These highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Levetiracetam Tablets, USP are available containing 500 mg, 750 mg or 1000 mg of levetiracetam, USP. • The 500 mg tablets are white, film-coated, modified capsule-shaped, scored tablets debossed with M to the left of the score and 615 to the right of the score on one side of the tablet and blank on the other side. • The 750 mg tablets are white, film-coated, modified capsule-shaped, scored tablets debossed with M to the left of the score and 617 to the right of the score on one side of the tablet and blank on the other side. • The 1000 mg tablets are white, film-coated, modified capsule-shaped, scored tablets debossed with M to the left of the score and 619 to the right of the score on one side of the tablet and blank on the other side.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4) ] .

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse reactions are discussed in more details in other sections of labeling: • Behavior Abnormalities and Psychotic Symptoms [see Warnings and Precautions (5.1) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] • Somnolence and Fatigue [see Warnings and Precautions (5.3) ] • Anaphylaxis and Angioedema [see Warnings and Precautions (5.4) ] • Serious Dermatological Reactions [see Warnings and Precautions (5.5) ] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.6) ] • Coordination Difficulties [see Warnings and Precautions (5.7) ] • Hematologic Abnormalities [see Warnings and Precautions (5.9) ] • Increase in Blood Pressure [see Warnings and Precautions (5.10) ]

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

11 DESCRIPTION

DESCRIPTION SECTION

Levetiracetam is an antiepileptic drug available as 500 mg (white), 750 mg (white) and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-( S )-α-Ethyl-2-oxo-1-pyrrolidineacetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam, USP is a white to off-white 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, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. Meets USP Dissolution Test 2.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). 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 psychotic symptoms [see Warnings and Precautions (5.1) ] . Suicidal Behavior and Ideation Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including levetiracetam tablets, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm. Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider [see Warnings and Precautions (5.2) ] . Effects on Driving or Operating Machinery Inform patients that levetiracetam 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 [see Warnings and Precautions (5.3) ] . Anaphylaxis and Angioedema Advise patients to discontinue levetiracetam and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.4) ]. Dermatological Adverse Reactions Advise patients that serious dermatological adverse reactions have occurred in patients treated with levetiracetam and instruct them to call their physician immediately if a rash develops [see Warnings and Precautions (5.5) ] . DRESS/Multiorgan Hypersensitivity Instruct patients and caregivers that a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately. Levetiracetam should be discontinued immediately if a serious hypersensitivity reaction is suspected [see Warnings and Precautions (5.6) ] . Withdrawal of Levetiracetam Advise patients and caregivers not to discontinue use of levetiracetam without consulting with their healthcare provider. Levetiracetam should normally be gradually withdrawn to reduce the potential of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.8) ]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during levetiracetam therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant [see Use in Specific Populations (8.1) ].

Medication Guide

SPL MEDGUIDE SECTION

Levetiracetam Tablets, USP (lee'' ve tye ra' se tam) 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 to treat partial-onset seizures in people 1 month of age and older. Levetiracetam is a prescription medicine taken by mouth that is used with other medicines to treat: • 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 to treat partial-onset seizures • 12 years of age to treat myoclonic seizures • 6 years of age to treat primary generalized tonic-clonic seizures 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. Who should not take levetiracetam? Do not take levetiracetam if you are allergic to levetiracetam. 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 Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of levetiracetam and other antiepileptic medicine during pregnancy. • are breastfeeding or plan to breastfeed. Levetiracetam can pass into your breast milk. It is not known if the levetiracetam that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive levetiracetam. Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. How should I take levetiracetam? • Take levetiracetam exactly as your healthcare provider tells you to take it. • Your healthcare provider will tell you how much levetiracetam to take and when to take it. Levetiracetam is usually taken 2 times each day. • Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider. • Take levetiracetam with or without food. • Swallow the tablets whole. Do not chew or crush tablets. Ask your healthcare provider for levetiracetam oral solution if you cannot swallow tablets. • If your healthcare provider has prescribed levetiracetam oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of levetiracetam oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way. • If you take too much levetiracetam, call your local Poison Control Center or go to the nearest emergency room right away. What should I avoid while taking levetiracetam? Do not drive, operate machinery or do other dangerous activities until you know how levetiracetam affects you. Levetiracetam may make you dizzy or sleepy. What are the possible side effects of levetiracetam? Levetiracetam can cause serious side effects including: • See “What is the most important information I should know about levetiracetam?” Call your healthcare provider right away if you have any of these symptoms: • mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior. • extreme sleepiness, tiredness, and weakness • allergic reactions such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives. • a skin rash. Serious skin rashes can happen after you start taking levetiracetam. There is no way to tell if a mild rash will become a serious reaction. • a serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death, particularly if it is not treated as early as possible. Call your healthcare provider right away if you have: • a skin rash • swelling of your face • dark urine • fever or swollen glands that do not go away • shortness of breath • yellowing of the skin or whites of the eyes • problems with muscle coordination (problems walking and moving) The most common side effects seen in people who take levetiracetam include: • sleepiness • infection • weakness • dizziness The most common side effects seen in children who take levetiracetam include, in addition to those listed above: • tiredness • decreased appetite • irritability • acting aggressive • nasal congestion Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of levetiracetam. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store levetiracetam? • Store levetiracetam at room temperature between 20° to 25°C (68° to 77°F) away from heat and light. • Keep levetiracetam and all medicines out o...

Package/Label Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-5699-0 LEVETIRACETAM TABLETS, USP 500 mg 10 TABLETS