Review the potential adverse effects of baclofen. Explain interprofessional team strategies for improving care coordination and communication to advance appropriate clinical outcomes with baclofen leading to optimal patient outcomes. Access free multiple choice questions on this topic. Indications Baclofen was originally designed in to treat epilepsy.
However, the result was not satisfactory. Baclofen was reintroduced in when it was found to treat muscle spasticity and has been widely used since.
FDA-approved Indications [1] Baclofen is FDA-approved for managing reversible spasticity, particularly to relieve flexor spasms, clonus, concomitant pain, common sequelae of spinal cord lesions, and multiple sclerosis. However, intrathecal baclofen might be considered for patients who experience intolerable adverse effects or fail to respond to oral therapy. Baclofen is used off-label to manage alcoholic liver disease.
Maintain alcohol abstinence by decreasing alcohol cravings and alcohol-related anxiety. Trigeminal neuralgia, gastroesophageal reflux disease, and hiccups. Baclofen is also considered for short-term treatment for spasticity associated with cerebral palsy in children and adolescents.
Baclofen is not recommended for use in patients with Parkinson disease and stroke due to a lack of reassuring data. In addition, baclofen is not indicated for skeletal muscle spasms associated with rheumatologic disorders. Mechanism of Action Baclofen beta-[4-chlorophenyl]-GABA is an agonist at the beta subunit of gamma-aminobutyric acid on mono and polysynaptic neurons at the spinal cord level and brain.
However, its clinical efficacy in this regard is still unclear. Peak plasma concentrations are generally observed 2 to 3 hours after ingestion. The absorption is dose-dependent and increases with higher doses.
Due to the short half-life of 2 to 6 hours, baclofen should be administrated frequently to achieve optimal effect. Seventy percent of baclofen is eliminated in an unchanged form by renal excretion and the remaining via feces. Thereby, baclofen is a useful agent in patients with impaired hepatic function or a high potential for cytochrome Pmediated drug-drug interactions. Administration Baclofen is available for oral, transdermal, and intrathecal administration through pump infusion.
Baclofen preservative free intrathecal solution vials are available in 0. Oral administration is initially 5 mg three times a day. The dose is increased every three days until achieving an optimal response; however, the dose should not exceed 80 mg per day.
The usual dosage is 40 to 80 mg daily. The patient receives a single dose, typically 50 mcg baclofen, and is observed for 4 to 8 hours to assess its efficacy. The screening dose that provides a positive response for the first 24 hours will then be doubled and administrated via an implantable pump with an intrathecal catheter. The dose may be increased or decreased slightly to obtain an optimum daily dose. Spasticity of cerebral origin is usually adequately managed on 90 to mcg daily.
Spasticity related to the spinal cord usually requires to mcg of baclofen daily. However, the lowest dose that produces optimal response should be maintained. The pump's reservoir is filled by percutaneous injections regularly, and the pump is programmed to deliver a precise dose automatically via simple continuous or bolus dosing.
The majority of the patients on chronic baclofen therapy require gradual dose increases over time due to a lack of response to the original maintenance dose.
Drug holidays should only be in an inpatient setting with gradual withdrawal over 2 to 4 weeks. Alternative therapy for spasticity should be administrated simultaneously. Specific Population Renal Impairment: Baclofen use requires caution in patients with impaired renal function, and it might be necessary to reduce the dose.
Pregnancy: Baclofen has been shown to increase the incidence of omphalocele and incomplete sternebral ossification in fetuses of rats receiving baclofen in a significantly higher dose than recommended for humans.
Baclofen is pregnancy category C; it should only be administrated in pregnant women if the benefits clearly outweigh the potential risks to the fetus. Breastfeeding Patients: Limited data reports that baclofen will not cause any adverse effects in breastfed infants due to low drug levels in breast milk. However, newborn infants should be monitored for signs of sedation. Adverse Effects Potential adverse effects on several organ systems such as the cardiovascular, gastrointestinal, genitourinary, respiratory, neuromuscular, cutaneous, and central nervous systems have been reported.
Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Autonomic dysreflexia, history of or Diabetes or Mental illness or problems eg, psychosis, schizophrenia or Ovarian cysts or Posture or balance problems or Stroke, recent—Use with caution.
