LEVETIRACETAM tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Clinical Solutions Wholesale, LLC

INN（国际名称）:

LEVETIRACETAM

组成:

LEVETIRACETAM 250 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Levetiracetam tablets USP 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 USP 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 USP 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. Levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS ( 5.4)] . Levetiracetam blood levels may decrease during pregnancy [see WARNINGS AND PRECAUTIONS ( 5.10)].

產品總結:

Levetiracetam tablets USP, 250 mg are blue coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X01" on the other side. They are supplied as follows: NDC 68180-112-09                Bottles of 90's NDC 68180-112-16                Bottles of 120's NDC 68180-112-02                Bottles of 500's Levetiracetam tablets USP, 500 mg are yellow coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X02" on the other side. They are supplied as follows: NDC 68180-113-09                Bottles of 90's NDC 68180-113-16                Bottles of 120's NDC 68180-113-02                Bottles of 500's Levetiracetam tablets USP, 750 mg are orange coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X03" on the other side. They are supplied as follows: NDC 68180-114-09                Bottles of 90's NDC 68180-114-16                Bottles of 120's NDC 68180-114-02                Bottles of 500's Levetiracetam tablets USP, 1000 mg are white to off-white coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X04" on the other side. They are supplied as follows: NDC 68180-115-07                Bottles of 60's NDC 68180-115-02                Bottles of 500's 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 child-resistant closure along with medication guide provided separately.

授权状态:

Abbreviated New Drug Application

资料单张

Clinical Solutions Wholesale, LLC
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MEDICATION GUIDE
LEVETIRACETAM (LEE-ve-tye-RA-se-tam)
TABLETS USP 250 mg, 500 mg, 750 mg and 1000 mg
Rx only
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 medici

产品特点

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
CLINICAL SOLUTIONS WHOLESALE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM TABLETS
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVETIRACETAM TABLETS
USP.
LEVETIRACETAM TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Contraindications ( 4) 4/2017
Warnings and Precautions, Anaphylaxis and Angioedema ( 5.4) 4/2017
Warnings and Precautions, Hematologic Abnormalities ( 5.8) 10/2017
INDICATIONS AND USAGE
Levetiracetam tablets USP are indicated for adjunctive therapy in the
treatment of:
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)
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
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)
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 Se