LEVETIRACETAM tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

PD-Rx Pharmaceuticals, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Levetiracetam tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 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 angioedema [ see Warnings and Precautions ( 5.4) ]. Levetiracetam blood levels may decrease during pregnancy [ see Warnings and Precautions ( 5.10)]. Pregnancy Category C There are no adequate and controlled studies in pregnan

Ապրանքի ամփոփագիր:

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 containers of 60 tablets                          (NDC 72789-152-60)   Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

PD-Rx Pharmaceuticals, Inc.
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MEDICATION GUIDE
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 tablet?
Levetiracetam tablet is a prescription medicine taken by mouth that is
used with other medicines to treat:
• partia

Ապրանքի հատկությունները

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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 4/2017
Angioedema (5.4)
Warnings and Precautions, Hematologic Abnormalities (5.8)10/2017
INDICATIONS AND USAGE
Levetiracetam tablet 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 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