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Levetiracetam 750 Mg Film

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Last Updated: 12 October 2020

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General | Latest Info

Keppra is an antiepileptic drug available in 250 mg, 500 mg, 750 mg, and 1000 mg tablets and as clear, colorless, grape - flavored liquid for oral administration. The chemical name of Levetiracetam, single enantiomer, is - ethyl - 2oxo - 1pyrrolidine acetamide, Its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170. 21. Levetiracetam is chemically unrelated to existing antiepileptic drugs. It has the following structural formula: Levetiracetam is white to off - white crystalline powder with a faint odor and bitter taste. It is very soluble in water. It is freely soluble in chloroform and in methanol, soluble in ethanol, sparingly soluble in acetonitrile and practically insoluble in N - hexane. Keppra tablets contain a labeled amount of Levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 250 mg tablets: FD & C Blue 2 / indigo carmine aluminum lake 500 mg tablets: iron oxide Yellow 750 mg tablets: FD & C Yellow 6 / sunset Yellow FCF aluminum lake, iron oxide red KEPPRA oral solution contain 100 mg of Levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

What are possible side effects?

Levetiracetam comes as solution, immediate - release tablet, extend - release tablet, and as a tablet for suspension to take by mouth. The solution, immediate - release tablet, and tablet for suspension are usually taken twice a day, once in morning and once at night, with or without food. Extend - release tablets are usually taken once daily with or without food. Try to take levetiracetam at around the same time every day. Follow directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take levetiracetam exactly as direct. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow levetiracetam immediate - release and extend - release tablets whole; do not split, chew, or crush them. Take whole levetiracetam tablets for suspension according to directions; do not split, chew, or crush them. To take levetiracetam tablet for suspension, use dry hands to peel foil from blister packaging; do not try to push tablets through foil. Immediately take out the number of tablets that your doctor has told you to take and place tablet on your tongue with a sip of liquid. Once the tablet completely dissolves on your tongue, swallow the mixture. A tablet may take about 10 seconds to dissolve. You can also take levetiracetam tablets for suspension by dissolving them in liquid. Place the number of tablets your doctor has told you to take into a cup and add a small amount of liquid. Swirl cup gently. After tablet suspension dissolve, drink mixture right away. If there is any medication left in the cup, add some more liquid and swirl the cup gently. Drink a mixture of water right away to be sure that you swallow all of the medication. If you are taking levetiracetam oral solution, do not use a household spoon to measure your dose. You might not get the right amount of medication. Ask your doctor or pharmacist to recommend a medicine dropper, spoon, cup, or syringe and to show you how to use it to measure your medication. Your doctor may start you on a low dose of levetiracetam and gradually increase your dose, not more often than once every 2 weeks. Levetiracetam controls epilepsy but does not cure it. Continue to take levetiracetam even if you feel well. Do not stop taking levetiracetam without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking levetiracetam, your seizures may become worse. Your doctor will probably decrease your dose gradually. Your doctor or pharmacist will give you the manufacturer's patient information sheet when you begin treatment with levetiracetam and each time you refill your prescription. Read information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration website or manufacturer's website to obtain a Medication Guide.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Interactions

In vitro data on metabolic interactions indicate that levetiracetam is unlikely to produce, or be subject to, pharmacokinetic interactions. Levetiracetam and its major metabolite, at concentrations well above C max levels achieve within the therapeutic dose range, are neither inhibitors of, nor high affinity substrates for, human liver cytochrome P450 isoforms, epoxide hydrolase or UDP - glucuronidation enzymes. In addition, levetiracetam does not affect in vitro glucuronidation of valproic acid. Potential pharmacokinetic interactions of or with levetiracetam were assessed in clinical pharmacokinetic studies and through pharmacokinetic screening in placebo - control clinical studies in epilepsy patients.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Mechanism Of Action

