LEVETIRACETAM- levetiracetam tablet, film coated, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Actavis Pharma, Inc.

INN (Διεθνής Όνομα):

LEVETIRACETAM

Σύνθεση:

LEVETIRACETAM 500 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Levetiracetam extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. Levetiracetam extended-release tablets are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4) ]. Levetiracetam extended-release tablets levels may decrease during pregnancy [see  Warnings and Precautions (5.9) ]. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. Levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal

Περίληψη προϊόντος:

Levetiracetam extended-release tablets USP, 500 mg are white, round, film coated tablets, with one hole on one side of the tablet imprinted with “WPI ” and “3635 ” on one side. They are available as: Bottles of 60 NDC 0591-3635-60 Levetiracetam extended-release tablets USP, 750 mg are white, round, film coated tablets, with one hole on one side of the tablet imprinted with “WPI ” and “3699 ” on one side. They are available as: Bottles of 60 NDC 0591-3699-60 PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Actavis Pharma, Inc.
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MEDICATION GUIDE
Levetiracetam (LEE-ve-tye-RA-se-tam) Extended-Release Tablets
Read this Medication Guide before you start taking levetiracetam
extended-release 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 extended-release tablets?
Like other antiepileptic drugs, levetiracetam extended-release 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 extended-release tablets without first
talking to a healthcare provider.
•
Stopping levetiracetam extended-release 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 extended-relea

Αρχείο Π.Χ.Π.

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM EXTENDED-RELEASE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVETIRACETAM EXTENDED-RELEASE TABLETS.
LEVETIRACETAM EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Contraindications (4) 3/2017
Warnings and Precautions, Anaphylaxis and Angioedema (5.4) 3/2017
Warnings and Precautions, Hematologic Abnormalities (5.8) 10/2017
INDICATIONS AND USAGE
Levetiracetam extended-release tablets are indicated for adjunctive
therapy in the treatment of partial onset seizures in
patients 12 years of age and older with epilepsy (1)
DOSAGE AND ADMINISTRATION
Initiate treatment with a dose of 1000 mg once daily; increase by 1000
mg every 2 weeks to a maximum recommended
dose of 3000 mg once daily (2)
See full prescribing information for use in patients with impaired
renal function (2.1)
DOSAGE FORMS AND STRENGTHS
500 mg white, film-coated extended-release tablet (3)
750 mg white, film-coated extended-release tablet (3)
CONTRAINDICATIONS
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis
have occurred (4)
WARNINGS AND PRECAUTIONS
Behavioral abnormalities including psychotic symptoms, suicidal
ideation, irritability, and aggressive behavior have
been observed; monitor patients for psychiatric signs and symptoms
(5.1)
Suicidal Behavior and Ideation: Monitor patients for new or worsening
depression, suicidal thoughts/behavior, and/or
unusual changes in mood or behavior (5.2)
Monitor for somnolence and fatigue and advise patients not to drive or
operate machinery until they have gained
sufficient experience on levetiracetam extended-release tablets (5.3)
Withdrawal Seizures: levetiracetam extended-release tablets must be
gradually withdrawn (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 5%
more than p