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Levetiracetam 500 mg Tablet, Film Coated, 120-count

by Prinston Pharmaceutical Inc. · 120 TABLET, FILM COATED in 1 BOTTLE (76494-529-12)

NDC 76494-0529-12

🏷️ FDA NDC (as labeled) 76494-529-12 billing pads the product segment with a zero

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 76494-529-12

Product NDC 76494-529

11-digit billing NDC 76494052912

RxCUI 311288, 311289, 311290, 387003

UNII 44YRR34555

Application # ANDA078106

SPL Set ID d818ef84-9b3e-434b-92d9-910cfa8af7da

Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2012-09-11

Route ORAL

Dosage form TABLET, FILM COATED

Substance LEVETIRACETAM

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 76494-529-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76494-0529-12. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Other antiepileptics class.

Drug family (ATC) Other antiepileptics

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPrinston Pharmaceutical Inc.

Application holderPRINSTON PHARMACEUTICAL INC

FDA applicationANDA078106 (ANDA)

Labeler code76494

First marketedSep 2012

Product typeHuman Prescription Drug

Portfolio4 products on file

🔎 All NDCs from Prinston Pharmaceutical Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Levetiracetam is used alone and along with other medications to control partial-onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age or older. Levetiracetam is also used in combination with other medications to treat seizure in adults and children 12 years of age or older with juvenile myoclonic epilepsy. Levetiracetam is also used in combination with other medications to treat primary generalized tonic-clonic seizures (formerly known as a grand mal seizure; seizure that involves the entire body) in adults and children 6 years of age...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

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?

📖 Read our full Levetiracetam guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Levetiracetam — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Levetiracetam (105 interactions) — ranked by severity →

Nutrient depletion considerations

Levetiracetam may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

VITAMIN K Insignificant Depletion

🧪 Full Levetiracetam nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Pink / White

ShapeOval

ImprintHH;936

Size23 mm

ScoringScored — splits in 2

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 2LRS185U6K
D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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.
UNII 1IVH67816N
Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
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.
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.
UNII VH2XOU12IE
Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
UNII UH6KR4953D
Polyethylene glycol 800 is a synthetic liquid polymer made from ethylene oxide. It acts as a solvent, humectant, and thickening agent to help dissolve active ingredients and improve the medicine's texture and stability.
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.
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.
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.
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.
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.
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

16 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Levetiracetam 500 mg 00378-5615-05	Mylan	500 tablets	$0.074	—	Availability likely	—
Levetiracetam 500 mg 00904-7124-61	Major	1 tablet	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 16714-0035-01	NorthStar	120 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 27808-0264-01	Cranbury	120 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 31722-0537-05	Camber	500 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 43547-0222-11	Solco	1000 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 50228-0471-05	ScieGen	500 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 51079-0821-20	Mylan	1 tablet	$0.074	—	Availability likely	—
Levetiracetam 500 mg 60687-0657-01	American	1 tablet	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 65862-0246-05	Aurobindo	500 tablets	$0.074	—	Availability likely	—
Levetiracetam 500 mg 67877-0769-05	Ascend	500 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 68001-0403-03	BluePoint	500 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 68180-0113-02	Lupin	500 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 72205-0095-92	Novadoz	120 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 82009-0122-05	Quallent	500 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 69102-0105-01	OWP	120 tablets	$0.074	AB	Availability likely	—
Levetiracetam 500 mg 13668-0015-05	Torrent	500 tablets	$0.095	AB	FDA listed	—
Keppra 500 mg 50474-0595-40	UCB,	120 tablets	$9.916	AB	Availability likely	—
Spritam 500 mg 43485-0102-60	Aprecia	1 tablet	$10.241	—	Availability likely	—
Levetiracetam 500 mg 00615-8499-05	NCS	15 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 43063-0499-60	PD-Rx	60 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 43063-0617-60	PD-Rx	60 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 43547-0881-15	Solco	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 48433-0052-20	Safecor	1 tablet	—	—	FDA listed	—
Levetiracetam 500 mg 50090-1333-00	A-S	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 50090-7521-00	A-S	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 50090-7717-00	A-S	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 50090-7768-00	A-S	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 50090-7820-00	A-S	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 50405-0301-01	SOHM,	30 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 51655-0325-52	Northwind	30 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 55111-0182-01	Dr.	100 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 55154-3367-00	Cardinal	1 tablet	—	AB	FDA listed	—
Levetiracetam 500 mg 55154-5699-00	Cardinal	1 tablet	—	—	FDA listed	—
Levetiracetam 500 mg 63187-0360-30	Proficient	30 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 63629-4137-01	Bryant	90 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 64980-0605-01	Rising	100 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 65162-0529-16	Amneal	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 67046-0420-03	Coupler	30 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 67046-2094-03	Coupler	30 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 68788-8254-01	Preferred	100 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 68788-8843-01	Preferred	100 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 70010-0522-03	Granules	30 tablets	—	—	FDA listed	—
Levetiracetam 500 mg 70518-1108-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 70518-1796-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Levetiracetam 500 mg 70518-4301-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 71335-0694-01	Bryant	90 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 71335-2282-01	Bryant	500 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 71335-9757-01	Bryant	90 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 72189-0229-60	DIRECT	60 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 72789-0152-60	PD-Rx	60 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 72865-0188-05	XLCare	500 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 76282-0247-12	Exelan	120 tablets	—	—	FDA listed	—
Levetiracetam 500 mgthis 76494-0529-12	Prinston	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 80425-0565-01	Advanced	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 80425-0566-01	Advanced	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 87063-0191-12	ASCLEMED	120 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 87234-0035-01	Injecta	1 tablet	—	AB	FDA listed	—
Levetiracetam 500 mg 87441-0046-01	Unit	30 tablets	—	AB	FDA listed	—
Levetiracetam 500 mg 66993-0101-60	Prasco	1 tablet	—	—	FDA listed	—
Levetiracetam 500 mg 70518-1772-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2012

