PHENYTOIN SODIUM capsule, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Phenytoin Sodium (UNII: 4182431BJH) (Phenytoin - UNII:6158TKW0C5)

Tillgänglig från:

Contract Pharmacy Services-PA

INN (International namn):

Phenytoin Sodium

Sammansättning:

Phenytoin Sodium 100 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Extended Phenytoin Sodium Capsules USP, 100 mg are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY ). Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.

Produktsammanfattning:

Extended Phenytoin Sodium Capsules USP, 100 mg are hard gelatin capsules No. 3 with an opaque orange body and cap, imprinted "TARO PHN 100" in black ink. They are available in: Blisters of 30…………..…NDC 67046-585-30 Blisters of 60……….….....NDC 67046-585-60 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
CONTRACT PHARMACY SERVICES-PA
----------
EXTENDED
PHENYTOIN SODIUM
CAPSULES USP, 100 MG
RX ONLY
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 sodium
5,5-diphenyl-2,4-
imidazolidinedione, having the following structural formula:
Each Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin
sodium, USP. Also contains
confectioner's sugar, hypromellose, lactose monohydrate, magnesium
stearate, and talc. The capsule
shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow
#10, edetate calcium disodium,
FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl
sulfate, sodium propionate, and
titanium dioxide. Product _in vivo_ performance is characterized by a
slow and extended rate of absorption
with peak blood concentrations expected in 4 to 12 hours.
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 potentiation prevents cortical seizure foci from
detonating adjacent cortical areas. Phenytoin
reduces the maximal activity of brain stem centers responsible for the
tonic phase of tonic-clonic (grand
mal) seizures.
The plasma half-life in man after oral administration of phenytoin
averages 22 hours, with a range of 7
to 42 hours. Steady-state therapeutic levels are achieved at least 7
to 10 days (5-7 half-lives) after
initiation of therapy with recommended doses of 300 mg/day.
When serum level determinations are necessary, they should be o