LEVETIRACETAM LEVETIRACETAM- levetiracetam solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Camber Pharmaceuticals, Inc.

INN (Alþjóðlegt nafn):

LEVETIRACETAM

Samsetning:

LEVETIRACETAM 100 mg in 1 mL

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Levetiracetam oral solution 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 oral solution 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 oral solution 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 oral solution is 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 well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmenta

Vörulýsing:

Levetiracetam oral solution USP, 100 mg/mL is a clear, colorless, grape-flavored liquid. It is supplied in 16 fl. oz. white HDPE bottles (NDC 31722-574-47). Store at 20º C to 25ºC (68º F to 77º F) [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
LEVETIRACETAM (lee-vah-tih-RACE-ah-tam)
oral solution
Read this Medication Guide before you start taking levetiracetam oral
solution 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 oral solution?
Like other antiepileptic drugs, levetiracetam oral solution 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 oral solution without first talking to a
healthcare provider.
• Stopping levetiracetam oral solution 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 oral solution?
Levetiracetam oral solution is a prescription medicine t

Vara einkenni

LEVETIRACETAM LEVETIRACETAM- LEVETIRACETAM SOLUTION
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM ORAL SOLUTION SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM
ORAL SOLUTION.
LEVETIRACETAM ORAL SOLUTION
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Contraindications (4) 4/2017
Warnings and Precautions, Anaphylaxis and Angioedema (5.4) 4/2017
Warnings and Precautions, Hematologic Abnormalities (5.8) 10/2017
INDICATIONS AND USAGE
Levetiracetam oral solution 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 daily (2.3)
Primary Generalized Tonic-