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Abrupt discontinuation of 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.
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. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).
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SUMMARY
LIORESAL INTRATHECAL (baclofen injection) is a muscle relaxant and antispastic.
LIORESAL INTRATHECAL is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of LIORESAL INTRATHECAL via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. 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. LIORESAL INTRATHECAL (baclofen injection) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of LIORESAL INTRATHECAL into the intrathecal space.
Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of LIORESAL INTRATHECAL was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of LIORESAL INTRATHECAL to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. LIORESAL INTRATHECAL was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.
Spasticity of Cerebral Origin: The efficacy of LIORESAL INTRATHECAL was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross- over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; LIORESAL INTRATHECAL was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross- over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p= 0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed.
LIORESAL INTRATHECAL therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of LIORESAL INTRATHECAL, patients must show a response to LIORESAL INTRATHECAL in a screening trial (see Dosage and Administration).
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NEWS HIGHLIGHTSMedia Articles Related to Lioresal Intrathecal (Baclofen Injection)
Muscle Spasms
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2009.06.17]
Title: Muscle Spasms
Category: Diseases and Conditions
Created: 6/16/2009
Last Editorial Review: 6/17/2009
Published Studies Related to Lioresal Intrathecal (Baclofen Injection)
Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial. [2009.05]
BACKGROUND: Intractable spasticity can be treated effectively with continuous infusion of intrathecal baclofen. Because evidence for its use in the treatment of children with spastic cerebral palsy is lacking, we conducted a randomised controlled trial. AIMS: To test whether continuous infusion of intrathecal baclofen is effective in comparison with standard treatment only... CONCLUSION: The results of this randomised controlled trial establish continuous infusion of intrathecal baclofen to be effective in carefully selected children with problems caused by intractable spastic cerebral palsy.
Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study. [2007.09]
Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB infusion, to assess the effective ITB bolus dose, and to evaluate the effects, side effects, and complications...
Survival of individuals with cerebral palsy receiving continuous intrathecal baclofen treatment: a matched-cohort study. [2009.10.07]
Aim To determine whether intrathecal baclofen (ITB) changes mortality risk in persons with cerebral palsy (CP). Method Records were reviewed for all persons with CP who were managed with ITB for hypertonicity at a specialty hospital in Minnesota between May 1993 and August 2007... Interpretation ITB therapy does not increase mortality in individuals with CP and may suggest an increase in life expectancy.
Intrathecal baclofen use in adults with cerebral palsy. [2009.10]
Intrathecal baclofen (ITB) is an effective treatment for both spasticity and dystonia in people with cerebral palsy (CP)... These and other unanswered questions should be addressed in a systematic way.
Intrathecal baclofen in patients with persistent vegetative state: 2 hypotheses. [2009.07]
Sporadic cases of recovery from persistent vegetative state (PVS) after administration of intrathecal baclofen (ITB) have been reported without giving any possible explanation for its paradoxical effect. We summarize our recent findings on 5 patients with PVS treated with ITB and make some speculations on the mechanisms responsible for the observed clinical improvement...
Clinical Trials Related to Lioresal Intrathecal (Baclofen Injection)
Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity [Recruiting]
Oral baclofen is used commonly to treat spasticity in children with cerebral palsy.
Although for adults there is dosing,safety and efficacy information in the package insert,
this is not the case for children. The purpose of this study is to determine how fast the
drug is cleared from the body, the correct dose, and long-term safety and efficacy for
children with spasticity.
Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study. [Recruiting]
The purpose of this research study is to learn about the use of a combination of two
medications, baclofen and naltrexone, for the treatment of alcohol dependence in men and
women ages 25-60 years old. Naltrexone is an FDA approved medication for treatment of
alcohol dependence. The most widely accepted idea for naltrexone's effect is that it
reduces the alcohol "high", which decreases a desire to consume alcohol. As a result,
alcoholic patients treated with naltrexone are less likely to relapse to heavy drinking.
Furthermore, naltrexone treated patients drink fewer days and are more likely to maintain
abstinence.
However, naltrexone does not have any effect on other symptoms that may contribute to
relapse such as anxiety, sleep problems and irritability. Baclofen, an FDA approved
medication for muscle spasms, may improve some of these symptoms.
Therefore, the purpose of the current study is to gather information on whether adding
baclofen to naltrexone is feasible and well tolerated.
Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes? [Not yet recruiting]
Baclofen is a drug that reduces the muscle stiffness. In disabled children that have very
stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and
pain. In this study we will check if treatment with Baclofen reduces pain in disabled
children with stiff muscles.
Effect of Baclofen on Marijuana Withdrawal and Relapse [Recruiting]
The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's
direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.
Randomized Study of L-Baclofen in Patients With Refractory Trigeminal Neuralgia [Recruiting]
OBJECTIVES: I. Evaluate the efficacy of L-baclofen in patients with refractory trigeminal
neuralgia.
II. Evaluate the safety and tolerance of L-baclofen in these patients.
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Page last updated: 2009-10-20
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