EXTENDED PHENYTOIN SODIUM- phenytoin sodium capsule, extended release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Marlex Pharmaceuticals Inc

INN（国際名）:

PHENYTOIN SODIUM

構図:

PHENYTOIN SODIUM 100 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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, USP is contraindicated in those patients with a history of hypersensitivity to phenytoin, USP, its inactive ingredients, or other hydantoins. Coadministration of extended 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.

製品概要:

Extended Phenytoin Sodium Capsules, USP 100mg are supplied as white opaque/light lavender opaque, hard gelatin capsules imprinted with “IP 212” on both cap and body. They are available as follows: Bottles of 100: NDC 10135-603-01 Bottles of 1000 NDC 10135-603-10 Store at 20° to 25°C (68° to 77°F) [See USP Con trolled Room Temperature]. Pres erve in tight, light-resis tant containers. Protect from mois ture. Rx only Manufactured for: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Distributed by: Marlex Pharmaceuticals , Inc. New Castle, DE 19720 Rev. 08/15

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Marlex Pharmaceuticals Inc
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MEDICATION GUIDE
Extended Phenytoin (FEN-i-toyn) Sodium Capsules
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 in 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 c

製品の特徴

EXTENDED PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
MARLEX PHARMACEUTICALS INC
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PHENYTOIN SODIUM ER
EXTENDED PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE
MARLEX PHARMACEUTICALS, INC. OF NEW CASTLE, DE.
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EXTENDED PHENYTOIN SODIUM CAPSULES, USP 100 MG
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
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
(grandmal) 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.