PHENYTOIN ORAL SUSPENSION, USP 125 mg/5 mL

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Genus Lifesciences Inc.

INN (International Name):

Phenytoin

Composition:

Phenytoin 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenytoin Oral Suspension, USP is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections). Phenytoin Oral Suspension, USP is contraindicated in those patients with a history of hypersensitivity to phenytoin, its inactive ingredients or other hydantoins. Coadministration of Phenytoin Oral Suspension, USP is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. Serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. The free acid form of phenytoin is used in Phenytoin Oral Suspension, USP. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage

Product summary:

Phenytoin Oral Suspension, USP, 125 mg/5 mL, an opaque orange liquid with orange-vanilla flavor, is available as follows: NDC 64950-231-24: Bottles of 8 fluid ounces (237 mL). SHAKE WELL BEFORE USING Store at controlled room temperature 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Preserve in a tight container. Avoid Freezing. Protect from light. Rx only

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PHENYTOIN- PHENYTOIN SUSPENSION
Genus Lifesciences Inc.
----------
MEDICATION GUIDE
Phenytoin Oral Suspension, USP
(FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE)
Rx Only
Read this Medication Guide before you start taking Phenytoin Oral
Suspension, USP and each time you get a
refill. There may be new information. This information does not take
the place of talking to your healthcare
provider about your medical condition or treatment. If you have any
questions about Phenytoin Oral
Suspension, USP, ask your healthcare provider or pharmacist.
What is the most important information I should know about Phenytoin
Oral Suspension, USP?
Do not stop taking Phenytoin Oral Suspension, USP without first
talking to your healthcare provider.
Stopping Phenytoin Oral Suspension, USP suddenly can cause serious
problems.
Phenytoin Oral Suspension, USP can cause serious side effects
including:
1.
Like other antiepileptic drugs, Phenytoin Oral Suspension, USP 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
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.
Do not stop taking Phenytoin Oral Suspension, USP without first
talking to a healthcare provider.
Stopping Pheny

Summary of Product characteristics

PHENYTOIN- PHENYTOIN SUSPENSION
GENUS LIFESCIENCES INC.
----------
PHENYTOIN ORAL SUSPENSION, USP
125 MG/5 ML
(FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE)
RX ONLY
DESCRIPTION
Phenytoin is related to the barbiturates in chemical structure, but
has a five-membered ring. The
chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the
following structural formula:
Each 5 ml of suspension contains 125 mg of phenytoin, USP; anhydrous
citric acid, USP;
carboxymethylcellulose sodium, USP; FD&C Yellow #6; flavor
orange-vanilla; glycerin, USP;
magnesium aluminum silicate, NF; polysorbate 80, NF; purified water,
USP; sodium benzoate, NF and
sucrose, NF.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Phenytoin is an antiepileptic drug which can be useful in the
treatment of epilepsy. The primary site of
action appears to be the _motor cortex _where spread of seizure
activity is inhibited. Possibly by
promoting sodium efflux from neurons, phenytoin tends to _stabilize
_the threshold against
hyperexcitability caused by excessive stimulation or environmental
changes capable of reducing
membrane sodium gradient. This includes the reduction of posttetanic
potentiation at sypnapses. Loss of
posttetanic potentiation prevents cortical seizure foci from
detonating adjacent cortical areas. Phenytoin
reduces the maximal activity of brain stem centers responsible for the
tonic phase of tonic-clonic (grand
mal) seizures.
PHARMACOKINETICS AND DRUG METABOLISM
The plasma half-life in man after oral administration of phenytoin
averages 22 hours, with a range of 7
to 42 hours. Steady-state therapeutic levels are achieved at least 7
to 10 days (5–7 half-lives) after
initiation of therapy with recommended doses of 300 mg/day.
When serum level determinations are necessary, they should be obtained
at least 5–7 half-lives after
treatment initiation, dosage change, or addition or subtraction of
another drug to the regimen so that
equilibrium or steady-state will have been achieved. Trough levels
provide information about clinically
ef