Levetiracetam 750 mg Tablet, 120-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other antiepileptics class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Levetiracetam is an anti-seizure medicine. Depending on the product and your age, it can be used to treat partial-onset seizures (seizures starting in one part of the brain), myocl...
- What is levetiracetam actually used for?
- It can, especially when you first start taking it. Drowsiness, fatigue, and dizziness are among the most common side effects and tend to be most noticeable in the first few weeks....
- Will levetiracetam make me feel tired or foggy?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Levetiracetam — tap one for details:
Levetiracetam may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 0VUT3PMY82
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
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UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1374 | $16.49 / 120 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levetiracetam 750 mg 00378-5617-05 | Mylan | 500 tablets | $0.109 | — | Availability likely | — |
| Levetiracetam 750 mg 00904-7125-61 | Major | 1 tablet | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 16714-0537-01 | NorthStar | 120 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 27808-0265-01 | Cranbury | 120 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 31722-0538-05 | Camber | 500 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 43547-0223-15 | Solco | 120 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 50228-0472-05 | ScieGen | 500 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 64980-0606-12 | Rising | 120 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 67877-0770-05 | Ascend | 500 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 68001-0404-03 | BluePoint | 500 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 68084-0882-01 | American | 1 tablet | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 68180-0114-02 | Lupin | 500 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 72205-0096-92 | Novadoz | 120 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 82009-0123-05 | Quallent | 500 tablets | $0.109 | AB | Availability likely | — |
| Levetiracetam 750 mg 13668-0016-05 | Torrent | 500 tablets | $0.137 | AB | FDA listed | — |
| Spritam 750 mg 43485-0103-60 | Aprecia | 1 tablet | $10.378 | — | Availability likely | — |
| Keppra 750 mg 50474-0596-40 | UCB, | 120 tablets | $13.461 | AB | Availability likely | — |
| Levetiracetam 750 mg 00615-8500-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 43547-0882-15 | Solco | 120 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 50090-7775-00 | A-S | 120 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 50405-0302-01 | SOHM, | 30 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mgthis 55111-0183-04 | Dr. | 120 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 63629-8315-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 65162-0538-16 | Amneal | 120 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 65862-0247-05 | Aurobindo | 500 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 67046-1615-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 70010-0523-03 | Granules | 30 tablets | — | — | FDA listed | — |
| Levetiracetam 750 mg 70518-4013-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 71335-2098-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 72865-0189-05 | XLCare | 500 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 76282-0248-12 | Exelan | 120 tablets | — | — | FDA listed | — |
| Levetiracetam 750 mg 76494-0530-12 | Prinston | 120 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 87063-0192-12 | ASCLEMED | 120 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 69102-0106-01 | OWP | 120 tablets | — | AB | FDA listed | — |
| Levetiracetam 750 mg 67046-1207-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55111-0183-01 | 100 TABLET in 1 BOTTLE (55111-183-01) | 2009-01-15 | Active |
| 55111-0183-04 You're viewing this | 120 TABLET in 1 BOTTLE (55111-183-04) | 2009-01-15 | Active |
| 55111-0183-05 | 500 TABLET in 1 BOTTLE (55111-183-05) | 2009-01-15 | Active |
| 55111-0183-30 | 30 TABLET in 1 BOTTLE (55111-183-30) | 2009-01-15 | Active |
| 55111-0183-79 | 1 BLISTER PACK in 1 CARTON (55111-183-79) / 10 TABLET in 1 BLISTER PACK | 2009-01-15 | Active |
Pack size FAQ
What quantity is in NDC 55111-0183-04?
What is the difference between NDC 55111-0183-04 and NDC 55111-0183-79?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Levetiracetam tablets are an antiepileptic drug indicated for adjunctive therapy in the treatment of: Partial onset seizures in patients one month of age and older with epilepsy (1.1) Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1Partial Onset Seizures Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3Primary Generalized Tonic-Clonic Seizures Levetiracetam tablets are 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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Use the oral solution for pediatric patients with body weight ≤ 20 kg (2.1) . For pediatric patients, use weight-based dosing for the oral solution with a calibrted measuring device (not a household teaspoon or tablespoon) (2.1) Partial Onset Seizures 1 Month To < 6 Months: 7 mg/kg twice daily, increase in increments of 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily (2.2) 6 Months To < 4 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily (2.2) 4 Years To < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.2) Adults 16 Years And Older: 500 mg twice daily, increase as needed and tolerated in increments of 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily (2.2) Myoclonic Seizures In Adults and Pediatric Patients 12 Years And Older 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.3) Primary Generalized Tonic-Clonic Seizures 6 Years To < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.4) Adults 16 Years And Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.4) Adult patients with impaired renal function Dose adjustment is recommended, based on the patient’s estimated creatinine clearance ( 2.5 , 8.6 )
2.1Important Administration Instructions Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function. Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg.
Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg. When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon). Levetiracetam tablets should be swallowed whole.
Levetiracetam tablets should not be chewed or crushed.
2.2Partial Onset Seizures Adults 16 Years and Older In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1) ], a consistent increase in response with increased dose has not been shown. Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily).
Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
Pediatric Patients 1 Month to < 6 Months Treatment should be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). The daily dose should be increased every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group.
The effectiveness of lower doses has not been studied. 6 Months to <4 Years: Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). The daily dose should be increased in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily).
If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group. 4 Years to < 16 Years Treatment should be initiated with a daily dose of 20 mg/kg in 2…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Levetiracetam tablets USP, 250 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘181’ on other side separating “1” and “81” with bisect line. Levetiracetam tablets USP, 500 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘182’ on other side separating “1” and “82” with bisect line. Levetiracetam tablets USP, 750 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘183’ on other side separating “1” and “83” with bisect line.
250 mg, 500 mg, 750 mg, film-coated, scored tablets (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. • None (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Psychiatric Symptoms: Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed. Monitor patients for psychiatric signs and symptoms (5.1) Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior (5.2) Somnolence and Fatigue: Monitor patients for these symptoms and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam (5.3) Withdrawal Seizures: Levetiracetam must be gradually withdrawn (5.6)
5.1Psychiatric Reactions In some patients levetiracetam causes behavioral abnormalities. The incidences of behavioral abnormalities in the myoclonic and primary generalized tonic-clonic seizure studies were comparable to those of the adult and pediatric partial onset seizure studies. A total of 13.3% of adult levetiracetam-treated patients and 37.6% of pediatric levetiracetam-treated patients (4 to 16 years of age) compared to 6.2% and 18.6% of adult and pediatric placebo patients respectively, experienced non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder).
A randomized double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in pediatric patients (4 to 16 years of age). The results from an exploratory analysis indicated a worsening in levetiracetam-treated patients on aggressive behavior (one of eight behavior dimensions) as measured in a standardized and systematic way using a validated instrument, the Achenbach Child Behavior Checklist (CBCL/6 to 18). In pediatric patients 1 month to < 4 years of age, irritability was reported in 11.7% of the levetiracetam-treated patients compared to 0% of placebo patients.
A total of 1.7% of adult levetiracetam-treated patients discontinued treatment due to behavioral adverse events, compared to 0.2% of placebo patients. The treatment dose was reduced in 0.8% of adult levetiracetam-treated patients and in 0.5% of placebo patients. Overall, 10.9% of levetiracetam-treated pediatric patients experienced behavioral symptoms associated with discontinuation or dose reduction, compared to 6.2% of placebo patients.
One percent of adult levetiracetam-treated patients, 2% of children 4 to 16 years of age, and 17% of children 1 month to <4 years of age experienced psychotic symptoms, compared to 0.2%, 2%, and 5% respectively, in the placebo patients. In the controlled study that assessed the neurocognitive and behavioral effects of levetiracetam in pediatric patients 4 to 16 years of age, 1 (1.6%) levetiracetam-treated patient experienced paranoia compared to no placebo patients. There were 2 (3.1%) levetiracetam-treated patients that experienced confusional state compared to no placebo patients [see Use in Specific Populations (8.4) ].
Two (0.3%) adult levetiracetam-treated 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 the pediatric patients who discontinued treatment due to psychotic and non-psychotic adverse reactions.
The above psychiatric signs symptoms should be monitored.
5.2Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including levetiracetam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual ch…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in more details in other sections of labeling: Psychiatric 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) ] Serious Dermatological Reactions [see Warnings and Precautions (5.4) ] Coordination Difficulties [see Warnings and Precautions (5.5) ] Withdrawal Seizures [see Warnings and Precautions (5.6) ] Hematologic Abnormalities [see Warnings and Precautions (5.7) ] Blood Pressure Increases [see Warnings and Precautions (5.8) ] Seizure Control During Pregnancy [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence in levetiracetam-treated patients is ≥ 5% more than in placebo-treated patients) include: Adult patients: somnolence, asthenia, infection and dizziness (6.1) Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. The prescriber should be aware that the adverse reaction incidence figures in the following tables, obtained when levetiracetam was added to concurrent AED therapy, cannot be used to predict the frequency of adverse reactions in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical trials.
Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse reaction incidences in the population studied. Partial Onset Seizures Adults In controlled clinical studies in adults with partial onset seizures, the most frequently reported adverse reactions in patients receiving levetiracetam in combination with other AEDs were somnolence, asthenia, infection and dizziness.
Of the most frequently reported adverse reactions in adults experiencing partial onset seizures, asthenia, somnolence and dizziness appeared to occur predominantly during the first 4 weeks of treatment with levetiracetam. Table 3 lists adverse reactions that occurred in at least 1% of adult epilepsy patients treated with levetiracetam participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either levetiracetam or placebo was added to concurrent AED therapy.
Adverse reactions were usually mild to moderate in intensity. Table 3: Incidence (%) Of Adverse Reactions In Placebo-Controlled, Add-On Studies In Adults Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 1% Of Levetiracetam-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients) Body System/ Adverse Reaction Levetiracetam (N=769) % Placebo (N=439) % Body as a Whole Asthenia 15 9 Headache 14 13 Infection 13 8 Pain 7 6 Digestive System Anorexia 3 2 Nervous System Somnolence 15 8 Dizziness 9 4 Depression 4 2 Nervousness 4 2 Ataxia 3 1 Vertigo 3 1 Amnesia 2 1 Anxiety 2 1 Hostility 2 1 Paresthesia 2 1 Emotional Lability 2 0 Respiratory System Pharyngitis 6 4 Rhinitis 4 3 Cough Increased 2 1 Sinusitis 2 1 Special Senses Diplopia 2 1 In controlled adult clinical studies, 15% of patients receiving levetiracetam and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse event.
Table 4 lists the…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No significant pharmacokinetic interactions were observed between levetiracetam or its major metabolite and concomitant medications via human liver cytochrome P450 isoforms, epoxide hydrolase, UDP-glucuronidation enzymes, P-glycoprotein, or renal tubular secretion [see Clinical Pharmacology (12.3) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Plasma levels of levetiracetam may be decreased and therefore need to be monitored closely during pregnancy. Based on animal data, may cause fetal harm ( 5.9 , 8.1 )
8.1Pregnancy Levetiracetam levels may decrease during pregnancy [see Warnings and Precautions (5.9) ]. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m 2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times the MRHD on a mg/m 2 basis). The developmental no effect dose was 70 mg/kg/day (0.2 times the MRHD on a mg/m 2 basis).
There was no overt maternal toxicity at the doses used in this study. Oral administration of levetiracetam to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and increased incidences of minor fetal skeletal abnormalities at doses ≥600 mg/kg/day (4 times MRHD on a mg/m 2 basis) and in decreased fetal weights and increased incidences of fetal malformations at a dose of 1800 mg/kg/day (12 times the MRHD on a mg/m 2 basis). The developmental no effect dose was 200 mg/kg/day (equivalent to the MRHD on a mg/m 2 basis).
Maternal toxicity was also observed at 1800 mg/kg/day. When levetiracetam was administered orally to pregnant rats during the period of organogenesis, fetal weights were decreased and the incidence of fetal skeletal variations was increased at a dose of 3600 mg/kg/day (12 times the MRHD). 1200 mg/kg/day (4 times the MRHD) was a developmental no effect dose.
There was no evidence of maternal toxicity in this study. Treatment of rats with levetiracetam during the last third of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the MRHD on a mg/m 2 basis). Pregnancy Registries To provide information regarding the effects of in utero exposure to levetiracetam, physicians are advised to recommend that pregnant patients taking levetiracetam enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry.
This can be done by calling the toll free number 1-888-233-2334, and must be done by the patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ .
8.2Labor and Delivery The effect of levetiracetam on labor and delivery in humans is unknown.
8.3Nursing Mothers Levetiracetam is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from levetiracetam, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
8.4Pediatric Use The safety and effectiveness of levetiracetam in the adjunctive treatment of partial onset seizures in pediatric patients age 1 month to 16 years old with epilepsy have been established [see Clinical Studies (14.1) ]. The dosing recommendation in these pediatric patients varies according to age group and is weight-based [see Dosage and Administration (2.2) ]. The safety and effectiveness of levetiracetam as adjunctive treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established [see Clinical Studies (14.2) ].
