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 Institutional 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: - 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)] . - Coadministration 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. There is a pregnancy exposure registry that monitors

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 51079-905-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. PHARMACIST:  Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mylan Institutional 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 aw

Summary of Product characteristics

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
MYLAN INSTITUTIONAL 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
Phenytoin sodium is available as 100 mg extended phenytoin sodium
capsules. ( 3)
CONTRAINDICATIONS
Hypersensitivity to phenytoin,