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Uses of baclofen: Baclofen Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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Effectiveness, Ease of Use, and Satisfaction

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Most voted positive review

94 People found this comment helpful

I was prescribed this drug by a Brain & Spine specialists, following an auto accident which further aggravated my spine & neck plus created additional, new damage including ligament damage, herniated discs, and pinched cervical & spinal nerves. The overall body pain (joint, nerve, muscular) was so strong & constant for 4 months I could not sleep. The Spine guy prescribed this as a muscle relaxer…

Most voted negative review

13 People found this comment helpful

When I read the side affects, I was like, why would anybody take a drug that has these side affects? Massage, exersize and a chiropractor helped me. Still working on feet. Alternative medication for me!

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Condition: Other EffectivenessEase of UseSatisfaction

I was prescribed Baclofen from my local emergency department because my lower back is hurting. I cant bend over, cant pick up my 10 month old son, cant laugh, cant cough and cant sneeze without it hurting my lower back. The doctor did NO scans of any kind, just prescribed me the Baclofen and sent me on my way. The doctor didnt tell me anything about the medication, the pharmacist didnt tell me anything other than it could cause drowsiness. The medication has made it so i can bend over a little bit, but i still get sharp pains if i try to lift up my son, stand up to quickly, straighten my back to quick, laugh, cough or sneeze. Ive experience false sense of euphoria, a bit of confusion, slight dizziness, ive cried over everything imaginable and ive been getting extremely nauseous about 4 hours after taking the medication. I take 20mg every 8 hours as needed. which its been needed because im still in pain. I dont know if i should go back and request a new medication because they didnt care enough the first time i was there, why would they care now? I dont recommend this medication. Do your research and look into any other medication that would fit your needs.Read More Read Less

ShapeCreated with Sketch. 2 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Other EffectivenessEase of UseSatisfaction

This was very helpful for me . Within 30mins or so the spasms and muscle pain weaken.

ShapeCreated with Sketch. 2 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

My G.P changed me from diazepam to baclofen,it does not work for my back pain leg pain and muscle spasms increased

1 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

I have been taking Baclofen for years. I have neck and back pain along with Fibromyalgia. It helps with the muscle spasms and I have not noticed any side effects.

1 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Other EffectivenessEase of UseSatisfaction

I take up it for fibromyalgia. It’s one of several medications, but baclofen is the one that allows me to more easily stand each morning. Prior to my new dr prescribing Baclofen, it took about 30 minutes for me to deal with the tingling, burning sensations in my feet and calves each morning. Now they’re gone.

3 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

I’ve had great success slowing muscle spasms from muscular dystrophy!! Once an appropriate dose was found. ..I’m in better control of my life and activities.

ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Other EffectivenessEase of UseSatisfaction

Horrible drug. Changed from oxycodone. Clumsiness, false sense of euphoria, insomnia, split finger tips, back pain, neck pain, mood change…pretty much every ‘rare’ side effect. I cannot believe how horrible this experience was. Very frightening especially since every side effect mirrors Covid-19. BE CAREFUL!!!

6 ShapeCreated with Sketch. 8 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

I have had an mri scan and had to have two operations for broken bones threw falling. I must admit it did stop the pain in my back but the side effects were too much. I started with half a tablet 3 times a day. Then went up to a full tablet 3 times a day – all the while increasing and decreasing over time. I am now on one tablet at night and shall cut down to half a tablet, before I stop. My doctor knows all this about coming off them.

