The third patient underwent three baclofen screening trials. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Discard any unused portion. A sudden large requirement for dose escalation suggests a catheter complication (i.e., catheter kink or dislodgement).Potential need for dose adjustments in chronic use:Explanation of symbols on product or package labelingRefer to the Indications, Drug Stability, and Emergency Procedures reference manual Refer to the appropriate information for prescribers booklet for contraindications, warnings, precautions, adverse events summary, individualization of treatment, patient selection, use in specific populations, and component disposal.Refer to the Lioresal Intrathecal (baclofen injection) drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures.The low reservoir alarm of an overinfusing pump will not sound if the pump reservoir is prematurely depleted.Contrast medium (pumps with a catheter access port) -inadvertent injection into the catheter access portInadvertent injection into the catheter access portThe low reservoir alarm of an overinfusing pump will not sound if the pump reservoir is prematurely depleted.Inadvertent injection into the catheter access portLioresal Intrathecal (baclofen injection) underdose/ withdrawalWe comply with the HONcode standard for trustworthy health information -
Special attention should be given to patients at apparent risk (e.g. *The contents of these kits have been sterilized by ethylene oxide gas. Five occurrences of overinfusion have been identified in Medtronic’s prospective, long-term multi-center registry study (Product Surveillance Registry) as of January 2016, resulting in a rate estimate of less than 0.14% (approximately 1 in 700).Failure to return at the prescribed times can also damage the pump, requiring surgical replacement.Refer to "Performing a reservoir rinse" on page 18 of this manual. It is not for use with the Medtronic MiniMed infusion pumps.Saol refill kits are contraindicated for all catheter access port procedures.Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. This 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 efficacy; the interpatient variability was great. Adequate genotoxicity assays of baclofen have not been performed.There are no adequate and well-controlled studies in pregnant women. Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias. Available for Android and iOS devices. Interactions attributed to the combined use of Lioresal Intrathecal and epidural morphine include hypotension and dyspnea.CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITYNo increase in tumors was seen in rats receiving baclofen orally for two years. Abrupt reduction or discontinuation of concomitant antispastics should be avoided.Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with Lioresal Intrathecal and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.Lioresal Intrathecal should be used with caution in patients with a history of autonomic dysreflexia. Reduction and discontinuation of oral anti-spasmotics should be done slowly and with careful monitoring by the physician.
Inadvertent injection into the subcutaneous tissue can occur if the reservoir refill septum is not properly accessed. Inadvertent injection into the subcutaneous tissue can occur if the reservoir refill septum is not properly accessed.