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This is not a complete list of possible side effectsIf you notice other effects not listed abovecontact your doctor or pharmacist.

One patienta 44 year-old male with MSdied in hospital on the second day following pump implantationAn autopsy demonstrated severe fibrosis of the coronary conduction systemA second patienta 52 year-old woman with MS and a history of an inferior wall myocardial infarctionwas found dead in bed 12 days after pump implantation2 hours after having had documented normal vital signsAn autopsy revealed pulmonary congestion and bilateral pleural effusionsIt is impossible to determine whether LIORESAL INTRATHECAL contributed to these deathsThe third patient underwent three baclofen screening trialsHis medical history included SCIaspiration pneumoniaseptic shockdisseminated intravascular coagulopathysevere metabolic acidosishepatic toxicityand status epilepticusTwelve days after screeninghe was not implantedhe again experienced status epilepticus with subsequent significant neurological deteriorationBased upon prior instructionextraordinary resuscitative measures were not pursued and the patient died.

On each occasion that the dosing rate of the pump and/or the concentration of LIORESAL INTRATHECALbaclofen injectionin the reservoir is adjustedclose medical monitoring is required until it is certain that the patient’s response to the infusion is acceptable and reasonably stable.

Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturerInadvertent injection into the subcutaneous tissue can occur if the reservoir refill septum is not properly accessedSubcutaneous injection may result in symptoms of a systemic overdose or early depletion of the reservoirRefill intervals should be carefully calculated to prevent depletion of the reservoiras this would result in the return of severe spasticity and possibly symptoms of withdrawal.

LIORESAL INTRATHECAL is for use in single bolus intrathecal injectionsvia a catheter placed in the lumbar intrathecal space or injection by lumbar punctureand in implantable pumps approved by the FDA specifically for the intrathecal administration of baclofenBecause of the possibility of potentially life-threatening CNS depressioncardiovascular collapseand/or respiratory failurephysicians must be adequately trained and educated in chronic intrathecal infusion therapy.

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Lioresal is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

It is mandatory that the patientall patient caregiversand the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatmentAll medical personnel and caregivers should be instructed in 1the signs and symptoms of overdose2procedures to be followed in the event of overdose and 3proper home care of the pump and insertion site.

Limited pharmacokinetic data suggest that a lumbar-cisternal concentration gradient of about 4:1 is established along the neuroaxis during baclofen infusionThis is based upon simultaneous CSF sampling via cisternal and lumbar tap in 5 patients receiving continuous baclofen infusion at the lumbar level at doses associated with therapeutic efficacythe interpatient variability was greatThe gradient was not altered by position.

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abrupt discontinuation of lioresal intrathecal, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

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Drowsinessdizzinessweaknesstirednessheadachetrouble sleepingnauseaincreased urinationor constipation may occurIf any of these effects persist or worsentell your doctor or pharmacist promptly.

Inactive IngredientsCellulose compoundsmagnesium stearatepovidoneand starch.

Baclofen is used to treat muscle spasms caused by certain conditionssuch as multiple sclerosisspinal cord injury/diseaseIt works by helping to relax the muscles.

Take this medication by mouth with or without food as directed by your doctorusually 3 times a dayTo reduce your risk of side effectsyour doctor may direct you to start this medication at a low dose and gradually increase your doseFollow your doctor’s instructions carefully.

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