EXTENDED PHENYTOIN SODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wockhardt Limited

INN (International Name):

PHENYTOIN SODIUM

Composition:

PHENYTOIN SODIUM 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Extended phenytoin sodium capsules, USP 100 mg are available in orange/orange size ‘3’ hard gelatin capsules imprinted on body ‘W720’ in black ink containing white to off white granular powder: 100’s    (NDC 64679-720-01) 1,000’s (NDC 64679-720-02) Store at 20°-25°C (68°-77°F) (See USP controlled room temperature). Preserve in tight, light-resistant containers. Protect from moisture. 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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

EXTENDED PHENYTOIN SODIUM- EXTENDED PHENYTOIN SODIUM CAPSULE
Wockhardt Limited
----------
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?
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 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 p

Summary of Product characteristics

EXTENDED PHENYTOIN SODIUM- EXTENDED PHENYTOIN SODIUM CAPSULE
WOCKHARDT LIMITED
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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
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 _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.
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 _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 1