IDARUBICIN HYDROCHLORIDE injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Hikma Pharmaceuticals USA Inc.

INN (الاسم الدولي):

IDARUBICIN HYDROCHLORIDE

تركيب:

IDARUBICIN HYDROCHLORIDE 1 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Idarubicin Hydrochloride injection, USP 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.

ملخص المنتج:

Idarubicin Hydrochloride Injection, USP Single Dose Glass Vials: Sterile single use only, contains no preservative. NDC 0143-9217-01 5 mg/5 mL vial (1 mg/mL), individually boxed. NDC 0143-9218-01 10 mg/10 mL vial (1 mg/mL), individually boxed. NDC 0143-9219-01 20 mg/20 mL vial (1 mg/mL), individually boxed. Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time of use. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

IDARUBICIN HYDROCHLORIDE- IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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IDARUBICIN HYDROCHLORIDE INJECTION
RX ONLY
FOR INTRAVENOUS USE ONLY
WARNINGS
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 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 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, USP contains idarubicin
hydrochloride and is a sterile,
semi-synthetic, preservative-free solution (PFS) antineoplastic
anthracycline for
intravenous use. Chemically, idarubicin hydrochloride is
(1_S_,3_S_)-3-Acetyl-1,2,3,4,6,11-
hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-naphthacenyl
3-amino-2,3,6-trideoxy-α-
L-_lyxo_-hexopyranoside, hydrochloride. The structural formula is as
follows:
C
H
NO •HCl
M.W. 533.95
Idarubicin Hydrochloride Injection, USP is a sterile, red-orange,
isotonic parenteral
preservative-free solution, available in 5 mL (5 mg), 10 mL (