EXTENDED PHENYTOIN SODIUM capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

TYA Pharmaceuticals

INN (Международно Name):

PHENYTOIN SODIUM

Композиция:

PHENYTOIN SODIUM 100 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 and sections). DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.

Каталог на резюме:

NDC:64725-0720-1 in a BOTTLE of 100 CAPSULES Rx only Moban is a registered trademark of Endo Pharmaceuticals, Inc. ® Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Rev.030412

Статус Оторизация:

Abbreviated New Drug Application

Листовка

EXTENDED PHENYTOIN SODIUM- EXTENDED PHENYTOIN SODIUM CAPSULE
TYA Pharmaceuticals
----------
SPL MEDGUIDE
MEDICATION GUIDE
Extended Phenytoin Sodium Capsules, USP 100 mg
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, USP?
Stopping extended phenytoin sodium capsules suddenly can cause serious
problems. Do not stop taking
extended phenytoin sodium capsules without first talking to your
healthcare provider.
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 health-care 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

Данни за продукта

EXTENDED PHENYTOIN SODIUM- EXTENDED PHENYTOIN SODIUM CAPSULE
TYA PHARMACEUTICALS
----------
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 USP-contains 100 mg phenytoin sodium, USP. Also contains
magnesium oxide light USP,
hypromellose USP, colloidal silicon dioxide NF, talc USP, magnesium
stearate NF. The capsule shell
contains gelatin, titanium dioxide, D&C yellow # 10, FD&C blue # 1,
FD&C red # 40 and black edible
ink. 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. _Extended Phenytoin
Sodium Capsule,in vivoPrompt_
_Phenytoin Sodium Capsules,_
Extended Phenytoin Sodium Capsules, USP, 100 mg complies with USP Test
1 dissolution
requirements.
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 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 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. _motor cortexstabilize_
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 day