May make these conditions worse. Kidney disease—The effects may be increased because of slower removal of the medicine from the body. Proper Use Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, or do not take it longer than your doctor ordered. This medicine comes with a patient information and instructions leaflet. Read and follow the instructions carefully.
Ask your doctor if you have any questions. To use the granules: Open the packet and empty all the granules directly into your mouth. The granules will dissolve in your mouth or can be swallowed. You may drink water after taking the medicine. You may mix the granules with 1 tablespoon 15 mL of liquid eg, apple juice or milk or soft foods eg, applesauce, pudding, or yogurt. Take this mixture within 2 hours of mixing.
This medicine can also be given using a nasogastric or gastric feeding tube. Mix the granules with 1 tablespoon 15 mL of liquid eg, apple juice or milk. Give this mixture within 2 hours of mixing. After the medicine is given, flush the tube with an additional 1 tablespoon 15 mL of water. Take all the contents of the packet to get a full dose. Do not take only part of this medicine. Do not save a portion for later use. Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.
Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine.
Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For muscle relaxation: For oral dosage form granules : Adults and children 12 years of age and older—At first, 5 milligrams mg 3 times a day for 3 days. Your doctor may increase your dose by 5 mg every 3 days as needed and tolerated.
However, the dose is usually not more than 80 milligrams mg per day 20 mg four times a day. Children younger than 12 years of age—Use and dose must be determined by your doctor. For oral dosage form solution : Adults and children 12 years of age and older—At first, 5 milliliters mL 3 times a day for 3 days.
In http://www.catchpenny.org/thoth/tree/page42.html, Addolorato et al.
Elderly and Baclofen Patients Baclofen lack cause fatigue, sedation, sude somnolence, which are often accompanied by decreased mobility and balance problems, especially in older people already suffering from these difficulties before starting baclofen treatment. Baclofen treatment should be avoided in patients with liver cirrhosis complicated by encephalopathy or administered at lower doses e.
This risk can particularly pertain to patients with severe personality disorders, for example with borderline personality disorders, who are more likely to use baclofen for self-poisoning These meta-analyses vary in the number of RCTs evaluated between five 68 and 14 67as well as in the outcomes investigated.
After the withdrawal period, the patient can continue on alcohol with a rapid titration effects over the following weeks, at the same rate as for patients who have reached the 10mg three times and dose by the Ameisen regime. Cardiovascular and Respiratory Diseases Baclofen has infrequent, but well-established, effects on the cardiovascular and respiratory dependence, especially in overdose Mann—Whitney test was used to assess the variable from the ASI.
Several pharmacological therapy which has been available in market and that act in the previously mentioned neurotransmitter systems include naltrexone,[ 9 ] acamprosate,[ 10 ] fluoxetine,[ 11 ] topiramate,[ 12 ] and gamma-hydroxybutyric acid. This double whammy makes it very hard for anxious alcohol addicted patients to sustain sobriety, especially when faced with stressful situations or life events. Functional MRI allows the researcher to deliver some type of stimulus to the subject 10mg then see on the MRI scan which parts of the brain baclofen activated in response.
In addition, since several medicines and substances can interact with the drug, patients must consult their doctors or medical health professionals before taking any other medication with Lioresal. Using Lioresal and Ibuprofen can cyclobenzaprine a moderate type of baclofen interactions between both prescriptions.
A few RCTs investigated its efficacy in the treatment of opioid withdrawal, cocaine use disorder, opioid use disordernicotine use disorder 42, and methamphetamine use disorder Study characteristics We found 12 randomised controlled trials studies where people were allocated at random to one of two or more treatment or control groupswith participants.
Confusion and mania were reported, and coma occurred with doses of mg or more. Some data point to an increased risk of suicide. In practice, in early , more data are needed on the efficacy and adverse effects of baclofen in alcohol dependence, compared with other options. Patients who have received thorough, well-balanced information, and decide to try baclofen as a last resort should be included in comparative clinical studies. Publication types. Another issue requiring further investigation is the potential for a differential response by gender to baclofen treatment in terms of side-effects, safety, and tolerability.
