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If lumbar puncture is not contraindicatedconsideration should be given to withdrawing 30-40 mL of CSF to reduce CSF baclofen concentration.

Drowsinessdizzinessweaknesstirednessheadachetrouble sleepingnauseaincreased urinationor constipation may occurIf any of these effects persist or worsentell your doctor or pharmacist promptly.

The more common1or moreadverse events reported in the prospectively followed 211 patients exposed to LIORESAL INTRATHECALbaclofen injectionhave been reportedIn the total cohortthe following adverse eventsnot described in the tableand arranged in decreasing order of frequencyand classified by body systemwere reported:

Intrathecal massCases of intrathecal mass at the tip of the implanted catheter have been reportedmost of them involving pharmacy compounded analgesic admixturesThe most frequent symptoms associated with intrathecal mass are1decreased therapeutic responseworsening spasticityreturn of spasticity when previously well controlledwithdrawal symptomspoor response to escalating dosesor frequent or large dosage increases2pain3neurological deficit/dysfunctionClinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptomsIn patients with new neurological signs or symptoms suggestive of an intrathecal massconsider a neurosurgical consultationsince many of the symptoms of inflammatory mass are not unlike the symptoms experienced by patients with severe spasticity from their diseaseIn some casesperformance of an imaging procedure may be appropriate to confirm or rule-out the diagnosis of an intrathecal mass.

Continuous InfusionThe mean CSF clearance for LIORESAL INTRATHECALbaclofen injectionwas approximately 30 mL/hour in a study involving ten patients on continuous intrathecal infusionConcurrent plasma concentrations of baclofen during intrathecal administration are expected to be low0-5 ng/mL

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