1 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

I have a C4 incomplete spinal cord injury (walking/wheelchair using quadriplegic) and Iâ??m three years post injury with a lot of spasticity in my lower back, that recently has stopped me from walking due to the extreme stiffness and potential spasms. I started taking baclofen for two days and I noticed my spasticity was getting worse to the point that I couldnâ??t transfer into bed. I stopped taking it and after a couple of days my body went back to normal with the the same spasticity I had before the baclofen. I tried lowering the dose to 5 mg three times a day and my spasticity was out of control, if I reached up to turn off the light from my wheelchair my back with nearly spasmed, when I got into bed I was unable to stretch out without spasming I had to stay in the fetal position for 30 minutes before I could even begin to roll onto my back. I stopped taking it after the third dose and Iâ??m still waiting for it to get out of my system. This is the worst tightness/spasticity that Iâ??ve felt since I was in the hospital and they had me on baclofen in the hospital for about eight months, Iâ??m wondering now if my spasticity was so terrible because of the medication. I must have some sort of allergy? Iâ??ve seen some other reviews saying the same thing, and Iâ??m actually glad to hear because my pharmacist told me that thereâ??s no way it would be the drug thatâ??s doing thisâ?¦ I know it is, I could tell after taking the first 5 mg.Read More Read Less

1 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Abnormal Movements of Face Muscles and Tongue EffectivenessEase of UseSatisfaction

I’m suffering from severe paranoia and the dose has to be constantly increased to work. I take 40mg/day – 10mg x 4 and I tried to stop taking it slowly and had 2 seizures. This drug is dangerous — PLEASE be careful and explore ALL options before you start it.

2 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

Oral Baclofen has no effect on stuck shut EUS as it does not cross the blood-brain barrier so has no effect on the sacral spinal cord. Intrathecal required, but Codman 3000 discontinued and I don’t want to be a defective Cyborg. Need another drug.

ShapeCreated with Sketch. 2 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

I have suffered with neck and back pain for many years. I just thought I had to live with excruciating pain every day. I reached a point where that’s it, I’ve had enough and went to my doctor. She prescribed Baclofen and it is a “miracle drug”. Right away I felt my neck muscles start to relax. I have had the best nights sleep in years.

3 ShapeCreated with Sketch. 2 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

Had 2 degenerative discs in my neck at 34 yrs old. Had emergency surgery the day after receiving an MRI due to the fact I couldnt walk and dropped things constantly as well as drop foot and numbness on the right side of my body. Fells like it’s working fine for me but hey I’m not out for the high like some people

3 ShapeCreated with Sketch. 2 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Facial Nerve Pain EffectivenessEase of UseSatisfaction

It’s not nearly as effective and the side effects are awful. I skipped a dose for a dental procedure felt so awful I couldn’t even make my appointment. So many other meds with far less side effects!

2 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

Baclofen caused me to have a terrible pain in both of my ankles. It felt like my ankles were tightening up so tight it would wake me up at night.

1 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

I take this 2x day with other meds, so I haven’t experienced being sick. I eat something like cerial or a banana along with Zantac 150. Since it is bed time anyway and being tired is a plus. The AM doseage is another thing. I just Bogart through it. After a few days I really don’t notice it anymore as I just adjusted. But the plus far outweighs any minuses. For the first time in years I can get up and move without being so stoved up after taking flexural. So if it works for you I suggest giving it a few days. Read More Read Less

3 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction

I’m glad I didn’t read the bad reviews on this drug before hand, but it’s good to know that this drug affects everyone differently. I have Chiari and Syringomyelia, and am 2.5 years post-op. My condition is not curable, and my symptoms are life changing. I have not been on narcotic pain medication as I want to address my severe spasticity first. Baclofen was ordered after 1 year of Robaxin (quit working) and 1 year of Tizanidine. I will admit that it is a strange titration period, but I have not experienced anything that would make me give up trying this medication. I did have really bad esophageal spasms but they went away after a few pretty uncomfortable days. I have really only experienced frequent urination. As far as drowsiness and brain fog, those are symptoms of my condition already. Adding Baclofen did not increase these drastically, but I am sleeping better. I wake up coughing in my sleep, which has been going on since surgery, and I still have numbness on my left side and in my extremities. I have not noticed much of a difference. However, the severe pain around my T4 vertebrae has been somewhat relieved (stably progressing syringomyelia syrinx). Am going to give this medication 6 months to see how comfortable I am/am not before waving the white flag and going to pain management.Read More Read Less

