البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
Levetiracetam (UNII: 44YRR34555) (Levetiracetam - UNII:44YRR34555)
LLC Federal Solutions
Levetiracetam
Levetiracetam 100 mg in 1 mL
ORAL
PRESCRIPTION DRUG
INDICATION AND USAGE Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam 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. Levetiracetam is 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. CONTRAINDICATIONS This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in Levetiracetam Oral Solution. DRUG ABUSE AND DEPENDENCE The abuse and dependence potential of Levetiracetam has not been evaluated in human studies.
HOW SUPPLIED Levetiracetam Oral Solution, 100 mg/mL, is a clear, colorless, grape-flavored liquid, and supplied in a 5 mL unit dose cup. One-hundred (100) cups per box. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light resistant container with a child-resistant closure. Repackaged by: Safecor Health, LLC Woburn, MA 01801 Distributed by: LLC Federal Solutions Miami, FL 33132 Rev 110-00 09/2013
Abbreviated New Drug Application
LEVETIRACETAM - LEVETIRACETAM SOLUTION LLC Federal Solutions ---------- MEDICATION GUIDE Levetiracetam 100 mg/mL Oral Solution Read this Medication Guide before you start taking Levetiracetam Oral Solution 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 medicine taken by mouth that is used with other medicines to treat: • partial onset seiz اقرأ الوثيقة كاملة
LEVETIRACETAM - LEVETIRACETAM SOLUTION LLC FEDERAL SOLUTIONS ---------- DESCRIPTION Levetiracetam is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) 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 (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 oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid, flavor, glycerin, methylparaben, propylparaben, purified water, sodium citrate, and sorbitol solution. 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 اقرأ الوثيقة كاملة