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Adverse experiences reported during all U.Sstudiesboth controlled and uncontrolledare shown in the following tableEight of 474 patients who received chronic infusion via implanted pumps had adverse experiences which led to a discontinuation of long term treatment in the preand post-marketing studies.

LIORESAL INTRATHECAL should be used with caution in patients with a history of autonomic dysreflexiaThe presence of nociceptive stimuli or abrupt withdrawal of LIORESAL INTRATHECALbaclofen injectionmay cause an autonomic dysreflexic episode.

Pump Dose Adjustment and Titration In most patientsit will be necessary to increase the dose gradually over time to maintain effectivenessa sudden requirement for substantial dose escalation typically indicates a catheter complicationi.ecatheter kink or dislodgement

Patients suffering from psychotic disordersschizophreniaor confusional states should be treated cautiously with LIORESAL INTRATHECAL and kept under careful surveillancebecause exacerbations of these conditions have been observed with oral administration.

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