Levetiracetam Extended-Release

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Initiate treatment with a dose of 1,000 mg once daily; increase by 1,000 mg every 2 weeks to a maximum recommended dose of 3,000 mg once daily ( 2 ) See full prescribing information for use in patients with impaired renal function ( 2.1 )
• Recommended Dosing For
• adults and adolescent patients, the recommended dosing for monotherapy and adjunctive therapy is the same; as outlined below.
• Adults and Adolescents 12 Years of Age and Older Weighing 50 kg or More Initiate treatment with a dose of 1,000 mg once daily.
• The once daily dosage may be adjusted in increments of 1,000 mg every 2 weeks to a maximum recommended daily dose of 3,000 mg/day once daily.
• Administration Levetiracetam extended-release tablets are administered once daily.
• Levetiracetam extended-release tablets should be swallowed whole.
• The tablets should not be chewed, broken, or crushed.
• 2.2 Dosage Adjustments in Adult Patients with Renal Impairment Levetiracetam extended-release tablets dosing must be individualized according to the patient's renal function status.
• Recommended dosage adjustments for adults are shown in Table 1.
• In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated.
• To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
• [140-age (years)] x weight (kg) CLcr = ---------------------------------------------- (x 0.85 for female patients) 72 x serum creatinine (mg/dL) Then CLcr is adjusted for body surface area (BSA) as follows:
• CLcr (mL/min) CLcr (mL/min/1.73m 2 ) = ----------------------------- x
• 1.73 BSA subject (m 2 ) Table 1:
• Dosage Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73m 2 ) Dosage (mg) Frequency Normal > 80 1,000 to 3,000 Every 24 hours Mild 50 - 80 1,000 to 2,000 Every 24 hours Moderate 30 - 50 500 to 1,500 Every 24 hours Severe < 30 500 to 1,000 Every 24 hours
• Discontinuation of Levetiracetam Extended-Release Tablets
• Avoid abrupt withdrawal from levetiracetam extended-release tablets in order to reduce the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5. 8)].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Safety and effectiveness in patients 12 years of age and older have been established based on pharmacokinetic data in
• adults and adolescents using levetiracetam extended-release tablets and efficacy and safety data in controlled pediatric studies using immediate-release levetiracetam tablets [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )].
• Safety and effectiveness in pediatric patients below the age of 12 have not been established.
• A 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release levetiracetam tablets as adjunctive therapy in 98 pediatric patients with inadequately controlled partial seizures, ages 4 to 16 years (levetiracetam tablets N=64; placebo N=34).
• The target dose of immediate-release levetiracetam tablets was 60 mg/kg/day.
• Neurocognitive effects were measured by the Leiter-R Attention and Memory (AM) Battery, which assesses various aspects of a child's memory and attention.
• Although no substantive differences were observed between the placebo- and levetiracetam-treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority between the drug and placebo.
• The Achenbach Child Behavior Checklist (CBCL/6-18), a standardized validated tool used to assess a child’s competencies and behavioral/emotional problems, was also assessed in this study.
• An analysis of the CBCL/6-18 indicated a worsening in aggressive behavior, one of the eight syndrome scores, in patients treated with levetiracetam tablets [see Warnings and Precautions ( 5.1 )] .
• Juvenile Animal Toxicity Data Studies of levetiracetam in juvenile rats (dosed on postnatal days 4 through 52) and dogs (dosed from postnatal weeks 3 through 7) at doses of up to 1,800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m 2 basis) did not demonstrate adverse effects on postnatal development.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• There were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam extended-release in these patients.
• It is expected that the safety of levetiracetam extended-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 the 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 [see Clinical Pharmacology ( 12.3 )].

