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ProductName : Zuvidox 50mg
GenericName : Doxorubicin Hydrochloride Injection
Doxorubicin Hydrochloride Injection, USP is a clear, red,sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL, 20mg/10 mL, 50 mg/25 mL, 150 mg/75 mL, or 200 mg/100 mL of doxorubicin HCl. Thedrug product has demonstrated inherent antimicrobial activitysuitable for a multiple dose presentation. Each milliliter of solution contains2 mg of doxorubicin HCl. Inactive ingredients include sodium chloride 0.9%,USP, and water for injection, USP, quantity sufficient. The pH of the solutionis adjusted to 3.0 with hydrochloric acid, USP.
DOSAGE AND ADMINISTRATION
Therecommended dose of doxorubicin HCl is 60 mg/m administered as an intravenousbolus on day 1 of each 21-day treatment cycle, in combination withcyclophosphamide, for a total of four cycles [see Clinical Studies].
MetastaticDisease, Leukemia, Or Lymphoma
PreparationOf Doxorubicin HCl For injection
Reconstitutedoxorubicin hydrochloride for injection with 0.9% Sodium Chloride Injection,USP to obtain a final concentration of 2 mg per mL as follows:
Thefollowing adverse reactions are discussed in more detail in other sections ofthe labeling.
Cardiomyopathy And Arrhythmias
DoxorubicinHCl can result in myocardial damage, including acuteleft ventricular failure. The risk of cardiomyopathy isgenerally proportional to the cumulative exposure. Include prior doses of otheranthracyclines or anthracenediones in calculations of total cumulative dosagefor doxorubicin HCl. Cardiomyopathy may develop during treatment or up toseveral years after completion of treatment and can include decrease in LVEFand signs and symptoms of congestive heart failure (CHF).