Levetiracetam

What is Levetiracetam?

• Levetiracetam (Keppra) is an antiepileptic drug used to treat epilepsy.

Levetiracetam

Levetiracetam ball-and-stick model

Levetiracetam3d

What are the uses of this medicine?

Levetiracetam tablets are a prescription medicine taken by mouth that is used with other medicines to treat:

• partial onset seizures in people 1 month of age and older with epilepsy
• myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.

How does this medicine work?

• Levetiracetam (lee" ve tre ra' se tam) is a pyrrolidine derivative unrelated in structure to other anticonvulsant medications.
• Its mechanism of action is not known, but it is believed to act by preventing secondary spread of focal seizure activity and to decrease simultaneous neuronal firing.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to levetiracetam.

What drug interactions can this medicine cause?

• No significant pharmacokinetic interactions were observed between levetiracetam or its major metabolite and concomitant medications.

Is this medicine FDA approved?

• Levetiracetam was approved for use in epilepsy in 1999 and current indications are as adjunctive therapy for partial onset seizures, generalized tonic-clonic seizures and myoclonic seizures in both children and adults.

How should this medicine be used?

Recommended dosage:

Partial Onset Seizures:

• 1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily.
• 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily.
• 4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily.
• Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1,500 mg twice daily.

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 1,500 mg twice daily.

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.
• Adults 16 Years and Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1,500 mg twice daily.

Adult Patients with Impaired Renal Function:

• Dose adjustment is recommended, based on the patient’s estimated creatinine clearance.

Administration:

• Take levetiracetam tablets 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 miss a dose of levetiracetam tablets, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
• If you take too much levetiracetam tablets, call your local Poison Control Center or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing dosage form:

• As 250 mg, 500 mg, 750 mg, and 1,000 mg film-coated, scored tablets
• 100 mg/mL solution
• Injection: 500 mg/5 mL single-use vial

This medicine is available in fallowing brand namesː

• Keppra

What side effects can this medication cause?

The most common side effects of this medicine include:

• sleepiness
• weakness
• infection
• dizziness

The most common side effects seen in children who take levetiracetam tablets include, in addition to those listed above:

• tiredness
• acting aggressive
• nasal congestion
• decreased appetite
• irritability

• These side effects can happen at any time but happen more often within the first 4 weeks of treatment except for infection.

What special precautions should I follow?

• Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms.
• Antiepileptic drugs (AEDs), including levetiracetam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior.
• Levetiracetam may cause somnolence and fatigue. Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam.
• Antiepileptic drugs, including levetiracetam, should be withdrawn gradually to minimize the potential of increased seizure frequency.
• Levetiracetam can cause anaphylaxis or angioedema after the first dose or at any time during treatment. If a patient develops signs or symptoms of anaphylaxis or angioedema, levetiracetam should be discontinued and the patient should seek immediate medical attention.
• Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both pediatric and adult patients treated with levetiracetam. f signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
• Levetiracetam may cause coordination difficulties. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it could adversely affect their ability to drive or operate machinery.
• Levetiracetam can cause hematologic abnormalities. A complete blood count is recommended in patients experiencing significant weakness, pyrexia, recurrent infections, or coagulation disorders.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• drowsiness
• somnolence
• agitation
• aggression
• depressed level of consciousness
• respiratory depression
• coma

Management of overdosage:

• 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.
• Standard hemodialysis procedures result in significant clearance of levetiracetam (approximately 50% in 4 hours) and should be considered in cases of overdose.

Can this medicine be used in pregnancy?

• 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. The purpose of this registry is to collect information about the safety of levetiracetam and other antiepileptic medicine during pregnancy.

Can this medicine be used in children?

• It is not known if levetiracetam tablets are safe or effective in children under 1 month of age.

What are the active and inactive ingredients in this medicine?

• Levetiracetam tablet active ingredient: levetiracetam, USP
• Inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide, and additional agents listed below:
• 250 mg tablets: FD&C Blue #2/Indigo Carmine Aluminum Lake500 mg tablets: Iron Oxide Yellow
• 750 mg tablets: FD&C Red #40/Allura Red A C Aluminum Lake

• KEPPRA tablet active ingredient: levetiracetam
• Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below:
• 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake
• 500 mg tablets: iron oxide yellow
• 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red

• KEPPRA oral solution active ingredient: levetiracetam
• Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.

Who manufactures and distributes this medicine?

Levetiracetam tablet: Distributed by:

• Amneal Pharmaceuticals LLC
• Bridgewater, NJ

KEPPRA: Distributed by

• UCB, Inc.
• Smyrna, GA

• KEPPRA is a registered trademark of the UCB Group of companies

What should I know about storage and disposal of this medication?

• Store levetiracetam tablets at room temperature, 59°F to 86°F (15°C to 30°C) away from heat and light.
• Keep levetiracetam tablets and all medicines out of the reach of children.

• Dailymed label info on Levetiracetam
• FDA Levetiracetam

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