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are discussed in more details in other sections of labeling:
• Behavioral abnormalities and Psychotic Symptoms [see Warnings and Precautions ( 5.1 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.2 )] Somnolence and Fatigue [see Warnings and Precautions ( 5.3 )] Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.4 )] Serious Dermatological Reactions [see Warnings and Precautions ( 5.5 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.6 )] Coordination Difficulties [see Warnings and Precautions ( 5.7 )] Hematologic Abnormalities [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥5% more than placebo) include:
• somnolence and irritability ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Levetiracetam Extended-Release Tablets In the controlled clinical study in patients with partial-onset seizures [see Clinical Studies ( 14.1 )] , the most common adverse reactions in patients receiving levetiracetam extended-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 extended-release tablets in the placebo-controlled study and were numerically more common than in patients treated with placebo.
• In this study, either levetiracetam extended-release tablets or placebo was added to concurrent AED therapy.
• Table 3:
• Adverse Reactions in the Placebo-Controlled, Adjunctive Study in Patients Experiencing Partial-Onset Seizures Levetiracetam Extended-Release Tablets (N=77) % Placebo (N=79) % Influenza 8 4 Somnolence 8 3 Irritability 7 0 Nasopharyngitis 7 5 Dizziness 5 3 Nausea 5 3 Discontinuation or Dose Reduction in the Levetiracetam Extended-Release Tablets Controlled Clinical Study In the controlled clinical study, 5% of patients receiving levetiracetam extended-release tablets and 3% receiving placebo discontinued as a result of an adverse reaction.
• The adverse reactions that resulted in discontinuation and that occurred more frequently in levetiracetam extended-release-treated patients than in placebo-treated patients were asthenia, epilepsy, mouth ulceration, rash, and respiratory failure.
• Each of these adverse reactions led to discontinuation in a levetiracetam extended-release-treated patient and no placebo-treated patients.
• Immediate-Release Levetiracetam Tablets Table 4 lists the adverse reactions in the controlled studies of immediate-release levetiracetam tablets in adult patients experiencing partial-onset seizures [see Clinical Studies ( 14.2 )] .
• Although the pattern of adverse reactions in the levetiracetam extended-release tablets study seems somewhat different from that seen in partial-onset seizure controlled studies for immediate-release levetiracetam tablets, this is possibly due to the much smaller number of patients in this study compared to the immediate-release tablet studies.
• The adverse reactions for levetiracetam extended-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, the 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-controlled studies and were numerically more common than in patients treated with placebo.
• In these studies, either immediate-release levetiracetam tablets or placebo was added to concurrent AED therapy.
• Table 4:
• Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Studies in
• Adults Experiencing Partial-Onset Seizures Levetiracetam (N=769) % Placebo (N=439) % Asthenia 15 9 Somnolence 15 8 Headache 14 13 Infection 13 8 Dizziness 9 4 Pain 7 6 Pharyngitis 6 4 Depression 4 2 Nervousness 4 2 Rhinitis 4 3 Anorexia 3 2 Ataxia 3 1 Vertigo 3 1 Amnesia 2 1 Anxiety 2 1 Cough Increased 2 1 Diplopia 2 1 Emotional Lability 2 0 Hostility 2 1 Paresthesia 2 1 Sinusitis 2 1 Pediatric Patients 4 Years to <16 Years In a pooled analysis of two controlled pediatric clinical studies in
• children 4 to 16 years of age with partial-onset seizures [see Clinical Studies ( 14.3 )] , the adverse reactions most frequently reported with the 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, decreased 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 was added to concurrent AED therapy.
• Adverse reactions were usually mild to moderate in intensity.
• Table 5:
• Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Studies in Pediatric Patients Ages 4 to 16 Years Experiencing Partial-Onset Seizures Levetiracetam (N=165) % Placebo (N=131) % Headache 19 15 Nasopharyngitis 15 12 Vomiting 15 12 Somnolence 13 9 Fatigue 11 5 Aggression 10 5 Upper Abdominal Pain 9 8 Cough 9 5 Nasal Congestion 9 2 Decreased Appetite 8 2 Abnormal Behavior 7 4 Dizziness 7 5 Irritability 7 1 Pharyngolaryngeal Pain 7 4 Diarrhea 6 2 Lethargy 6 5 Insomnia 5 3 Agitation 4 1 Anorexia 4 3 Head Injury 4 0 Constipation 3 1 Contusion 3 1 Depression 3 1 Fall 3 2 Influenza 3 1 Mood Altered 3 1 Affect Lability 2 1 Anxiety 2 1 Arthralgia 2 0 Confusional State 2 0 Conjunctivitis 2 0 Ear Pain 2 1 Gastroenteritis 2 0 Joint Sprain 2 1 Mood Swings 2 1 Neck Pain 2 1 Rhinitis 2 0 Sedation 2 1 In controlled pediatric clinical studies in patients 4 to 16 years of age, 7% of patients treated with immediate-release levetiracetam tablets and 9% of patients on placebo discontinued as a result of an adverse event.
