LEVETIRACETAM- levetiracetam solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Cardinal Health

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Levetiracetam Oral Solution USP 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 USP 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 USP 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. 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 t

Product samenvatting:

Levetiracetam Oral Solution USP is a clear, colorless, grape-flavored liquid. It is supplied in the following oral dosage forms: 5 mL Unit Dose Cups - available overbagged with 5 cups per bag, NDC 55154-9447-5 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

LEVETIRACETAM- LEVETIRACETAM SOLUTION
Cardinal Health
----------
MEDICATION GUIDE
LEVETIRACETAM ORAL SOLUTION USP
(LEE VE TYE RA SE TAM)
MG0799102 R10/15
Read this Medication Guide before you start taking Levetiracetam Oral
Solution USP 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 USP?
Like other antiepileptic drugs, Levetiracetam Oral Solution USP 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 USP without first talking to a
healthcare provider.
•
Stopping Levetiracetam Oral Solution USP 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 So

Productkenmerken

LEVETIRACETAM- LEVETIRACETAM SOLUTION
CARDINAL HEALTH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM ORAL SOLUTION USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM
ORAL SOLUTION USP.
LEVETIRACETAM ORAL SOLUTION USP
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions, (5.1, 5.3, 5.7, 5.8)
03/2015
INDICATIONS AND USAGE
Levetiracetam Oral Solution USP is indicated for adjunctive therapy in
the treatment of:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
Partial Onset Seizures
•
•
•
•
Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older
•
Primary Generalized Tonic-Clonic Seizures
•
•
Adult Patients with Impaired Renal Function
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Partial onset seizures in patients 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)
Use the oral solution for pediatric patients with body weight less
than or equal to 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)
1 Month to less than 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 less than 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 less than 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)
500 mg twice daily; increase by 500 mg twice daily every 2 w