Levetiracetam

Levetiracetam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness
• unsteady walking
• loss of balance or coordination
• confusion
• headache
• loss of appetite
• vomiting
• diarrhea
• constipation
• excessive sleepiness
• joint pain
• neck pain
• double vision

Some side effects can be serious. If you experience any of the following symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• seizures that are worse or different than the seizures you had before
• fever, sore throat, or other signs of infection
• rash
• blisters on skin
• hives
• itching
• swelling of the face and tongue

Levetiracetam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Take levetiracetam exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The injectable form of levetiracetam is for adult use only.

Levetiracetam regular release tablets and solution

The recommended dose range of levetiracetam for the treatment of partial onset seizures in adults is 1000 to 3000 mg, equally divided into 2 doses per day.

The recommended dose range of levetiracetam for the treatment of partial onset seizures ages 1 month to less than 6 months old is 4 mg/kg in two divided doses (7 mg/kg twice daily) to 42 mg/kg (21 mg/kg twice daily).

The recommended dose range of levetiracetam for the treatment of partial onset seizures ages 6 months to less than 4 years old is 20 mg/kg in two divided doses (10 mg/kg twice daily) to 50 mg/kg (25 mg/kg twice daily).

The recommended dose range of levetiracetam for the treatment of partial onset seizures ages 4 years old to less than 16 years old is 20 mg/kg in two divided doses (10 mg/kg twice daily) to 60 mg/kg (30 mg/kg twice daily).

The levetiracetam tablet dose range for partial onset seizures in children weighing 20 to 40 kg is 500 mg given as twice daily dosing (250 mg twice daily) to 1500 mg (750 mg twice daily).

For levetiracetam tablet dosing for partial onset seizures in children weighing more than 40 kg, treatment should be started with 1000 mg/day given as twice daily dosing (500 mg twice daily) to 3000 mg (1500 mg twice daily).

The recommended dose range of levetiracetam for the treatment of myoclonic seizures in those with juvenile myoclonic epilepsy in adults (ages 12 years old and older) is 1000 to 3000 mg, equally divided into 2 doses per day.

The recommended dose range of levetiracetam for the treatment of primary generalized tonic-clonic seizures in adults (ages 16 years old and older) is 1000 to 3000 mg, equally divided into 2 doses per day.

The recommended dose range of levetiracetam for the treatment of primary generalized tonic-clonic seizures in children ages 6 to less than 16 years old is 20 mg/kg in two divided doses (10 mg/kg twice daily) to 60 mg/kg (30 mg/kg twice daily).

Levetiracetam extended release tablets

The recommended starting dose of levetiracetam extended release tablets, for the treatment of partial onset seizures in patients ≥ 12 years of age with epilepsy, is 1000 mg once daily. The dosage may be adjusted in increments of 1000 mg every 2 weeks, to a maximum recommended dose of 3000 mg once daily.

Dose changes may be made depending on degree of kidney dysfunction.

Levetiracetam is an anti-epileptic drug, also called an anticonvulsant.

Levetiracetam is used to treat partial onset seizures in adults and children who are at least 1 month old. The Spritam brand of this medicine is not for use in children younger than 4 years old or children who weigh less than 44 pounds.

Levetiracetam is also used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old.

Levetiracetam may also be used for purposes not listed in this medication guide.

Some people have thoughts about suicide when first taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Avoid drinking alcohol. It can increase some of the side effects of levetiracetam and may also increase the risk of seizures.

Levetiracetam may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• unusual changes in mood or behavior (unusual risk-taking behavior, being irritable or talkative);

• confusion, hallucinations, loss of balance or coordination;

• extreme drowsiness, feeling very weak or tired;

• bruising, severe tingling, numbness, pain, muscle weakness;

• problems with walking or movement;

• the first sign of any skin rash, no matter how mild;

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling; or

• signs of infection--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing.

Common side effects may include:

• dizziness, drowsiness;

• feeling tired;

• weakness;

• feeling aggressive or irritable;

• loss of appetite;

• stuffy nose; or

• infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Take levetiracetam only as directed by your doctor, to help your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change your dose without checking first with your doctor.

levetiracetam comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Levetiracetam may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed. You should try to take levetiracetam at the same time each day.

Swallow the tablet or the extended-release tablet whole. Do not break, crush, or chew it. There is an oral liquid form of levetiracetam if you or your child cannot swallow the tablets.

If you are using the Spritam® tablet or the Spritam® tablet for suspension, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue and take a sip of water. After it has melted, swallow.

You may also add one whole Spritam® tablet for suspension to a small volume of liquid in a cup (1 tablespoon or enough to cover the medicine), and swirl gently. Swallow right away after it has dissolved. Then add a small volume of liquid to cup again, swirl gently, and swallow the liquid.

Measure the oral liquid with a marked measuring spoon, dropper, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. If you have any questions about this, ask your doctor or pharmacist.

levetiracetam can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Take only the form of levetiracetam that your doctor prescribed. If you refill your prescription and your pills look different, do not take the medicine and tell your doctor or pharmacist right away.

