Important Administration Instructions

SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. As a primary method of administration, place tablet on the tongue with a dry hand, follow with a sip of liquid and swallow only after the tablet disintegrates. Do not swallow tablet(s) intact. Partial tablet(s) should not be administered. 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 to cover the medicine). Allow the tablet(s) to disperse prior to consuming the entire contents immediately. After administration of the suspension, re-suspend any residue by adding an additional small volume of liquid and swallow the full amount. No attempt should be made to administer partial quantities of the dispersed tablet(s).

Administer SPRITAM orally, with or without food. The SPRITAM dosing regimen depends on the indication, age group, and renal function.

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

Partial-Onset Seizures

The recommended dosing for monotherapy and adjunctive therapy is the same; as outlined below.

Adults and Pediatric Patients 4 Years and Older Weighing Over 40 kg:

Initiate SPRITAM with a daily dose of 1000 mg, given as twice daily dosing (500 mg twice daily). The daily dose may be increased every 2 weeks by increments of 1000 mg (500 mg twice daily) to a maximum recommended daily dose of 3000 mg (1500 mg twice daily). There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Pediatric Patients 4 years and Older Weighing 20 kg to 40 kg:

Initiate SPRITAM with a daily dose of 500 mg, given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg (250 mg twice daily) to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy

Initiate SPRITAM with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day (500 mg twice daily) every 2 weeks to the recommended daily dose of 3000 mg (1500 mg twice daily). The effectiveness of doses lower than 3000 mg/day has not been studied.

Primary Generalized Tonic-Clonic Seizures in Patients 6 Years of Age and Older

Adults and Pediatric Patients 6 Years and Older Weighing Over 40 kg:

Initiate SPRITAM with a daily dose of 1000 mg, given as twice daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day (500 mg twice daily) every 2 weeks to the recommended daily dose of 3000 mg (1500 mg twice daily). The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

Pediatric Patients 6 years and Older Weighing 20 kg to 40 kg:

Initiate SPRITAM with a daily dose of 500 mg, given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg (250 mg twice daily) to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

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 1. 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 ([see Warnings and Precautions (5.7)].)