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:

Mylan 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. Extended phenytoin sodium capsules are contraindicated in patients with: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as extended phenytoin sodium capsules, during pregnancy. Physicians are advised to recommend that pregnant patients taking extended phenytoin sodium capsules enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the tollfree 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/ In humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Prenatal phenytoin exposure is a

Product summary:

Extended Phenytoin Sodium Capsules, USP are available containing 100 mg of phenytoin sodium, USP. The 100 mg capsules are hard-shell gelatin capsules with a light lavender opaque cap and white opaque body filled with one white to off-white capsule-shaped tablet. The capsules are axially printed with MYLAN over 1560 in black ink on both the cap and body. They are available as follows: NDC 0378-1560-01 bottles of 100 capsules NDC 0378-1560-10 bottles of 1000 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST:  Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mylan Pharmaceuticals Inc.
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Medication Guide
Extended Phenytoin Sodium Capsules, USP
(fen′ i toin soe′ dee um)
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
•
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
in activity and
talking (mania)
•
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

Summary of Product characteristics

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
MYLAN 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
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 2/2021
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
Phenytoin sodium is available as 100 mg extended phenytoin sodium
capsules. (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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
effec