LEVETIRACETAM tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Laurus Generics Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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. Levetiracetam tablet 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

Ringkasan produk:

Levetiracetam tablets, USP, 250 mg, are supplied as blue, oblong-shaped, scored, film-coated tablets debossed with “OL” and “250” on one side. They are supplied in white HDPE bottles and are available as follows: Bottles of 120:                       NDC 42385-954-12 Levetiracetam tablets, USP, 500 mg, are supplied as yellow, oblong-shaped, scored, film-coated tablets debossed with “OL” and “500”on one side. They are supplied in white HDPE bottles and are available as follows: Bottles of 120:                        NDC 42385-955-12 Bottles of 500:                        NDC 42385-955-05 Levetiracetam tablets, USP, 750 mg, are supplied as dark pink, oblong-shaped, scored, film-coated tablets debossed with “OL” and “750” on one side. They are supplied in white HDPE bottles and are available as follows: Bottles of 120:                       NDC 42385-956-12 Levetiracetam tablets, USP, 1,000 mg, are supplied as white, oblong-shaped, scored, film-coated tablets debossed with “OL” and “1000” on one side. They are supplied in white HDPE bottles and are available as follows: Bottles of 60:                        NDC  42385-957-60 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]. Dispense in a tight, light-resistant container with a child-resistant closure.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Laurus Generics Inc.
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Dispense with
Medication Guide available at:
https://www.laurusgenerics.us/images/Leve-MG.PDF
MEDICATION GUIDE
Levetiracetam (LEE-
ve-tye-RA-se-tam) Tablets, USP
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?
Levetiracet

Ciri produk

LEVETIRACETAM- LEVETIRACETAM TABLET
LAURUS GENERICS 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
Indication and Usage (1.1) 10/2019
Dosage and Administration (2.2, 2.6) 10/2019
INDICATIONS AND USAGE
Levetiracetam tablets are indicated for the treatment of partial-
onset seizures in patients 1 month of age
and older (1.1)
Levetiracetam tablets are 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 1,500 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 twice daily, inc