LEVETIRACETAM tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

China Resources Saike Pharmaceutical Co., Ltd.

INN (Tên quốc tế):

LEVETIRACETAM

Thành phần:

LEVETIRACETAM 500 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Levetiracetam tablets are indicated for the treatment of partial-onset in patients 1month 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 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 regis

Tóm tắt sản phẩm:

Levetiracetam tablets USP, 500 mg are yellow, oval-shaped, scored, film-coated tablets engraved with "500 MG" on one side. They are supplied in white HDPE bottles as follows: NDC 43489-122-09 bottles of 120 tablets NDC 43489-122-05 bottles of 1,000 tablets Levetiracetam tablets USP, 1,000 mg are white, oval-shaped, scored, film-coated tablets engraved with "1000 MG" on one side. They are supplied in white HDPE bottles as follows: NDC 43489-124-08 bottles of 60 tablets NDC 43489-124-03 bottles of 500 tablets Levetiracetam Tablets USP, 500 mg and 1,000 mg are functionally scored. 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].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

China Resources Saike Pharmaceutical Co., Ltd.
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MEDICATION GUIDE
LEVETIRACETAM TABLETS, USP
(lee-va-tye-RA-se-tam)
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 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 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 tablets are a prescription medicine taken by mouth that
is used to treat partial-onset
seizures in people 1

Đặc tính sản phẩm

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
CHINA RESOURCES SAIKE PHARMACEUTICAL CO., LTD.
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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, 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 tablets are indicated for the treatment of partial-onset
seizures in patients 1 month of age and older ( 1.1)
Levetiracetam tablets are 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 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 1,500 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 1,500 mg twice daily ( 2.3)
Primary Generalized Tonic-Clon