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Lioresal intrathecal should only be administered to end stage renal failure patients when benefit outweighs risk.
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Spasticity of Cerebral OriginThere were three deaths occurring among the 211 patients treated with LIORESAL INTRATHECAL in pre-marketing studies as of March 1996These deaths were not attributed to the therapy.
Rapidaccurate diagnosis and treatment in an emergency-room or intensive-care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawalThe suggested treatment for intrathecal baclofen withdrawal is the restoration of intrathecal baclofen at or near the same dosage as before therapy was interruptedHoweverif restoration of intrathecal delivery is delayedtreatment with GABA-ergic agonist drugs such as oral or enteral baclofenor oralenteralor intravenous benzodiazepines may prevent potentially fatal sequelaeOral or enteral baclofen alone should not be relied upon to halt the progression of intrathecal baclofen withdrawal.
Safety and effectiveness in pediatric patients below the age of 4 have not been established.
Special attention must be given to recognizing the signs and symptoms of overdosageespecially during the initial screening and dose-titration phase of treatmentbut also during re-introduction of LIORESAL INTRATHECAL after a period of interruption in therapy.
OverdoseSigns of overdose may appear suddenly or insidiouslyAcute massive overdose may present as comaLess sudden and/or less severe forms of overdose may present with signs of drowsinesslightheadednessdizzinesssomnolencerespiratory depressionseizuresrostral progression of hypotonia and loss of consciousness progressing to comaShould overdose appear likelythe patient should be taken immediately to a hospital for assessment and emptying of the pump reservoirIn cases reported to dateoverdose has generally been related to pump malfunctioninadvertent subcutaneous injectionor dosing errorSee Drug Overdose Symptoms and Treatment
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there is the potential for life-threatening cns depression, cardiovascular collapse, and or respiratory failure with lioresal intrathecal given as a single bolus injection or via an implantable pump.