LEVETIRACETAM tablet, film coated, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Solco healthcare U.S., LLC

INN (Међународно име):

LEVETIRACETAM

Састав:

LEVETIRACETAM 500 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Levetiracetam extended-release tablets are indicated for the treatment of partial-onset 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 tablets 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 registri

Резиме производа:

Levetiracetam extended-release 500 mg tablets, USP, are white, oval, biconvex film-coated extended-release tablets debossed with "HH" on one side and “172” on the other side. They are supplied in white HDPE bottles as follows: NDC 43547-345-06: bottles of 60 NDC 43547-345-50: bottles of 500 Levetiracetam extended-release 750 mg tablets, USP, are white, oval, biconvex film-coated extended-release tablets debossed with "HH" on one side and “173” on the other side. They are supplied in white HDPE bottles as follows: NDC 43547-346-06: bottles of 60 NDC 43547-346-50: bottles of 500 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
Solco healthcare U.S., LLC
----------
MEDICATION GUIDE
Levetiracetam Extended-Release Tablets USP, for oral use
(LEE-ve-tye-RA-se-tam)
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/levetiracetam-er-
tablets.pdf
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 follo

Карактеристике производа

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
SOLCO HEALTHCARE U.S., LLC
----------
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 is indicated for the treatment
of partial-onset 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
•
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US,
LLC AT 1-866-257-
2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 6/2023
500 mg white, film-coated extended-release tablet (3)
750 mg white, film-coated extended-release tablet (3)
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis
have occurred (4, 5.4)
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