PHENYTOIN SODIUM capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

PHENYTOIN SODIUM

Composition:

PHENYTOIN SODIUM 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenytoin is indicated for the control of tonic-clonic (grand mal) and 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 ADMINISTRATIONand CLINICAL PHARMACOLOGYsections). Phenytoin is contraindicated in those patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. Coadministration of phenytoin sodium is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

Product summary:

Extended phenytoin sodium capsules USP, 100 mg are supplied as follows: Transparent # 3 capsule filled with white to off-white powder, with the code '402' imprinted on the cap and body. Bottles of 30:  NDC 63187-891-30 Bottles of 60:  NDC 63187-891-60 Bottles of 90   NDC 63187-891-90 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].  Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
Proficient Rx LP
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MEDICATION GUIDE
EXTENDED PHENYTOIN (FEN-i-toyn) SODIUM CAPSULES, USP
Read this Medication Guide before you start taking extended phenytoin
sodium capsules 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 capsules, ask your healthcare provider or
pharmacist.
What is the most important information I should know about extended
phenytoin sodium capsules?
Do not stop taking extended phenytoin sodium capsules without first
talking to your healthcare provider.
Stopping extended phenytoin sodium capsules suddenly can cause serious
problems.
Extended phenytoin sodium capsules can cause serious side effects
including:
1. Like other antiepileptic drugs, extended phenytoin sodium capsules
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 healthcare 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 capsules without first
talking to a healthcare provider.
•

Summary of Product characteristics

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
PROFICIENT RX LP
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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 Extended Phenytoin Sodium Capsule, USP contains 100 mg phenytoin
sodium, USP. Also contains
lactitol monohydrate, sodium lauryl sulfate, talc and magnesium
stearate. The capsule shell contains
gelatin, and black printing ink, which contains black iron oxide, FD&C
Blue No. 2, FD&C Red No. 40,
FD&C Blue No. 1, D&C Yellow No. 10, shellac glaze and SDA 3A alcohol
or N-butyl alcohol and
propylene glycol. 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 excessive stimulation or environmental
changes capable of reducing
membrane sodium gradient. This includes the reduction of post tetanic
potentiation at synapses. Loss of
post tetanic 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.
PHARMACOKINETICS AND DRUG METABOLISM
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-