LEVETIRACETAM- levetiracetam tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Lotus Pharmaceutical Co., Ltd. Nantou Plant

INN (International ime):

LEVETIRACETAM

Sastav:

LEVETIRACETAM 750 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Levetiracetam tablets, USP 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, 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 blood levels may decrease during pregnancy [ see Warnings and Precautions (5.9) ]. Pregnancy Category C There are no adequate and 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 should be used during pregnancy only if the potential benefit justifies the potent

Proizvod sažetak:

Levetiracetam tablets, USP, 250 mg are blue to light blue, oval, film-coated tablets, bisect debossed with logo "TL" and "622" on one side. The other side is blank. They are supplied in white HDPE bottles containing 120 tablets (NDC 40051-135-11). Levetiracetam tablets, USP, 500 mg are yellow to light yellow, oval, film-coated tablets, bisect debossed with logo "BK"and "500" on one side. The other side is blank. They are supplied in white HDPE bottles containing 120 tablets (NDC 40051-136-12). Levetiracetam tablets, USP, 750 mg are orange to light orange, oval, film-coated tablets, bisect debossed with logo "TL" and "623" on one side. The other side is blank. They are supplied in white HDPE bottles containing 120 tablets (NDC 40051-137-11). Levetiracetam tablets, USP, 1,000 mg are white, oval, film-coated tablets, bisect debossed with logo "TL" and "624" on one side. The other side is blank. They are supplied in white HDPE bottles containing 60 tablets (NDC 40051-138-11). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Lotus Pharmaceutical Co., Ltd. Nantou Plant
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MEDICATION GUIDE
Levetiracetam (lee-vah-tih-RACE-ah-tam) Tablets, USP
Read this Medication Guide before you start taking levetiracetam 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?
Like other antiepileptic drugs, levetiracetam 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 without first talking to a healthcare
provider.
•
Stopping levetiracetam 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 prescription medicine taken by mouth that is used
with other medicines to treat:
•
partial onset seizure

Svojstava lijeka

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
LOTUS PHARMACEUTICAL CO., LTD. NANTOU PLANT
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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, FILM COATED FOR ORAL USE.
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levetiracetam tablets, USP are 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 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 1