LEVETIRACETAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. Levetiracetam tablets are 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

Product summary:

Levetiracetam 250 mg tablets, USP are blue colored, oval shaped, film-coated tablets debossed with breakline separating '250' and 'MG' on one side and '1014' on other side. They are supplied as:                                 Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6051-61 Levetiracetam 500 mg tablets, USP are yellow colored, oval shaped, film-coated tablets debossed with breakline separating '500' and 'MG' on one side and '1015' on other side. They are supplied as:                                 Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6052-61 Levetiracetam 750 mg tablets, USP are orange colored, oval shaped, film-coated tablets debossed with breakline separating '750' and 'MG' on one side and '1016' on other side. They are supplied as:                                 Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6053-61 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

Major Pharmaceuticals
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MEDICATION GUIDE
Levetiracetam (LEE-ve-tye-RA-se-tam) Tablets, USP
Read this Medication Guide before you start taking levetiracetam 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
to treat partial-onset seizures in people
1 month of age and older.
Levetiracetam is

Summary of Product characteristics

LEVETIRACETAM- LEVETIRACETAM TABLET
MAJOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVETIRACETAM TABLETS.
LEVETIRACETAM TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage ( 1.1) 10/2019
Dosage and Administration ( 2.2, 2.6) 10/2019
INDICATIONS AND USAGE
Levetiracetam is indicated for the treatment of partial-onset seizures
in patients 1 month of age and older
( 1.1)
Levetiracetam is indicated for adjunctive therapy for the treatment
of:
•
•
DOSAGE AND ADMINISTRATION
•
•
Partial-Onset Seizures (monotherapy or adjunctive therapy)
•
•
•
•
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
•
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)
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 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 1500 mg twice daily ( 2.2)
500 mg twice daily; increase by 500 mg twic