LEVETIRACETAM- levetiracetam tablet, for suspension 
Prasco Laboratories

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MEDICATION GUIDE
Levetiracetam Tablets for Oral Suspension
(lee" ve tye ra' se tam)

What is the most important information I should know about Levetiracetam tablets for oral suspension?
Like other antiepileptic drugs, Levetiracetam tablets for oral suspension 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
  • new or worse depression
  • feeling agitated or restless
  • trouble sleeping (insomnia)
  • acting aggressive, being angry, or violent
  • an extreme increase in activity or talking (mania)
 
  • attempts to commit suicide
  • new or worse anxiety
  • panic attacks
  • new or worse irritability
  • acting on dangerous impulses
  • other unusual changes in behavior or mood
 

Do not stop Levetiracetam tablets for oral suspension without first talking to a healthcare provider.

  • Stopping Levetiracetam tablets for oral suspension 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 tablets for oral suspension?

Levetiracetam tablets for oral suspension are a prescription medicine taken by mouth that is used to treat partial-onset seizures in people 4 years of age and older weighing more than 44 pounds (20 kilograms).
Levetiracetam tablets for oral suspension are 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 tablets for oral suspension are safe or effective in children under:

  • 4 years 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

Levetiracetam tablets for oral suspension are not recommended for children that weigh 44 pounds (20 kilograms) or less.

Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your carton (box). Tell your pharmacist immediately if you think you have been given the wrong medicine.

Who should not take Levetiracetam tablets for oral suspension?

Do not take Levetiracetam tablets for oral suspension if you are allergic to levetiracetam.

What should I tell my healthcare provider before starting Levetiracetam tablets for oral suspension?

Before taking Levetiracetam tablets for oral suspension, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had depression, mood problems or suicidal thoughts or behavior.
  • have kidney problems.
  • are pregnant or planning to become pregnant. It is not known if Levetiracetam tablets for oral suspension will harm your unborn baby. You and your healthcare provider will have to decide if you should take Levetiracetam tablets for oral suspension while you are pregnant. If you become pregnant while taking Levetiracetam tablets for oral suspension, 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 the registry is to collect information about the safety of Levetiracetam tablets for oral suspension and other antiepileptic medicine during pregnancy.
  • are breastfeeding or plan to breastfeed. Levetiracetam tablets for oral suspension can pass into your breast milk. It is not known if the Levetiracetam tablets for oral suspension 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 tablets for oral suspension.

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 tablets for oral suspension?

