PHENYTOIN ER- phenytoin sodium 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:

PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)

から入手可能:

STAT RX USA LLC

INN（国際名）:

PHENYTOIN SODIUM

構図:

PHENYTOIN SODIUM 100 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-Diphenylhydantoin sodium salt, having a molecular weight of 274.25 and having the following structural formula and molecular formula: Each extended phenytoin sodium capsule, USP, for oral administration, contains 100 mg phenytoin sodium, USP. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. In addition, each of the empty gelatin capsules contains the following: D and C Red No. 28, D and C Red No. 33, FD and C Blue No. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains the following: black iron oxide, D and C Yellow No. 10 Aluminum Lake, FD and C Blue No. 1 Aluminum Lake, FD and C Blue No. 2 Aluminum Lake, FD and C Red No. 40 Aluminu

認証ステータス:

Abbreviated New Drug Application

製品の特徴

PHENYTOIN ER- PHENYTOIN SODIUM CAPSULE
STAT RX USA LLC
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DESCRIPTION
Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related
to the barbiturates in chemical
structure, but has a five-membered ring. The chemical name is
5,5-Diphenylhydantoin sodium salt,
having a molecular weight of 274.25 and having the following
structural formula and molecular
formula:
Each extended phenytoin sodium capsule, USP, for oral administration,
contains 100 mg phenytoin
sodium, USP. Each capsule also contains the following inactive
ingredients: colloidal silicon dioxide,
hydroxyethyl cellulose, magnesium oxide, magnesium stearate,
microcrystalline cellulose, povidone
and sodium lauryl sulfate. In addition, each of the empty gelatin
capsules contains the following: D and
C Red No. 28, D and C Red No. 33, FD and C Blue No. 1, gelatin, sodium
lauryl sulfate and titanium
dioxide.
The imprinting ink contains the following: black iron oxide, D and C
Yellow No. 10 Aluminum Lake, FD
and C Blue No. 1 Aluminum Lake, FD and C Blue No. 2 Aluminum Lake, FD
and C Red No. 40
Aluminum Lake, propylene glycol and shellac glaze.
Product_ in vivo_ performance is characterized by a slow and extended
rate of absorption with peak blood
concentrations expected in 4 to 12 hours as contrasted to prompt
phenytoin sodium capsules, USP with a
rapid rate of absorption with peak blood concentration expected in
11⁄2 to 3 hours.
Extended phenytoin sodium capsules, USP 100 mg meet _USP Dissolution
Test 2._
LABEL IMAGE
CLINICAL PHARMACOLOGY
Phenytoin is an antiepileptic drug which can be used in the treatment
of epilepsy. The primary site of
action appears to be the _motor cortex_ where spread of seizure
activity is inhibited. Possibly by
promoting sodium efflux from neurons, phenytoin tends to _stabilize_
the threshold against
hyperexcitability caused by excessive stimulation or environmental
changes capable of reducing
membrane sodium gradient. This includes the reduction of posttetanic
potentiation at synapses. Loss of
posttetanic potentiat