PRODUCT INFORMATION FORM FOR AMERICAN HOSPITAL FORMULARY SERVICE* (DESIGNED TO SUPPLEMENT THE OFFICIAL PACKAGE INSERT)
- Date September, 1990
- AHFS Pharmacologic Therapeutic Category 10:00 Antineoplastic Agent
- Nonproprietary Name in U.S. Idarubicin Hydrochloride
- Trade Name (indicate whether trade mark applies to entire chemical or only to an active moiety) IDAMYCIN®
- Physical Properties of the Chemical Entity
- Macroscopic appearance Orange-red crystalline powder
- Solubility (in g/mL or in USP terms) in water slighty alcohol sparingly others _______
- Chemical Properties
- Structurally related to the following available compounds or groups of compounds daunomycin, other napthacenequinones
- Incompatibilities; if possible, specify whether the incompatibility is physical or chemical, the result of the incompatibility, and concentrations tested Physically incompatible with heparin, prolonged contact with alkaline solutions will result in degradation.
- Stability to temperature, light and moisture Idarubicin should be protected from exposure to sunlight
- pH range over which drug is stable in solution _____________
- pH of liquid preparation (parenteral or oral; commercially available product or reconstituted product) 5.0 to 7.0
- What is the diluent for parenteral or liquid oral preparation(s) if provided with the commercial package? N/A pH of the di uent? N/A
- Actual amount of active ingredient in the vial and total volume of solution after reconstitution 5 and 10 mg total volume aher reconstitution approximately 5 and 10 ml (1 mg/1 ml) respectively.
- Expiration date for commercially available preparations; specify length of time 5 mg via - 36 months 10 mg vial - 36 months
- Time and stability of reconstituted preparations 72 hours at room temperature (15-30°C) 7 days under refrigeration (2-8°C)
- Recommended storage conditions for commercially available products Protect from sunlight, store at controlled room temperature, 15-30°C (59-86°F)
- Recommended storage conditions for reconstituted products Maintain under refrigeration (2-8°C)
- Pharmacologic Properties
- Pharmacologically related to the following available compounds or groups of compounds chemotherapeutic agents
- Site of action rapidly proliferating cells, i.e. tumors, epithelial cells of alimentary tract and hematopoietic elements of bone marrow and Iymphoid tissue.
- Mechanism of action related to ability of idarubicin to bind to DNA, inhibit nucleic acid synthesis, and interact with topoisomerase II.
- Therapeutically effective serum levels (minimum) to (maximum) Not known
Serum levels with recommended dosage (minimum) N/A t o (maximum)____________
Toxic serum levels (minimum) _______ to (maximum) Not known Lethal serum levels (minimum) ________ to (maximum) Not known
- Well absorbed from gastrointestinal tract following oral administration?
Yes 30% ( approximately) No _________
- Onset of action oral: N/A intramuscular: N/A intravenous: ________ rectal: N/A subcutaneous: N/A other(specifyroute): N/A
- Duration of action oral: N/A intramuscular: N/A intravenous: _________ rectal: N/A subcutaneous: N/A other (specify route): N/A
- Distribution of body tissues: Highest concentrations: No human data available. Tissues of highest concentration in rats and mice are kidney, spleen and liver.
Also detectable: ____________
- Does it pass placental barrier not determined What levels ________
- Does it pass into spinal fluid yes What levels barely detectable
- Does it appear in milk of nursing mothers? N/A
- Is there any evidence of teratogenicity? List animals tested (cite references) Embryotoxic and teratogenic in rats and embryotoxic in rabbits
- Where detoxified: liver majority kidney ______ other various tissues
- Where excreted fecal at what rate _______
- Percent of single dose excreted in 6 hours 2% 12 hours not determined 24 hours not determined
- In what chemical form or state is it excreted (list metabolites) 3-5% unchanged drug and 3-10% Idarubicinol excreted in urine over 48 hours
- Method of Administration: oral _______, IM _______, IV push X, IV drip _____, SC_______, topical _______ , rectal _________, other ________
- Drug interactions; list any other drugs or agents which potentiate or inhibit the therapeutic effect of this drug when administered concurrently. (Indicate which effect, cite references) none known
- Does expression of dosage and strengths of available dosage forms refer to entire chemical or to active moiety (e.g., base, rather than salt, etc.) entire chemical
- Any additional dosage forms contemplated ______ Proposed date of marketing December 1990
*Permission to use the Product Information Form for the American Hospital Formulary Service has been granted by the American Society of Hospital Pharmacists Inc. 4630 Montgamery Ave Washington D C. 20014 The answers to all questions are prepared and furnished by the manufacturer. The answers were not supplied by the Society nor are they intended to imply the endorsement of the American Society of Hospital Pharmacists; neither does the Society affirm or deny the accuracy of the answers contained herein. Copyright © 1972, American Society of Hospital Pharmacists, Inc., all rights reserved.