Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
NCS HealthCare of KY, Inc dba Vangard Labs
LEVETIRACETAM
LEVETIRACETAM 1000 mg
ORAL
PRESCRIPTION DRUG
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.
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].
Abbreviated New Drug Application
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 Přečtěte si celý dokument