• In addition, the following adverse reactions were seen in other controlled studies of immediate-release levetiracetam tablets:
• balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and blurred vision.
• Comparison of Gender, Age and Race There are insufficient data for levetiracetam extended-release tablets to support a statement regarding the distribution of adverse reactions by gender, age, and race.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of immediate-release levetiracetam tablets.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• The listing is alphabetized:
• abnormal liver function test, acute kidney injury, anaphylaxis, angioedema, agranulocytosis, choreoathetosis, drug reaction with eosinophilia and systemic symptoms (DRESS), dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, muscular weakness, obsessive-compulsive disorders (OCD), pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, weight loss, and worsening of seizures including in patients with SCN8A mutations.
• Alopecia has been reported with immediate-release levetiracetam use; recovery was observed in majority of cases where immediate-release levetiracetam was discontinued.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Levetiracetam Extended-Release Tablets In the controlled clinical study in patients with partial-onset seizures [see Clinical Studies ( 14.1 )] , the most common adverse reactions in patients receiving levetiracetam extended-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 extended-release tablets in the placebo-controlled study and were numerically more common than in patients treated with placebo.
• In this study, either levetiracetam extended-release tablets or placebo was added to concurrent AED therapy.
• Table 3:
• Adverse Reactions in the Placebo-Controlled, Adjunctive Study in Patients Experiencing Partial-Onset Seizures Levetiracetam Extended-Release Tablets (N=77) % Placebo (N=79) % Influenza 8 4 Somnolence 8 3 Irritability 7 0 Nasopharyngitis 7 5 Dizziness 5 3 Nausea 5 3 Discontinuation or Dose Reduction in the Levetiracetam Extended-Release Tablets Controlled Clinical Study In the controlled clinical study, 5% of patients receiving levetiracetam extended-release tablets and 3% receiving placebo discontinued as a result of an adverse reaction.
• The adverse reactions that resulted in discontinuation and that occurred more frequently in levetiracetam extended-release-treated patients than in placebo-treated patients were asthenia, epilepsy, mouth ulceration, rash, and respiratory failure.
• Each of these adverse reactions led to discontinuation in a levetiracetam extended-release-treated patient and no placebo-treated patients.
• Immediate-Release Levetiracetam Tablets Table 4 lists the adverse reactions in the controlled studies of immediate-release levetiracetam tablets in adult patients experiencing partial-onset seizures [see Clinical Studies ( 14.2 )] .
• Although the pattern of adverse reactions in the levetiracetam extended-release tablets study seems somewhat different from that seen in partial-onset seizure controlled studies for immediate-release levetiracetam tablets, this is possibly due to the much smaller number of patients in this study compared to the immediate-release tablet studies.
• The adverse reactions for levetiracetam extended-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, the 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-controlled studies and were numerically more common than in patients treated with placebo.
• In these studies, either immediate-release levetiracetam tablets or placebo was added to concurrent AED therapy.
• Table 4:
• Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Studies in
• Adults Experiencing Partial-Onset Seizures Levetiracetam (N=769) % Placebo (N=439) % Asthenia 15 9 Somnolence 15 8 Headache 14 13 Infection 13 8 Dizziness 9 4 Pain 7 6 Pharyngitis 6 4 Depression 4 2 Nervousness 4 2 Rhinitis 4 3 Anorexia 3 2 Ataxia 3 1 Vertigo 3 1 Amnesia 2 1 Anxiety 2 1 Cough Increased 2 1 Diplopia 2 1 Emotional Lability 2 0 Hostility 2 1 Paresthesia 2 1 Sinusitis 2 1 Pediatric Patients 4 Years to <16 Years In a pooled analysis of two controlled pediatric clinical studies in
• children 4 to 16 years of age with partial-onset seizures [see Clinical Studies ( 14.3 )] , the adverse reactions most frequently reported with the 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, decreased 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 was added to concurrent AED therapy.
• Adverse reactions were usually mild to moderate in intensity.
• Table 5:
• Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Studies in Pediatric Patients Ages 4 to 16 Years Experiencing Partial-Onset Seizures Levetiracetam (N=165) % Placebo (N=131) % Headache 19 15 Nasopharyngitis 15 12 Vomiting 15 12 Somnolence 13 9 Fatigue 11 5 Aggression 10 5 Upper Abdominal Pain 9 8 Cough 9 5 Nasal Congestion 9 2 Decreased Appetite 8 2 Abnormal Behavior 7 4 Dizziness 7 5 Irritability 7 1 Pharyngolaryngeal Pain 7 4 Diarrhea 6 2 Lethargy 6 5 Insomnia 5 3 Agitation 4 1 Anorexia 4 3 Head Injury 4 0 Constipation 3 1 Contusion 3 1 Depression 3 1 Fall 3 2 Influenza 3 1 Mood Altered 3 1 Affect Lability 2 1 Anxiety 2 1 Arthralgia 2 0 Confusional State 2 0 Conjunctivitis 2 0 Ear Pain 2 1 Gastroenteritis 2 0 Joint Sprain 2 1 Mood Swings 2 1 Neck Pain 2 1 Rhinitis 2 0 Sedation 2 1 In controlled pediatric clinical studies in patients 4 to 16 years of age, 7% of patients treated with immediate-release levetiracetam tablets and 9% of patients on placebo discontinued as a result of an adverse event.
• In addition, the following adverse reactions were seen in other controlled studies of immediate-release levetiracetam tablets:
• balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and blurred vision.
• Comparison of Gender, Age and Race There are insufficient data for levetiracetam extended-release tablets to support a statement regarding the distribution of adverse reactions by gender, age, and race.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of immediate-release levetiracetam tablets.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• The listing is alphabetized:
• abnormal liver function test, acute kidney injury, anaphylaxis, angioedema, agranulocytosis, choreoathetosis, drug reaction with eosinophilia and systemic symptoms (DRESS), dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, muscular weakness, obsessive-compulsive disorders (OCD), pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, weight loss, and worsening of seizures including in patients with SCN8A mutations.
• Alopecia has been reported with immediate-release levetiracetam use; recovery was observed in majority of cases where immediate-release levetiracetam was discontinued.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Medication Guide).
• The Medication Guide accompanies the product and can also be accessed on https://gsms.us/ or by calling Apotex Corp at 1-800-706-5575.
• Psychiatric Reactions and Changes in Behavior Advise patients that levetiracetam extended-release tablets may cause changes in behavior (e.g. irritability and aggression).
• In addition, patients should be advised that they may experience changes in behavior that have been seen with other formulations of levetiracetam, which include agitation, anger, anxiety, apathy, depression, hostility, and psychotic symptoms [see Warnings and Precautions ( 5.1 )] .
• Suicidal Behavior and Ideation Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including levetiracetam extended-release tablets, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm.
• Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider [see Warnings and Precautions ( 5.2 )] .
• Effects on Driving or Operating Machinery Inform patients that levetiracetam extended-release tablets may cause dizziness and somnolence.
• Inform patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam extended-release tablets to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions ( 5.3 )] .
• Anaphylaxis and Angioedema Advise patients to discontinue levetiracetam extended-release tablets and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions ( 5.4 )] .
• Dermatological Adverse Reactions Advise patients that serious dermatological adverse reactions have occurred in patients treated with levetiracetam and instruct them to call their physician immediately if a rash develops [see Warnings and Precautions ( 5.5 )] .
• DRESS/Multiorgan Hypersensitivity Instruct patients and caregivers that a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately.
• Levetiracetam extended-release tablets should be discontinued immediately if a serious hypersensitivity reaction is suspected [see Warnings and Precautions ( 5.6 )].
• Dosing and Administration Patients should be instructed to only take levetiracetam extended-release tablets once daily and to swallow the tablets whole.
• They should not be chewed, broken, or crushed.
• Inform patients that they should not be concerned if they occasionally notice something that looks like swollen pieces of the original tablet in their stool.
• Withdrawal of Levetiracetam Advise patients and caregivers not to discontinue use of levetiracetam extended-release tablets without consulting with their healthcare provider.
• Levetiracetam extended-release tablets should normally be gradually withdrawn to reduce the potential of increased seizure frequency and status epilepticus [see Warnings and Precautions ( 5.8 )].
• Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during levetiracetam tablets therapy.
• Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant [see Use in Specific Populations ( 8.1 ) ] .
• APOTEX INC.
• LEVETIRACETAM EXTENDED-RELEASE TABLETS, USP 500 mg, 750 mg and 1,000 mg Manufactured by Manufactured for Apotex Inc.
• Apotex Corp.
• Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Revision:
• 14 Marketed by:
• GSMS, Inc.
• Camarillo, CA 93012 USA

