infusion 10 mg/5 mL
5 mL x 1's
Zodox-50 soln for infusion 50 mg/25 mL
25 mL x 1's
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