4 ShapeCreated with Sketch. 1 thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Muscle Spasms caused by a Spinal Disease EffectivenessEase of UseSatisfaction 2 ShapeCreated with Sketch.thumb_up copy 5Created with Sketch.Report this postFill 3Created with Sketch. Condition: Other EffectivenessEase of UseSatisfaction

I take Baclofen for muscle spasms in my neck and lower back along with degenerative disc disease. I also take this to help with GERD along with my PPI it has been the only thing that has helped me with epigastric pain! This has been a great help! and

31 ShapeCreated with Sketch. 4 thumb_up copy 5Created with Sketch. Report this postFill 3Created with Sketch. Condition: Facial Nerve Pain EffectivenessEase of UseSatisfaction

It worked for the first 6 months but I am now having break through pain. 🙁 I am taking 90mg per day

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Baclofen (Oral Route) Description and Brand Names

Description and Brand Names

Drug information provided by: IBM Micromedex

Canadian Brand Name

  1. Lioresal
  2. Lioresal Double Strength

Descriptions

Baclofen is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems, such as 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.

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.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

  • Tablet
  • Solution
  • Powder for Suspension

 

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Portions of this document last updated: Sept. 01, 2021

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Baclofen: Uses, Interactions, Mechanism of Action

Indication

Baclofen is administered for the relief of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and associated pain and clonus, in addition to muscular rigidity Label.

Patients receiving this drug should have reversible spasticity for baclofen to promote the restoration of residual function. This drug is not indicated in the treatment of skeletal muscle spasm caused by rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been determined and, therefore, baclofen is not recommended for these conditions Label.

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Associated Conditions
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Pharmacodynamics

In neurological diseases associated with spasm of the skeletal muscles, the clinical effects of baclofen occur due to baclofen action on reflex muscle contractions and of significant relief from painful spasm, automatism, as well as clonus. Baclofen, when used as indicated, improves mobility, increasing levels of independence, and facilitates both passive and active physiotherapy. Baclofen also stimulates gastric acid secretion 16.

GABA-B receptor activation by baclofen may produce protective neurological effects. Baclofen also possesses anti-inflammatory properties that may be of interest in the study of addiction treatment 12. Preclinical studies have shown that GABA-B receptors have roles in memory storage and retrieval, reward, motivation, mood, as well as anxiety. Neuroimaging studies in humans indicate that baclofen produces region-specific alterations in brain activity.

Mechanism of action

The exact mechanism of action of baclofen is not fully understood at this time Label, 17. Many studies indicate that baclofen is a GABA-B receptor agonist 2, 8, 9, 10, 11. Despite this, there is no conclusive evidence that the effects of baclofen on GABA systems are involved in the production of its clinical effects Label.

Baclofen is an effective and widely used antispastic agent with a spinal site of action. Its mechanism of action and pharmacological properties are different from the effects of other antispastic agents. In addition, baclofen has central sites of action, shown by its adverse event profile and general CNS depressant properties 16. GABA-B receptors interact with signal transduction pathways and neurotransmitter systems. Baclofen exerts an antinociceptive effect. The clinical significance of this warrants further research data for clarification.

Baclofen depresses monosynaptic and polysynaptic reflex transmission, by various actions, and possibly including the stimulation of GABAβ-receptors. This stimulation results in the inhibition of excitatory neurotransmitter (glutamate and aspartate) release, which may normally contribute to pain and spasticity16. Although baclofen is an analog of the inhibitory neurotransmitter gamma-amino-butyric acid (GABA), there are no conclusive data indicating GABA systems are involved in its clinical effects Label.

Absorption

Rapidly and almost completely absorbed from the gastrointestinal tract. Absorption may be dose-dependent, being reduced with increased doses Label.

Baclofen, when introduced directly into the intrathecal space, allows for effective CSF concentrations to be achieved with resulting plasma concentrations 100 times less than concentrations occurring with oral administration 17, Label.

Volume of distribution

Apparent volume of distribution: 59 liters Label.

Baclofen does not readily cross the blood-brain barrier Label.

Protein binding

30% Label

Metabolism

Approximately 15% of the dose is metabolized in the liver, mainly by deamination Label.

