Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy 1. Clinical pharmacology and pharmacokinetics of levetiracetam. Levetiracetam extendedrelease tablet is usually taken once a day. Levetiracetam is a white to offwhite crystalline powder with a faint odor and a bitter taste.
Levetiracetam tablets 250 mg, 500 mg and 750 mg rx only. Levetiracetam fda prescribing information, side effects. Keppra injection may be mixed with the following diluents and antiepileptic drugs. One vial of keppra injection contains 500 mg levetiracetam 500 mg5 ml. The chemical name of levetiracetam, a single enantiomer, is s. Levetiracetam extended release tablets fda prescribing. Levetiracetam levetiracetam, the initial total daily of levetiracetam injection should be equivalent to those of oral levetiracetam. Levetiracetam injection is for intravenous use only partialonset seizures. Levetiracetam in sodium chloride injection is an antiepileptic drug indicated for adult patients 16 years and older when oral administration is temporarily not feasible. Keppra levetiracetam injection for intravenous use fda. Keppra xr levetiracetam extendedrelease tablets, for oral use. It is supplied in singleuse 5 ml vials, available in cartons of 10 vials ndc 5047400263.
The keppra dosing regimen depends on the indication, age group, dosage form tablets or oral solution, and renal function. Page 1 of 37 highlights of prescribing information these highlights do not include all the information needed to use levetiracetam oral solution safely and effectively. Levetiracetam hospira, inn levetiracetam european medicines. See table 1 for the recommended preparation and administration of keppra injection to achieve a dose of 500 mg, mg, or 1500 mg. For children with renal impairment, levetiracetam dose needs to be adjusted based on the renal function as levetiracetam clearance is related to renal function.
Information for the patient keppra 250 mg filmcoated tablets keppra 500 mg filmcoated tablets keppra 750 mg filmcoated tablets keppra mg filmcoated tablets levetiracetam read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you. Keppra is an antiepileptic drug available as 250 mg blue, 500 mg yellow, 750 mg orange, and mg white tablets and as a clear, colorless, grapeflavored liquid 100 mgml for oral administration. At the end of the intravenous treatment period, the patient may be levetiracetam oral administration at the equivalent daily frequency 2. A antiepileptic agent for the treatment of epilepsy, partial seizure.
Information on the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for ucb, inc. Levetiracetam injection, usp sagent pharmaceuticals. See full prescribing information for levetiracetam oral solution. Levocarnitine injection usp is compatible and stable when mixed in parenteral solutions of sodium chloride 0.
If changing from a treatment regimen with an intermediate or longacting insulin to a. Our products are available from authorized distributors. Your healthcare provider will tell you how much levetiracetam extendedrelease tablets to take and when to take it. Lantus, the recommended initial lantus dose is 80% of the toujeo dose that is being discontinued. Keppra injection is for intravenous use only and must be diluted prior to administration. For complete ordering information, please contact your local pharmaceutical distributor. Keppra levetiracetam rx only 250 mg, 500 mg, 750 mg, and mg tablets 100 mgml oral solution description. Moderate and strong cyp3a4 inducers, including enzymeinducing aeds such asphenytoin, carbamazepine, and. Keppra levetiracetam 500 mg5 ml injection is a clear, colorless, sterile solution. Levetiracetam is chemically unrelated to existing antiepileptic drugs aeds. Levetiracetam is an antiepileptic medicine a medicine used to treat seizures in epilepsy. Levetiracetam hospira 100 mgml concentrate for solution for infusion. Keppra is indicated for adjunctive therapy for the treatment of. These highlights do not include all the information needed.
Guide may also be found in the full prescribing information for keppra posted on or by calling 1866. Food and drug administration fda registered facilities and comply with all fda rules and guidelines. The printed package leaflet of the medicinal product must state the name and address of. Levetiracetam levetiracetam injection, solution hospira, inc. Asthenia immediaterelease levetiracetam tablets in controlled trials of adult patients with epilepsy experiencing partial onset seizures, 15% of levetiracetam. Keppra 100 mgml concentrate for solution for infusion. Highlights of prescribing information these highlights. 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. Highlights of prescribing information these highlights do not include all the information needed to use levetiracetam injection safely and effectively. Acetic acid, usp 64197 as needed to adjust ph sodium chloride, usp 7647145 45 mgml sodium acetate trihydrate, usp 61904 8. The administration of levetiracetam to patients with renal impairment may require dose adaptation. These highlights do not include all the information needed to use. This dose reduction will lower the likelihood of hypoglycemia see warnings and precautions 5. Dailymed levetiracetam injection, solution, concentrate.
Levetiracetam levetiracetam injection, solution auromedics pharma llchighlights of prescribing information these highlights do not include all the information needed to use levetiracetam injection safely and effectively. Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain. Keppra levetiracetam rx only 250 mg, 500 mg, 750 mg, and. See full prescribing information for levetiracetam in. Levetiracetam injection fda prescribing information. Take levetiracetam extendedrelease tablets exactly as prescribed. See full prescribing information for levetiracetam injection.
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