LEVETIRACETAM tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Zydus Pharmaceuticals USA Inc.

ИНН (Международная Имя):

LEVETIRACETAM

состав:

LEVETIRACETAM 250 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month 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. Levetiracitam 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 registry by calling 1-888-233-2334 or vi

Обзор продуктов:

Levetiracetam Tablets, 250 mg are white to off-white, oval-shaped, biconvex, film-coated tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '32' and other side is plain and are supplied as follows: NDC 68382-165-19 in bottle of 120 tablets NDC 68382-165-10 in bottle of 1000 tablets NDC 68382-165-30 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Levetiracetam Tablets, 1000 mg are white to off-white, oval-shaped, biconvex, film-coated tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '35' and other side is plain and are supplied as follows: NDC 68382-168-14 in bottle of 60 tablets NDC 68382-168-10 in bottle of 1000 tablets NDC 68382-168-30 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Store at 20° C to 25°C (68° F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

Zydus Pharmaceuticals USA Inc.
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MEDICATION GUIDE
Levetiracetam (lee" ve tye ra' se tam) Tablets
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 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 is a prescription medicine taken by mouth that is used
to treat partial-onset seizures in people
1 month of age and older.
Levetiracet

Характеристики продукта

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVETIRACETAM TABLETS.
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 tablet is indicated for the treatment of partial-onset
seizures in patients 1 month of age
and older (1.1)
Levetiracetam tablet 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)
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 1500 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-CLONIC SEIZURES
6 Years to < 16 Years: 10 mg/kg