LEVETIRACETAM tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

DIRECT RX

INN (Միջազգային անվանումը):

LEVETIRACETAM

Կազմը:

LEVETIRACETAM 500 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

1.1 Partial Onset Seizures Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam tablets USP are 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 gener

Ապրանքի ամփոփագիր:

Levetiracetam tablets USP, 250 mg are blue coloured, oblong-shaped, biconvex, film-coated tablets, debossed with "L" and "U" on either side of the breakline on one side and "X01" on the other side. They are supplied as follows: NDC 68180-112-09                Bottles of 90's NDC 68180-112-16                Bottles of 120's NDC 68180-112-02                Bottles of 500's Levetiracetam tablets USP, 500 mg are yellow coloured, oblong-shaped, biconvex, film-coated tablets, debossed with "L" and "U" on either side of the breakline on one side and "X02" on the other side. They are supplied as follows: NDC 68180-113-09                Bottles of 90's NDC 68180-113-16                Bottles of 120's NDC 68180-113-02                Bottles of 500's Levetiracetam tablets USP, 750 mg are orange coloured, oblong-shaped, biconvex, film-coated tablets, debossed with "L" and "U" on either side of the breakline on one side and "X03" on the other side. They are supplied as follows: NDC 68180-114-09                Bottles of 90's NDC 68180-114-16                Bottles of 120's NDC 68180-114-02                Bottles of 500's Levetiracetam tablets USP, 1000 mg are white to off-white coloured, oblong-shaped, biconvex, film-coated tablets, debossed with "L" and "U" on either side of the breakline on one side and "X04" on the other side. They are supplied as follows: NDC 68180-115-07                Bottles of 60's NDC 68180-115-02                Bottles of 500's Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with child-resistant closure along with medication guide provided separately.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
DIRECT RX
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
LEVETIRACETAM TABLETS USP
250 mg, 500 mg, 750 mg and 1000 mg
Rx only
Read this Medication Guide before you start taking levetiracetam
tablets 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 tablets?
Like other antiepileptic drugs, levetiracetam tablets 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 tablets without first talking to a
healthcare provider.
Stopping levetiracetam tablets 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 are levetiracetam tablets?
Levetiracetam tablets are a prescription medicine taken by mouth that
is used with other med

Ապրանքի հատկությունները

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
DIRECT RX
----------
LEVETIRACETAM
INDICATIONS & USAGE SECTION
1.1 Partial Onset Seizures
Levetiracetam tablets USP are indicated as adjunctive therapy in the
treatment of partial
onset seizures in adults and children 4 years of age and older with
epilepsy.
Information describing the use of levetiracetam in pediatric patients
less than 4 years of
age as adjunctive therapy in the treatment of partial onset seizures
is approved for UCB,
Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing
exclusivity rights, this
drug product is not labeled with that pediatric information.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets USP are indicated as adjunctive therapy in the
treatment of
myoclonic seizures in adults and adolescents 12 years of age and older
with juvenile
myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets USP are 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.
DOSAGE & ADMINISTRATION SECTION
2.1 Important Administration Instructions
Levetiracetam tablets are given orally with or without food. The
levetiracetam dosing
regimen depends on the indication, age group, dosage form (tablets or
oral solution),
and renal function.
Prescribe the oral solution for pediatric patients with body weight
≤ 20 kg. Prescribe
the oral solution or tablets for pediatric patients with body weight
above 20 kg.
Levetiracetam tablets should be swallowed whole. Levetiracetam tablets
should not
be chewed or crushed.
2.2 Partial Onset Seizures
Adults 16 Years and Older
In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg,
given as twice-daily
dosing were shown to be effective. Although in some studies there was
a tendency
toward greater response with higher dose [see CLINICAL STUDIES (
14.1)], a
consistent increase in response with increased dose has no