LEVETIRACETAM tablet, film coated, extended release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

AvKARE, Inc.

INN (Tên quốc tế):

LEVETIRACETAM

Thành phần:

LEVETIRACETAM 500 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Levetiracetam extended-release tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. None. Levetiracetam extended-release levels may decrease during pregnancy [ see Warnings and   Precautions ( 5.8 ) ] . 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 (equivalent to the maximum recommended human dose of 3000 mg [MRHD]

Tóm tắt sản phẩm:

Levetiracetam Extended-release Tablets USP, 500 mg are white, oblong-shaped, film-coated tablets debossed with "500" on one side. They are supplied in bottles of 60 tablets (NDC 42291-387-60). Levetiracetam Extended-release Tablets USP, 750 mg are white, oblong-shaped, film-coated tablets debossed with "750" on one side. They are supplied in bottles of 60 tablets (NDC 42291-388-60). Store at 25°C (77°F); excursions permitted to 15⁰ to 30°C (59⁰ to 86°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
AvKARE, Inc.
----------
MEDICATION GUIDE
Patient should be instructed to take extended-release levetiracetam
tablets only as prescribed.
Levetiracetam Extended-Release Tablets
Read this Medication Guide before you start taking extended-release
levetiracetam 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
extended-release levetiracetam tablets?
Like other antiepileptic drugs, extended-release levetiracetam 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 extended-release levetiracetam tablets without first
talking to a healthcare provider.
Stopping extended-release levetiracetam 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 schedule
Call your healthcare provider

Đặc tính sản phẩm

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
AVKARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
LEVITIRACETAM EXTENDED-RELEASE TABLETS USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM EXTENDED-RELEASE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FORLEVETIRACETAM EXTENDED-RELEASE TABLETS.
LEVETIRACETAM EXTENDED-RELEASE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage ( 1)
08/2014
Warnings and Precautions ( 5.1, 5.3, 5.7)
03/2015]
INDICATIONS AND USAGE
Levetiracetam extended-release tablets USP are indicated for
adjunctive therapy in the treatment of partial onset seizures
in patients 12 years of age and older with epilepsy ( 1)
DOSAGE AND ADMINISTRATION
Initiate treatment with a dose of 1000 mg once daily; increase by 1000
mg every 2 weeks to a maximum
recommended dose of 3000 mg once daily ( 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
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)
Withdrawal Seizures: levetiracetam extended-release tablets must be
gradually withdrawn ( 5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% more than in placebo)
include: somnolence and irritability ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AVKARE, INC. AT
1-855-