The precise mechanism by which Levetiracetam exerts its Antiepileptic effect is unknown. Antiepileptic activity of Levetiracetam was assessed in a number of animal models of epileptic seizures. Levetiracetam does not inhibit single seizures induced by maximal stimulation with electrical current or different chemoconvulsants and shows only minimal activity in submaximal stimulation and in threshold tests. Protection was observe, 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 displays inhibitory properties in kindling models in rats, another model of human complex Partial Seizures, both during kindling development and in fully kindle state. The predictive value of these animal models for specific types of human epilepsy is uncertain. In vitro and in vivo recordings of epileptiform activity from hippocampus have shown that Levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting that Levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity. Levetiracetam at concentrations of up to 10 M does not demonstrate binding affinity for a variety of known receptors, such as those associated with benzodiazepines, GABA, glycine, NMDA, re - uptake sites, and second messenger systems. Furthermore, in vitro studies have failed to find effect of Levetiracetam on neuronal voltage - gated sodium or T - type calcium currents and Levetiracetam does not appear to directly facilitate GABAergic neurotransmission. However, in vitro studies have demonstrated that Levetiracetam opposes activity of negative modulators of GABA - and glycine - gate currents and partially inhibits N - type calcium currents in neuronal cells. Saturable and stereoselective neuronal binding sites in rat brain tissue have been described for Levetiracetam. Experimental data indicate that this binding site is synaptic vesicle protein SV2A, thought to be involved in regulation of vesicle exocytosis. Although the molecular significance of Levetiracetam binding to synaptic vesicle protein SV2A is not understood, Levetiracetam and related analogs show rank order of affinity for SV2A which correlates with the potency of their antiseizure activity in audiogenic seizure - prone mice. These findings suggest that interaction of Levetiracetam with SV2A protein may contribute to the Antiepileptic mechanism of action of the drug.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Special Populations

Absorption and Distribution Absorption of Levetiracetam is rapid, with peak plasma concentrations occurring in about an hour following oral ADMINISTRATION in fasted subjects. The Oral bioavailability of Levetiracetam Tablets is 100% and tablets and oral solution are bioequivalent in rate and extent of Absorption. Food does not affect the extent of absorption of Levetiracetam but it decreases C max by 20% and delays T max by 1. 5 hours. The pharmacokinetics of Levetiracetam are linear over dose range of 500 to 5000 mg. Steady state is achieved after 2 days of multiple twice - daily dosing. Levetiracetam and its major metabolite are less than 10% bound to plasma proteins; clinically significant interactions with other drugs through competition for protein binding sites are therefore unlikely. Metabolism Levetiracetam is not extensively metabolized in humans. The major metabolic pathway is enzymatic hydrolysis of the acetamide group, which produces carboxylic acid metabolite, ucb L057 and is not dependent on any liver cytochrome P450 isoenzymes. Major metabolites are inactive in animal seizure models. Two minor metabolites were identified as product of hydroxylation of 2 - oxo - pyrrolidine ring and opening of 2 - oxo - pyrrolidine ring in position 5. There is no enantiomeric interconversion of Levetiracetam or its major metabolite. Elimination of Levetiracetam plasma half - life in adults is 7 1 hours and is unaffected by either dose or repeat ADMINISTRATION. Levetiracetam is eliminated from systemic circulation by Renal excretion as an unchanged drug which represents 66% of administered dose. Total body clearance is 0. 96 mL / min / kg and Renal clearance is 0. 6 mL / min / kg. The mechanism of excretion is glomerular filtration with subsequent partial tubular reabsorption. Metabolite ucb L057 is excreted by glomerular filtration and active tubular secretion with Renal clearance of 4 mL / min / kg. Levetiracetam elimination is correlated to creatinine clearance. Levetiracetam clearance is reduced in Patients With Renal Impairment. Specific Populations Elderly Pharmacokinetics of Levetiracetam were evaluated in 16 elderly subjects with creatinine clearance ranging from 30 to 74 mL / min. Following oral ADMINISTRATION of twice - daily dosing for 10 days, total body clearance decreased by 38% and half - life was 2. 5 hours longer for elderly compared to healthy adults. This is most likely due to decrease in Renal Function in these subjects. Pediatric Patients Pharmacokinetics of Levetiracetam were evaluated in 24 Pediatric Patients after single dose. Body weight adjusted apparent clearance of Levetiracetam was approximately 40% higher than in adults. A repeat dose pharmacokinetic study was conducted in pediatric patients at doses of 20 mg / kg / day, 40 mg / kg / day, and 60 mg / kg / day. Evaluation of the pharmacokinetic profile of Levetiracetam and its metabolite in 14 Pediatric Patients demonstrate rapid absorption of Levetiracetam at all doses with T max of about 1 hour and T 1 / 2 of 5 hours across three dosing levels. The Pharmacokinetics of Levetiracetam in children was linear between 20 to 60 mg / kg / day. Potential interaction of Levetiracetam with other AEDs was also evaluated in these patients. Levetiracetam had no significant effect on plasma concentrations of carbamazepine, valproic acid, topiramate or lamotrigine.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Study 1

