LEVETIRACETAM tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (इंटरनेशनल नाम):

LEVETIRACETAM

रचना:

LEVETIRACETAM 500 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Levetiracetam tablet 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 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 tablet 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 tablet 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.   Levetiracetam tablets are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and a

उत्पाद समीक्षा:

Levetiracetam tablets USP, 250 mg are blue coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘87’ on other side. Levetiracetam tablets USP, 500 mg are yellow coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘88’ on other side. They are supplied in: Blistercards of 30 (NDC 0615-7977-39) Blistercards of 15 (NDC 0615-7977-05) Unit dose boxes of 30 (NDC 0615-7977-30) Levetiracetam tablets USP, 750 mg are orange coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘90’ on other side. Levetiracetam tablets USP, 1000 mg are white coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘91’ on other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

NCS HealthCare of KY, LLC dba Vangard Labs
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MEDICATION GUIDE:
LEVETIRACETAM (lee-vah-tih-RACE-ah-tam) tablets
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 tablet?
Levetiracetam tablet is a prescription medicine taken by mouth that is
used with other medicines to treat:
•
partial onse

उत्पाद विशेषताएं

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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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 tablet is indicated for adjunctive therapy in the
treatment of: (1)
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 (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
(2)
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 (2)
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 Function (2)
Do