PHENYTOIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Phenytoin (UNII: 6158TKW0C5) (Phenytoin - UNII:6158TKW0C5)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Phenytoin

Composition:

Phenytoin 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin oral suspension 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)] . - 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. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as phenytoin, during pregnancy. Physicians are advised to recommend that pregnant patients taking phenytoin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by call

Product summary:

Phenytoin Oral Suspension USP, 125 mg phenytoin/5 mL is supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Taro Pharmaceuticals U.S.A., Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: April 2022
Dispense with Medication Guide available at:
https://www.taro.com/usa-medication-guides
MEDICATION GUIDE
Phenytoin (fen' i toin) Oral Suspension
What is the most important information I should know about phenytoin
oral suspension?
1.
Do not stop taking phenytoin oral suspension without first talking to
your healthcare provider.
•
Stopping phenytoin oral suspension 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, phenytoin oral suspension 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.
Phenytoin oral suspension can cause a type of serious allergic
reaction that may affect different parts
of the body such as your liver, kidneys, blood,

Summary of Product characteristics

PHENYTOIN- PHENYTOIN SUSPENSION
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYTOIN ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PHENYTOIN ORAL
SUSPENSION.
PHENYTOIN ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1953
INDICATIONS AND USAGE
Phenytoin oral suspension is indicated for the treatment of
tonic-clonic (grand mal) and psychomotor
(temporal lobe) seizures. (1)
DOSAGE AND ADMINISTRATION
Adult starting dose in patients who have received no previous
treatment is 5 mL three times daily, with
dose adjustments as necessary, up to 25 mL daily. (2.2)
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
mg/kg/day to 8 mg/kg/day.
(2.3)
Serum blood level determinations may be necessary for optimal dosage
adjustments—the clinically
effective serum total concentration is 10 mcg/mL to 20 mcg/mL (unbound
phenytoin concentration is 1
mcg/mL to 2 mcg/mL). (2.1)
DOSAGE FORMS AND STRENGTHS
Phenytoin oral suspension is available as a 125 mg phenytoin/5 mL oral
suspension. (3)
CONTRAINDICATIONS
Hypersensitivity to phenytoin, its ingredients, or other hydantoins
(4, 5.5)
A history of prior acute hepatotoxicity attributable to phenytoin (4,
5.8)
Coadministration with delavirdine (4)
WARNINGS AND PRECAUTIONS
_Withdrawal Precipitated Seizure:_ May precipitate status epilepticus.
Dose reductions or discontinuation
should be done gradually. (5.1)
_Suicidal Behavior and Ideation:_ Monitor patients for the emergence
or worsening of depression, suicidal
thoughts or behavior, and/or any unusual changes in mood or behavior.
(5.2)
_Serious Dermatologic Reactions:_ Discontinue phenytoin oral
suspension at the first sign of a rash,
unless the rash is clearly not drug-related. If signs or symptoms
suggest SJS/TEN, use of this drug
should not be resumed and alternative therapy should be consid