PEGANONE- ethotoin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETHOTOIN (UNII: 46QG38NC4U) (ETHOTOIN - UNII:46QG38NC4U)

Available from:

RECORDATI RARE DISEASES, INC.

INN (International Name):

ETHOTOIN

Composition:

ETHOTOIN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PEGANONE (ethotoin tablets, USP) is indicated for the control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures. PEGANONE (ethotoin tablets, USP) is contraindicated in patients with hepatic abnormalities or hematologic disorders.

Product summary:

PEGANONE (ethotoin tablets, USP) 250 mg grooved, white tablets bearing the letter R on one side and the number 61 on the other and are supplied in bottles of 100 (NDC 55292-602-01). Recommended storage: Store at 20-25ºC (68-77ºF). See USP controlled room temperature. Dispense in a tight light-resistant container, as defined in the USP, with a child-resistant cap. Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A. For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. ® Trademark of Recordati Rare Diseases Inc. Revised: July 2016 MS-04228 R3.0

Authorization status:

New Drug Application

Patient Information leaflet

PEGANONE- ETHOTOIN TABLET
RECORDATI RARE DISEASES, INC.
----------
MEDICATION GUIDE
Peganone® 250 mg Tablets
(PEG-ah-noan)
(ethotoin tablets, USP)
Read this Medication Guide before you start taking PEGANONE 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.
What is the most important information I should know about PEGANONE?
Do not stop taking PEGANONE without first talking to your healthcare
provider.
Stopping PEGANONE suddenly can cause serious problems.
PEGANONE can cause serious side effects, including:
Like other antiepileptic drugs, PEGANONE 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 PEGANONE without first talking to a healthcare provider.
•
Stopping PEGANONE suddenly can cause serious problems. Stopping a
seizure medicine suddenly
in a patient who has epilepsy can cause seizures that will not stop
(status epilepticus).
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts
or actions, your healthc

Summary of Product characteristics

PEGANONE- ETHOTOIN TABLET
RECORDATI RARE DISEASES, INC.
----------
PEGANONE 250 MG TABLETS
(ETHOTOIN TABLETS, USP)
RX ONLY
DESCRIPTION
PEGANONE (ethotoin tablets, USP) is an oral antiepileptic of the
hydantoin series and is chemically
identified as 3-ethyl-5-phenyl-2,4-imidazolidinedione. It is
represented by the following structural
formula:
PEGANONE tablets are available in a dosage strength of 250 mg.
INACTIVE INGREDIENTS: Acacia, lactose, sodium carboxymethylcellulose,
stearic acid and talc.
CLINICAL PHARMACOLOGY
PEGANONE (ethotoin tablets, USP) exerts an antiepileptic effect
without causing general central
nervous system depression. The mechanism of action is probably very
similar to that of phenytoin. The
latter drug appears to stabilize rather than to raise the normal
seizure threshold, and to prevent the
spread of seizure activity rather than to abolish the primary focus of
seizure discharges.
Ethotoin is fairly rapidly absorbed; the extent of oral absorption is
not known. The drug exhibits
saturable metabolism with respect to the formation of N-deethyl and
p-hydroxyl-ethotoin, the major
metabolites. Where plasma concentrations are below about 8 μg/mL, the
elimination half-life of ethotoin
is in the range of 3 to 9 hours. A study comparing single doses of 500
mg, 1000 mg, and 1500 mg of
PEGANONE (ethotoin tablets, USP) demonstrated that ethotoin, and to a
lesser extent 5-
phenylhydantoin, a major metabolite, exhibits substantial nonlinear
kinetics. The degree of nonlinearity
with multiple dosing may be increased over that seen after a single
dose, given the likelihood of plasma
accumulation based on a reported elimination half-life of 6 to 9 hours
and a dosing interval of 4 to 6
hours. Experience suggests that therapeutic plasma concentrations fall
in the range of 15 to 50 μg/mL;
however, this range is not as extensively documented as those quoted
for other antiepileptics.
In laboratory animals, the drug was found effective against
electroshock convulsions, and to a lesser
extent, against complex partia