HIGHLIGHTS OF PRESCRIBING INFORMATION

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)

Предлага се от:

Sun Pharmaceutical Industries, Inc.

INN (Международно Name):

LEVETIRACETAM

Композиция:

LEVETIRACETAM 500 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older. Levetiracetam extended-release tablets are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including levetiracetam extended-release tablets, during pregnancy. Encourage women who are taking levetiracetam extended-release tablets during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary Prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy regis

Каталог на резюме:

Levetiracetam extended-release tablets, 500 mg are oval, blue and white to off-white colored, biconvex, bilayer, film-coated, extended-release tablets having laser drill on blue layer and imprinted with “573” with black ink on one side and plain on other side. They are supplied as follows: Bottles of 60’s with child-resistant cap…................... NDC 47335-573-86 Bottles of 100’s with child-resistant cap…................. NDC 47335-573-88 Bottles of 500.............................…................………. NDC 47335-573-13   Levetiracetam extended-release tablets, 750 mg are oval, blue and white to off-white colored, biconvex, bilayer, film-coated, extended-release tablets having laser drill on blue layer and imprinted with “576” with black ink on one side and plain on other side. They are supplied as follows:   Bottles of 60’s with child-resistant cap…................... NDC 47335-576-86 Bottles of 100’s with child-resistant cap…................. NDC 47335-576-88 Bottles of 500...…...................…...................………. NDC 47335-576-13 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Levetiracetam Extended-Release Tablets
(LEE-ve-tye-RA-se-tam)
Read this Medication Guide before you start taking levetiracetam
extended-release tablets 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
levetiracetam extended-release tablets?
Like other antiepileptic drugs, levetiracetam extended-release tablets
may cause suicidal thoughts or
actions
in
a
very
small
number
of
people,
about
1
in
500
people
taking
it.
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
Do not stop levetiracetam extended-release tablets without first
talking to a healthcare provider.
•
Stopping levetiracetam extended-release tablets suddenly can cause
serious problems. Stopping a
seizure medicine suddenly 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 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.
What
are
levetiracetam
ext

Данни за продукта

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVETIRACETAM EXTENDED-RELEASE
TABLETS.
LEVETIRACETAM EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage (1) 10/2019
Dosage and Administration (2.1, 2.3) 10/2019
INDICATIONS AND USAGE
Levetiracetam is indicated for the treatment of partial-onset seizures
in patients 12 years of age and older (1)
DOSAGE AND ADMINISTRATION
Initiate treatment with a dose of 1,000 mg once daily; increase by
1,000 mg every 2 weeks to a maximum recommended
dose of 3,000 mg once daily (2)
See full prescribing information for use in patients with impaired
renal function (2.1)
DOSAGE FORMS AND STRENGTHS
500 mg blue and white to off-white colored biconvex, bilayer,
film-coated extended-release tablet (3)
750 mg blue and white to off-white colored biconvex, bilayer,
film-coated extended-release tablet (3)
CONTRAINDICATIONS
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis
have occurred (4, 5.4)
WARNINGS AND PRECAUTIONS
Behavioral abnormalities including psychotic symptoms, suicidal
ideation, irritability, and aggressive behavior have
been observed; monitor patients for psychiatric signs and symptoms
(5.1)
Suicidal Behavior and Ideation: Monitor patients for new or worsening
depression, suicidal thoughts/behavior, and/or
unusual changes in mood or behavior. (5.2)
Monitor for somnolence and fatigue and advise patients not to drive or
operate machinery until they have gained
sufficient experience on levetiracetam extended-release tablets. (5.3)
Serious Dermatological Reactions: Discontinue levetiracetam at the
first sign of rash unless clearly not drug related.
(5.5)
Coordination Difficulties: Monitor for ataxia, abnormal gait, and
incoordination. Advise