LEVETIRACETAM EXTENDED-RELEASE- levetiracetam tablet, extended release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Omnivium Pharmaceuticals LLC

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

Levetiracetam extended-release tablets USP, 750 mg tablets are white to off-white, oblong-shaped, film-coated tablets debossed in with “CY 02” on one side. They are supplied in white HDPE bottles containing 60 tablets (NDC 81665-100-60) and 120 tablets(NDC 81665-100-12). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

LEVETIRACETAM EXTENDED-RELEASE- LEVETIRACETAM TABLET, EXTENDED RELEASE
Omnivium Pharmaceuticals LLC
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MEDICATION GUIDE
Levetiracetam (lee" ve tye ra' se tam)
Extended-Release Tablets, for oral use
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

Toote omadused

LEVETIRACETAM EXTENDED-RELEASE- LEVETIRACETAM TABLET, EXTENDED
RELEASE
OMNIVIUM PHARMACEUTICALS LLC
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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 extended-release tablets are 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
750 mg white, 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 patients to not
drive or operate machinery until they have gained experience on
levetiracetam. ( 5.6)
Withdrawal Seizure