Study 2 was a double - blind, placebo - control, crossover study conducted at 62 centers in Europe comparing KEPPRA 1000 mg / day, KEPPRA 2000 mg / day, and placebo given in equally divided doses twice daily. The First Period of Study was designed to be analyzed as a parallel - Group Study. After a prospective Baseline Period of up to 12 weeks, patients were randomized to one of three treatment groups described above. The 16 - week treatment period consists of a 4 - week titration period followed by a 12 - week fixed dose evaluation period, during which concomitant AED regimens are held constant. The primary measure of effectiveness was between Group comparison of percent reduction in weekly partial seizure frequency relative to placebo over the entire randomized treatment period. Secondary outcome variables include Responder Rate. Results of analysis of period are displayed in Table 2. The percentage of patients who achieved 50% Reduction in weekly Seizure rates From Baseline in partial onset Seizure frequency over the entire randomized treatment period within three treatment groups is present in Figure 2. Figure 2: Responder Rate in Study 2: Period * statistically significant versus placebo comparison of KEPPRA 2000 mg / day to KEPPRA 1000 mg / day for Responder Rate was statistically significant. Analysis of trial as cross - over yielded similar results.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

2 DOSAGE AND ADMINISTRATION

Levetiracetam Tablets are given orally with or without food. The Levetiracetam Dosing Regimen depends on indication, age group, dosage form, and renal function. Prescribe oral solution for Pediatric Patients with a body weight of 20 kg. Prescribe oral solution or Tablets for Pediatric Patients with body weight above 20 kg. When using oral solution in Pediatric Patients, dosing is weight - base using a calibrated measuring device. Levetiracetam tablets should be swallowed whole. Levetiracetam Tablets should not be chewed or crush. Recommend dosing for monotherapy and adjunctive therapy is the same; as outlined below. Adults 16 years of age and older initiate treatment with a daily dose of 1000 mg / day, given as twice - daily dosing. Additional dosing increments may be given to the maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg / day confer additional benefit. Initiate treatment with a daily dose of 14 mg / kg in 2 divided doses. Increase daily dose every 2 weeks by increments of 14 mg / kg to recommend a daily dose of 42 mg / kg. In the clinical trial, mean daily dose was 35 mg / kg in this age group. Initiate treatment with a daily dose of 20 mg / kg in 2 divided doses. Increase daily dose in 2 weeks by increment of 20 mg / kg to recommend daily dose of 50 mg / kg. If patient cannot tolerate daily dose of 50 mg / kg, daily dose may be reduce. In the clinical trial, mean daily dose was 47 mg / kg in this age group. Initiate treatment with a daily dose of 20 mg / kg in 2 divided doses. Increase daily dose every 2 weeks by increments of 20 mg / kg to recommend a daily dose of 60 mg / kg. If patient cannot tolerate daily dose of 60 mg / kg, daily dose may be reduce. In the clinical trial, mean daily dose was 44 mg / kg. The maximum daily dose was 3000 mg / day. For Levetiracetam tablet Dosing in Pediatric Patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg give twice daily dosing. Increase daily dose every 2 weeks by increments of 500 mg to the maximum recommended daily dose of 1500 mg. For Levetiracetam tablet Dosing in Pediatric Patients weighing more than 40 kg, Initiate treatment with a daily dose of 1000 mg / day give twice the daily dosing. Increase daily dose every 2 weeks by increments of 1000 mg / day to the maximum recommended daily dose of 3000 mg. The following calculation should be used to determine the appropriate daily dose of oral solution for Pediatric Patients: Initiate treatment with a dose of 1000 mg / day, give as twice - daily dosing. Increase dosage by 1000 mg / day every 2 weeks to the recommended daily dose of 3000 mg. The Effectiveness of doses lower than 3000 mg / day has not been Study. Adults 16 years of age and older initiate treatment with a dose of 1000 mg / day, given as twice - daily dosing.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

