LEVETIRACETAM injection, solution, concentrate

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Hainan Poly Pharm. Co., Ltd.

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. Levetiracetam is 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 injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. Levetiracetam is 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 injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. Levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam

製品概要:

Levetiracetam 500 mg/5 mL injection is a clear, colorless, sterile solution. It is supplied in single-dose 5 mL vials (NDC 14335-050-01), available in cartons of 10 vials (NDC 14335-050-10) and cartons of 25 vials (NDC 14335-050-25). Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

LEVETIRACETAM- LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE
HAINAN POLY PHARM. CO., LTD.
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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
Contraindications ( 4)
4/2017
Warnings and Precautions, Anaphylaxis and Angioedema ( 5.3)
4/2017
Warnings and Precautions, Hematologic Abnormalities ( 5.7)
10/2017
INDICATIONS AND USAGE
Levetiracetam is indicated for adjunctive therapy, as an alternative
when oral administration is temporarily not feasible, in
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 1,500 mg twice daily ( 2.1)
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 ( 2.2)
Primary Generalized Tonic-Clonic Seizures
6 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg
twice daily every 2 weeks to rec