LEVETIRACETAM injection, solution, concentrate

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Mylan Institutional LLC

INN (שם בינלאומי):

LEVETIRACETAM

הרכב:

LEVETIRACETAM 100 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam injection is 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 injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. Levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.3)]. 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

leaflet_short:

Levetiracetam injection, USP 500 mg/5 mL is a clear, colorless, sterile solution. It is supplied in single-dose 5 mL vials, available in cartons of 10 vials (NDC 67457-790-05). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LEVETIRACETAM- LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE
MYLAN INSTITUTIONAL LLC
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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
INDICATIONS AND USAGE
•
•
•
DOSAGE AND ADMINISTRATION
Levetiracetam injection is for intravenous use only (2.1)
Partial-Onset Seizures (monotherapy or adjunctive therapy)
•
•
•
•
Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older
•
Primary Generalized Tonic-Clonic Seizures
•
•
Switching From or To Oral Levetiracetam
When switching from or to oral levetiracetam, the total daily
dosage/frequency of levetiracetam injection should be
equivalent to those of oral levetiracetam (2.4, 2.5)
See full prescribing information for preparation and administration
instructions (2.6) and dosage adjustment in adults with
renal impairment (2.7)
DOSAGE FORMS AND STRENGTHS
Injection: 500 mg/5 mL single-dose vial (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
•
Levetiracetam injection is indicated for the treatment of
partial-onset seizures in patients 1 month of age and older
(1.1)
Levetiracetam injection is indicated for adjunctive therapy for the
treatment of:
o
o
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)
Levetiracetam injection is for intravenous use only as an alternative
for patients when oral administration is
temporarily not feasible (1.4)
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 Year