The safety and effectiveness of levetiracetam as adjunctive therapy in the treatment of primar…
🤰 Pregnancy ▾
8.1Pregnancy Levetiracetam levels may decrease during pregnancy [see Warnings and Precautions (5.9) ]. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m 2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times the MRHD on a mg/m 2 basis). The developmental no effect dose was 70 mg/kg/day (0.2 times the MRHD on a mg/m 2 basis).
There was no overt maternal toxicity at the doses used in this study. Oral administration of levetiracetam to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and increased incidences of minor fetal skeletal abnormalities at doses ≥600 mg/kg/day (4 times MRHD on a mg/m 2 basis) and in decreased fetal weights and increased incidences of fetal malformations at a dose of 1800 mg/kg/day (12 times the MRHD on a mg/m 2 basis). The developmental no effect dose was 200 mg/kg/day (equivalent to the MRHD on a mg/m 2 basis).
Maternal toxicity was also observed at 1800 mg/kg/day. When levetiracetam was administered orally to pregnant rats during the period of organogenesis, fetal weights were decreased and the incidence of fetal skeletal variations was increased at a dose of 3600 mg/kg/day (12 times the MRHD). 1200 mg/kg/day (4 times the MRHD) was a developmental no effect dose.
There was no evidence of maternal toxicity in this study. Treatment of rats with levetiracetam during the last third of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the MRHD on a mg/m 2 basis). Pregnancy Registries To provide information regarding the effects of in utero exposure to levetiracetam, physicians are advised to recommend that pregnant patients taking levetiracetam enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry.
This can be done by calling the toll free number 1-888-233-2334, and must be done by the patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ .
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of levetiracetam in the adjunctive treatment of partial onset seizures in pediatric patients age 1 month to 16 years old with epilepsy have been established [see Clinical Studies (14.1) ]. The dosing recommendation in these pediatric patients varies according to age group and is weight-based [see Dosage and Administration (2.2) ]. The safety and effectiveness of levetiracetam as adjunctive treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established [see Clinical Studies (14.2) ].
The safety and effectiveness of levetiracetam as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established [see Clinical Studies (14.3) ]. A 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in 98 (levetiracetam N=64, placebo N=34) pediatric patients, ages 4 to 16 years old, with partial seizures that were inadequately controlled.
The target dose was 60 mg/kg/day. Neurocognitive effects were measured by the Leiter-R Attention and Memory (AM) Battery, which measures various aspects of a child's memory and attention. Although no substantive differences were observed between the placebo and drug treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority of the drug and placebo.
The Achenbach Child Behavior Checklist (CBCL/6 to 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 to 18 indicated on average a worsening in levetiracetam treated patients in aggressive behavior, one of the eight syndrome scores. [see Warnings and Precautions (5.1) ] Studies of levetiracetam in juvenile rats (dosing from day 4 through day 52 of age) and dogs (dosing from week 3 through week 7 of age) at doses of up to 1800 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 indicate a potential for age-specific toxicity.
🧓 Geriatric Use ▾
8.5Geriatric Use There were 347 subjects in clinical studies of 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 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) ].
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans The highest known dose of levetiracetam received in the clinical development program was 6000 mg/day. Other than drowsiness, there were no adverse events in the few known cases of overdose in clinical trials. Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses in postmarketing use.
10.2Management of Overdose There is no specific antidote for overdose with levetiracetam. If indicated, elimination of unabsorbed drug should be attempted by emesis or gastric lavage; usual precautions should be observed to maintain airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the patient’s clinical status.
A Certified Poison Control Center should be contacted for up to date information on the management of overdose with levetiracetam.
10.3Hemodialysis Standard hemodialysis procedures result in significant clearance of levetiracetam (approximately 50% in 4 hours) and should be considered in cases of overdose. Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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 kindled 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 the 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 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, in vitro 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, in vitro 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 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.
12.2Pharmacodynamics Effects on QTc Interval The effect of levetiracetam on QTc prolongation was evaluated in a randomized, double-blind, positive-controlled (moxifloxacin 400 mg) and placebo-controlled crossover study of levetiracetam (1000 mg or 5000 mg) in 52 healthy subjects. The upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc was below 10 milliseconds. Therefore, there was no evidence of significant QTc prolongation in this study.
