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LEVETIRACETAM Extended-release
Overview
What is LEVETIRACETAM Extended-release?
Levetiracetam Extended-release Tablets is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release 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 CHNO 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 Extended-release Tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, ethylcellulose, glyceryl behenate, hypromellose2910, lactose monohydrate, povidone K90, magnesium stearate, titanium dioxide and triacetin.
The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.
USP dissolution test is pending
What does LEVETIRACETAM Extended-release look like?
What are the available doses of LEVETIRACETAM Extended-release?
Levetiracetam Extended-release Tablets 500mg are white oval oblong tablets, debossed with “LP332” on one side and blank on the other side.
Levetiracetam Extended-release Tablets 750mg are white oval oblong tablets, debossed with “LP79” on one side and blank on the other side.
What should I talk to my health care provider before I take LEVETIRACETAM Extended-release?
How should I use LEVETIRACETAM Extended-release?
Levetiracetam Extended-release Tablets is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.
What interacts with LEVETIRACETAM Extended-release?
Sorry No Records found
What are the warnings of LEVETIRACETAM Extended-release?
Sorry No Records found
What are the precautions of LEVETIRACETAM Extended-release?
Sorry No Records found
What are the side effects of LEVETIRACETAM Extended-release?
Sorry No records found
What should I look out for while using LEVETIRACETAM Extended-release?
None.
What might happen if I take too much LEVETIRACETAM Extended-release?
How should I store and handle LEVETIRACETAM Extended-release?
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.Naproxen Tablets, USP:‘I’‘G’‘340’Naproxen Tablets, USP:with ‘IG’‘341’Naproxen Tablets, USP:‘I’ ‘G’ ‘342’Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].Dispense in tight, lightresistant containers.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 kindled state. The predictive value of these animal models for specific types of human epilepsy is uncertain.
In vitro
in vivo
Levetiracetam at concentrations of up to 10 μM did not demonstrate binding affinity for a variety of known receptors, such as those associated with benzodiazepines, GABA (gamma-aminobutyric acid), glycine, NMDA (N-methyl-D-aspartate), re-uptake sites, and second messenger systems. Furthermore, studies have failed to find an effect of levetiracetam on neuronal voltage-gated sodium or T-type calcium currents and levetiracetam does not appear to directly facilitate GABAergic neurotransmission. However, studies have demonstrated that levetiracetam opposes the activity of negative modulators of GABA- and glycine-gated currents and partially inhibits N-type calcium currents in neuronal cells.
A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis. Although the molecular significance of levetiracetam binding to synaptic vesicle protein SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice. These findings suggest that the interaction of levetiracetam with the SV2A protein may contribute to the antiepileptic mechanism of action of the drug.
Non-Clinical Toxicology
None.ACE-inhibitors
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
Antacids and Sucralfate
Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen.
Aspirin
When naproxen as naproxen tablets, administered with aspirin, its protein binding is reduced, although the clearance of free naproxen is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse effects.
Cholestyramine
As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of naproxen.
Diuretics
Clinical studies, as well as postmarketing observations, have shown that naproxen tablets can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.
Lithium
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Methotrexate
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Naproxen and other nonsteroidal anti-inflammatory drugs have been reported to reduce the tubular secretion of methotrexate in an animal model. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Warfarin
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. No significant interactions have been observed in clinical studies with naproxen and coumarin-type anticoagulants. However, caution is advised since interactions have been seen with other nonsteroidal agents of this class. The free fraction of warfarin may increase substantially in some subjects and naproxen interferes with platelet function.
Selective Serotonin Reuptake Inhibitors (SSRIs)
There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs. Caution should be used when NSAIDs are administered concomitantly with SSRIs.
Other Information Concerning Drug Interactions
Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarintype anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. Patients simultaneously receiving naproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required.
Naproxen and other nonsteroidal anti-inflammatory drugs can reduce the antihypertensive effect of propranolol and other beta-blockers.
Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.
Levetiracetam Extended-release Tablets may cause behavioral abnormalities and psychotic symptoms. Patients treated with Levetiracetam Extended-release Tablets should be monitored for psychiatric signs and symptoms.
Behavioral abnormalities
Levetiracetam Extended-release Tablets
A total of 7% of Levetiracetam Extended-release Tablets -treated patients experienced non-psychotic behavioral disorders (reported as irritability and aggression) compared to 0% of placebo-treated patients. Irritability was reported in 7% of Levetiracetam Extended-release Tablets -treated patients. Aggression was reported in 1% of Levetiracetam Extended-release Tablets -treated patients.
No patient discontinued treatment or had a dose reduction as a result of these adverse reactions.
The number of patients exposed to Levetiracetam Extended-release Tablets was considerably smaller than the number of patients exposed to immediate-release Levetiracetam tablets in controlled trials. Therefore, certain adverse reactions observed in the immediate-release Levetiracetam controlled trials will likely occur in patients receiving Levetiracetam Extended-release Tablets.
Immediate-Release Levetiracetam Tablets
A total of 13% of adult patients and 38% of pediatric patients (4 to 16 years of age) treated with immediate-release Levetiracetam experienced non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder), compared to 6% and 19% of adult and pediatric patients on placebo. A randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release Levetiracetam tablets as adjunctive therapy in pediatric patients (4 to 16 years of age). An exploratory analysis suggested a worsening in aggressive behavior in patients treated with immediate-release Levetiracetam tablets in that study [ ].
A total of 1.7% of adult patients treated with immediate-release Levetiracetam discontinued treatment due to behavioral adverse reactions, compared to 0.2% of placebo-treated patients. The treatment dose was reduced in 0.8% of adult patients treated with immediate-release Levetiracetam, compared to 0.5% of placebo-treated patients. Overall, 11% of pediatric patients treated with immediate-release Levetiracetam experienced behavioral symptoms associated with discontinuation or dose reduction, compared to 6.2% of placebo-treated pediatric patients.
One percent of adult patients and 2% of pediatric patients (4 to 16 years of age) treated with immediate-release Levetiracetam experienced psychotic symptoms, compared to 0.2% and 2%, respectively, in adult and placebo-treated pediatric patients. In the controlled study that assessed the neurocognitive and behavioral effects of immediate-release Levetiracetam in pediatric patients 4 to 16 years of age, 1.6% Levetiracetam-treated patients experienced paranoia, compared to no placebo-treated patients. There were 3.1% patients treated with immediate-release Levetiracetam who experienced confusional state, compared to no placebo-treated patients [ ].
Psychotic symptoms
Immediate-Release Levetiracetam tablets
One percent of Levetiracetam-treated adult patients experienced psychotic symptoms compared to 0.2% of placebo-treated patients.
Two (0.3%) Levetiracetam-treated adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, developed within the first week of treatment and resolved within 1 to 2 weeks following treatment discontinuation. There was no difference between drug and placebo-treated patients in the incidence of pediatric patients who discontinued treatment due to psychotic and non-psychotic adverse reactions.
The following adverse reactions are discussed in more details in other sections of labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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