LEVETIRACETAM- levetiracetam tablet, film coated

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 is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Information describing the use of levetiracetam tablets in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets. However, due to UCB Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. None. Levetiracetam blood levels may decrease during pregnancy [see Warnings and Precautions (5.9)]. P r e gnancy Category C There are no adequate a

Product summary:

Levetiracetam tablets, USP 250 mg are available as light blue, capsule-shaped, biconvex, film-coated tablets, debossed “250” and a score on one side and “0136” on the reverse side of the tablets. Levetiracetam tablets, USP 250 mg are available as follows: Bottles of 60 (NDC 64376-136-61) Bottles of 90 (NDC 64376-136-90) Bottles of 120 (NDC 64376-136-12) Bottles of 500 (NDC 64376-136-05) Unit Dose of 100 (10 tablets per card, 10 cards per carton) (NDC 64376-136-99) Levetiracetam tablets, USP 500 mg are available as yellow, capsule-shaped, biconvex, film-coated tablets, debossed “500” and a score on one side and “0137” on the reverse side of the tablets. Levetiracetam tablets, USP 500 mg are available as follows: Bottles of 60 (NDC 64376-137-61) Bottles of 90 (NDC 64376-137-90) Bottles of 120 (NDC 64376-137-12) Bottles of 500 (NDC 64376-137-05) Unit Dose of 100 (10 tablets per card, 10 cards per carton) (NDC 64376-137-99) Levetiracetam tablets, USP 750 mg are available as light orange pink, capsule-shaped, biconvex, film-coated tablets, debossed “750” and a score on one side and “0138” on the reverse side of the tablets. Levetiracetam tablets, USP 750 mg are available as follows: Bottles of 60 (NDC 64376-138-61) Bottles of 90 (NDC 64376-138-90) Bottles of 120 (NDC 64376-138-12) Bottles of 500 (NDC 64376-138-05) Unit Dose of 100 (10 tablets per card, 10 cards per carton) (NDC 64376-138-99) Dispensed in a blister pack for Institutional Use Only. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
Reference Label Set Id: 92cdf763-8aea-4f3a-be05-e515f3cd4317
----------
MEDICATION GUIDE
Levetiracetam (LEE-ve-tye-RA-se-tam) Tablets, USP
Read this Medication Guide before you start taking levetiracetam
tablets, USP 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 tablets, USP?
Like other antiepileptic drugs, levetiracetam tablets, USP 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 tablets, USP without first talking to a
healthcare provider.
•
Stopping levetiracetam tablets, USP 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 is levetiracetam?
Levetiracetam is a prescript

Summary of Product characteristics

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
REMEDYREPACK INC.
REFERENCE LABEL SET ID: 92CDF763-8AEA-4F3A-BE05-E515F3CD4317
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEVETIRACETAM.
LEVETIRACETAM TABLETS, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions, ( 5.1, 5.3, 5.7, 5.8) 03/2015
INDICATIONS AND USAGE
Levetiracetam is indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients 4 years of age and older with
epilepsy ( 1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile
myoclonic epilepsy ( 1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age
and older with idiopathic generalized epilepsy ( 1.3)
DOSAGE AND ADMINISTRATION
• Use the oral solution for pediatric patients with body weight ≤
20 kg ( 2.1).
• For pediatric patients, use weight-based dosing for the oral
solution with a calibrated measuring device (not a household
teaspoon or tablespoon) ( 2.1)
Partial Onset Seizures_ _
• 4 Years To < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg
twice daily every 2 weeks to recommended dose of
30 mg/kg twice daily ( 2.2)
• Adults 16 Years And Older: 500 mg twice daily; increase by 500 mg
twice daily every 2 weeks to a recommended dose of
1,500 mg twice daily ( 2.2)
Myoclonic Seizures In Adults and Pediatric Patients 12 Years And
Older_ _
• 500 mg twice daily, increase by 500 mg twice daily every 2 weeks
to recommended dose of 1,500 mg twice daily ( 2.3)
Primary Generalized Tonic-Clonic Seizures_ _
• 6 Years To < 16 Years: 10 mg/kg twice daily; increase in
increments of 10 mg/kg twice daily every 2 weeks to
recommended dose of 30 mg/kg twice daily ( 2.4)
• Adults 16 Years And Older : 500 mg twice daily, increase by 500 mg
twice daily every 2 weeks to recommended dose of
1,500 mg twice daily ( 2.4)
Adult Patients With Impaired Renal Fun