DILANTIN- phenytoin sodium capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, Inc.

INN (International Name):

Phenytoin Sodium

Composition:

Phenytoin Sodium 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dilantin is 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 its inactive ingredients or other hydantoins.

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Hard, filled No. 3 capsules containing a white powder. The medium orange cap having "PD" printed in black ink and the white, opaque body having "DILANTIN" over "100 mg" printed in black ink. 100's (NDC 0071-0369-24) 1,000's (NDC 0071-0369-32) Unit Dose 100's (NDC 0071-0369-40) Store at 20–25°C (68–77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DILANTIN- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
Aphena Pharma Solutions - Tennessee, Inc.
----------
MEDICATION GUIDE
DILANTIN (Dī lan' tĭn)
(Phenytoin and Phenytoin sodium)
Oral Suspension, Tablets, Extended Oral Capsules
Read this Medication Guide before you start taking DILANTIN 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
DILANTIN, ask your healthcare
provider or pharmacist.
What is the most important information I should know about DILANTIN?
Do not stop taking DILANTIN without first talking to your healthcare
provider.
Stopping DILANTIN suddenly can cause serious problems.
DILANTIN can cause serious side effects including:
1.
Like other antiepileptic drugs, DILANTIN 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 DILANTIN without first talking to a healthcare
provider.
•
Stopping DILANTIN suddenly can cause serious problems. Stopping a
seizure medicine suddenly
in a patient who has epilepsy can cause seizu

Summary of Product characteristics

DILANTIN- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
DILANTIN
(EXTENDED PHENYTOIN SODIUM CAPSULES, USP) 100 MG
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 Dilantin—_ 100 mg (extended phenytoin sodium capsule,
USP)_—contains 100 mg phenytoin sodium.
Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc,
USP; and magnesium stearate,
NF. The capsule body contains titanium dioxide, USP and gelatin, NF.
The capsule cap contains FD&C
red No. 28; FD&C yellow No. 6; and gelatin NF. 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 (5–7 half-lives) after
initiation of therapy with r