EXTENDED PHENYTOIN SODIUM- phenytoin sodium capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

State of Florida DOH Central Pharmacy

INN (Kansainvälinen yleisnimi):

PHENYTOIN SODIUM

Koostumus:

PHENYTOIN SODIUM 100 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Extended phenytoin sodium capsules, USP 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 sections). Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.

Tuoteyhteenveto:

Extended Phenytoin Sodium Capsules, USP 100 mg are supplied as white opaque / light lavender opaque, hard gelatin capsules imprinted with "IP 212" on both cap and body. They are supplied by State of Florida DOH Central Pharmacy as follows: They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Rx only

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

EXTENDED PHENYTOIN SODIUM - PHENYTOIN SODIUM CAPSULE
State of Florida DOH Central Pharmacy
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MEDICATION GUIDE
Extended Phenytoin Sodium Capsules
Read this Medication Guide before you start taking extended phenytoin
sodium and each time you get a
refill. There may be new information. This information does not take
the place of talking to your
healthcare provider about your medical condition or treatment. If you
have any questions about extended
phenytoin sodium, ask your healthcare provider or pharmacist.
What is the most important information I should know about
extendedphenytoin sodium?
Do not stop taking extended phenytoin sodium without first talking to
your healthcare provider. Stopping
extended phenytoin sodium suddenly can cause serious problems.
Extended phenytoin sodium can cause serious side effects including:
1. Like other antiepileptic drugs, extended phenytoin sodium may cause
suicidal thoughts or actions
in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they
are new, worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase activity and talking (mania)
•
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
•
Keep all follow-up visits with your health-care provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
Do not stop taking extended phenytoin sodium without first talking to
a healthcare provider.
•
Stopping extended phenytoin sodium suddenly can cause serious
problems. Stopp

Valmisteyhteenveto

EXTENDED PHENYTOIN SODIUM - PHENYTOIN SODIUM CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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EXTENDED PHENYTOIN SODIUM CAPSULES, USP
DESCRIPTION
Phenytoin sodium, USP is an antiepileptic drug. Phenytoin sodium, USP
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. Each capsule
also contains the following inactive ingredients: D&C Red #28, D&C Red
#33, FD&C Blue #1, gelatin,
hydroxypropyl cellulose, mannitol, magnesium stearate, talc 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 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
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 to 7 half-lives) after
initiation of therapy with recommended doses of 300 mg/day.
When serum level determinations are necessary, they