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DOSINg & Administration

Taking SPRITAM is as easy as…

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 administration. If there is any medicine left in the cup, add a small volume of liquid to the cup, swirl gently, and swallow the liquid.

SPRITAM tablet 11. Boudriau S, Harvey C, Massicotte J, et al. Randomized Comparative bioavailability of a nocel three-dimensional printed fast-melt formulation of levetiracetam following the administration of a single 1000-mg dose to healthy human volunteers under fasting and fed conditions, Drugs R D. 2016;16(2):229–238.:

E

Should be taken whole

E

Should not be swallowed intact

E

Can be taken with or without food

Fasting vs Fed

In a clinical study of 33 healthy volunteers, consuming food (a high-fat, high-calorie breakfast) decreased the peak plasma concentration (Cmax) by 36% and delayed the time to peak plasma concentration (Tmax) by 3.5 hours. However, it did not affect the extent of absorption. 11. Boudriau S, Harvey C, Massicotte J, et al. Randomized Comparative bioavailability of a nocel three-dimensional printed fast-melt formulation of levetiracetam following the administration of a single 1000-mg dose to healthy human volunteers under fasting and fed conditions, Drugs R D. 2016;16(2):229–238.

Refer to the Full Prescribing Information for complete dosing recommendations 11. Boudriau S, Harvey C, Massicotte J, et al. Randomized Comparative bioavailability of a nocel three-dimensional printed fast-melt formulation of levetiracetam following the administration of a single 1000-mg dose to healthy human volunteers under fasting and fed conditions, Drugs R D. 2016;16(2):229–238.:

Partial Onset Seizures

Patient Age and Weight Initiation Titration Maximum Recommended Dose
Adults and pediatric patients 4 years and older (>40 kg) 1,000 mg/day (500 mg twice daily) Increments of 1,000 mg/day every 2 weeks (500 mg twice daily) 3,000 mg/day (1,500 mg twice daily)
Pediatric patients 4 years and older (20 kg to 40 kg) 500 mg/day (250 mg twice daily) Increments of 500 mg/day every 2 weeks (250 mg twice daily) 1,500 mg/day (750 mg twice daily)

Myoclonic Seizures

Patient Age Initiation Titration Maximum Recommended Dose
Patients 12 years and older with juvenile myoclonic epilepsy 1,000 mg/day (500 mg twice daily) Increments of 1,000 mg/day every 2 weeks (500 mg twice daily) 3,000 mg/day (1,500 mg twice daily)

Primary Generalized Tonic-Clonic Seizures

Patient Age and Weight Initiation Titration Maximum Recommended Dose
Adults and pediatric patients 6 years and older (>40 kg) 1,000 mg/day (500 mg twice daily) Increments of 1,000 mg/day every 2 weeks (500 mg twice daily) 3,000 mg/day (1,500 mg twice daily)
Patients 6 years and older (20 to 40 kg) 500 mg/day (250 mg twice daily) Increments of 500 mg/day every 2 weeks (250 mg twice daily) 1,500 mg/day (750 mg twice daily)

Switching to SPRITAM from a conventional form of immediate-release (IR) levetiracetam

All 4 strengths of SPRITAM are designed to deliver an equal amount of levetiracetam as other marketed dosage forms based on pharmacokinetic bridging studies.11. Boudriau S, Harvey C, Massicotte J, et al. Randomized Comparative bioavailability of a nocel three-dimensional printed fast-melt formulation of levetiracetam following the administration of a single 1000-mg dose to healthy human volunteers under fasting and fed conditions, Drugs R D. 2016;16(2):229–238.

For example:

SPRITAM 250 mg = Conventional IR levetiracetam tablet 250 mg = Levetiracetam liquid 2.5 mL (100 mg per mL)