LEVETIRACETAM- levetiracetam tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Preferred Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

LEVETIRACETAM

Kompozīcija:

LEVETIRACETAM 500 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with 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. 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. Levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS ( 5.4)] . Levetiracetam blood levels may decrease during pregnancy [see WARNINGS AND PRECAUTIONS (5.10)].   Pregnancy Category C There are no adequate and controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratoge

Produktu pārskats:

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 68788-6838-2                Bottles of 20's NDC 68788-6838-3                Bottles of 30's NDC 68788-6838-6                Bottles of 60's NDC 68788-6838-9                Bottles of 90's NDC 68788-6838-1                Bottles of 100'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.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
LEVETIRACETAM (LEE-ve-tye-RA-se-tam)
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?

Produkta apraksts

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM
TABLETS USP.
LEVETIRACETAM TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Contraindications (4) 4/2017
Warnings and Precautions, Anaphylaxis and Angioedema (5.4) 4/2017
Warnings and Precautions, Hematologic Abnormalities (5.8) 10/2017
INDICATIONS AND USAGE
Levetiracetam tablets USP are indicated for adjunctive therapy in the
treatment of:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
Partial Onset Seizures
•
•
•
•
Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older
•
Primary Generalized Tonic-Clonic Seizures
•
•
Adult Patients with Impaired Renal Function
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis
have occurred (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% more than placebo)
include:
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICAL
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Pregnancy: Plasma levels of levetiracetam may be decreased and
therefore need to be monitored closely during
pregnancy. Based on animal data, may cause fetal harm (5.10, 8.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 9/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Partial Onset Seizures
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
1.3 Primary Generalized Tonic-Clonic Seizures
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Dosing for Partial Onset Seizures
2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and
Older with Juvenile Myoclonic
Epilepsy
2.4 D