DILANTIN phenytoin sodium capsule extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

PHENYTOIN SODIUM

Sammensetning:

PHENYTOIN SODIUM 100 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DILANTIN- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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DILANTIN
(EXTENDED PHENYTOIN SODIUM CAPSULES, USP)
DESCRIPTION
Phenytoin sodium is related to the barbiturates in chemical structure,
but has a five-membered ring. The
chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having
the following structural formula:
Each 30 mg Dilantin- (_extended phenytoin sodium capsule_,
USP)-contains 30 mg phenytoin sodium, USP.
Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc,
USP; and magnesium stearate,
NF. The capsule shell cap and body components contain titanium dioxide
(cap and body); gelatin (cap
and body); D&C yellow No. 10 (cap); FD&C red No. 3 (cap). 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.
Each 100 mg Dilantin- 100 mg _(extended phenytoin sodium capsule,
USP)_ -contains 100 mg phenytoin
sodium. Also contains lactose monohydrate, NF; confectioner's sugar,
NF; talc, USP; and magnesium
stearate, NF. The capsule body contains titanium dioxide, USP and
gelatin, NF. The capsule cap
contains FD&C red No. 28; FD&C yellow No. 6; and gelatin NF. 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.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Phenytoin is an antiepileptic drug which can be useful 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 e