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:

ACETRIS HEALTH, LLC

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. Levetiracetam tablets are 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 tablets are 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. Levetiracetam tablets are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. Levetiracetam blood levels may decrease during pregnancy [see Warnings and Precautions (5.10)] . Teratogenic Effects Pregnancy Category C   There are no adequate and controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, inc

Product summary:

Levetiracetam Tablets USP, 250 mg  are blue oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘10’ on one side and plain on the other side.   Bottles of 120                      NDC 52343-069-12   Bottles of 500                      NDC 52343-069-05  Levetiracetam Tablets USP, 500 mg  are yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘11’ on one side and plain on the other side.   Bottles of 120                      NDC 52343-070-12   Bottles of 500                      NDC 52343-070-05  Levetiracetam Tablets USP, 750 mg  are orange oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘12’ on one side and plain on the other side.   Bottles of 120                      NDC 52343-071-12   Bottles of 500                      NDC 52343-071-05  Levetiracetam Tablets USP, 1000 mg  are white to off-white modified oval shaped biconvex film-coated tablets debossed with a deep breakline separating ‘E’ and ‘13’ on one side and plain on the other side.   Bottles of 60                        NDC 52343-072-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
ACETRIS HEALTH, LLC
----------
MEDICATION GUIDE
Levetiracetam Tablets USP
(lee'' ve tye ra' se tam)
Read this Medication Guide before you start taking 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
levetiracetam tablets?
Like other antiepileptic drugs, 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 levetiracetam tablets without first talking to a
healthcare provider.
•
Stopping 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 scheduled.
•
Call your healthcare provider between visits as needed, especially if
you are worried about
symptoms.
What are levetiracetam tablets?
Levetiracetam tablets are a prescription medicine t

Summary of Product characteristics

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
ACETRIS HEALTH, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM
TABLETS.
LEVETIRACETAM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Contraindications (4) 4/2017
Warnings and Precautions, Anaphylaxis and Angioedema (5.4) 4/2017
INDICATIONS AND USAGE
Levetiracetam is indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients one month 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
1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice
daily every 2 weeks to recommended dose of
21 mg/kg twice daily (2.2)
6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg
twice daily every 2 weeks to recommended dose of
25 mg/kg twice daily (2.2)
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 1500 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 1500 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
r