PHENYTOIN SODIUM capsule extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

McKesson Contract Packaging

INN (Tarptautinis Pavadinimas):

PHENYTOIN SODIUM

Sudėtis:

PHENYTOIN SODIUM 100 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
MCKESSON CONTRACT PACKAGING
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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:
C H N NAO
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&C
Red No. 28, D&C Red No. 33, FD&C Blue No. 1, gelatin, sodium lauryl
sulfate and titanium dioxide.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&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 1½
to 3 hours.
Extended phenytoin sodium capsules USP, 100 mg meet _USP Dissolution
Test 2._
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 potentia