GEODON ziprasidone hydrochloride monohydrate capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)

Доступна с:

Lake Erie Medical DBA Quality Care Products LLC

ИНН (Международная Имя):

ZIPRASIDONE HYDROCHLORIDE

состав:

ZIPRASIDONE HYDROCHLORIDE 20 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

New Drug Application

Характеристики продукта

GEODON - ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
GEODON 20 MG
11 DESCRIPTION
GEODON is available as capsules (ziprasidone hydrochloride) for oral
administration and as an
injection (ziprasidone mesylate) for intramuscular use only.
Ziprasidone is a psychotropic agent that is
chemically unrelated to phenothiazine or butyrophenone antipsychotic
agents. It has a molecular weight
of 412.94 (free base), with the following chemical name:
5-[2-[4-(1,2-benzisothiazol-3-yl)-1-
piperazinyl]ethyl]-6-chloro-1,3-dihydro-2_H_-indol-2-one. The
empirical formula of C
H ClN OS
(free base of ziprasidone) represents the following structural
formula:
GEODON Capsules contain a monohydrochloride, monohydrate salt of
ziprasidone. Chemically,
ziprasidone hydrochloride monohydrate is
5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-
chloro-1,3-dihydro-2_H_-indol-2-one, monohydrochloride, monohydrate.
The empirical formula is
C
H ClN OS • HCl • H O and its molecular weight is 467.42.
Ziprasidone hydrochloride
monohydrate is a white to slightly pink powder.
GEODON Capsules are supplied for oral administration in 20 mg
(blue/white), 40 mg (blue/blue), 60
mg (white/white), and 80 mg (blue/white) capsules. GEODON Capsules
contain ziprasidone
hydrochloride monohydrate, lactose, pregelatinized starch, and
magnesium stearate.
GEODON for Injection contains a lyophilized form of ziprasidone
mesylate trihydrate. Chemically,
ziprasidone mesylate trihydrate is
5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-
dihydro-2_H_-indol-2-one, methanesulfonate, trihydrate. The empirical
formula is C
H ClN OS •
CH SO H • 3H O and its molecular weight is 563.09.
GEODON for Injection is available in a single-dose vial as ziprasidone
mesylate (20 mg
ziprasidone/mL when reconstituted according to label instructions)
_[See Dosage and Administration_
_(2.3)]. _Each mL of ziprasidone mesylate for injection (when
reconstituted) contains 20 mg of
ziprasidone and 4.7 mg o