LEVETIRACETAM solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Atlantic Biologicals Corps

DCI (Dénomination commune internationale):

LEVETIRACETAM

Composition:

LEVETIRACETAM 100 mg in 1 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 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. This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam oral solution. Levetiracetam levels may decrease during pregnancy [ ]. see Warnings and Precautions ( ) 5.9 There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidenc

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

LEVETIRACETAM- LEVETIRACETAM SOLUTION
Atlantic Biologicals Corps
----------
MEDICATION GUIDE
Levetiracetam 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

Résumé des caractéristiques du produit

LEVETIRACETAM- LEVETIRACETAM SOLUTION
ATLANTIC BIOLOGICALS CORPS
----------
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 100 MG/ML ORAL
SOLUTION INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage, Partial Onset Seizures ( ) [05/2012] Dosage and
Administration,
Partial Onset Seizures ( , , ) [05/2012] Warnings and Precautions ( ,
, , , , ,
) [05/2012] 1.1
2.12.22.5
5.15.35.45.55.75.85.9
INDICATIONS AND USAGE
Levetiracetam oral solution is an antiepileptic drug indicated as
adjunctive therapy in the treatment of:
Partial onset seizures in adults and children 1 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_
7 mg/kg twice daily, increase in increments of 7 mg/kg twice daily
every 2 weeks to recommended dose of 21 mg/kg
twice daily ( ) 1 Month to <6 Months:2.2
10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily
every 2 weeks to recommended dose of 25 mg/kg
twice daily ( ) 6 Months To <4 Years:2.2
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 ( ) 4 years To <16 Years:2.2
500 mg twice daily, increase as needed and tolerated in increments of
500 mg twice daily every 2 weeks to a maximum
dose of 1500 mg twice daily ( ) Adults 16 Years And Older:2.2
_Myoclonic Seizures in Adults and Pediatric Patients 12 Years And
Older_
500