On the market since

Sep 2012

📍

2026

Currently FDA-listed

14 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Levetiracetam — the program that covers self-administered drugs. 30 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Levetiracetam. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$42.44M

Claims incl. refills

1.2M

Beneficiaries

606K

Spend / beneficiary

$70.03

Spend / claim

$35.28

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Levetiracetam — the ingredient across all brands.

Top reported reactions

Seizure15,978

Fatigue5,591

Somnolence4,177

Epilepsy4,136

Convulsion4,085

Fall3,756

Headache3,734

Reporter sex

Serious outcomes

Hospitalization49,182

Death11,940

Life-threatening8,185

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
76494-0529-12 You're viewing this	120 TABLET, FILM COATED in 1 BOTTLE (76494-529-12)	2012-09-11	Active

🧭 About this NDC listing & data coverage

Finished prescription product

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.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 76494-529-12, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76494-0529-12, written without dashes as 76494052912. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 76494-0529-12, the first segment (76494) is the labeler code FDA assigned to Prinston Pharmaceutical Inc.; the middle segment (0529) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Prinston Pharmaceutical Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Prinston Pharmaceutical Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Levetiracetam is an antiepileptic drug indicated for adjunctive therapy in the treatment of: • Partial onset seizures in patients four years 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 is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.2Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam is 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 is 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 ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Partial Onset Seizures • 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 is given orally with or without food. The Levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets), and renal function. 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 Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 4 Years to < 16 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 every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical efficacy trial, the mean daily dose was 44 mg/kg.

The maximum daily dose was 3000 mg/day. For Levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, treatment should be initiated with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). The daily dose should be increased every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

For Levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, treatment should be initiated with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). The daily dose should be increased every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

2.3Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower t…

💊 Dosage Forms and Strengths 140 words ▾

3 DOSAGE FORMS AND STRENGTHS Levetiracetam tablets, USP, 250 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "932" on either side of the score and plain on the other side. Levetiracetam tablets, USP, 500 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "934" on either side of the score and plain on the other side. Levetiracetam tablets, USP, 750 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "935" on either side of the score and plain on the other side.

Levetiracetam tablets, USP, 1000 mg are white to off-white, modified capsules shaped, bi-convex, scored film-coated tablets debossed "HH" AND "936" on either side of the score and plain on the other side. • 250 mg, 500 mg, 750 mg, and 1000 mg film-coated, scored tablets ( 3 )

⛔ Contraindications 8 words ▾

4 CONTRAINDICATIONS None • None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

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/6-18). 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 and 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…

🤒 Adverse Reactions ~3 min read ▾

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 Prinston Pharmaceuticals, Inc. at 866-257-2597 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, for events with rates greater than placebo, 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 ha…

🔄 Drug Interactions 38 words ▾

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 ~3 min read ▾

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 ) Information describing the use of levetiracetam tablets and levetiracetam oral solution in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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.

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of Levetiracetam in the adjunctive treatment of partial onset seizures in pediatric patients age 4 years 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) ]. Pediatric use information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution.

