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Baclofen (Baclofen) - Summary

 
 



BACLOFEN SUMMARY

Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.
Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform.

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.
Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.


See all Baclofen indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Baclofen

Baclofen Pump (Therapy for Multiple Sclerosis)
Source: MedicineNet Muscle Cramps Specialty [2016.09.13]
Title: Baclofen Pump (Therapy for Multiple Sclerosis)
Category: Procedures and Tests
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 9/13/2016 12:00:00 AM

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Published Studies Related to Baclofen

Baclofen for the Treatment of Alcohol Dependence and Possible Role of Comorbid Anxiety. [2014]
baclofen in the treatment of alcohol dependence... CONCLUSIONS: In spite of the small sample for a 3-arm clinical trial, this study

Randomised clinical trial: arbaclofen placarbil in gastro-oesophageal reflux disease--insights into study design for transient lower sphincter relaxation inhibitors. [2013]
characteristics of patients who were responders... CONCLUSIONS: Arbaclofen placarbil was not superior to placebo in the primary

Baclofen reduces binge eating in a double-blind, placebo-controlled, crossover study. [2012]
Baclofen has shown promise in treating substance use disorders and also reduced binge frequency in an open-label trial...

Defining the Role of Baclofen for the Treatment of Alcohol Dependence: A Systematic Review of the Evidence. [2011.12.06]
The pharmacological properties of baclofen, a GABA(B) receptor agonist, have led to investigation of its use for the off-label treatment of alcohol dependence. Literature examining the role of baclofen in alcohol dependence suggests that it may be a useful medication in the treatment armamentarium with an additional benefit of promoting abstinence and reducing alcohol-associated cravings and anxiety...

treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial. [2011.10]
BACKGROUND: Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS). OBJECTIVE: To determine the effect of the gamma-aminobutyric acid (GABA)-B agonist baclofen on the course of acute symptomatic AWS... CONCLUSIONS: We found that the use of baclofen was associated with a significant reduction in the use of high doses of benzodiazepine (lorazepam) in the management of symptomatic AWS. The use of low-dose baclofen in the management of AWS deserves further study, as reduced dependence on high-dose benzodiazepines in AWS management could improve patient safety. Copyright (c) 2011 Society of Hospital Medicine.

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Clinical Trials Related to Baclofen

Baclofen for Smoking Cessation in a Non-Psychiatric Population [Terminated]
The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures. The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i. e. take the medication as directed for the trial period) than those in the placebo group. The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.

Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis [Recruiting]
Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life. The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump [Active, not recruiting]

Oral and IV Baclofen in Adult Volunteers [Completed]
The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation. This study is a randomized crossover study with two treatment arms. All subjects will receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1: 1 manner. The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.

Action of Baclofen Capsules in Spasticity Due to Multiple Sclerosis [Recruiting]
This is a double-blind, randomized, placebo-controlled trial to evaluate duration of action of Baclofen ER capsules (GRS) compared with placebo in subjects with spasticity due to Multiple sclerosis. The trial will include male and female subjects greater than or equal to 18 years of age with spasticity with multiple sclerosis.

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Reports of Suspected Baclofen Side Effects

Overdose (86)Coma (65)Muscle Spasms (61)Neurotoxicity (59)Vomiting (52)Death (50)Completed Suicide (50)Muscle Spasticity (48)Dizziness (45)Convulsion (45)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Baclofen has an overall score of 8.50. The effectiveness score is 8.50 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Baclofen review by 31 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Muscle pain and stiffness due to fibromyalgia
Dosage & duration:   10mg taken 3x/day for the period of 2 years/ongoing
Other conditions:   Bipolar Disorder, Hypothyroidism, Fibromyalgia
Other drugs taken:   Levoxyl, Tramadol, Oxcarmazapine, Hydroxizine Pamoate, Clonazepam
  
Reported Results
Benefits:   Significant reduction in cramping, stiffness, and "knots" in muscles.
Side effects:   Drowsiness, somewhat impaired balance
Comments:   I was prescribed Baclofen with a number of other drugs to treat muscle and joint pain and stiffness due to fibromyalgia. When I first began taking the medication, I slept ALL the time--as much as 22 hours a day. I literally could not stay awake. This may have been due not only to the drug's sedating affect, but to the vast sleep deficit of that years of pain and insomnia had produced. As time went on, I slept less, and was less dependent on the Baclofen as a "maintenance" medication--I began to "save" it to take in slightly more concentrated doses when a severe muscle spasm or strain, or a "flare" occurs, which happens frequently in fibromyalgia patients. I have noticed that the drug is less effective than it used to be, requiring higher doses to treat the same level of stiffness or cramping.

 

Baclofen review by 62 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   30 mg qhs taken daily for the period of 3 months
Other conditions:   hypothyroid
Other drugs taken:   valium, trazadone, naturthroid
  
Reported Results
Benefits:   Helped with sleep. Could reduce valium, trazadone without withdrawal symptoms
Side effects:   A little drooziness in AM
Comments:   Was looking for another drug without as much addiction potential for life long sleep disorder. Found this through a friend, there are posts on the internet about it, also used for addictions off label. My MD agreed to try it.

 

Baclofen review by 62 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   30 mg qhs taken daily for the period of 3 months
Other conditions:   hypothyroid
Other drugs taken:   valium, trazadone, naturthroid
  
Reported Results
Benefits:   Helped with sleep. Could reduce valium, trazadone without withdrawal symptoms
Side effects:   A little drooziness in AM
Comments:   Was looking for another drug without as much addiction potential for life long sleep disorder. Found this through a friend, there are posts on the internet about it, also used for addictions off label. My MD agreed to try it.

See all Baclofen reviews / ratings >>

Page last updated: 2016-09-13

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