IDARUBICIN HYDROCHLORIDE injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Amneal-Agila, LLC

INN (Международно Name):

IDARUBICIN HYDROCHLORIDE

Композиция:

IDARUBICIN HYDROCHLORIDE 5 mg in 5 mL

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

IDARUBICIN HYDROCHLORIDE- IDARUBICIN HYDROCHLORIDE INJECTION
AMNEAL-AGILA, LLC
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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 (