Baclofen is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems, including multiple sclerosis or certain injuries to the spine. Baclofen does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.
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How does Baclofen work ?
Baclofen acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine’s side effects. Baclofen may also be used to relieve other conditions as determined by your doctor.
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. The thinking is that baclofen reduces the release of excitatory neurotransmitters in the pre-synaptic neurons and stimulates inhibitory neuronal signals in the post-synaptic neurons with resultant relief of spasticity. Baclofen is also found to have an affinity for voltage-gated calcium channels. However, its clinical efficacy in this regard is still unclear.
Baclofen has a 70% to 85% bioavailability and is rapidly absorbed through the gastrointestinal tract following oral administration. 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 P450-mediated drug-drug interactions. Research has observed significant inter-individual variability in baclofen’s absorption and elimination processes.
This medicine is available only with your doctor’s prescription.
This product is available in the following dosage forms:
Off-labeled Uses of Baclofen
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.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of baclofen oral liquid and granules in children younger than 12 years of age. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of baclofen tablets in the pediatric population. Safety and efficacy have not been established..
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of baclofen oral liquid and granules in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving this medicine.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of baclofen tablet in the elderly. Side effects such as hallucinations, confusion or mental depression, other mood or mental changes, and severe drowsiness may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of this medicine.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Calcium Oxybate
- Gabapentin Enacarbil
- Magnesium Oxybate
- Morphine Sulfate Liposome
- Potassium Oxybate
- Ropeginterferon Alfa-2b-njft
- Sodium Oxybate
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. 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
- Epilepsy 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.
Baclofen Withdrawal Syndrome
Discontinuation of baclofen can be associated with a withdrawal syndrome which resembles benzodiazepine withdrawal and alcohol withdrawal. Withdrawal symptoms are more likely if baclofen is administered intrathecally or for long periods of time (more than a couple of months) and can occur from low or high doses.
The severity of baclofen withdrawal depends on the rate at which it is discontinued. Thus to minimise withdrawal symptoms, the dose should be tapered down slowly when discontinuing baclofen therapy. Abrupt withdrawal is more likely to result in severe withdrawal symptoms. Acute withdrawal symptoms can be eased or completely reversed by re-initiating therapy with baclofen.
Withdrawal symptoms may include auditory hallucinations, visual hallucinations, tactile hallucinations, delusions, confusion, agitation, delirium, disorientation, fluctuation of consciousness, insomnia, dizziness, nausea, inattention, memory impairments, perceptual disturbances, itching, anxiety, depersonalization, hypertonia, hyperthermia (higher than normal temperature without infection), formal thought disorder, psychosis, mania, mood disturbances, restlessness, and behavioral disturbances, tachycardia, seizures, tremors, autonomic dysfunction, hyperpyrexia (fever), extreme muscle rigidity resembling neuroleptic malignant syndrome and rebound spasticity.
Russian baclofen (trade name “Baclosan”) 25 mg tablets with a warning: “Caution: the drug may suppress psychomotor reactions”
Baclofen, at standard dosing, does not appear to possess addictive properties, and has not been associated with any degree of drug craving. Euphoria is however listed as a common to very common side-effect of baclofen in the BNF 75 There are very few cases of abuse of baclofen for reasons other than attempted suicide.
In contrast to baclofen, another GABAB receptor agonist, γ-hydroxybutyric acid (GHB), has been associated with euphoria, abuse, and addiction. These effects are likely mediated not by activation of the GABAB receptor, but rather by activation of the GHB receptor. Baclofen possesses both sedative and anxiolytic properties.
Toxicity of taking Baclofen
Overdose primarily arises from drug screening before pump implantation or human error during pump refilling and programming. Baclofen overdose may cause altered mental status, somnolence, seizure, hypothermia, respiratory depression, and coma. In the presence of overdose symptoms, the medical staff should empty the pump reservoir, and the patient should receive symptomatic management. In patients when the lumbar puncture is not contraindicated, consider withdrawing 30-40 mL of CSF to reduce baclofen CSF concentration.
Overdosed on baclofen tablets has reported vomiting, drowsiness, muscular hypotonia, accommodation disorders, coma, respiratory depression, and seizures. When the patient is alert, consider vacating the stomach immediately by inducing emesis and then performing lavage. In the unconscious patients, do not induce emesis. Before beginning lavage, secure the airway with an endotracheal tube. Avoid the use of respiratory stimulants and adequately maintain respiratory exchange.