In a clinical study with radiolabeled baclofen, approximately 85% of the dose was excreted unchanged in the urine and feces. The γ-hydroxy metabolite, 3-(p-chlorophenyl)-4-hydroxybutyric acid, is formed by the deamination of baclofen Label.

Because baclofen is partially metabolized in the liver, patients with impaired liver function should be regularly monitored with liver function tests 16.

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Route of elimination

Baclofen is rapidly and extensively eliminated from the body. There is significant intersubject variation in elimination rates. Baclofen is excreted mainly by the kidney as unchanged drug. Seventy to eighty (70 – 80%) of a dose is measured in the urine as unchanged drug. The remainder of the dose is excreted as unchanged drug in the feces or as metabolites in the urine and feces. Excretion is complete within 72 hours after administration Label.

Half-life

Elimination half-life: Approximately 5.5 hours Label.

Clearance

Total systemic clearance: 180 mL/min LabelRenal clearance: 103 mL/min Label

Baclofen is primarily excreted unchanged by the kidneys. It should be administered cautiously, and it may be necessary to reduce the dosage in patients with reduced renal function Label.

Adverse Effects

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Toxicity

LD50 after oral administration in rats: 145 mg/kg MSDS

Overdosage: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures may occur with overdosage Label.

Pregnancy: This drug is a pregnancy category C drug. There are no adequate and well-controlled studies that have been performed with pregnant women. Baclofen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Label.

Excretion in breastmilk: It is unknown whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution is warranted when baclofen is administered to a nursing woman Label.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

pms-Baclofen – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Baclofen belongs to two groups of medications known as muscle relaxants and antispastics. It is used to treat spasticity (uncontrolled muscle movements) caused by multiple sclerosis, spinal cord injuries, or spinal cord diseases. It is believed to work mainly by relaxing the muscles.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

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What form(s) does this medication come in?

10 mg
Each white, oval tablet, debossed “pms” over the score line and “10” under the score line on one side of the tablet, and “BACLOFEN” on the other side, contains 10 mg of baclofen.  Nonmedicinal ingredients: calcium phosphate, colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

20 mg
Each white, capsule-shaped tablet, debossed “pms” over the score line and “20” under a score line on one side of the tablet, and “BACLOFEN” on the other side, contains 20 mg of baclofen. Nonmedicinal ingredients: calcium phosphate, colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate

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How should I use this medication?

The recommended adult dose of baclofen varies according to need. It is usually started at doses of 5 mg taken 3 times a day for 3 days, followed by 10 mg taken 3 times a day for 3 days, increasing each dose by 5 mg every 3 days until the best dose is reached.  The maximum recommended dose of baclofen is 20 mg 4 times daily.

This medication can be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

This medication should not be stopped suddenly. If you believe it is necessary to stop taking this medication, contact your doctor to discuss the best way for you to stop the medication without causing problems.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to baclofen or any ingredients of the medication

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal or stomach pain or discomfort
  • constipation
  • decreased sexual ability
  • diarrhea
  • difficulty sleeping
  • dizziness
  • drowsiness
  • dry mouth
  • fatigue
  • frequent urination
  • headache
  • increased perspiration
  • low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, nausea)
  • nausea
  • tiredness
  • trouble sleeping
  • vomiting
  • weakness

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • breathing problems
  • confusion
  • difficulty speaking
  • false sense of well-being
  • hallucinations (seeing or hearing things that aren’t there)
  • loss of coordination
  • muscle pain
  • nightmares or vivid dreams
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of heart problems (e.g., tiredness, swelling in the legs, shortness of breath)
  • signs of urinary tract problems (e.g., decreased urine production, difficulty urinating, bloody or dark urine)
  • skin rash or hives
  • slow heartbeat
  • symptoms of high blood sugar (e. g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • tingling or numbness of the hands or feet
  • trembling
  • uncontrolled eye movements
  • vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Drowsiness/reduced alertness: Baclofen may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. This occurs because baclofen is primarily removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medical conditions: Certain medical conditions may make it more likely for you to experience serious side effects. People with certain types of bladder problems, stomach ulcers, breathing problems, and seniors with cerebrovascular problems (disorder of the blood vessels supplying the brain) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mental health: Baclofen may cause symptoms of psychosis or schizophrenia to get worse for people who have mental health problems. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Seizures: Baclofen may cause a loss of seizure control, causing seizures to occur more often. If you have a history of epilepsy or medical conditions that increase your risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Withdrawal effects: If baclofen is suddenly stopped after regular use, withdrawal symptoms may occur, including:

