Doxorubicin Hydrochloride - Serum Institute of India - Marketed Lyophilized Drug Products

OVERDOSAGE
Acute overdosage enhance the toxic effects of mucositis, leukopenia and thrombocytopenia. Treat the severly myelosuppressed patients by hospitalization, antibiotics, platelet and granulocyte transfusions and give symptomatic treatment of mucositis.
The cumulative dose of DOXORUBICIN HYDROCHLORIDE by the intavenous route,irrespective of dosage schedule ,should not exceed 550 mg / m2.Chronic overdosage with cumulative dose exceeding 550 mg/m2 increases the risk of cardiomyopathy and resultant CHF. Treatment consists of vigorous management of CHF with digitalis preparations and diuretics. Use of peripheral vasodilators is recommended.,
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 repated 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.
IV infusion : Administer DOXORUBICIN HYDROCHLORIDE slowly into the tubing of a freely running IV infusion of 0.9 % Sodium Chloride Injection or 5 % Dextrose Injection . Attach the tubing to a needle inserted into a large vein. Avoid veins over joints or in extremities with compromised venous or lymphatic drainage. Rate depends on the size of the vein and the dosage however, do not administer in less than 3 to 5 minutes. Local erythematous streaking along the vein as well as facial flushing may indicate too rapid adminstration.
Extravasation :A burning or stinging sensation may be indicative indicate of perivenous infiltration and infusion should be immediately terminated and restarted in another vein.
PREPARATION OF SOLUTION
Reconstitute the10 mg vial with 5 ml, 50 mg vial with 25 ml of sterile water for injection I.P. to give a final concentration of 2 mg / ml. Bacteriostatic diluents are not recommended. Reconstituted solution is stable for 24 hours at room temperature and 48 hours at 2? to 8? C ( 36? to 46? F ) Protect from sunlight , discard unused solution.
HANDLING OF PRODUCT
DOXORUBICIN HYDROCHLORIDE is a toxic compound known to be carcinogenic and mutagenic. Direct contact may cause irritation of skin,eyes and mucous membranes.In case the solution touches skin by accident,the area of contact should be thoroughly washed with soap and water immediately.
Observe all the necessary routine precautions in handling of cytotoxic drugs in respect of this antineoplastic formulation too.
STORAGE
Store at a temperature not exceeding 25oC
Keep the product away from light.
SHELF LIFE
30 months from date of manufacture.
PRESENTATION
DOXORUBICIN HYDROCHLORIDE FOR INJECTION U.S.P. 10 mg : Lyophilised vial supplied with 5 ml ampoule of Sterile Water for Injection I.P. for reconstitution.
DOXORUBICIN HYDROCHLORIDE FOR INJECTION U.S.P. 50 mg : Lyophilised vial.