IDARUBICIN HYDROCHLORIDE- idarubicin hydrochloride injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

IDARUBICIN HYDROCHLORIDE (UNII: 5VV3MDU5IE) (IDARUBICIN - UNII:ZRP63D75JW)

Доступна с:

Sandoz Inc

ИНН (Международная Имя):

IDARUBICIN HYDROCHLORIDE

состав:

IDARUBICIN HYDROCHLORIDE 1 mg in 1 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Idarubicin Hydrochloride Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.

Обзор продуктов:

Idarubicin Hydrochloride Injection: Single Dose Glass Vials: Sterile single use only, contains no preservative. NDC 66758-055-01 5 mg/5 mL vial (1 mg/mL), single vials. NDC 66758-055-03 10 mg/10 mL vial (1 mg/mL), single vials. NDC 66758-055-05 20 mg/20 mL vial (1 mg/mL), single vials. Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time of use. For Sandoz Customer Service call, 1-800-525-8747. Rx only January 2011   REFERENCES 1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society. 1999: 32–41. 2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC; Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Department of Health and Human Services, Public Health Service Publication NIH 92–2621. 3. AMA Council on Scientific Affairs. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985; 253: 1590–1591. 4. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. 1987. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115. 5. Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426–428. 6. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA Cancer J Clin.1983; 33: 258–263. 7. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033–1049. 8. Controlling Occupational Exposure to Hazardous Drugs (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm. 1996; 53: 1669–1685.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

IDARUBICIN HYDROCHLORIDE- IDARUBICIN HYDROCHLORIDE INJECTION
SANDOZ INC
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IDARUBICIN HYDROCHLORIDE INJECTION
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-Á-L-_lyxo_-
hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride,
(7S-_cis_). The structural
formula is as follows:
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.
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