LEVETIRACETAM- levetiracetam tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam extended-release tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. Levetiracetam extended-release tablet is contraindicated in patients with a hypersensitivity to levetiracetam . Reactions have included anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS ( 5.4)]. Extended-release levetiracetam tablets levels may decrease during pregnancy [see WARNINGS AND PRECAUTIONS ( 5.9)]. 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. Extended-release levetiracetam 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 ske

Product summary:

Levetiracetam Extended-release Tablets USP, 500 mg are white to off white, oblong-shaped, biconvex, film coated tablets, imprinted 'L008' (in black ink) on one side and plain on the other side. They are supplied in white HDPE bottles containing 60 tablets (NDC 68180-117-07) and white HDPE bottles containing 500 tablets (NDC 68180-117-02). Levetiracetam Extended-release Tablets USP, 750 mg are white to off white, oblong-shaped, biconvex, film coated tablets, imprinted 'L009' (in black ink) on one side and plain on the other side. They are supplied in white HDPE bottles containing 60 tablets (NDC 68180-118-07) and white HDPE bottles containing 500 tablets (NDC 68180-118-02). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
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MEDICATION GUIDE
LEVETIRACETAM (LEE-ve-tye-RA-se-tam) EXTENDED-RELEASE TABLETS USP
Rx Only
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 exten

Summary of Product characteristics

LEVETIRACETAM- LEVETIRACETAM TABLET, EXTENDED RELEASE
REMEDYREPACK 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
Contraindications ( 4) 3/2017
Warnings and Precautions, Anaphylaxis and Angioedema ( 5.4) 3/2017
Warnings and Precautions, Hematologic Abnormalities ( 5.8) 10/2017
INDICATIONS AND USAGE
Levetiracetam extended-release tablet is 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
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis
have occurred ( 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 extended-release levetiracetam tablets ( 5.3)
Withdrawal Seizures: Extended-release levetiracetam tablets must be
gradually withdrawn ( 5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% more than placebo)
include: somnolenc