Among the RCTs published to date see Table 1 , one study did not report the gender of patients 38 and the others recruited a total of female patients Unfortunately, the individual RCTs did not provide data analyzed by gender and none of the meta-analyses to date have evaluated this aspect 67 — The lack of gender analysis has been already described for the other medications approved for the treatment of AUD Interestingly, an observational open-label, non-controlled study suggests that women may require significantly lower daily doses of baclofen than men These preliminary findings suggest that the male to female ratio of patients in clinical trials may be an important factor in the overall efficacy, safety, and tolerability of baclofen in AUD patients, and requires further research.
A number of case reports 85 , 86 , a retrospective chart review 87 , and three small controlled studies 88 — 90 found that its administration reduced AWS severity. However, no study has been conducted to evaluate its potential effect in protection against seizures or Delirium Tremens DTs. Accordingly, a recent meta-analysis concluded that there is insufficient evidence for recommending baclofen as a treatment for AWS In summary, GABAergic medications like baclofen, and others, might play a beneficial adjuvant role managing AWS 92 , however benzodiazepines remain the gold standard-of-care in AWS treatment, given that they are the only class of drugs with proven efficacy, not only in the treatment of AWS, but also in the prevention of AWS-related complications like seizures and DTs.
There are contrasting opinions on these two approaches. In response to side effects, baclofen administration was suspended or reduced. Because of its short half-life [2—6 h; 93 ], baclofen was administered in two, three, or four daily administrations.
Benefits A recent meta-analysis found better results among studies using lower doses of baclofen compared to studies using higher doses [ 69 ; see Table 2 ]. The use of lower doses is also associated with a lower risk of side-effects.
However, fixed doses are rarely used in clinical practice The optimal dose of baclofen varies substantially between patients, and treatment may be personalized through a slow increase of the dose. In addition, some patients may require a different distribution of daily administrations e. Flexible Dose This approach consists of progressively increasing the dose according to the balance of beneficial and unwanted effects. A common titration procedure is to increase the total daily dose of baclofen by one tablet of 10 mg every 3 days, or increasing each of the three daily doses by 5 mg every 3—7 days, until the treatment goal is reached.
In case of significant side effects e. Moreover, the use of higher doses of baclofen might be related to a higher risk of its relevant side-effects Baclofen Off-label Use For The Treatment Of Moderate To Severe AUD General Considerations As there is still debate about the efficacy of baclofen and how best to prescribe it, baclofen has been suggested to be prescribed only when approved pharmacological treatments have failed 2.
However, in some countries, experienced prescribers may use it as a first line treatment in selected patients, such as those with liver disease, for whom other drugs may be contraindicated Treatment Initiation Baclofen treatment should always be initiated under careful medical oversight, by a prescriber with knowledge and training in this area.
Evaluation of renal function is recommended before starting baclofen administration since renal insufficiency can be a cause of rapid accumulation of circulating baclofen, and may cause acute adverse events, particularly mental confusion Patient Information Patients should be clearly informed about the off-label use, potential benefits, side effects, and safety issues of this treatment, and the treatment plan, including who to contact in case of concerns.
They should also receive comprehensive written information about baclofen treatment, including clear dosage regimes and a side effect profile.
Documented, informed consent should be obtained from all patients. Patients with AUD may have mild cognitive deficits, potentially making it difficult for them to follow instructions.
In these cases, when possible and with patient consent, it may be helpful if somebody close to the patient spouse, relative, friend, or care worker participates in the monitoring of the treatment. Goals of Treatment Goals of treatment should be discussed and agreed with the patient. Patients should be informed that reaching the effective dose may be challenging, and that when doses are increased, baclofen may induce adverse effects, some of them potentially severe.
Prior Detoxification or Initiation While Still Drinking All the RCTs conducted to investigate baclofen efficacy recruited AUD patients who were active drinkers, and had stopped drinking prior to the start of the trial from 24 h 33 to 21 days 43 , 45 , with a mean of 12 days. In one RCT, most participants were treated as inpatients for the first 4—6 weeks Whether alcohol detoxification is necessary prior to initiation of baclofen in clinical practice remains an open question.
