LEVETIRACETAM injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Solco Healthcare US, LLC

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 a

Обзор продуктов:

Levetiracetam 500 mg/5 mL injection, USP, is a clear, colorless, sterile solution. It is supplied in single-dose 5 mL vials (NDC 43547-454-41), available in cartons of 10 vials (NDC 43547-454-10). Store at 25o C (77o F); excursions permitted to 15o C to 30o C (59o F to 86o F) [see USP Controlled Room Temperature].

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

LEVETIRACETAM- LEVETIRACETAM INJECTION
SOLCO HEALTHCARE US, 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
RECENT MAJOR CHANGES
Indications and Usage (1.1) 10/2019
Dosage and Administration (2.1, 2.8) 10/2019
INDICATIONS AND USAGE
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•
o
o
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DOSAGE AND ADMINISTRATION
Levetiracetam injection is for intravenous use only (2.1)
Partial-Onset Seizures (monotherapy or adjunctive therapy)
•
•
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Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older
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Primary Generalized Tonic-Clonic Seizures
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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
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis
have occurred (4, 5.3)
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:
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 dai