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Levetiracetam extended-release, USP 500 mg tablets are white, oval, biconvex film-coated tablets, engraved with "APO" on one side, "LXR 500" on the other side.
• Levetiracetam extended-release, USP 750 mg tablets are white, capsule shaped, biconvex film-coated tablets, engraved with "APO" on one side, "LXR 750" on the other side.
• Levetiracetam extended-release, USP 1,000 mg tablets are white, oval shaped, biconvex film-coated tablets, engraved with "APO" on one side, "LXR 1000" on the other side. 500 mg white, film-coated extended-release tablet ( 3 ) 750 mg white, film-coated extended-release tablet ( 3 ) 1,000 mg white, film-coated extended-release tablet ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Levetiracetam extended-release tablets, USP 500 mg are white, oval, biconvex film-coated tablets, engraved with “APO” on one side, “LXR 500” on the other side.
• They are supplied as follows:
• Bottles of 60s (NDC 60429-349-60) Levetiracetam extended-release tablets, USP 750 mg are white, capsule shaped, biconvex film-coated tablets, engraved with “APO” on one side, “LXR 750” on the other side.
• They are supplied as follows: Bottles of 60s (NDC 60429-350-60)
• Storage
• Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Dispense in a tight, light-resistant container [see USP].
• Protect from moisture.
• Levetiracetam extended-release tablets, USP 500 mg are white, oval, biconvex film-coated tablets, engraved with “APO” on one side, “LXR 500” on the other side.
• They are supplied as follows:
• Bottles of 60s (NDC 60429-349-60) Levetiracetam extended-release tablets, USP 750 mg are white, capsule shaped, biconvex film-coated tablets, engraved with “APO” on one side, “LXR 750” on the other side.
• They are supplied as follows: Bottles of 60s (NDC 60429-350-60)

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from moisture.

Quoted from the official label, section “Storage and Handling”.

What is in it

• Levetiracetam extended-release tablets, USP are an antiepileptic drug available as 500 mg, 750 mg and 1,000 mg (white) extended-release tablets, USP for oral administration.
• The chemical name of levetiracetam, a single enantiomer, is (αS)-α-ethyl-2-oxo-1-pyrrolidineacetamide, 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 (AEDs).
• It has the following structural formula:
• Levetiracetam USP is a white to off-white powder.
• 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, USP contain the labeled amount of levetiracetam.
• Inactive ingredients:
• colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.
• 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.
• Meets USP Dissolution Test 5. levetiracetamxr-01

Quoted from the official label, section “Description”.

Ingredients people check for

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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