Spritam Dosage

Important Preparation and Administration Instructions

The SPRITAM dosing regimen depends on the indication, age group, and renal function. Administer SPRITAM with or without food. Do not administer partial tablets.

Patients should be instructed not to push the tablet through the foil. The foil should be peeled away from the blister by bending up and lifting the peel tab around the blister seal.

Oral Administration

SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid, one tablet at a time. As a primary method of administration, place one tablet on the tongue with a dry hand, follow with a sip of liquid and swallow only after the tablet disintegrates. Repeat this step, if needed, until the full dose has been administered. Do not swallow tablet(s) intact. SPRITAM disintegrates in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth when taken with a sip of liquid.

​Alternately, add whole SPRITAM tablet(s) to a small volume of liquid in a cup (one tablespoon or enough liquid to cover the medicine). Allow the tablet(s) to fully disperse, then immediately consume the entire contents by mouth using the cup or an oral syringe. After administration of the suspension, re-suspend any residue by adding an additional small volume of liquid to the cup, swirl, then swallow the entire contents.

Nasogastric Tube (NG Tube) or Gastrostomy Tube (G-Tube) Administration

​For patients who have a NG tube or G tube (French size 10 to 14) in place, administer SPRITAM as follows:

• ​Place the number of whole tablets needed for the prescribed dose in a small dosing cup,
• ​Add approximately 10 mL of room temperature water.
• ​Gently swirl the cup until the tablet(s) disperse.
• ​Draw up the mixture into a 10 mL oral catheter-tip syringe, hold the syringe in a vertical position, and administer immediately via feeding tube.
• ​After administration, flush the feeding tube twice, as follows:
  • Add another 10 mL of room temperature water to the dosing cup that contained the dispersion.
  • Swirl the cup to re-suspend any tablet residue.
  • Draw up the mixture into the same oral syringe and immediately push through the feeding tube.

Recommended Dosage

See Table 1 for the recommended dosage for patients with partial-onset seizures, myoclonic seizures with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures.

Table 1: Recommended Dosage for Patients with:
Partial-Onset Seizures (4 years age and older)*,
Myoclonic Seizures (12 years of age and older), and
Primary Generalized Tonic-Clonic Seizures (PGTC) (6 years of age and older)

Dosage Adjustments in Adult Patients with Renal Impairment

SPRITAM dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 2. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

Then CLcr is adjusted for body surface area (BSA) as follows:

Discontinuation of SPRITAM

Avoid abrupt withdrawal of SPRITAM in order to reduce the risk of increased seizure frequency and status epilepticus.