PHENYTOIN SODIUM capsule, extended release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

TYA Pharmaceuticals

INN (Rahvusvaheline Nimetus):

Phenytoin Sodium

Koostis:

Phenytoin Sodium 100 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 and sections). DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY Phenytoin is contraindicated in those patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. Coadministration of phenytoin 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.

Toote kokkuvõte:

NDC:64725-4111-1 in a BOTTLE of 100 CAPSULE, EXTENDED RELEASES [see USP Controlled Room Temperature]. Store at 20°-25°C (68°-77°F) Preserve in tight, light-resistant containers. Protect from moisture.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

TYA Pharmaceuticals
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MEDICATION GUIDE
Extended Phenytoin (fen' i toin) Sodium Capsules, USP
Read this Medication Guide before you start taking Extended Phenytoin
Sodium Capsules, USP 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, USP ask your healthcare provider
or pharmacist.
What is the most important information I should know about Phenytoin?
Do not stop taking Phenytoin without first talking to your healthcare
provider.
Stopping phenytoin suddenly can cause serious problems.
Phenytoin can cause serious side effects including:
1.
Like other antiepileptic drugs, Phenytoin 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.
Stopping Phenytoin suddenly can cause serious problems. Stopping a
seizure medicine suddenly in a
patient who has epilepsy can cause seizures that will not stop (status
epilepticus). Do not stop taking
Phenytoin without first talking to a healthcare provider.
Suicidal thoughts o

Toote omadused

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
TYA PHARMACEUTICALS
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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 performance is characterized by a slow and
extended rate of absorption with
peak blood concentrations expected in 4 to 12 hours as contrasted to ,
USP with a rapid rate of
absorption with peak blood concentration expected in 1½ to 3 hours.
_in vivoPrompt Phenytoin Sodium_
_Capsules_
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 where spread of seizure activity is
inhibited. Possibly by promoting sodium
efflux from neurons, phenytoin tends to 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. _motor cortexstabilize_
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 therap