PHENYTOIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenstone LLC

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 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 calling the tollfree number 1-888-233

Product summary:

Phenytoin Oral Suspension is supplied as follows: Phenytoin Oral Suspension, USP, 125 mg phenytoin/5 mL contains a maximum alcohol content not greater than 0.6 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:

New Drug Application Authorized Generic

Patient Information leaflet

Greenstone LLC
----------
MEDICATION GUIDE
Phenytoin Oral Suspension, USP
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 10/2018
What is the most important information I should know about phenytoin?
1.
Do not stop taking phenytoin without first talking to your healthcare
provider.
•
Stopping phenytoin 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 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 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

Summary of Product characteristics

PHENYTOIN- PHENYTOIN SUSPENSION
GREENSTONE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYTOIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PHENYTOIN.
PHENYTOIN ORAL SUSPENSION, USP
INITIAL U.S. APPROVAL: 1953
INDICATIONS AND USAGE
Phenytoin 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 5mL 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 is available as a 125 mg/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 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 considered. (5.3)
_Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS)/Multiorgan Hypersensitivity:_ If signs
or symptoms of