PHENYTOIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYTOIN (UNII: 6158TKW0C5) (PHENYTOIN - UNII:6158TKW0C5)

Available from:

VistaPharm, Inc.

INN (International Name):

PHENYTOIN

Composition:

PHENYTOIN 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenytoin is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. 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 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)].  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. Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to

Product summary:

Phenytoin Oral Suspension USP, 125 mg/5 mL, an opaque orange color with an orange-vanilla flavor, is available as follows: NDC 66689-775-01: 4 mL unit-dose cup NDC 66689-775-50: Case contains 50 unit-dose cups of 4 mL (66689-775-01), packaged in 5 trays of 10 unit-dose cups NDC 66689-775-08:  Bottles of 8 fluid ounces (237 mL) SHAKE WELL BEFORE USING NOTE: Due to the viscous nature of this product, an overage is added in each unit-dose container in order to deliver 4 mL. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature]. Protect from light. Do not freeze.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VistaPharm, Inc.
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MEDICATION GUIDE
Phenytoin (fen-i-toh-in) 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, 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 these
symptoms:
•
Fever
•
Rash
•
Swollen lymph

Summary of Product characteristics

PHENYTOIN- PHENYTOIN SUSPENSION
VISTAPHARM, INC.
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 7/2019
Warnings and Precautions (5.6) 10/2018
Warnings and Precautions (5.7) 7/2019
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 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 to 20 mcg/mL (unbound phenytoin
concentration is 1 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 s