PHENYTOIN SODIUM capsule, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

RedPharm Drug, Inc.

INN (इंटरनेशनल नाम):

PHENYTOIN SODIUM

रचना:

PHENYTOIN SODIUM 100 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

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 100: NDC 62756-402-01 Bottles of 100 Non Child Resistant Cap: NDC 62756-402-02 Bottles of 1000 Non Child Resistant Cap: NDC 62756-402-03 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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
RedPharm Drug, Inc.
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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.
Stopping extended phenytoin sodium capsules suddenly can

उत्पाद विशेषताएं

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
REDPHARM DRUG, INC.
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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:
[chemical-structure]
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-lives) after
initiation