ITB™ Therapy Dosing Chart Severe Spasticity of Cerebral and Spinal Origin Spinal Origin Initial Dosing
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• Postimplant Dose Titration • (up to 60 days) •
Maintenance Therapy Goals
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Increase 10 to 30% once every 24 hours until desired clinical effect is achieved. 2 Effects first seen 6-8 hours after initiation of continuous infusion. Maximum effect observed in 24-48 hours. 2 Maintain muscle tone close to normal. (1-2 Ashworth scale) 2
Cerebral Origin
Pediatric
Same
Same
Same •
Increase 5 to 15% once every 24 hours until desired clinical effect is achieved. 2 Same
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Titrate dose to desired degree of muscle tone for optimal function or ease of care. 2
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Ashworth scores may be 2 or higher to optimize function. 2
• •
Reduce frequency and severity of spasms. (0-1 Spasm scale) 2 10 to 40%*increases once every 24 hours. 2
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5 to 20% increases once every 24 hours. 2
Dosing ranges in clinical studies:2 Range: 12-2003 mcg/day Usual range: 300-800 mcg/day (most patients effective at this range)
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Dosing ranges in clinical studies: 2 Range: 22-1400 mcg/day Usual range: 90-703 mcg/day (most patients effective at this range) Mean: 323 mcg/day Median: 210 mcg/day
*10-30% Europe/ROW
Dose Reductions Complex Programming 1 2
Drug package insert Medtronic data on file
Same as cerebral
Same as cerebral •
Maintenance Therapy Dosing (Beyond 60 days)
2x the effective screening dose if effect lasted less than 8 hours. If effect lasted more than 8 hours, use same dose as effective screening dose over 24 hrs. 1 No dosing increases during first 24 hours. 2
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10 to 20% slowly. 2
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May be a day/night variation 1
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Same
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Dosing ranges in clinical studies: 2 Range: 24-1199 mcg/day Mean: 274 mcg/day Median: 180 mcg/day
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In children over 12, doses were no different than those for adults with spasticity of cerebral origin. Same
•
May use variable programming throughout the day (more in the morning, less when transferring; or day/night variation). 1
Same •
May use variable programming throughout the day (more in the morning, less when transferring; or day/night variation). 1