LEVETIRACETAM solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 100 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of myoclonic seizures patients12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients6 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) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including levetiracetam, during pregnancy. Encourage women who are taking levetiracetam during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by cal

Product summary:

Levetiracetam Oral Solution, USP: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure along with medication guide provided separately.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lupin Pharmaceuticals, Inc.
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MEDICATION GUIDE
Levetiracetam (LEE-ve-tye-RA-se-tam) Oral Solution USP
Rx only
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 medic

Summary of Product characteristics

LEVETIRACETAM - LEVETIRACETAM SOLUTION
LUPIN 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
INDICATIONS AND USAGE
Levetiracetam oral solution is indicated for the treatment of
partial-onset seizures in patients 1 month of
age and older (1.1)
Levetiracetam oral solution is indicated for adjunctive therapy for
the treatment of:
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 (monotherapy or adjunctive therapy)
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 by10 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 1500 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 1500 mg
twice daily (2.3)
Primary Generalized Tonic-Clonic Seizures
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