LEVETIRACETAM tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

State of Florida DOH Central Pharmacy

DCI (Dénomination commune internationale):

LEVETIRACETAM

Composition:

LEVETIRACETAM 500 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam is 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 is indicated as adjunctive therapy in the treatment of primary generalized tonicoclonic 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.

Descriptif du produit:

Levetiracetam tablets, 500 mg are yellow, oblong-caplet (capsule-shaped tablet), scored, film-coated tablets marked with "" and "500" on one side. They are supplied by State of Florida DOH Central Pharmacy as follows: ATTENTION PHARMACIST: Each patient is required to receive the accompanying Medication Guide. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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LEVETIRACETAM TABLETS
500 MG
RX ONLY
DESCRIPTION
Levetiracetam is an antiepileptic drug available as 500 mg oblong
(yellow) tablets for oral
administration.
The chemical name of levetiracetam, a single enantiomer, is
(-)-(S)-α-ethyl-2-oxo-1-pyrrolidine
acetamide, its molecular formula is C8H14N2O2 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, hydroxypropyl methylcellulose, hypromellose,
iron oxide yellow, lactose
monohydrate, magnesium stearate, povidone, titanium dioxide, and
triacetin.
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