ETOPOSIDE capsule

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:

Mylan Pharmaceuticals Inc.

INN（国際名）:

ETOPOSIDE

構図:

ETOPOSIDE 50 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Etoposide capsules are indicated in the management of the following neoplasms: Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. Etoposide capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

製品概要:

Etoposide Capsules, USP are available containing 50 mg of etoposide, USP. The 50 mg capsule is an opaque dark pink, soft gelatin capsule printed with E50 in black ink. They are available as follows: NDC 0378-3266-94 20 Capsules - Unit Dose Capsules are to be stored under refrigeration, between 2° to 8°C (36° to 46°F). Protect from freezing. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ETOPOSIDE- ETOPOSIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
----------
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-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 588.56 and a molecular
formula of C
H O .
Etoposide may be administered either intravenously or orally.
Etoposide capsules, USP are available as
50 mg opaque dark pink, oblong capsules. Each liquid filled, soft
gelatin capsule contains 50 mg of
etoposide, USP in a vehicle consisting of citric acid anhydrous,
glycerol and polyethylene glycol. The
soft gelatin capsules contain anidrisorb, gelatin and glycerol with
the following dye system: red iron
oxide and titanium dioxide; the capsules are printed with edible black
ink containing FD&C Blue No. 1
Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose and
propylene glycol.
The structural formula is:
CLINICAL PHARMACOLOGY
Etoposide 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 mcg/mL 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 radi