Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
Rebel Distributors Corp
LEVETIRACETAM
LEVETIRACETAM 250 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 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). 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 Repackaged by Rebel Distributors Corp. Thousand Oaks, CA 91320
Abbreviated New Drug Application
Rebel Distributors Corp ---------- 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 used with other medicine Přečtěte si celý dokument
LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED REBEL DISTRIBUTORS CORP ---------- LEVETIRACETAM TABLETS 250 MG, 500 MG AND 750 MG RX ONLY DESCRIPTION Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow) and 750 mg (orange) tablets. The chemical name of levetiracetam, 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 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, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 250 mg tablets: FD&C Blue #2 aluminium lake 500 mg tablets: Yellow Iron Oxide 750 mg tablets:FD&C Blue #2 aluminium lake, FD&C Yellow #6 aluminium lake, Iron Oxide Red 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 chemo Přečtěte si celý dokument