Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)
Hetero Drugs Ltd.,
LEVETIRACETAM
LEVETIRACETAM 250 mg
ORAL
PRESCRIPTION DRUG
Levetiracetam Tablet 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. 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 levetiracetamhas not been evaluated in human studies.
Levetiracetam tablets, 250 mg are blue coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘87’ on other side. They are supplied in containers of 30 tablets (NDC 65977-5036-0) 60 tablets (NDC 65977-5036-1) 120 tablets (NDC 65977-5036-2) 500 tablets (NDC 65977-5036-3) 1000 tablets (NDC 65977-5036-4) Levetiracetam tablets, 500 mg are yellow coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘88’ on other side. They are supplied in containers of 30 tablets (NDC 65977-5037-0) 60 tablets (NDC 65977-5037-1) 120 tablets (NDC 65977-5037-2) 500 tablets (NDC 65977-5037-3) 1000 tablets (NDC 65977-5037-4) Levetiracetam tablets, 750 mg are orange coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘90’ on other side. They are supplied in containers of 30 tablets (NDC 65977-5038-0) 60 tablets (NDC 65977-5038-1) 120 tablets (NDC 65977-5038-2) 500 tablets (NDC 65977-5038-3) 30 tablets (NDC 65977-5039-0) 60 tablets (NDC 65977-5039-1) 120 tablets (NDC 65977-5039-2) 500 tablets (NDC 65977-5039-3) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
Hetero Drugs Ltd., ---------- SPL MEDGUIDE MEDICATION GUIDE Levetiracetam Tablets Rx Only Read this Medication Guidebefore you start taking levetiracetam and each time you get a refill. There may be new information. This informationdoes not take the place of talkingto your healthcare provider about your medical condition or treatment What is the most important information I shouldknow about levetiracetam? Like other antiepileptic drugs, levetiracetam may cause suicidal thoughts or actions in a very smallnumber of people, about 1 in 500 people taking it. Call a healthcareprovider 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 commitsuicide • new or worsedepression • new or worse anxiety • feeling agitated orrestless • panic attacks • trouble sleeping(insomnia) • new or worseirritability • acting aggressive,being angry, or violent • acting on dangerous impulses • an extremeincrease in activity and talking (mania) • other unusual changesin behavior or mood Do not stop levetiracetam without first talking to a healthcare provider. • Stopping levetiracetamsuddenly can cause serious problems. Stopping aseizure 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 checkfor other causes. How canI 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-upvisits with your healthcare provideras scheduled. • Call your healthcare providerbetween 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 ofage and older with epilepsy • myocl Lesen Sie das vollständige Dokument
LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED HETERO DRUGS LTD., ---------- LEVETIRACETAM TABLETS DESCRIPTION Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow),750 mg (orange), and 1000 mg (white) 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 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 (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate and additional agents listed below: 250 mg tablets: opadry II blue (polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, FD&C blue #2/indigo carmine aluminum lake) 500 mg tablets: opadry II yellow (polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, iron oxide yellow) 750 mg tablets: opadry II orange (polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red) 1000 mg tablets: opadry II white (polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc) CLINICAL PHARMACOLOGY MECHANISM OF ACTION The precise mechanism(s) by which levetiracetamexerts its antiepileptic effect is unknown. The antiepileptic activity oflevetiracetam was assessed in a number of animal models of epileptic seizures.Levetiracetam did not inhibit single seizures induced by maximal stimulationwith electrical current or d Lesen Sie das vollständige Dokument