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Information about Lioresal.
The dosage is based on your medical condition and response to treatmentDo not increase your dose or take it more often than prescribed.
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.
Lioresal has been shown to increase the incidence of omphalocelesventral herniasin fetuses of rats given approximately 13 times the maximum dose recommended for human useat a dose which caused significant reductions in food intake and weight gain in damsThis abnormality was not seen in mice or rabbitsThere was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human doseand an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human doseIn miceno teratogenic effects were observedalthough reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 or 34 times the human daily doseThere are no studies in pregnant womenLioresal should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.
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.
The pump system should not be implanted until the patient’s response to bolus LIORESAL INTRATHECAL injection is adequately evaluatedEvaluationconsisting of a screening proceduresee Dosage and Administrationrequires that LIORESAL INTRATHECAL be administered into the intrathecal space via a catheter or lumbar punctureBecause of the risks associated with the screening procedure and the adjustment of dosage following pump implantationthese phases must be conducted in a medically supervised and adequately equipped environment following the instructions outlined in the Dosage and Administration section.
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special attention must be given to recognizing the signs and symptoms of overdosage, especially during the initial screening and dose- titration phase of treatment, but also during re- introduction of lioresal intrathecal after a period of interruption in therapy.
