PHENYTOIN SODIUM capsule, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Physicians Total Care, Inc.

Designació comuna internacional (DCI):

Phenytoin Sodium

Composición:

Phenytoin Sodium 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 sections). Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.

Resumen del producto:

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: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Physicians Total Care, Inc.
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MEDICATION GUIDE
Extended Phenytoin 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 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.
Do not stop taking phenytoin without first talking to a healthcare
provider.
•
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).
Suicidal thoughts or actions c

Fitxa tècnica

PHENYTOIN SODIUM - PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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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_ 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