Dosing

The dose of levetiracetam will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of levetiracetam. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (Keppra XR® extended-release tablets):
  • For partial onset seizures:
    • Adults and children 16 years and older—At first, 1000 milligrams (mg) once per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 16 years—Use and dose must be determined by your doctor.
• For oral dosage form (Keppra® solution or tablets):
  • For partial onset seizures:
    • Adults and children 16 years and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 4 to 15 years—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
    • Children 6 months to 3 years—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 mg per kg of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per kg of body weight per day.
    • Children 1 to 5 months—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 7 mg per kg of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 42 mg per kg of body weight per day.
    • Children younger than 1 month—Use and dose must be determined by your doctor.
  • For juvenile myoclonic seizures:
    • Children 12 years and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years—Use and dose must be determined by your doctor.
  • For primary generalized tonic-clonic seizures:
    • Adults and children 16 years and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 6 to 15 years—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
    • Children younger than 6 years—Use and dose must be determined by your doctor.
• For oral dosage forms (Spritam® tablets, Spritam® tablets for suspension):
  • For partial onset seizures:
    • Adults and children 4 years and older weighing over 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 4 years and older weighing 20 to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 250 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children younger than 4 years and weighing less than 20 kg—Use is not recommended.
  • For juvenile myoclonic seizures:
    • Children 12 years and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years—Use and dose must be determined by your doctor.
  • For primary generalized tonic-clonic seizures:
    • Adults and children 6 years and older weighing over 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 6 years and older weighing 20 to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 250 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children younger than 6 years and weighing less than 20 kg—Use is not recommended.

Missed Dose

If you miss a dose of levetiracetam, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Anticonvulsant, Miscellaneous

Note: Use oral solution in children ≤20 kg; oral solution, immediate release tablets, and tablets for oral suspension may be used in children >20 kg. When switching from oral to IV formulations, the total daily dose should be the same.

Myoclonic seizures:

Oral: Immediate release (tablets, oral solution, tablets for oral suspension): Children ≥12 years and Adolescents: Refer to adult dosing.

IV: Children ≥12 years and Adolescents: Refer to adult dosing.

Partial onset seizures:

Oral:

Immediate release (tablets, oral solution):

Infants 1 month to <6 months: Initial: 7 mg/kg/dose twice daily; increase every 2 weeks by 7 mg/kg/dose to a recommended dose of 21 mg/kg/dose twice daily

Infants and Children 6 months to <4 years: Initial: 10 mg/kg/dose twice daily; increase every 2 weeks by 10 mg/kg/dose to a recommended dose of 25 mg/kg/dose twice daily

Children and Adolescents 4 to <16 years:

Oral solution: Initial: 10 mg/kg/dose twice daily; increase every 2 weeks by 10 mg/kg/dose to a recommended dose of 30 mg/kg/dose twice daily (maximum daily dose: 3,000 mg/day)

Tablets:

20 to 40 kg: Initial: 250 mg twice daily, increase every 2 weeks by 250 mg twice daily to the maximum recommended dose of 750 mg twice daily

>40 kg: Initial: 500 mg twice daily, increase every 2 weeks by 500 mg twice daily to the maximum recommended dose of 1,500 mg twice daily

Adolescents ≥16 years: Refer to adult dosing.

Immediate release (tablets for oral suspension):

Children ≥4 years and weighing 20 kg to 40 kg: Initial: 250 mg twice daily; increase every 2 weeks by 250 mg/dose to the maximum recommended dose of 750 mg twice daily.

Children ≥4 years (weighing >40 kg) and Adolescents: Refer to adult dosing.

Extended release: Children ≥12 years and Adolescents: Refer to adult dosing.

IV:

Infants 1 month to <6 months: Initial: 7 mg/kg twice daily; increase every 2 weeks by 7 mg/kg/dose to a recommended dose of 21 mg/kg twice daily. In clinical trials the average daily dose was 35 mg/kg/day. Efficacy of lower doses has not been established.

Infants and Children 6 months to <4 years: Initial: 10 mg/kg twice daily; increase every 2 weeks by 10 mg/kg/dose to a recommended dose of 25 mg/kg twice daily. If the patient cannot tolerate 50 mg/kg/day, reduce the daily dose. In clinical trials the average daily dose was 47 mg/kg/day.

Children and Adolescents 4 to <16 years: Initial: 10 mg/kg twice daily; increase every 2 weeks by 10 mg/kg/dose to the recommended dose of 30 mg/kg twice daily. If the patient cannot tolerate 60 mg/kg/day, reduce the daily dose. In clinical trials the average daily dose was 44 mg/kg/day and the maximum daily dose was 3,000 mg/day.

Adolescents ≥16 years: Refer to adult dosing.

Tonic-clonic seizures:

Oral:

Immediate release (tablets, oral solution):

Children and Adolescents 6 to <16 years: Initial: 10 mg/kg/dose twice daily; increase every 2 weeks by 10 mg/kg/dose to the recommended dose of 30 mg/kg twice daily. Efficacy of doses other than 60 mg/kg/day has not been established.

