Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
Lake Erie Medical DBA Quality Care Products LLC
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. 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, 250 mg are blue coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and “U” on either side of the breakline on one side and “X01” on the other side. They are supplied in containers of 90 tablets (NDC 68180-112-09), 120 tablets (NDC 68180-112-16) and 500 tablets (NDC 68180-112-02). Levetiracetam tablets, 500 mg are yellow coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and “U” on either side of the breakline on one side and “X02” on the other side. They are supplied in containers of 90 tablets (NDC 68180-113-09), 120 tablets (NDC 68180-113-16) and 500 tablets (NDC 68180-113-02). Levetiracetam tablets, 750 mg are orange coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and “U” on either side of the breakline on one side and “X03” on the other side. They are supplied in containers of 90 tablets (NDC 68180-114-09), 120 tablets (NDC 68180-114-16) and 500 tablets (NDC 68180-114-02). 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 Mumbai 400 098 INDIA Revised: 1st May 2010 ID #: 221659
Abbreviated New Drug Application
Lake Erie Medical DBA Quality Care Products LLC ---------- MEDICATION GUIDE LEVETIRACETAM TABLETS 250 mg, 500 mg and 750 mg tablets 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 is Lue koko asiakirja
LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- LEVETIRACETAM TABLETS 250 MG, 500 MG AND 750 MG RX ONLY 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 value of these animal models for specific types of human epilepsy is uncertain. _In vitro _and _in vivo _recordings of epileptiform activity from the hippocampus have shown that levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting that levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity. Levetiracetam at concentrations of up to 10 µM did not demonstrate binding affinity for a variety of known receptors, such as those associated with benzodiazepines, GABA (gamma-aminobutyric acid), glycine, NMDA (N-methyl-D-aspartate), re-uptake sites, and second messenger systems. Furthermore, _in vitro _studies have failed to find an effect of levetiracetam on neuronal voltage-gated sodium or T- type calcium currents and Levetiracetam does not appear to directly facilitate GABAergic neurotransmission. However, _in vitro_ studies have demo Lue koko asiakirja