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The most frequent1adverse events reported during all clinical trials are shown in the following tableNine patients discontinued long term treatment due to adverse events.
Precautions in special patient populationsCareful dose titration of LIORESAL INTRATHECAL is needed when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function and care.
Limited pharmacokinetic data suggest that a lumbar-cisternal concentration gradient of about 4:1 is established along the neuroaxis during baclofen infusionThis is based upon simultaneous CSF sampling via cisternal and lumbar tap in 5 patients receiving continuous baclofen infusion at the lumbar level at doses associated with therapeutic efficacythe interpatient variability was greatThe gradient was not altered by position.
Additional considerations pertaining to dosage adjustmentIt may be important to titrate thedose to maintain some degree of muscle tone and allow occasional spasms to1help support circulatory function2possibly prevent the formation of deep vein thrombosis3optimize activities of daily living and ease of care.
Pharmacokinetics of . LIORESAL INTRATHECALThe pharmacokinetics of CSF clearance of LIORESAL INTRATHECAL calculated from intrathecal bolus or continuous infusion studies approximates CSF turnoversuggesting elimination is by bulk-flow removal of CSF.
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