Spritam
Pronunciation: SPREE-tam
Generic name: levetiracetam
Dosage form: tablets for oral suspension (250 mg, 500 mg, 750 mg, 1000 mg)
Drug class: Pyrrolidine anticonvulsants
What is Spritam?
Spritam is 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 20 kg (44 pounds). It is also used alongside other medicines to treat myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.
It is not known if this medicine is 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
Spritam is not recommended for children who weigh 20 kg (44 pounds) or less.
Before taking your medicine, make sure you have received the correct medicine. Compare the name above with the name on your package. Tell your pharmacist immediately if you think you have been given the wrong medicine.
Spritam is a three-dimensionally printed medication that allows for the disintegration of the tablet within seconds with a small volume of liquid. Spritam is approved for administration in 3 ways:
- Dissolving on the tongue with a small sip of liquid
- Dispersed in a tablespoonful of water, then swallowed
- Dispersed in a cup of water and then administered via a nasogastric or gastrostomy tube.
Important information
Like other antiepileptic drugs, Spritam 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 aggressively, being angry, or being 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 this medicine without first talking to a healthcare provider.
- Stopping Spritam 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.
Who should not take Spritam?
Do not take Spritam if you are allergic to levetiracetam.
Before taking Spritam
Before you start treatment, 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 Spritam will harm your unborn baby. You and your healthcare provider will have to decide if you should take Spritam while you are pregnant. If you become pregnant during treatment, 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 at www.aedpregnancyregistry.org. The purpose of the registry is to collect information about the safety of Spritam and other antiepileptic medicines during pregnancy.
- are breastfeeding or plan to breastfeed. Spritam can pass into your breast milk. It is not known if the Spritam that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby during treatment.
What other drugs will affect Spritam?
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 Spritam?
Take Spritam exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much to take and when to take it. Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
- Spritam is usually taken 2 times each day.
- It can be taken with or without food.
- The main way to take Spritam is by letting the tablet dissolve (disintegrate) in your mouth with a sip of liquid.
- Another way to take Spritam is by adding the whole tablet or tablets to a small amount of liquid in a cup.
- You may also give Spritam using a nasogastric tube (NG tube) or a gastrostomy tube (G-tube).
How to take Spritam with a sip of liquid:
- Empty the tablet into your dry hand. Do not swallow the tablet whole.
- Place the Spritam tablet on your tongue and follow with a sip of liquid. Before swallowing, let the tablet dissolve 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 Spritam, put only one tablet in your mouth to dissolve at a time.
- Repeat these steps as needed to take your full dose.
How to take Spritam with a small amount of liquid in a cup:
- Add a whole Spritam tablet or tablets 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 Spritam 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 Spritam 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 Spritam.
- 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 Spritam 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 to 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.
Dosing information
Dose of Spritam for Partial-Onset Seizures (monotherapy or adjunctive therapy)
- Adults and children 4 years and older (weight > 40 kg): 500 mg twice daily
- Increase as needed/tolerated by 500 mg twice daily every 2 weeks.
- Maximum: 1500 mg twice daily
- Children 4 years and older (weight 20 kg to 40 kg): 250 mg twice daily
- Increase as needed/tolerated by 250 mg twice daily every 2 weeks.
- Maximum: 750 mg twice daily
Dose of Spritam for Myoclonic Seizures
- Adults and children 12 years and older: 500 mg twice daily
- Increase by 500 mg twice daily every 2 weeks
- Recommended dose: 1500 mg twice daily.
Dose of Spritam for Primary Generalized Tonic-Clonic Seizures
- Adults and children 6 years and older (weight > 40 kg): 500 mg twice daily
- Increase as needed/tolerated by 500 mg twice daily every 2 weeks
- Maximum: 1500 mg twice daily.
- Children 6 years and older (weight 20 kg to 40 kg): 250 mg twice daily
- Increase as needed/tolerated by 250 mg twice daily every 2 weeks
- Maximum: 7500 mg twice daily.
What should I avoid while taking Spritam?
Do not drive, operate machinery, or do other dangerous activities until you know how Spritam affects you. It may make you dizzy or sleepy.
Spritam side effects
Spritam can cause serious side effects. 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 Spritam. 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 Spritam.
- problems with muscle coordination (problems walking and moving).
The most common side effects seen in adults include:
- sleepiness
- infection
- weakness
- dizziness
The most common side effects seen in children 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 do not go away.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Aprecia Pharmaceuticals, LLC at 1-844-882-7732 or the FDA at 1-800-FDA-1088.
Related/similar drugs
Storage
Store Spritam at room temperature, between 59°F to 86°F (15°C to 30°C).
Keep all medicines out of the reach of children and pets.
What are the ingredients in Spritam?
Active ingredient: levetiracetam
Inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor.
Manufacturer
Spritam is manufactured by Aprecia Pharmaceuticals, LLC, Blue Ash, OH 45242 USA.
Frequently asked questions
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- Drug class: pyrrolidine anticonvulsants
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.