ETOPOSIDE injection

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ETOPOSIDE (UNII: 6PLQ3CP4P3) (ETOPOSIDE - UNII:6PLQ3CP4P3)

から入手可能:

Accord Healthcare Inc.

INN（国際名）:

ETOPOSIDE

構図:

ETOPOSIDE 20 mg in 1 mL

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

Etoposide Injection USP is indicated in the management of the following neoplasms: Etoposide Injection USP in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. Etoposide Injection USP in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. Etoposide Injection USP is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

製品概要:

Etoposide Injection USP NDC 16729-262-31 – 100mg/5 mL Sterile, Multiple Dose Vial NDC 16729-262-32 – 250 mg/12.5 mL Sterile, Multiple Dose Vial Store between 20°-25°C (68°-77°F). [See USP controlled room temperature].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ETOPOSIDE- ETOPOSIDE INJECTION
ACCORD HEALTHCARE INC.
----------
NOVAPLUS
ETOPOSIDE INJECTION USP
RX ONLY
WARNINGS
Etoposide Injection USP should be administered under the supervision
of a qualified
physician experienced in the use of cancer chemotherapeutic agents.
Severe
myelosuppression with resulting infection or bleeding may occur.
DESCRIPTION
Etoposide Injection USP (also commonly known as VP-16) is a
semisynthetic derivative
of podophyllotoxin used in the treatment of certain neoplastic
diseases. It is 4'-
demethylepipodophyllotoxin
9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very
soluble in methanol and chloroform, slightly soluble in ethanol and
sparingly soluble in
water and ether. It is made more miscible with water by means of
organic solvents. It
has a molecular weight of 588.58 and a molecular formula of C
H
O
.
Etoposide Injection USP is administered intravenously. Etoposide
Injection USP is
available in 100 mg (5 mL) and 250 mg (12.5 mL) sterile, multiple dose
vials. The pH of
the clear, colorless to pale yellow liquid is 3 to 4. Each mL contains
20 mg etoposide
USP, 2 mg anhydrous citric acid, 30 mg benzyl alcohol, 80 mg
polysorbate 80/tween 80,
650 mg polyethylene glycol 300, and 30.5 percent (v/v) dehydrated
alcohol. Vial head
space contains nitrogen.
The structural formula is:
®
29
32
13
CLINICAL PHARMACOLOGY
Etoposide Injection USP has been shown to cause metaphase arrest in
chick fibroblasts.
Its main effect, however, appears to be at the G
portion of the cell cycle in mammalian
cells. Two different dose-dependent responses are seen. At high
concentrations (10
mcg/mL or more), lysis of cells entering mitosis is observed. At low
concentrations (0.3
to 10 mcg/mL), cells are inhibited from entering prophase. It does not
interfere with
microtubular assembly. The predominant macromolecular effect of
etoposide appears to
be the induction of DNA strand breaks by an interaction with DNA
topoisomerase II or
the formation of free radicals.
PHARMACOKINETICS
On intravenous administration, the