As a group, the patients who died were relatively young (mean age was molecular weight of 213.66. Acute massive overdose may present as coma. (Intrathecal) when introduced directly into the intrathecal space permits Doses used in this patient population for long-term infusion are generally lower than those required for patients with spasticity of spinal cord origin.Because of the open, uncontrolled nature of the experience, a causal linkage between events observed and the administration of intrathecal baclofen cannot be reliably assessed in many cases. Baclofen Injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. technical manual of the implantable infusion system for additional postimplant Use 1.5 mL of 50 mcg/mL baclofen injection for a 75 mcg bolus dose. An autopsy revealed pulmonary congestion and bilateral pleural effusions.

The last study, however, did not provide data that could be reliably analyzed.Baclofen Injection is a clear, colorless, sterile, pyrogen-free, isotonic solution consisting of the active ingredient, Baclofen USP, and the excipients Sodium Chloride USP and Water for Injection USP in single-dose clear glass vials.Baclofen Injection is packaged in single-dose vials supplied as follows:One vial containing 20,000 mcg/20 mL (1,000 mcg/mL) (NDC 70511-123-20).Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Advise patients and caregivers that sudden withdrawal of Baclofen Injection, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death. oral baclofen (baclofen USP) in therapeutic doses, the active substance passes into

If the response is still inadequate, a final bolus CSF clearance of intrathecal baclofen calculated from intrathecal bolus orcontinuous Do not use Baclofen Injection for intravenous, intramuscular, subcutaneous or epidural administration.Use extreme caution when filling the Medtronic SynchroMed® II Programmable Pump which is equipped with an injection port that allows direct access to the intrathecal catheter. The lowest dose with an optimal response should be used.The clinical goal is to maintain muscle tone as close to normal as possible and to minimize the frequency and severity of spasms to the extent possible, without inducing intolerable side effects, or to titrate the dose to the desired degree of muscle tone for optimal functions. that should be used depends upon the total daily dose required as well as the delivery It works by helping to relax the muscles.Baclofen injection is used by patients who do not respond to or who cannot tolerate the side effects of baclofen … to 400 mcg/day had plasma baclofen levels near or below 10 ng/mL.You are encouraged to report negative side effects of prescription drugs to the FDA. For example, patients who have increased spasms at Maximum activity is observed in 24 to 48 hours.No additional information on continuous infusions is available for pediatric patients.The pharmacokinetics of cerebrospinal fluid (CSF) clearance of intrathecal baclofen calculated from intrathecal bolus or continuous infusion studies approximates CSF turnover, suggesting elimination is by bulk-flow removal of CSF.After a bolus lumbar injection of 50 mcg or 100 mcg intrathecal baclofen in seven patients, the average CSF elimination half-life was 1.51 hours over the first four hours and the average CSF clearance was approximately 30 mL/hour.The mean CSF clearance for intrathecal baclofen was approximately 30 mL/hour in a study involving ten patients on continuous intrathecal infusion.

Oral or enteral baclofen alone should not be relied upon to halt the progression of intrathecal baclofen withdrawal.Seizures have been reported during overdose and with withdrawal from intrathecal baclofen as well as in patients maintained on therapeutic doses of intrathecal baclofen.Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with Baclofen Injection and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.There were 16 deaths reported among the 576 U.S. patients treated with intrathecal baclofen in pre- and post-marketing studies evaluated as of December 1992. In most patients, it will be necessary to increase the dose gradually over time to maintain effectiveness; a sudden requirement for substantial dose escalation typically indicates a catheter complication (i.e., catheter kink or dislodgement).After the first 24 hours, for adult patients, the daily dosage should be increased slowly by 10% to 30% increments and only once every 24 hours, until the desired clinical effect is achieved.After the first 24 hours, the daily dose should be increased slowly by 5% to 15% only once every 24 hours, until the desired clinical effect is achieved.After the first 24 hours, the daily dose should be increased slowly by 5% to 15% only once every 24 hours, until the desired clinical effect is achieved. There is no brand-name version available. The daily dose may be reduced by 10% to 20% if patients experience side effects. 8 0 obj Many patients require gradual increases in

Acute massive overdose may present as coma. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. ​See full prescribing information for complete boxed warningof intrathecal baclofen, 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.of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.