  • anxiety with racing heart and sweating
  • confusion
  • hallucinations (seeing and hearing things that aren’t there)
  • insomnia (difficulty sleeping)
  • involuntary movements
  • psychotic, manic, or paranoid states
  • seizures
  • worsening of spasticity (loss of control of muscles)

Except when serious side effects occur, the dose should be reduced slowly when stopping the medication (over a period of approximately 1 to 2 weeks).

Pregnancy: The safe use of baclofen during pregnancy has not been established. Baclofen crosses the placental barrier and may affect the developing baby. Babies born to women who have taken baclofen during pregnancy may experience withdrawal symptoms after birth. If you are or may become pregnant, speak to your doctor. This medication should be taken during pregnancy only when the potential benefits outweigh the possible risks.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking baclofen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safe use of baclofen by children under the age of 12 years has not been established and is not recommended.

Seniors: People over the age of 65 are more likely to experience side effects of taking baclofen. Doses for seniors should generally be lower and increased more slowly than for other adults.

What other drugs could interact with this medication?

There may be an interaction between baclofen and any of the following:

  • alcohol
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • antidiabetes medications (e.g., glyburide, insulin)
  • azelastine
  • barbiturates (e.g., butalbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • brimonidine
  • buspirone
  • chloral hydrate
  • dimenhydrinate
  • efavirenz
  • entacapone
  • general anesthetics (medications used to put people to sleep for surgery)
  • guanfacine
  • magnesium sulfate
  • medications used to treat high blood pressure
  • mirtazapine
  • monoamine oxidase inhibitors (MAOIs; e. g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • other muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
  • nabilone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • pramipexole
  • ropinirole
  • rotigotine
  • scopolamine
  • seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • tapentadol
  • thalidomide
  • tramadol
  • tricyclic antidepressants (e.g., amitriptyline, imipramine)
  • zolpidem
  • zopiclone

If you are taking any medications containing this drug, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription) and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or illegal drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/pms-Baclofen

Intrathecal Baclofen Pump For Muscle Spasticity Treatment

Overview

What is spasticity?

Spasticity is a movement disorder that can occur in conditions which affect the brain or the spinal cord, such as multiple sclerosis, stroke, cerebral palsy, spinal cord injury, or brain injury. Spasticity is caused by an imbalance between signals that inhibit or stimulate the spinal cord. This results in hyperexcitable stretch reflexes, increased muscle tone, and involuntary movements.

What are the symptoms of spasticity?

Spasticity causes muscle stiffness and tightness, which interferes with voluntary movements. Spasticity can also cause muscle spasms (jerky involuntary movements) or clonus (repetitive involuntary movement). Stiffness and spasms are often bothersome and sometimes painful, and they interfere with the ability to carry out daily activities. Spasms may also disrupt sleep and increase daytime fatigue. When spasticity is severe, contractures (fixed limitations of range of motion) may develop.

How can spasticity be treated?

Stretching, exercise, and rehabilitation are the first line of interventions for spasticity. Oral medications are often effective, but may cause side effects such as drowsiness. When spasticity affects only a few muscles, local injections of botulinum toxin can be helpful. When spasticity is diffuse and severe, intrathecal baclofen (Lioresal®) (ITB) may be a good treatment option.

What is baclofen?

Baclofen is one of the medications most commonly used to treat spasticity. Baclofen acts in the spinal cord, and improves hyperactive reflexes and excessive muscle tone. Some of the side effects of baclofen are:

Stopping baclofen suddenly may cause withdrawal symptoms that include seizures. You should avoid suddenly stopping this medication.

