EXTENDED PHENYTOIN SODIUM- 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

PHENYTOIN SODIUM

Composition:

PHENYTOIN SODIUM 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin is contraindicated in patients with: - A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)] . Reactions have included angioedema. - A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.8)]. - Co-administration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as phenytoin sodium, during pregnancy. Physicians are advised to recommend that pregnant patien

Product summary:

Extended phenytoin sodium capsules, USP 100 mg are supplied as white opaque/light lavender opaque, hard gelatin capsules imprinted with "IP 212" on both cap and body. They are supplied as follows: Bottles of 30:                                    NDC 43063-492-30 Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
documents.amneal.com/mg/extended-phenytoin-sodium.pdf
Extended phenytoin sodium (fen‘ i toyn soe‘ dee um) capsules
What is the most important information I should know aboutextended
phenytoin sodium capsules?
1. Do not stop takingextended phenytoin sodium capsules without first
talking to your healthcare
provider.
•
Stopping extended phenytoin sodium capsules suddenly can cause serious
problems.
•
Stopping a seizure medicine suddenly can cause you to have seizures
more often or seizures that
will not stop (status epilepticus).
2. 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
•
New or worse anxiety
•
Trouble sleeping (insomnia)
•
Acting on dangerous impulses
•
Attempts to commit suicide
•
Feeling agitated or restless
•
New or worse irritability
•
An extreme increase in activity and talking (mania)
•
New or worse depression
•
Panic attacks
•
Acting aggressive, being angry, or violent
•
Other unusual changes in behavior or mood
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts
or actions, your healthcare provider may check for other causes.
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.
3.Extended phenytoin sodium capsules can cause a type of serious
allergic reaction that may affect
different parts of the body such as your liver, kidneys, blood, heart,
skin or other parts of

Summary of Product characteristics

EXTENDED PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXTENDED PHENYTOIN
SODIUM CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR EXTENDED
PHENYTOIN SODIUM CAPSULES.
EXTENDED PHENYTOIN SODIUM CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
INDICATIONS AND USAGE
Extended phenytoin sodium capsules are indicated for the treatment of
tonic-clonic (grand mal) and
psychomotor (temporal lobe) seizures and prevention and treatment of
seizures occurring during or
following neurosurgery. (1)
DOSAGE AND ADMINISTRATION
Adult starting dose in patients who have received no previous
treatment is one 100 mg extended
phenytoin sodium capsule three times a day, with dose adjustments as
necessary. For most adults, the
satisfactory maintenance dose will be one capsule three to four times
a day. An increase, up to two
capsules three times a day may be made, if necessary. ( 2.1)
Adult once-a-day dose: If seizure control is established with divided
doses of three 100 mg extended
phenytoin sodium capsules daily, once-a-day dosage with 300 mg
extended phenytoin sodium capsules
may be considered. ( 2.1)
Adult loading dose: reserved for patients in a clinic or hospital
setting who require rapid steady-state
serum levels and where intravenous administration is not desired.
Refer to full prescribing information. (
2.1)
Pediatric starting dose is 5 mg/kg/day in two to three equally divided
doses, with dosage adjustments
as necessary, up to a maximum of 300 mg daily. Maintenance dosage is 4
to 8 mg/kg/day. ( 2.2)
Serum blood level determinations may be necessary for optimal dosage
adjustments—the clinically
effective serum total concentration is 10 to 20 mcg/mL (unbound
phenytoin concentration is 1 to 2
mcg/mL). ( 2.3)
DOSAGE FORMS AND STRENGTHS
Extended phenytoin sodium capsules, USP are available as 100 mg
capsules. (3)
CONTRAINDICATIONS
Hypersensitivity to phenytoin, its ingred