Doxorubicin HCl
DOXONISH-50

Features:

BRAND NAME:
DOXONISH - Doxorubicin Hydrochloride

INFORMATION:
*50mg Lyophilized Powder for I.V.
*Injection/ Infusion
*Antineoplastic

INDICATION:
Acute lymphoblastic/myelogenous leukemia, chronic leukemia, Hodgkin’s disease & non-Hodgkin’s lymphoma, multiple myeloma, osteosarcoma, Ewing’s sarcoma, neuroblastoma, rhabdomyosarcoma, Wilm’s tumor. Breast, endometrial, ovarian, non-seminatous testicular, prostate, transitional bladder cell, lung, stomach, primary hepatocellular, head & neck, thyroid cancer.

DOSAGE AND ADMINISTRATION:
Starting dose 60-90 mg/m2 of BSA as a single or divided dose over 3 successive days or given days 1 & 8. Combination w/ other toxic drugs w/ overlapping toxicities 30-60 mg/m2/cycle. Hepatic dysfunction Bilirubin 1.2-3 mg/dL ½ of starting dose; >3 mg/dL ¼ of starting dose.

CONTRAINDICATIONS:
Marked myelosuppression; severe hepatic impairment, myocardial insufficiency & infarction,arrhythmias; previous treatment w/ max doses of doxorubicin, daunorubicin, epirubicin,idarubicin &/or other anthracyclines & anthracenediones. Intravesical

SP:
Patient should recover from acute toxicities of prior cytotoxic treatment before beginning treatment. Monitor cardiac function. Obese patients. Myelosuppression.

AR:
Infection, sepsis/septicemia, acute lymphatic/myelogenous leukemia, leukopenia, neutropenia, anemia, thrombocytopenia. Anaphylaxis, anorexia, dehydration, hyperuricemia, conjunctivitis/keratitis, lacrimation. Sinus tachycardia, tachyarrhythmias, AV & bundle branch block, CHF. Hemorrhage, hot flush, phlebitis, thrombophlebitis, thromboembolism, shock. Nausea/vomiting, mucositis/stomatitis, hyperpigmentation of oral mucosa, esophagitis, abdominal pain, gastric erosions, GIT bleeding, diarrhea, colitis. Alopecia, local toxicity, rash/itch, skin changes, skin & nail hyperpigmentation, photosensitivity, hypersensitivity to irritated skin, urticaria, acral erythema, palmar plantar erythrodysesthesia, amenorrhea, oligospermia, azoospermia. Malaise/asthenia, fever, chills. Abnormal ECG, asymptomatic reductions in the left venticular ejection fraction, changes in transaminase levels. Wt gain early breast cancer.

DI:
Increased conc & clinical effect w/ CYP3A4, CYP2D6 &/or P-gp inhibitors (eg verapamil). Decreased conc w/ CYP3A4 inducers (eg phenobarb, phenytoin, St. John’s wort) & P-gp inducers. Potentiate toxicity of other anticancer therapy. Increased plasma conc w/ paclitaxel, minor effect when anthracycline is administered prior to paclitaxel. Exacerbate cyclophosphamide-induced hemorrhage cystitis & enhance hepatotoxicity of 6-mercaptopurine.

P/P:
Inj 10 mg/5 mL x 1’s, 50 mg/25mL


















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