DOSING & ADMINISTRATION
SPRITAM is available in 250 mg tablets for oral suspension, which can be prescribed in incremental quantities appropriate for your patient’s regimen.
Three Options for Administering SPRITAM
SPRITAM (levetiracetam) offers three flexible administration options to support individualized patient care. Now approved for Nasogastric (NG) and Gastrostomy (G) tube delivery, SPRITAM can be administered orally, in a small amount of liquid in a cup, or through a feeding tube in sizes of 10-14 French, offering versatility in treatment options.
See the U.S. Full Prescribing Information and Medication Guide for complete administration instructions.
INSTRUCTIONS FOR HANDLING TABLETS
Do NOT push the tablet through the foil. Bend up and lift the peel tab around the blister seal. Empty the exposed tablet into a dry hand. Partial tablets should not be administered.
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.:
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Should be taken whole
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Should be swallowed intact
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Can be taken with or without food
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Do not administer partial tablets
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 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) |
When picking up their prescription, patients should make sure they have received the right medicine and strength. If they think they have received the wrong medicine or strength, they should tell their pharmacist.22. SPRITAM Medication Guide. Aprecia Pharmaceuticals Company.
Switching to SPRITAM from a conventional form of immediate-release (IR) levetiracetam
SPRITAM 250 mg tablets for oral suspension is 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:
