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:

Major Pharmaceuticals

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: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as extended phenytoin sodium, during pregnancy. Physicians are advised to recommend that pregnant patients taking extended phenytoin sodium enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ Risk Summary In humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse development outcomes. An increased incidence of major malf

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: Cartons of 100 capsules (10 capsules each blister pack x 10): NDC 0904-6187-61 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

EXTENDED PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE
Major Pharmaceuticals
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MEDICATION GUIDE
Extended phenytoin (FEN-i-toyn) sodium oral capsules
What is the most important information I should know about extended
phenytoin sodium capsules?
1. 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.
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 your body.
These can be very serious and cause death. Call your healthcare
provider right away if you have any or all
of the

Summary of Product characteristics

EXTENDED PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE
MAJOR PHARMACEUTICALS
----------
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
DOSAGE FORMS AND STRENGTHS
Extended phenytoin sodium capsules, USP are available as 100 mg
capsules. (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions are nervous system reactions,
including nystagmus, ataxia, slurred speech,
decreased coordination, somnolence, and mental confusion. (6)
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