LEVETIRACETAM solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

levetiracetam (UNII: 44YRR34555) (levetiracetam - UNII:44YRR34555)

थमां उपलब्ध:

Atlantic Biologicals Corps.

INN (इंटरनेशनल नाम):

levetiracetam

रचना:

levetiracetam 100 mg in 1 mL

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Levetiracetam oral solution 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 oral solution 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 oral solution. However, due to UCB Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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. None. Levetiracetam levels may decrease during pregnancy . [see ]

उत्पाद समीक्षा:

NDC:17856-0241-1 in a CUP of 10 SOLUTIONS NDC:17856-0241-5 in a CUP of 5 SOLUTIONS Levetiracetam Oral Solution 100 mg/mL is a clear, colorless, grape-flavored liquid. It is supplied in 16 fl. oz. (473 mL) white HDPE bottles. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; excursions permitted to 15°-30°C (59°-86°F). Dispense accompanying Medication Guide to each patient.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

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 prescriptio

उत्पाद विशेषताएं

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 ORAL SOLUTION
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levetiracetam oral solution is an antiepileptic drug indicated for
adjunctive therapy in the treatment of:
•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
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
•Psychiatric Symptoms: Behavioral abnormalities including psychotic
symptoms, suicidal ideation, irritability, and
aggressive behavior have been observed. Monitor patients for
psychiatric signs and symptoms ( ) 5.1•Suicidal Behavior
and Ideation: Monitor patients for new or worsening depression,
suicidal thoughts/behavior, and/or unusual changes in
mood or behavior ( ) 5.2•Somnolence and Fatigue: Monitor patients
for these symptoms and advise patients not to drive or
operate machinery until they have gained sufficient experience on
levetiracetam ( ) 5.3•Withdrawal Seizures:
Levetiracetam must be gradually withdrawn ( ) 5.6
ADVERSE REACTIONS
Most common adverse reactions (incidence in levetiracetam-treated
patients is ≥ 5% more than in placebo-treated
patients) include:
Use the oral solution for pediatric patients with body weight ≤ 20
kg ( ). 2.1
For pediatric patients, use weight-based dosing for the ora