LEVETIRACETAM injection solution concentrate

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:

American Regent, Inc.

INN (Tên quốc tế):

LEVETIRACETAM

Thành phần:

LEVETIRACETAM 100 mg in 1 mL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

LEVETIRACETAM- LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE
AMERICAN REGENT, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM
INJECTION.
LEVETIRACETAM INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Indications and Usage (1.1, 1.2, 1.3)
10/2014
Dosage and Administration (2.1, 2.3, 2.6)
10/2014
Warnings and Precautions (5.1, 5.2, 5.7)
10/2014
Warnings and Precautions, Hematologic Abnormalities (5.6)
03/2015
INDICATIONS AND USAGE
Levetiracetam njection is indicated for adjunctive therapy, as an
alternative when oral administration is temporarily not
feasible, for the treatment of:
Partial onset seizures in patients 1 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
Levetiracetam injection is for intravenous use only (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 (2.1)
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 (2.1)
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 (2.1)
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 (2.1)
Myoclonic Seizures in Adult Patients 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 (2.2)
Primary Generalized Tonic-Clonic Seizures
6 Years to < 16 Years: 10 mg/kg twice daily; incre