LEVETIRACETAM tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Cardinal Health 107, LLC

INN (Международно Name):

LEVETIRACETAM

Композиция:

LEVETIRACETAM 250 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. Levetiracetam tablets are 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 tablets are 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)]. 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 tablets should be used during pregnancy only if the potential benefit justifies the poten

Каталог на резюме:

Levetiracetam Tablets, USP are available containing 500 mg of levetiracetam, USP. The 500 mg tablets are white, film-coated, modified capsule-shaped scored tablets debossed with M to the left of the score and 615 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5699-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
Cardinal Health 107, LLC
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MEDICATION GUIDE
Levetiracetam Tablets, USP
(lee'' va tye ra' se tam)
Read this Medication Guide before you start taking levetiracetam
tablets 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 tablets?
Like other antiepileptic drugs, levetiracetam tablets 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 tablets without first talking to a
healthcare provider.
•
Stopping levetiracetam tablets 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 are levetiracetam tablets?
Levetiracetam tablets are a prescription medic

Данни за продукта

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levetiracetam tablets are 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 one 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 ≤ 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 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, in