However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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/6-18), 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 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 112 words ▾

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 195 words ▾

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 ~3 min read ▾

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 500-5000 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 competitio…

🧬 Mechanism of Action ~2 min read ▾

📦 How Supplied / Storage and Handling 199 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Levetiracetam tablets, USP, 250 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "932" on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 76494-528-12). Levetiracetam tablets, USP, 500 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "934" on either side of the score and plain on the other side.

They are supplied in containers of 120 tablets (NDC 76494-529-12), and 1,000 tablets (NDC 76494-529-11). Levetiracetam tablets, USP, 750 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "935" on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 76494-530-12).

Levetiracetam tablets, USP, 1000 mg are white to off-white, modified capsules shaped, bi-convex, scored film-coated tablets debossed "HH" AND "936" on either side of the score and plain on the other side. They are supplied in containers of 60 tablets (NDC 76494-531-06).

16.2Storage Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure.

📋 Description ~1 min read ▾

11 DESCRIPTION Levetiracetam is an antiepileptic drug available as 250 mg (pink), 500 mg (pink), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-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 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 tablets contain the labeled amount of Levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone, talc, and additional agents listed below: 250 mg, 500 mg, and 750 mg tablets: Opadry II Pink 40L94198, which contains D&C Red No.27; FD&C Blue No.2; FD&C Red No. 40; FD&C Yellow No.

6; hypromellose 2910 3cP, 6cP, and 50cP; polydextrose FCC; polyethylene glycol 800; titanium dioxide; and triacetin. 1000 mg tablets: Opadry II white Y-22-7719, which contains hypromellose 2910 3cP, 6cP, and 50cP; polydextrose FCC; polyethylene glycol 800; titanium dioxide; and triacetin. USP dissolution test is pending.

Levetiracetam Structural Formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved Patient Labeling ( Medication Guide ), separately provided. 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) ]. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd.

Linhai, Zhejiang, China, 317024 Distributed by: Prinston Pharmaceuticals, Inc. Cranbury, New Jersey, USA, 08512 Revised: 02/2015

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Levetiracetam (lee” ve tye ra’ se tam) Tablets, USP Read this Medication Guide before you start taking Levetiracetam 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? Like other antiepileptic drugs, Levetiracetam 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 without first talking to a healthcare provider. • Stopping Levetiracetam 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 is Levetiracetam? Levetiracetam is a prescription medicine taken by mouth that is used with other medicines to treat: • partial onset seizures in people 4 years 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 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 provided below. Tell your pharmacist immediately if you think you have been given the wrong medicine.

250 mg levetiracetam tablets, USP, are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "932" on either side of the score and plain on the other side. 500 mg levetiracetam tablets, USP, are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "934" on either side of the score and plain on the other side. 750 mg levetiracetam tablets, USP, are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "HH" AND "935" on either side of the score and plain on the other side.

1000 mg levetiracetam tablets, USP, are white to off-white, modified capsules shaped; bi-convex, scored film-coated tablets debossed "HH" AND "936" on either side of the score and plain on the other side. What should I tell my healthcare provider before starting Levetiracetam? Before taking Levetiracetam, 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 will harm your unborn baby. You and your healthcare provider will have to decide if you should take Levetiracetam while you are pregnant. If you become pregnant while taking Levetiracetam, talk to your healthcare provider about registering with the North American Antiepi…

Glossary — plain-language definitions of medical terms used in this label:

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

aggression: Hostile or violent feelings or behavior directed toward other people.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

asthenia: Unusual weakness or lack of physical strength and energy.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

diplopia: Double vision, or seeing two images of a single object.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

emotional lability: Rapid, exaggerated mood changes that shift quickly from one feeling to another.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

glucuronidation: The process where enzymes attach a sugar-like molecule to a drug so it dissolves in water and leaves the body.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

non-inferiority: A study designed to show a new treatment works about as well as an existing one, not necessarily better.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

P-glycoprotein: A tiny pump in cells that pushes certain medicines back out, affecting how much of a medicine is absorbed or stays in the body.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

psychosis: A state of losing touch with reality, such as seeing or hearing things that are not there or holding false beliefs.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

status epilepticus: A seizure that lasts a long time, or repeated seizures without recovery in between, which is a medical emergency.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

suicidal behavior: Actions a person takes to try to end their own life, or steps taken in preparation for it.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 76494-0528-12 · Prinston 76494-0530-12 · Prinston →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Levetiracetam 500 mg Tablet, Film Coated, 120-count

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