LEVETIRACETAM tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Lupin Pharmaceuticals, Inc

INN (Международно Name):

LEVETIRACETAM

Композиция:

LEVETIRACETAM 1000 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam tablets. The abuse and dependence potential of levetiracetam has not been evaluated in human studies.

Каталог на резюме:

Levetiracetam tablets, 1000 mg are white to off-white, 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 in containers of 60 tablets (NDC 68180-115-07) and 500 tablets (NDC 68180-115-02). Store at 25°C (77°F); excursions permitted to 15° - 30°C (59°-86°F). [See USP Controlled Room Temperature] Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure along with medication guide provided separately. Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by Lupin Limited Goa 403 722 INDIA Revised: 1st May 2010                                                                         ID #: 221660

Статус Оторизация:

Abbreviated New Drug Application

Листовка

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
Lupin Pharmaceuticals, Inc
----------
MEDICATION GUIDE
LEVETIRACETAM TABLETS
1000 mg
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 is LEVETIRACETAM TABLET?
LEVETIRACETAM TABLET is a prescription medicine taken by mouth that i

Данни за продукта

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
LUPIN PHARMACEUTICALS, INC
----------
LEVETIRACETAM TABLETS
1000 MG
RX ONLY
DESCRIPTION
Levetiracetam is an antiepileptic drug available as 1000 mg (White)
tablets.
The chemical name of levetiracetam, a single enantiomer, is
(-)-(S)-α-ethyl-2-oxo-1-pyrrolidine
acetamide, its molecular formula is C H N O and its molecular weight
is 170.21. Levetiracetam is
chemically unrelated to existing antiepileptic drugs (AEDs). It has
the following structural formula:
Levetiracetam is a white to off-white crystalline powder with a faint
odor and a bitter taste. It is very
soluble in water (104.0 g/100 mL). It is freely soluble in chloroform
(65.3 g/100 mL) and in methanol
(53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble
in acetonitrile (5.7 g/100 mL)
and practically insoluble in n-hexane. (Solubility limits are
expressed as g/100 mL solvent.)
Levetiracetam tablets contain the labeled amount of levetiracetam.
Inactive ingredients: colloidal silicon
dioxide, corn starch, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose, povidone,
polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism(s) by which levetiracetam exerts its
antiepileptic effect is unknown. The
antiepileptic activity of levetiracetam was assessed in a number of
animal models of epileptic seizures.
Levetiracetam did not inhibit single seizures induced by maximal
stimulation with electrical current or
different chemoconvulsants and showed only minimal activity in
submaximal stimulation and in threshold
tests. Protection was observed, however, against secondarily
generalized activity from focal seizures
induced by pilocarpine and kainic acid, two chemoconvulsants that
induce seizures that mimic some
features of human complex partial seizures with secondary
generalization. Levetiracetam also displayed
inhibitory properties in the kindling model in rats, another model of
human complex partial seizures,
bo