- Safety & Side Effects
- Taking SPRITAM
SPRITAM is a prescription medicine taken by mouth that is used to treat partial-onset seizures in patients 4 years of age and older weighing more than 20 kg (44 pounds) with epilepsy.
SPRITAM is also used as adjunctive therapy to treat:
- Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
- Primary generalized tonic-clonic seizures in patients 6 years of age and older weighing more than 20 kg (44 pounds) with idiopathic generalized epilepsy.
SPRITAM disintegrates in the mouth in an average time of 11 seconds (ranging from 2 to 27 seconds) when taken with a sip of liquid.
SPRITAM may be covered by your insurance. Contact your insurance provider to learn more. You may also be able to lower your out-of-pocket copay costs for SPRITAM through the Savings Program.
SPRITAM is manufactured by Aprecia Pharmaceuticals in Blue Ash, Ohio, USA. The manufacturing facility is the first and only in the world to have commercial scale, GMP-compliant equipment and processes for three-dimensionally printed, FDA-approved pharmaceutical products.
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
- Attempts to commit suicide
- New or worsening depression
- New or worsening anxiety
- Feeling agitated or restless
- Panic attacks
- Trouble sleeping (insomnia)
- New or worsening irritability
- Acting aggressively, being angry, or violent
- Acting on dangerous impulses
- An extreme increase in activity or talking (mania)
- Other unusual changes in behavior or mood
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.
Before taking SPRITAM, 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 while taking SPRITAM, 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 the registry is to collect information about the safety of SPRITAM and other antiepileptic medicine during pregnancy
- Are breastfeeding. SPRITAM can pass into your milk and may harm your baby. You and your healthcare provider should discuss whether you should take SPRITAM or breastfeed; you should not do both
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription 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.
The most common side effects seen in adults who take SPRITAM include:
- Weakness or dizziness
The most common side effects seen in children who take SPRITAM include the side effects above and:
- Decreased appetite
- Acting aggressively
- Nasal congestion
These side effects can happen at any time, but some happen more often within the first 4 weeks of treatment, except for infection.
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 SPRITAM. For more information, ask your healthcare provider or pharmacist.
Take SPRITAM exactly as prescribed.
- Your healthcare provider will tell you how much SPRITAM to take and when to take it. SPRITAM is usually taken 2 times each day. Take SPRITAM at the same times each day
- Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider
- Take the whole SPRITAM tablet along with a sip of liquid. SPRITAM can be taken with or without food
- If you take too much SPRITAM, call your Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away
Click here to see more administration details.
No, SPRITAM must be taken with a sip of liquid. SPRITAM is intended to disintegrate in your mouth when taken with a sip of liquid. Please refer to the dosing instructions in the Medication Guide for more details regarding the proper dosing and administration of SPRITAM.
SPRITAM must be taken with a sip of liquid. In a study involving 33 subjects, the average sip volume was approximately 1 tablespoon, or 15 mL, of water. Please refer to complete dosing and administration instructions in the Medication Guide for more information.
Yes. Because SPRITAM is made using 3D printing, which does not use compression forces, it is normal to see a small amount of residual powder remaining in the blister pack.
Do not change your dose or stop taking SPRITAM without first talking to your healthcare provider.
- Stopping SPRITAM suddenly can cause you to have seizures more often
No, SPRITAM does not contain any gluten or dyes.
Mannitol is one of the inactive ingredients contained in SPRITAM. Mannitol is derived from cornstarch. Therefore, SPRITAM may contain negligible amounts of corn-based material. If you are allergic to corn, you should talk to your doctor about whether or not you should avoid products containing or derived from cornstarch.
SPRITAM does not contain soy, although it may contain negligible amounts of soy-based material. One of the inactive ingredients, butylated hydroxyanisole, contains refined soy oil. If you are allergic to soy, you should talk to your doctor about whether or not you should avoid products containing or derived from refined soy oil.
SPRITAM contains two sugar alcohols, mannitol and glycerin, across all tablet strengths. Their calorie and carbohydrate impact across all strengths is negligible. At the maximum recommended daily dose of 3,000 mg/day, SPRITAM would contribute no more than 1 calorie and approximately 0.25 grams of carbohydrates based upon the amount of glycerin and mannitol that would be consumed. This impact would be proportionally lower for total daily doses less than 3,000 mg/day.