LEVETIRACETAM tablet, film coated, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Physicians Total Care, Inc.

INN (Nama Internasional):

LEVETIRACETAM

Komposisi:

LEVETIRACETAM 500 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Levetiracetam extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients ≥ 16 years of age with epilepsy. None Teratogenic Effects Pregnancy category C There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. Levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥ 350 mg/kg/day (approximately equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (

Ringkasan produk:

Levetiracetam extended-release tablets are available as follows: 500 mg – white, oval-shaped, film-coated tablets imprinted with “TV/7795” with black ink on one side and plain on the other, in bottles of 90.....NDC 54868-6316-0. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
Physicians Total Care, Inc.
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MEDICATION GUIDE
Levetiracetam Extended-Release Tablets
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
them.
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

Karakteristik produk

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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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
Warnings and Precautions (5.1) [04/2009]
Patient Counseling Information (17) [04/2009]
INDICATIONS AND USAGE
Levetiracetam extended-release tablets are an antiepileptic drug
indicated for adjunctive therapy in the treatment of partial
onset seizures in patients ≥ 16 years of age with epilepsy (1)
DOSAGE AND ADMINISTRATION
Treatment should be initiated with a dose of 1000 mg once daily. The
daily dosage may be adjusted in increments of 1000
mg every 2 weeks to a maximum recommended daily dose of 3000 mg (2).
See full prescribing information for use in patients with impaired
renal function (2.1).
DOSAGE FORMS AND STRENGTHS
500 mg white, film-coated extended-release tablet (3)
750 mg white, film-coated extended-release tablet (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
SUICIDAL BEHAVIOR AND IDEATION (5.1)
NEUROPSYCHIATRIC ADVERSE REACTIONS: Levetiracetam extended-release
tablets cause somnolence, dizziness, and
behavioral abnormalities. The adverse reactions that may be seen in
patients receiving levetiracetam extended-release
tablets are expected to be similar to those seen in patients receiving
immediate-release levetiracetam tablets. (5.2)
In controlled trials of immediate-release levetiracetam tablets in
patients experiencing partial onset seizures,
immediate-release levetiracetam causes somnolence and fatigue,
coordination difficulties, and behavioral abnormalities
(e.g., psychotic symptoms, suicidal ideation, and other
abnormalities). (5.2)
WITHDRAWAL SEIZURES: Levetiracetam extended-release tablets must be
gradually withdrawn. (5.3)
ADVERSE REACTIONS
M