Doxorubicin Ebewe

Doxorubicin Ebewe

doxorubicin

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Doxorubicin HCl
Indications/Uses
Soft tissue & osteogenic sarcomas, Hodgkin's disease & non-Hodgkin's lymphoma, acute lymphoblastic & myeloblastic leukaemia, carcinomas of the thyroid, breast, ovary & bladder, small cell bronchogenic carcinoma & neuroblastoma. May be used intravesically in multiple myeloma, endometrium carcinoma, carcinoma of the cervix, Wilms tumour, tumours of the head & neck, gastric cancer, cancer of pancreas, prostate, testicle & liver.
Dosage/Direction for Use
Adult Monotherapy 60-75 mg/m2 as single agent by IV inj over 2-5 min once every 3 wk. Alternatively 20 mg/m2 IV for 3 consecutive days once every 3 wk. Max cumulative dose: 550 mg/m2. Combination w/ other oncolytics 50-75 mg/m2. Superficial bladder carcinoma & bladder carcinoma in situ 50 mg in 50 mL normal saline initially given wkly & later on mthly. Duration: 6-12 mth.
Contraindications
Hypersensitivity. Marked myelosuppression, preexisting or acute cardiac insufficiency or patients who have previously received max cumulative dose of doxorubicin or daunorubicin. Presence of buccal ulceration. Not to be used intravesically for bladder carcinoma in patients w/ urethral stenosis, invasive tumours that have penetrated the bladder wall, UTIs or inflammatory bladder conditions. Pregnancy & lactation.
Special Precautions
Not to be given intrathecally, IM, SC or long-term infusion. Increased risk of cardiotoxicity in patient previously treated w/ mediastinal or pericardial irradiation, other or previous anthracycline &/or anthracenediones, history of cardiac disease. Discontinue immediately if extravasation occurs. Myelosuppression; risk of hyperuricaemia. Patients w/ existing heart disease (eg, recent MI, heart failure, cardiomyopathy, pericarditis or dysrhythmias) or who have received other cardiotoxic agents eg, cyclophosphamide. Assess cardiac function prior to, throughout & after treatment. Carry out hepatic function tests (SGOT, SGPT, alkaline phosphatase & bilirubin) prior to & during treatment. May impair driving performance. Men & women should take effective contraception during & for at least 3 mth after therapy. Childn <15 yr. Elderly ≥70 yr.
Adverse Reactions
Myelosuppression including transient leukopenia, anemia & thrombocytopenia; nausea, vomiting, mucositis & diarrhoea; alopecia, hyperpigmentation of nailbeds, dermal creases, onycholysis, local pain, irritation, inflammation, thrombophlebitis, hypersensitivity reactions. Cardiotoxicity, ECG changes, cardiomyopathy; transient increases of liver enzymes, severe hepatotoxicity. Intravesical administration: Hematuria, vesical & urethral irritation, stranguria & polyuria, hemorrhagic cystitis, red discoloration of urine.
Drug Interactions
Enhanced cardiotoxicity w/ other cardiotoxic or anticancer agents. Peak levels, terminal half-life & vol of distribution may be increased w/ verapamil. May exacerbate hemorrhagic cystitis caused by previous cyclophosphamide therapy. Reduced hepatic clearance w/ hepatotoxic chemotherapeutic agents eg, methotrexate. May increase myelotoxicity & cause excessive immunosuppression w/ high dose cyclosporin. Metabolism may be decreased w/ cytochrome P-450 inhibitors (eg, cimetidine & ranitidine) & stimulated w/ cytochrome P-450 inducers (eg, rifampicin & barbiturates). Potentiated effect of radiation therapy.
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.
Presentation/Packing
Form
Doxorubicin Ebewe soln for infusion 10 mg/5 mL
Packing/Price
1's
Form
Doxorubicin Ebewe soln for infusion 50 mg/5 mL
Packing/Price
1's
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