País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)
Amneal-Agila, LLC
IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE 5 mg in 5 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
IDARUBICIN HYDROCHLORIDE- IDARUBICIN HYDROCHLORIDE INJECTION AMNEAL-AGILA, LLC ---------- IDARUBICIN HYDROCHLORIDE INJECTION RX ONLY FOR INTRAVENOUS USE ONLY WARNINGS 1. Idarubicin hydrochlorideinjection should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration. 2. As is the case with other anthracyclines the use of idarubicin hydrochloridecan cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have pre-existing cardiac disease. 3. As is usual with antileukemic agents, severe myelosuppression occurs when idarubicin hydrochloride is used at effective therapeutic doses. 4. It is recommended that idarubicin hydrochloride be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. 5. Dosage should be reduced in patients with impaired hepatic or renal function. (See DOSAGE AND ADMINISTRATION.) DESCRIPTION Idarubicin hydrochloride injection contains idarubicin hydrochloride, USP and is a sterile, semi- synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride, USP is 5, 12-Naphthacenedione,9-acetyl-7-[(3-amino-2,3,6-trideoxy-α- L-_lyxo_-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-_cis_). The structural formula is as follows: C H NO .HCL M.W. 533.96 C H NO .HCL M.W. 533.96 Idarubicin hydrochloride, USP is a sterile, red-orange, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL ( Llegiu el document complet