LEVETIRACETAM tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

NCS HealthCare of KY, Inc dba Vangard Labs

DCI (Denominação Comum Internacional):

LEVETIRACETAM

Composição:

LEVETIRACETAM 1000 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. Levetiracetam tablets 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 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. 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.

Resumo do produto:

Levetiracetam tablets, 1000 mg are beige, oval shaped, biconvex, film coated tablets debossed with '248' on one side and 'RDY' on other side, 'RD' and 'Y' separated with bisect line. They are supplied in blistercardss of 30's. Blistercards of 30                                                                              NDC 0615-7553-39 Dispense in a tight light-resistant container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

LEVETIRACETAM- LEVETIRACETAM TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
LEVETIRACETAM TABLETS
RX ONLY
REVISED: MARCH, 2011
DESCRIPTION
Levetiracetam USP is an antiepileptic drug available as beige colored
tablets in 1000 mg strength for
oral administration.
The chemical name of levetiracetam USP, 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 USP is a white to off-white crystalline powder. It is
very soluble in water, freely soluble
in methanol, chloroform and ethanol. It is soluble in acetonitrile and
practically insoluble in n-hexane.
Levetiracetam tablets contain the labeled amount of levetiracetam.
Inactive ingredients: magnesium
stearate, povidone, and film coating agent instacoat universal
ICG-U-10052 beige containing
hypromellose 3cp, hypromellose 6cp, iron oxide yellow, iron oxide red,
polyethylene glycol 400,
polysorbate 80 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,
both during kindling development and in the fully kindled state. The
predictive v