LEVETIRACETAM tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Dispensing Solutions, Inc.

INN (Kansainvälinen yleisnimi):

LEVETIRACETAM

Koostumus:

LEVETIRACETAM 250 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Levetiracetam tablets USP are 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 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 tablets USP 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 USP 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. None. Levetiracetam levels may decrease during pregnancy [see Warnings and Precautions (5.9)] . Pregnancy Category

Tuoteyhteenveto:

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 65862-245-08             Bottles of 500               NDC 65862-245-05 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 65862-246-08             Bottles of 500               NDC 65862-246-05 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 65862-247-08             Bottles of 500               NDC 65862-247-05 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 30                 NDC 65862-315-30             Bottles of 60                 NDC 65862-315-60             Bottles of 500               NDC 65862-315-05    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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
Dispensing Solutions, Inc.
----------
MEDICATION GUIDE
Levetiracetam Tablets USP
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 taken by mouth that
i

Valmisteyhteenveto

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
DISPENSING SOLUTIONS, INC.
----------
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 USP.
LEVETIRACETAM TABLETS USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage, Partial Onset Seizures (1.1) [12/2011]
Dosage and Administration, Partial Onset Seizures (2.1, 2.2, 2.5)
[12/2011]
Warnings and Precautions (5.1, 5.3, 5.4, 5.7, 5.8, 5.9) [12/2011]
INDICATIONS AND USAGE
Levetiracetam is an antiepileptic drug 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 in increments of
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 as needed and
tolerated in increments of 500 mg twice daily
every 2 weeks to a maximum 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
recommended dose of 30 mg/kg twice daily (2.4)
Adults 16 Years And Older: 50