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:

Hikma Pharmaceuticals USA 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 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 and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. Etoposide 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, 20 mg/mL, is supplied as follows: NDC 0143-9510-01                   100 mg/5 mL, Sterile Multiple Dose Vial, individually boxed. NDC 0143-9511-01                   500 mg/25 mL, Sterile Multiple Dose Vial, individually boxed. NDC 0143-9512-01                   1 g/50 mL, Sterile Multiple Dose Vial, individually boxed. Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. 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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ETOPOSIDE- ETOPOSIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
ETOPOSIDE INJECTION, USP
RX ONLY
WARNINGS
Etoposide 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 (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-[4,6-0-(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 available for intravenous use as 20 mg/mL
solution in 100 mg
(5 mL), 500 mg (25 mL), and 1 g (50 mL) sterile, multiple-dose vials.
The pH of the clear,
nearly colorless to yellow liquid is 3 to 4. Each mL contains 20 mg
etoposide USP, 2 mg
citric acid, 30 mg benzyl alcohol, 80 mg modified polysorbate 80/tween
80, 650 mg
polyethylene glycol 300, and 30.5 percent (v/v) alcohol.
The structural formula is:
29
32
13
CLINICAL PHARMACOLOGY
Etoposide has been shown to cause metaphase arrest in chick
fibroblasts. Its main
effect, however, appears to be at the G2 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 disposition of etoposide is best
described as a
biphasic process with a distribution half-