5 WARNINGS AND PRECAUTIONS

In controlled trials of adult patients with epilepsy experiencing Partial Onset Seizures, 15% of KEPPRA - treated Patients reported Somnolence, compared to 8% of placebo - treated Patients. There was no clear dose response up to 3000 mg / day. In a study where there was no titration, about 45% of patients receiving 4000 mg / day reported somnolence. Somnolence was considered Serious in 0. 3% of KEPPRA - treated patients, compared to 0% in the placebo group. About 3% of KEPPRA - treated patients discontinue treatment due to somnolence, compared to 0. 7% of placebotreated patients. In 1. 4% of KEPPRA - treated patients and 0. In 9% of placebo - treated patients, dose was reduce, while 0. 3% of KEPPRA - treated patients were hospitalized due to somnolence.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

6 ADVERSE REACTIONS

There were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of Levetiracetam extend - Release in these patients. It is expected that the safety of Levetiracetam extend - Release in elderly patients 65 and over would be comparable to the safety observed in clinical studies of immediate - Release Levetiracetam Tablets. There were 347 subjects in clinical studies of immediate - Release Levetiracetam that were 65 and over. No overall differences in safety were observed between these subjects and younger subjects. There were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of immediate - Release Levetiracetam in these patients. Levetiracetam is known to be substantially excreted by kidney, and the risk of adverse reactions to this drug may be greater in patients with Impaired Renal Function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drug cannot be directly compared to rates in clinical trials of another drug and may not reflect rates observed in practice. Levetiracetam extend - Release Tablets in Controlled Clinical Study in Patients with partial - onset seizures, most common adverse reactions in patients receiving Levetiracetam extend - Release Tablets in combination with other AEDs, for events with rates greater than placebo, were irritability and somnolence. Table 3 lists adverse reactions that occurred in at least 5% of epilepsy patients receiving Levetiracetam extend - Release Tablets in the placebo - control study and were numerically more common than in patients treated with placebo. In this study, either Levetiracetam extend - Release Tablets or placebo were added to concurrent AED therapy. Discontinuation or Dose Reduction in Levetiracetam extend - Release Tablets control Clinical Study in Controlled Clinical Study, 5% of patients receiving Levetiracetam extend - Release Tablets and 3% receiving placebo discontinue as result of adverse reaction. Adverse reactions that result in discontinuation and that occur more frequently in Levetiracetam extend - Release - treat patients than in placebo - treated Patients were asthenia, epilepsy, mouth ulceration, rash, and respiratory failure. Each of these adverse reactions led to discontinuation of Levetiracetam extend - Release - treat patients and no placebo - treated patients. Immediate - Release Levetiracetam Tablets Table 4 lists adverse reactions in Controlled studies of immediate - Release Levetiracetam Tablets in adult patients experiencing partial - onset seizures. Although the pattern of adverse reactions in Levetiracetam extend - Release Tablets study seems somewhat different from that seen in partial - onset seizure control studies for immediate - Release Levetiracetam Tablets, this is possibly due to the much smaller number of patients in this study compared to immediate - Release tablet studies. Adverse reactions to Levetiracetam extend - Release Tablets are expected to be similar to those seen with immediate - Release Levetiracetam Tablets. Adults in Controlled Clinical studies of immediate - Release Levetiracetam Tablets as adjunctive therapy to other AEDs in adults with partial - onset seizures, most common adverse reactions, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness. Table 4 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving immediate - Release Levetiracetam Tablets in placebo - control studies and were numerically more common than in patients treated with placebo. In these studies, either immediate - Release Levetiracetam Tablets or placebo were added to concurrent AED therapy. Pediatric Patients 4 Years to < 16 Years in pooled analysis of two control pediatric clinical studies in children 4 to 16 Years of Age with partial - onset seizures, adverse reactions most frequently reported with use of immediate - Release Levetiracetam Tablets in combination with other AEDs, and with greater frequency than in Patients on placebo, were fatigue, aggression, nasal congestion, decrease appetite, and irritability. Table 5 lists adverse reactions that occurred in at least 2% of pediatric patients treated with immediate - Release Levetiracetam Tablets and were more common than in pediatric patients on placebo. In these studies, either immediate - Release Levetiracetam Tablets or placebo were added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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