PHENYTOIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Morton Grove Pharmaceuticals, 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 Oral Suspension, during pregnancy. Physicians are advised to recommend that pregnant patients taking Phenytoin Oral Suspension enroll in the North American Antiepileptic Drug (NAA

Product summary:

Phenytoin Oral Suspension is supplied as follows: Package Configuration                      Strength                                  NDC 8-oz bottles                                          125 mg phenytoin/5mL             60432-131-08 Phenytoin Oral Suspension, USP, 125 mg phenytoin/5 mL contains an alcohol content of 0.35 percent in an orange suspension with an orange-vanilla flavor. 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

PHENYTOIN - phenytoin suspension
Morton Grove Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Phenytoin (fen' i toin) Oral Suspension, USP
125 mg/5 mL
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

Summary of Product characteristics

PHENYTOIN - PHENYTOIN SUSPENSION
MORTON GROVE PHARMACEUTICALS, 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, USP
INITIAL U.S. APPROVAL: 1953
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 2/2021
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
suggest SJS/TEN, use of this drug
should not be resu