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Information about Lioresal.

Continuous InfusionNo additional information is available for pediatric patients.

DrowsinessDrowsiness has been reported in patients on LIORESAL INTRATHECALPatients should be cautioned regarding the operation of automobiles or other dangerous machineryand activities made hazardous by decreased alertnessPatients should also be cautioned that the central nervous system depressant effects of LIORESAL INTRATHECALbaclofen injectionmay be additive to those of alcohol and other CNS depressants.

Seizures have been reported during overdose and with withdrawal from LIORESAL INTRATHECAL as well as in patients maintained on therapeutic doses of LIORESAL INTRATHECAL.

An attempt should be made to discontinue concomitant oral antispasticity medication to avoid possible overdose or adverse drug interactionseither prior to screening or following implant and initiation of chronic LIORESAL INTRATHECAL infusionReduction and discontinuation of oral anti-spasmotics should be done slowly and with careful monitoring by the physicianAbrupt reduction or discontinuation of concomitant antispastics should be avoided.

PREGNANCY There are no adequate and well-controlled studies in pregnant womenIn animal studiesbaclofen had adverse effects on embryofetal development when administered orally to pregnant ratsLIORESAL INTRATHECAL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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