LEVETIRACETAM- levetiracetam solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Roxane Laboratories, Inc

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 100 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam Oral Solution, USP 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 and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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 levels may decrease during pregnancy [see Warnings and Precautions (

Product summary:

Levetiracetam Oral Solution, USP is supplied as a clear, colorless, cherry-flavored liquid. 0054-0224-63 100 mg/mL, 500 mL bottle Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVETIRACETAM- LEVETIRACETAM SOLUTION
Roxane Laboratories, Inc
----------
MEDICATION GUIDE
Levetiracetam Oral Solution, USP
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?
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?
Levetiracetam is a prescription medicine taken by mouth that is used
with other medicines to treat:
•
par

Summary of Product characteristics

LEVETIRACETAM- LEVETIRACETAM SOLUTION
ROXANE LABORATORIES, INC
----------
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
INDICATIONS AND USAGE
Levetiracetam Oral Solution, USP is an antiepileptic drug 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
•
WARNINGS AND PRECAUTIONS
•
•
•
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)
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)
4 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 (2.2)
Adults 16 Years And Older: 500 mg twice daily, increase as needed and
tolerated in increments of 500 mg twice daily
every 2 weeks to a maximum recommended dose of 1500 mg twice daily
(2.2)
500 mg twice daily, increase by 500 mg twice daily every 2 weeks to
recommended dose of 1500 mg twice daily (2.3)
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