How do I know that I am a good candidate for ITB?

If you have severe spasticity, and oral medications are not helpful, your treating physician may refer you for a consultation to evaluate if ITB could be a good option for you. Detailed clinical assessments are performed, usually by a physician and physical/occupational therapists. These professionals provide information about ITB for discussion.

A test injection is then performed to further evaluate the appropriateness of ITB. The test consists of a spinal tap, with a small dose of baclofen injected into the spinal fluid. A few hours later, the effects of the medication are evaluated. These effects are temporary, but provide very useful information that help with the decision process.

What happens if the test is successful?

If the test is successful, you will be referred to a neurosurgeon who will implant the baclofen pump system. After the surgery, you will stay in the hospital for a short time. In some cases, inpatient rehabilitation is needed to adjust the pump and perform functional training before returning home. In all cases, outpatient or home rehabilitation is needed to optimize the benefits of ITB.

Procedure Details

What is intrathecal baclofen therapy?

Baclofen is usually taken by mouth several times per day. Intrathecal baclofen therapy (ITB) consists of delivering a liquid form of baclofen into the spinal fluid, using a device called a baclofen pump. ITB is approved by the FDA for the treatment of severe spasticity. ITB has been used at the Mellen Center since 1990.

What is a baclofen pump?

The baclofen pump system consists of a pump and a catheter that brings the medication from the pump into the spinal fluid. The pump is a round metallic disc (about 1 inch thick and 3 inches in diameter), which is surgically implanted under the skin of the abdomen.

The pump contains a battery, which usually lasts between 5 and 7 years, a reservoir for the medication, and a microprocessor. The pump can be programmed with a small computer which communicates with the pump via a wand placed over the skin. The catheter is a thin flexible tube implanted under the skin. One end of the catheter is connected to the pump, and the other end is inserted into the spine at various levels.

What is involved in the management of a baclofen pump?

The pump needs to be refilled at regular intervals (usually every 1 to 6 months) by a trained healthcare professional who possesses the equipment needed. The pump is refilled by inserting a needle through the skin into a refill port on the pump. In some cases the refills can be done at home, but follow-up visits are needed one to two times per year to ensure that the therapy is working appropriately. The dose of baclofen can be adjusted at any time, but the adjustment must be done by a trained professional. When the battery approaches the end of its life, the pump needs to be replaced (but not the catheter). When a problem with the baclofen pump is suspected, medical attention should be sought as soon as possible.

Risks / Benefits

What are the advantages of ITB compared to taking baclofen by mouth?

  • ITB is usually much more effective in controlling the symptoms of spasticity, because the medication is brought directly in contact with the spinal cord.
  • With ITB, the medication is delivered continuously, day and night, giving a more steady relief of symptoms.
  • ITB, in most cases, causes less side effects than oral baclofen, particularly when high doses are needed to treat severe spasticity.
  • ITB programming is very flexible, allows more precise dosing of baclofen, and gives the ability to deliver different doses at different times of the day.
  • Compared to other surgical treatments, ITB is reversible, as the pump can be stopped and removed if needed.

What are the potential risks and adverse effects of ITB?

The baclofen pump system needs to be surgically implanted under anesthesia, leading to the usual risks of surgery.

Complications more specific to ITB include the risk of infection around the device, and the risk of device malfunction. Baclofen withdrawal (from abrupt interruption of the delivery of baclofen via the pump) and baclofen overdose (usually as a result of human error) have also occurred with ITB. Serious complications from ITB are infrequent, and in most cases reversible as long as they are diagnosed and treated in a timely fashion. Even without complications, ITB can cause increased weakness, because it is very potent.

Additional Details

Does insurance cover ITB therapy?

Because ITB is approved by the FDA, it is often covered by healthcare insurance, including Medicare and Medicaid. However, since coverage varies greatly between individual insurance plans, we encourage you to check with your insurance ahead of time.

