LEVETIRACETAM tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

DIRECT RX

INN (Tarptautinis Pavadinimas):

LEVETIRACETAM

Sudėtis:

LEVETIRACETAM 250 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

16.1 How Supplied 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 16.2 Storage 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.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

LEVETIRACETAM- LEVETIRACETAM TABLET
DIRECT RX
----------
SPL MEDGUIDE SECTION
See FDA-approved Patient Labeling (Medication Guide).
Counsel patients on the benefits and risks of receiving levetiracetam.
Provide the Medication Guide to
patients and/or caregivers, and instruct them to read the Medication
Guide prior to taking levetiracetam.
Instruct patients to take levetiracetam only as prescribed.
Suicidal Behavior and Ideation
Counsel patients, their caregivers, and/or families that antiepileptic
drugs (AEDs), including
levetiracetam, may increase the risk of suicidal thoughts and behavior
and advise patients to be alert for
the emergence or worsening of symptoms of depression; unusual changes
in mood or behavior; or
suicidal thoughts, behavior, or thoughts about self-harm. Advise
patients, their caregivers, and/or families
to immediately report behaviors of concern to a healthcare provider.
Psychiatric Reactions and Changes in Behavior
Advise patients that levetiracetam may cause changes in behavior (e.g.
aggression, agitation, anger,
anxiety, apathy, depression, hostility, and irritability) and in rare
cases, psychotic symptoms have
occurred.
Effects on Driving or Operating Machinery
Inform patients that levetiracetam may cause dizziness and somnolence.
Inform patients not to drive or
operate machinery until they have gained sufficient experience on
levetiracetam to gauge whether it
adversely affects their ability to drive or operate machinery.
Dermatological Adverse Reactions
Advise patients that serious dermatological adverse reactions have
occurred in patients treated with
levetiracetam and instruct them to call their physician immediately if
a rash develops.
Pregnancy
Advise patients to notify their healthcare provider if they become
pregnant or intend to become pregnant
during levetiracetam therapy. Encourage patients to enroll in the
North American Antiepileptic Drug
(NAAED) pregnancy registry if they become pregnant. This registry is
collecting information about the
safety of antiepileptic drugs during

Prekės savybės

LEVETIRACETAM- LEVETIRACETAM TABLET
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.
2. DOSAGE AND ADMINISTRATION
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 not been shown.
Tre