12.3Pharmacokinetics 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 the 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 the 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 competi…
🧬 Mechanism of Action ▾
12.1Mechanism 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 kindled 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 the 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 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, in vitro 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, in vitro 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 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Levetiracetam tablets USP, 250 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘181’ on other side separating “1” and “81” with bisect line. They are supplied in bottles of 30, 100, 120, 500 and unit dose package of 10 (1 x 10). Bottles of 30 NDC 55111-181-30 Bottles of 100 NDC 55111-181-01 Bottles of 120 NDC 55111-181-04 Bottles of 500 NDC 55111-181-05 Unit dose package of 10 (1 x 10) NDC 55111-181-79 Levetiracetam tablets USP, 500 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘182’ on other side separating “1” and “82” with bisect line.
They are supplied in bottles of 30, 100, 120, 500 and unit dose package of 10 (1 x 10). Bottles of 30 NDC 55111-182-30 Bottles of 100 NDC 55111-182-01 Bottles of 120 NDC 55111-182-04 Bottles of 500 NDC 55111-182-05 Unit dose package of 10 (1 x 10) NDC 55111-182-79 Levetiracetam tablets USP, 750 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘183’ on other side separating “1” and “83” with bisect line. They are supplied in bottles of 30, 100, 120, 500 and unit dose package of 10 (1 x 10).
Bottles of 30 NDC 55111-183-30 Bottles of 100 NDC 55111-183-01 Bottles of 120 NDC 55111-183-04 Bottles of 500 NDC 55111-183-05 Unit dose package of 10 (1 x 10) NDC 55111-183-79 Pharmacist: Dispense in a tight light-resistant container with a child-resistant closure.
16.2Storage Store levetiracetam tablets 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].
📋 Description ▾
11 DESCRIPTION Levetiracetam USP is an antiepileptic drug available as beige colored tablets in 250 mg, 500 mg and 750 mg strengths for oral administration. The chemical name of levetiracetam USP, a single enantiomer, is (-)-(S)-a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam USP is chemically unrelated to existing antiepileptic drugs (AEDs).
It has the following structural formula: Levetiracetam USP is a white to off-white crystalline powder. It is very soluble in water, freely soluble in methanol, chloroform and ethanol. Soluble in acetonitrile and practically insoluble in n-hexane.
Levetiracetam tablets USP contain the labeled amount of levetiracetam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, povidone, talc, sodium starch glycolate and coloring agent contains hypromellose 3cp, hypromellose 6cp, iron oxide yellow, iron oxide red, polyethylene glycol 400, polysorbate 80 and titanium dioxide.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved Patient Labeling (Medication Guide) . Counsel patients on the benefits and risks of receiving levetiracetam. Provide the Medication Guide to patients and/or caregivers, and instruct them to read the Medication Guide prior to taking levetiracetam.
Instruct patients to take levetiracetam only as prescribed. Suicidal Behavior and Ideation Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including levetiracetam, 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.
Psychiatric Reactions and Changes in Behavior Advise patients that levetiracetam may cause changes in behavior (e.g. aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability) and in rare cases, psychotic symptoms have occurred. Effects on Driving or Operating Machinery Inform patients that levetiracetam may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects their ability to drive or operate machinery.
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. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during levetiracetam therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant.
This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334. [see Use In Specific Populations (8.1) ].
💬 Medication Guide ▾
MEDICATION GUIDE Levetiracetam Tablets USP, 250 mg, 500 mg and 750 mg Read this Medication Guide before you start taking levetiracetam tablets 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 tablets? Like other antiepileptic drugs, levetiracetam tablets 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 tablets without first talking to a healthcare provider .
Stopping levetiracetam tablets 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 are levetiracetam tablets?
Levetiracetam tablets are a prescription medicine taken by mouth that is used with other medicines to treat: partial onset seizures in people 1 month of age and older with epilepsy myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy. It is not known if levetiracetam tablets are is safe or effective in children under 1 month of age. Before taking your medicine, make sure you have received the correct medicine.
Compare the name above with the name on your bottle and the appearance of your medicine with the description of levetiracetam tablets provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine. Levetiracetam tablets USP, 250 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘181’ on other side separating “1” and “81” with bisect line.
Levetiracetam tablets USP, 500 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘182’ on other side separating “1” and “82” with bisect line. Levetiracetam tablets USP, 750 mg are beige, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘183’ on other side separating “1” and “83” with bisect line. What should I tell my healthcare provider before starting levetiracetam tablets?
Before taking levetiracetam tablets, tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems or suicidal thoughts or behavior have kidney problems are pregnant or planning to become pregnant. It is not known if levetiracetam tablets will harm your unborn baby. You and your healthcare provider will have to decide if you should take levetiracetam tablets while you are pregnant.
If you become pregnant while taking levetiracetam tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-…