  • Take Levetiracetam tablets for oral suspension exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much Levetiracetam tablets for oral suspension to take and when to take it. Levetiracetam tablets for oral suspension are usually taken 2 times each day.
  • Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
  • The main way to take Levetiracetam tablets for oral suspension is by letting the tablet dissolve (disintegrate) in your mouth with a sip of liquid.
  • Another way to take Levetiracetam tablets for oral suspension is by adding the whole tablet or tablets to a small amount of liquid in a cup.
  • You may also give Levetiracetam tablets for oral suspension using a Nasogastric Tube (NG Tube) or Gastrostomy Tube (G-Tube).
  • Make sure your hands are dry before you remove your Levetiracetam tablet(s) for oral suspension.
  • Do not push the tablet through the foil packaging.
  • Peel the foil away from the blister by bending up and lifting the peel tab around the blister seal.
  • Take the whole tablet as instructed below. Do not break up the tablet.
    • How to take Levetiracetam tablets for oral suspension with a sip of liquid:
      • Empty the tablet into your dry hand. Do not swallow the tablet whole.
      • Place the Levetiracetam tablet for oral suspension on your tongue and follow with a sip of liquid. Before swallowing, let the tablet dissolve all the way on your tongue, which will take an average time of 11 seconds (ranging from 2 to 27 seconds).
      • If your dose is more than one tablet of Levetiracetam tablets for oral suspension, put only one tablet in your mouth to dissolve at a time. Repeat the step, if needed to take your full dose.
    • How to take Levetiracetam tablets for oral suspension with a small amount of liquid in a cup:
      • Add whole Levetiracetam tablet(s) for oral suspension to a small amount of liquid in a cup (1 tablespoon or enough liquid to cover the medicine), and swirl gently.
      • Allow the tablet or tablets to fully break apart (disperse) in the liquid. Then swallow all of the medicine mixture by mouth right away using the cup or an oral syringe.
      • If there is any Levetiracetam tablets for oral suspension mixture left in the cup, add a small amount of liquid to the cup, swirl gently, and swallow the remaining medicine mixture by mouth using the cup or oral syringe. 
    • How to give Levetiracetam tablets for oral suspension using a Nasogastric Tube (NG Tube) or Gastrostomy Tube (G-Tube):
      • Your healthcare provider will tell you the right size of tube to use to give Levetiracetam tablets for oral suspension.
      • Place the number of whole tablets needed for the prescribed dose in a small dosing cup. Do not use partial tablets.
      • Add about 10 mL (2 teaspoonfuls) of room temperature water into the small dosing cup.
      • Gently swirl the cup until the tablet or tablets break apart in the liquid.
      • Place a 10 mL oral catheter-tip syringe in the medicine mixture.
      • Pull up on the syringe plunger to withdraw all the medicine mixture from the cup into the syringe.
      • Hold the syringe in an up and down (vertical) position and attach it to the feeding tube. Push the plunger to give the medicine mixture right away through the feeding tube.
      • Remove the empty syringe from the feeding tube.
      After giving Levetiracetam tablets for oral suspension through a feeding tube, flush the feeding tube 2 times as follows to make sure the full dose is given:
      • Add another 10 mL of room temperature water in the dosing cup that contained the medicine mixture.
      • Swirl the cup to mix any remaining medicine.
      • Place the same 10 mL syringe into the remaining medicine mixture and pull up on the syringe plunger to withdraw all the medicine mixture.
      • Right away, attach the syringe to the feeding tube and push the plunger to flush the feeding tube.
  • Levetiracetam tablets for oral suspension can be taken with or without food.
  • If you take too much Levetiracetam tablets for oral suspension, call your Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away.

What should I avoid while taking Levetiracetam tablets for oral suspension?
Do not drive, operate machinery or do other dangerous activities until you know how Levetiracetam tablets for oral suspension affect you. Levetiracetam tablets for oral suspension may make you dizzy or sleepy.

What are the possible side effects of Levetiracetam tablets for oral suspension?
Levetiracetam tablets for oral suspension can cause serious side effects. See “What is the most important information I should know about Levetiracetam tablets for oral suspension?”
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 tablets for oral suspension. There is no way to tell if a mild rash will become a serious reaction. Call your healthcare provider right away if you get a rash while taking Levetiracetam tablets for oral suspension.
  • 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 adults who take Levetiracetam tablets for oral suspension include:

 
  • sleepiness
  • infection
 
  • weakness
  • dizziness
 The most common side effects seen in children who take Levetiracetam tablets for oral suspension include the side effects above and:
 
  • 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 tablets for oral suspension. 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.
You may also report side effects to Aprecia Pharmaceuticals, LLC at 1-844-882-7732.

How should I store Levetiracetam tablets for oral suspension?

  • Store Levetiracetam tablets for oral suspension at room temperature, between 59°F to 86°F (15°C to 30°C).
  • Keep Levetiracetam tablets for oral suspension and all medicines out of the reach of children.

General information about the safe and effective use of Levetiracetam tablets for oral suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Levetiracetam tablets for oral suspension for a condition for which it was not prescribed. Do not give Levetiracetam tablets for oral suspension to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Levetiracetam tablets for oral suspension that is written for health professionals. You can also get information about Levetiracetam tablets for oral suspension at 1-844-882-7732.

What are the ingredients in Levetiracetam tablets for oral suspension?

Active ingredient: levetiracetam

Inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor.


Distributed by: Prasco Laboratories, Mason, OH 45040 USA
Manufactured by: Aprecia Pharmaceuticals, LLC, Mason, OH 45040 USA   

© 2025 Aprecia Pharmaceuticals, LLC all rights reserved. Printed in the USA.
Patent(s): www.aprecia.com/patents

 This Medication Guide has been approved by the U.S. Food and Drug Administration.   Revised: 7/2025
 LB-PG-0001.R.AG1.A
Revised: 7/2025
Prasco Laboratories