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Patients should be infection-free prior to the screening trial with lioresal intrathecal baclofen injection because the presence of a systemic infection may interfere with an assessment of the patient s response to bolus lioresal intrathecal.

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Baclofen USP is a white to off-whiteodorless or practically odorless crystalline powderwith a molecular weight of 213.66It is slightly soluble in watervery slightly soluble in methanoland insoluble in chloroform.

In patients with epilepsythe clinical state and electroencephalogram should be monitored at regular intervalssince deterioration in seizure control and EEG have been reported occasionally in patients taking Lioresal.

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.

Screening doseModel 8563sone ampule containing 0.05 mg/1 mL50 mcg/mLNDC 58281-562-01

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