Doxorubicin Ebewe Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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.

Click to view Doxorubicin Ebewe detailed prescribing information

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.

Click to view Doxorubicin Ebewe detailed prescribing information

Overdosage

View Doxorubicin Ebewe overdosage for action to be taken in the event of an overdose.

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.

Click to view Doxorubicin Ebewe detailed prescribing information

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.

Click to view Doxorubicin Ebewe detailed prescribing information

Use In Pregnancy & Lactation

Click to view Doxorubicin Ebewe detailed prescribing information

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.

Click to view Doxorubicin Ebewe detailed prescribing information

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.

Click to view Doxorubicin Ebewe detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Doxorubicin Ebewe detailed prescribing information

Storage

View Doxorubicin Ebewe storage conditions for details to ensure optimal shelf-life.

Description

View Doxorubicin Ebewe description for details of the chemical structure and excipients (inactive components).

Action

View Doxorubicin Ebewe mechanism of action for pharmacodynamics and pharmacokinetics details.

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.

Regulatory Classification

POM

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

Doxorubicin Ebewe

doxorubicin

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences