COMPOSITION:
Each vial of 10 mg contains :
Doxorubicin Hydrochloride U.S.P. 10 mg
Lactose U.S.P. q.s

Each vial of 50 mg contains :
Doxorubicin Hydrochloride U.S.P. 50 mg
Lactose U.S.P. q.s

PREPARATION OF SOLUTION:
Reconstitute 10 mg vial with 5 ml, 50 mg vial with 25 ml of sterile water for injection to give a final concentration of 2 mg / ml.

STORAGE:
Store at a temperature not exceeding 25^o C. Keep the product away from light.

PRESENTATION:
Vial containing 10 mg plus diluent
Vial containing 50 mg

ACTIONS:
It binds to DNA and inhibits nucleic synthesis.

INDICATIONS
Acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma,. thyroid carcinoma, lymphomas of both Hodgkin and non-Hodgkin types, bronchogenic carcinoma and gastric carcinoma.

CONTRAINDICATIONS:
Treatment is contraindicated in patients who receive previous treatment with complete cumulative doses of Doxorubicin Hydrochloride and/or Daunorubicin and also in patients who have marked myelosuppression, or those at risk of cardiac diseases.

PREGNANCY:
Safety for use during pregnancy not established. Use only when the potential benefits outweigh the potential hazards to the fetus.

DRUG INTERACTIONS:
The drug may potentiate the toxicity of the other antineoplastics. Exacerbation of cyclphosphamide-induced hemorrhagic cystitis and enhancement of the hepatotoxicity of 6 mecraptopurine have occurred. Barbiturates may increase the total plasma clearance of Doxorubicin Hydrochloride. Serum levels of digoxin may be decreased by combination chemotherapy (including Doxorubicin Hydrochloride).

ADVERSE REACTIONS:
The major dose-limiting toxicities are myelosuppression and cardiotoxicity.

OVERDOSAGE
Acute overdosage enhance the toxic effects of mucositis, leukopenia and thrombocytopenia. Treat the severely myelosuppressed patients by hospitalization, antibiotics, platelet and granulocyte transfusions and give symptomatic treatment of mucositis.

DOSAGE AND ADMINISTRATION:
For IV use only.
Recommended dosage schedule based on body surface area : 60 to 75 mg/m² as a single IV injection administered at 21 day intervals. Give the lower dose to patients with inadequate marrow reserves due to old age, prior therapy or neoplastic marrow infiltration.
Alternative dose schedules : 30 mg/m² on each of 3 successive days repeated every 4 weeks. Another alternative dose schedule is weekly doses of 20 mg/m² which may produce a lower incidence of CHF.
Dosages in patients with elevated bilirubin : Serum bilirubin 1.2 to 3 mg/dl give 50 % of normal dose;>3mg/dl, give 25% of normal dose.