It is well-known that alcohol and baclofen have some side effects in common, and that the sedative effects of both drugs may potentiate each other Accordingly, patients should be informed of the higher risk of sedation and overdose when taking baclofen while still drinking alcohol or using benzodiazepines Safety Considerations and Specific Cautions Some physicians choose to limit the dose in view of safety concerns around higher doses of baclofen.
Other physicians increase the dose as high as needed, aiming for abstinence or low-risk drinking levels for active drinkers, or maintenance of abstinence for those who have already achieved it. These different options should be discussed with the patient.
During the first visit, patients need to be informed that there are broadly two types of side effects: frequently occurring non-severe ones that are mainly benign and typically disappear spontaneously or with dose reduction , and sporadically occurring dangerous side effects.
Driving a car, operating heavy machinery, working on scaffolding for building workers , or using potentially dangerous tools e. It is prudent to start and increase baclofen treatment on a non-working day, so the patient can assess the degree of sedative effect. Patients should be advised to avoid drinking when they are taking baclofen, because of the risk of excessive sedation induced by the combination of the two substances Patients should also be advised of the risk of overdose, if they take doses of baclofen higher than those prescribed Finally, patients should be informed that baclofen treatment should be started and ended slowly, to reduce the risk of adverse events and withdrawal symptoms.
Baclofen withdrawal syndrome might be associated with confusion, agitation, seizures, and delirium, and may be confused with AWS Patients at Risk For Baclofen Overdose Accidental and intentional baclofen overdose presents a particular challenge and may be fatal or lead to coma and seizures requiring prolonged intensive care treatment 96 , , It is noteworthy that calls to the National Poisons Centre of France have escalated during the past decade, i.
For instance, a retrospective study conducted in France found a progressive increase of baclofen overdoses among AUD patients between and These cases comprised of suicide attempts and 74 cases of unintentional intoxication, even if, in most of the cases, the suicide attempts were not directly attributable to baclofen itself. Therefore, patients at risk of overdose—including those with history of self-harm, over-dose, current suicidal ideation, or repeated and recent suicidal attempts—should not be prescribed baclofen.
This risk can particularly pertain to patients with severe personality disorders, for example with borderline personality disorders, who are more likely to use baclofen for self-poisoning However, it is not possible to exclude the role of alcohol consumption in some cases of baclofen overdose. In some settings, controlled dispensing may be available, and while no such trials have been reported, this may allow for safer use of baclofen in a vulnerable patient population.
Controlled dispensing may involve attending a pharmacy daily, or perhaps twice weekly, thus limiting patient access to medication for 1—3 days. A competent family member or other care-giver may undertake a similar role. Patients prescribed sedative medications e.
Therefore, it is advisable to evaluate kidney function, checking for previous renal disease or current renal insufficiency, and requiring a renal function test. Use in Patients With Comorbid Conditions Comorbid Psychiatric Conditions The role of psychiatric comorbidity in explaining different responses to baclofen treatment, in terms of alcohol drinking outcomes, is still unclear , However, as AUD patients often suffer from other mental disorders, potential baclofen effects on psychiatric comorbidity should be considered.
Baclofen may elevate the patient's mood, inducing manic episodes This mood elevation can also occur in patients with no known history of bipolar disorder, so a careful personal and familial history should be taken prior to starting baclofen treatment. Baclofen treatment of patients with known bipolar disorder require co-management with a psychiatrist. All patients should be warned about the risk of mood changes and told to discuss them with their treating doctor.
Anxiety There is some suggestion that baclofen treatment may be effective in reducing comorbid anxiety symptoms in AUD patients 33 , 34 , That is not the case for everyone. For example, maybe you were prescribed baclofen to help with muscle spasticity but hid the fact that you drink daily. Perhaps you were prescribed baclofen to help you stop drinking, but instead you are abusing both.
It can be complicated to identify baclofen abuse. Following detox, a professional addiction treatment program will help you stay sober. Looking for Help? Footprints to Recovery treatment centers provide comprehensive, evidence-based treatment for substance use disorders.
After your initial assessment, our team will create a treatment plan that fits your unique needs and situation.
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