IDARUBICIN HYDROCHLORIDE- idarubicin hydrochloride injection
Sandoz Inc
Rx only
FOR INTRAVENOUS USE ONLY
WARNINGS
1. Idarubicin Hydrochloride Injection 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 Hydrochloride Injection can 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 Injection is used at effective therapeutic doses.
4. It is recommended that Idarubicin Hydrochloride Injection 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 and is a sterile, semi-synthetic, preservative-free solution antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride is 5, 12- Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-� -L-lyxo -hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis). The structural formula is as follows:
structrual formula
(click image for full-size original)
Idarubicin Hydrochloride Injection is a sterile, red-orange, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-use-only vials.
Each mL contains Idarubicin HCl, USP 1 mg and the following inactive ingredients: Glycerin, USP 25 mg and Water for Injection, USP q.s. Hydrochloric Acid, NF and Sodium Hydroxide, NF are used to adjust the pH to a target of 3.5.
CLINICAL PHARMACOLOGY
Mechanism of Action
Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. The absence of a methoxy group at position 4 of the anthracycline structure gives the compound a high lipophilicity which results in an increased rate of cellular uptake compared with other anthracyclines.
