Does SPRITAM contain corn or ingredients derived from corn?
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 your patient is allergic to corn, you should consider whether or not they should avoid products containing or derived from cornstarch.
Does SPRITAM contain soy?
SPRITAM does not contain soy, although it may contain negligible amounts of soybased material. One of the inactive ingredients, butylated hydroxyanisole, contains refined soy oil. If your patient is allergic to soy, you should consider whether or not they should avoid products containing or derived from refined soy oil.
How many calories and/or carbohydrates are in SPRITAM?
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.
Can SPRITAM be swallowed without liquid/water?
No, SPRITAM must be taken with a sip of liquid. SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. Please refer to the dosing instructions in the US Full Prescribing Information for more details regarding the proper dosing and administration of SPRITAM.
How much liquid do patients need to take when they take/administer SPRITAM with a sip of liquid?
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 US Full Prescribing Information for more information.
There is some powder in the blister pack when my patients open and remove the SPRITAM tablet. Is this normal?
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.
Where is Spritam manufactured?
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.