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Lioresal may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
CARCINOGENESISMUTAGENESISAND IMPAIRMENT OF FERTILITY No increase in tumors was seen in rats receiving baclofen orally for two yearsAdequate genotoxicity assays of baclofen have not been performed.
Older adults may be more sensitive to the side effects of this drugespecially drowsiness and mental/mood changessuch as confusion
LIORESAL INTRATHECALbaclofen injectionis indicated for use in the management of severe spasticityPatients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pumpFor spasticity of spinal cord originchronic infusion of LIORESAL INTRATHECAL via an implantable pump should be reserved for patients unresponsive to oral baclofen therapyor those who experience intolerable CNS side effects at effective dosesPatients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapyLIORESAL INTRATHECAL is intended for use by the intrathecal route in single bolus test dosesvia spinal catheter or lumbar punctureandfor chronic useonly in implantable pumps approved by the FDA specifically for the administration of LIORESAL INTRATHECAL into the intrathecal space.
Extreme caution must be used when filling an FDA approved implantable pump equipped with an injection port that allows direct access to the intrathecal catheterDirect injection into the catheter through the catheter access port may cause a life-threatening overdose.
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the precise mechanisms of action of lioresal baclofen as an antispastic agent are not fully understood.
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