Adolescents ≥16 years: Refer to adult dosing.

Immediate release (tablets for oral suspension):

Children ≥6 years and weighing 20 kg to 40 kg: Initial: 250 mg twice daily; increase every 2 weeks by 250 mg/dose to the maximum recommended dose of 750 mg twice daily.

Children ≥6 years (weighing >40 kg) and Adolescents: Refer to adult dosing.

IV:

Children and Adolescents 6 to <16 years: Initial: 10 mg/kg twice daily; increase every 2 weeks by 10 mg/kg/dose to the recommended dose of 30 mg/kg twice daily. Efficacy of doses lower than 60 mg/kg/day has not been established.

Adolescents ≥16 years: Refer to adult dosing.

Status epilepticus (off-label use): Infants, Children, and Adolescents: IV: 20 to 60 mg/kg administered at a rate of 2 to 5 mg/kg/minute (NCS [Brophy 2012]) or 60 mg/kg as a single dose (maximum dose: 4,500 mg) (AES [Glauser 2016]).

Oral solution, tablets, tablets for oral suspension: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Premixed solution for infusion: Store at 20°C to 25°C (68°F to 77°F).

Vials for injection: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Admixed solution in NS, LR, or D5W is stable for 4 hours in PVC bags kept at room temperature (Note: The manufacturer's labeling for Keppra injection previously stated the admixed solution is stable for 24 hours in PVC bags at room temperature; this was changed to 4 hours as of April 2016 although there was no change in the formulation (Personal Communication, UCB, Inc. 2016). The manufacturer’s labeling for generic levetiracetam injectable products may have differing recommendations; refer to individual manufacturer’s labeling for details.

Incidences are for all indications and populations (adults and children) unless otherwise specified.

>10%:

Cardiovascular: Increased blood pressure (diastolic; infants and children: 17%)

Central nervous system: Behavioral problems (includes aggression, agitation, anger, anxiety, apathy, depersonalization, emotional lability, irritability, neurosis: children and adolescents: 7% to 38%; adults: 7% to 13%), headache (14% to 19%), drowsiness (8% to 15%); immediate release 4,000 mg/day, no titration: 45%; serious [patients hospitalized]: <1%), psychotic symptoms (infants and children: 17%; adults: 1%), irritability (infants, children, and adolescents: 6% to 12%), fatigue (10% to 11%)

Gastrointestinal: Vomiting (children and adolescents: 15%)

Infection: Infection (13%)

Neuromuscular & skeletal: Weakness (15%)

Respiratory: Nasopharyngitis (7% to 15%)

1% to 10%:

Central nervous system: Aggressive behavior (children and adolescents: 10%; adults: 1%), dizziness (5% to 9%), pain (7%), lethargy (children and adolescents: 6%), insomnia (children and adolescents: 5%), depression (3% to 5%), vertigo (3% to 5%), emotional lability (2% to 5%), agitation (children and adolescents: 4%), nervousness (4%), ataxia (partial-onset seizures: 3%; includes abnormal gait, incoordination), falling (children and adolescents: 3%), mood changes (children and adolescents: 3%), confusion (2% to 3%), amnesia (2%), anxiety (2%), hostility (2%), paranoia (children and adolescents: 2%), paresthesia (2%), sedation (children and adolescents: 2%)

Gastrointestinal: Upper abdominal pain (children and adolescents: 9%), decreased appetite (children and adolescents: 8%), diarrhea (6% to 8%), nausea (5%), anorexia (3% to 4%), constipation (children and adolescents: 3%), gastroenteritis (children and adolescents: 2%)

Hematologic & oncologic: Eosinophilia (children and adolescents: 9%), bruise (children and adolescents: 3%), decreased white blood cell count (3%), decreased neutrophils (2%)

Infection: Influenza (3% to 8%)

Neuromuscular & skeletal: Neck pain (2% to 8%), arthralgia (children and adolescents: 2%), joint sprain (children and adolescents: 2%)

Ophthalmic: Conjunctivitis (children and adolescents: 2%), diplopia (2%)

Otic: Otalgia (children and adolescents: 2%)

Respiratory: Nasal congestion (children and adolescents: 9%), cough (2% to 9%), pharyngolaryngeal pain (children and adolescents: 7%), pharyngitis (6% to 7%), rhinitis (2% to 4%), sinusitis (2%)

Miscellaneous: Head trauma (children and adolescents: 4%)

<1% (Limited to important or life-threatening): Abnormal hepatic function tests, acute renal failure, agranulocytosis, alopecia, anaphylaxis, angioedema, blurred vision, choreoathetosis, decreased hematocrit, decreased hemoglobin, decreased red blood cells, disturbance in attention, DRESS syndrome, dyskinesia, eczema, equilibrium disturbance, erythema multiforme, hepatic failure, hepatitis, hyperkinesia, hyponatremia, leukopenia, memory impairment, myalgia, myasthenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression in some cases), panic attack, personality disorder, pruritus, psychosis, skin rash, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, thrombocytopenia, toxic epidermal necrolysis, weight loss