Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
Rebel Distributors Corp
LEVETIRACETAM
LEVETIRACETAM 500 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. 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 250 mg tablets are blue colored, oval shaped, film-coated tablets debossed with breakline separating ‘250’ and ‘MG’ on one side and ‘1014’ on other side. They are supplied as: Bottle of 60 NDC -21695-071-60 Levetiracetam 500 mg tablets are yellow colored, oval shaped, film-coated tablets debossed with breakline separating ‘500’ and ‘MG’ on one side and ‘1015’ on other side. They are supplied as: Bottle of 60 NDC -21695-006-60 Levetiracetam 750 mg tablets are orange colored, oval shaped, film-coated tablets debossed with breakline separating ‘750’ and ‘MG’ on one side and ‘1016’ on other side. They are supplied as: Bottle of 60 NDC -21695-136-60 Levetiracetam 1000 mg tablets are white to off white, oval shaped, film-coated tablets debossed with breakline separating ‘1000’ and ‘MG’ on one side and ‘1017’ on other side. They are supplied as: Bottle of 60 NDC -21695-016-60 Storage Store at 20o - 25o C (68o - 77o F); excursions permitted to 15o - 30o C (59o - 86o F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.
Abbreviated New Drug Application
Rebel Distributors Corp ---------- MEDICATION GUIDE Levetiracetam Tablets Rx Only Read this Medication Guide before you start taking levetiracetam 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? Like other antiepileptic drugs, levetiracetam 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 without first talking to a healthcare provider. • Stopping levetiracetam 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? Levetiracetam is a prescription medicine taken by mouth that is used with other medicines to treat: • partial onset seizures in people 4 years of age and older with e Aqra d-dokument sħiħ
LEVETIRACETAM- LEVETIRACETAM TABLET REBEL DISTRIBUTORS CORP ---------- LEVETIRACETAM RX ONLY DESCRIPTION Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. 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, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam, USP 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, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below: 250 mg tablets: FD&C Blue # 2 Lake of indigo carmine 500 mg tablets: Ferric oxide yellow 750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow CLINICALS 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 fe Aqra d-dokument sħiħ