In summary:

  • ITB can be very effective on severe spasticity and can markedly improve quality of life.
  • Because ITB is a surgical treatment with known risks, thorough testing and education are needed before starting this therapy.
  • Compliance with follow-up visits, and with rehabilitation and home exercise, are essential to maximize the chances of success and to minimize the risk of adverse effects or complications.

6 Baclofen (Lioresal) Uses + Side Effects, Risks & Dosage

Baclofen is a drug used to treat muscle spasms and is similar to the neurotransmitter GABA. It is currently being researched for its potential in treating addiction and withdrawal. But baclofen also has a potential for abuse and doesn’t come without side effects. Read on to learn about the uses, risks, and dosage of baclofen.

What is Baclofen?

Baclofen (brand name Lioresal) is a prescription medication used to treat muscle spasms or stiffness, especially in people with multiple sclerosis or spinal cord injuries [1].

Baclofen was first synthesized in the 1960s in the search for an anti-seizure drug. It was not effective for treating seizures, but researchers soon found that baclofen could be used to treat muscle spasticity, a condition that causes muscle spasms and stiffness [1].

Baclofen is used off-label for a number of other conditions, including helping manage alcohol dependence and acid reflux [1].

There are 3 ways baclofen can be administered [1]:

  • As a cream, where it is absorbed through the skin
  • As oral tablets
  • As injections directly into the spinal fluid (intrathecally), using an implanted pump

Is Baclofen a Narcotic?

Narcotics typically refer to opioid drugs, which baclofen is not. Baclofen does, however, fall under the broader category of ‘Central Nervous System Depressants’, drugs that can cause sedation and have a potential for abuse [2, 3].

Mechanism of Action

Baclofen has a structure and function similar to the neurotransmitter GABA. Normally, GABA acts to reduce activity in the brain, which is why it’s sometimes known as a “calming” substance [4, 5].

Baclofen specifically activates GABA-B receptors, which may play a role in many psychiatric and brain disorders as well as pain [4, 5].

All GABA activity in the brain and nerves is “inhibitory”, meaning it blocks the release of other neurotransmitters brain cells use to communicate. By acting on GABA receptors, baclofen blocks the overactivation of nerves that may trigger muscle spasms, pain, brain damage, and mood changes [6, 7].

Much more is known about the effects of baclofen on pain and muscle spasms than on mood and addictive behavior [4].

What is Baclofen Used for?

FDA-Approved Uses

1) Muscle Spasticity

Muscle spasticity occurs when the muscles continuously contract, causing spasms, tightness, and stiffness, which can interfere with everyday life. This condition is usually caused by damage to the nervous system [8].

Baclofen is a muscle relaxant that is FDA-approved to treat muscle spasticity that is associated with multiple sclerosis or spinal cord injury [1].

A systematic review of 25 clinical trials suggests that oral baclofen is effective for reducing muscle spasms and stiffness in cases of mild, moderate, and severe muscle spasticity regardless of the underlying cause [9].

Researchers also found that baclofen was at least as effective as other muscle relaxants, such as tizanidine and diazepam [9].

However, according to the same review, side effects were commonly reported with oral baclofen and affected between 25% to 70% of patients [9].

Multiple Sclerosis

Baclofen is considered to be one of the first-line treatment options for muscle spasms associated with multiple sclerosis (MS) [10].

A 5-week randomized placebo-controlled trial of 106 patients with MS found that baclofen reduces spams, pain, and stiffness while improving movement [11].

In two long-term clinical trials lasting 5 to 6 years including a total of 28 MS patients, baclofen injections reduced spasms and pain [12, 13].

Spinal Cord Injury

Baclofen is also approved to treat muscle spasticity due to spinal cord injuries [1].

A long-term randomized placebo-controlled trial of 93 patients with muscle spasticity due to spinal cord injury found that intrathecal injections of baclofen reduce rigidity, muscle spasms, and pain [14].

Off-Label Uses

Baclofen is sometimes used for several off-label conditions, which we’ll discuss in the following sections. If you are prescribed baclofen, always take the medication as directed by your doctor.

2) Alcoholism

Baclofen is sometimes used to help manage alcohol dependence, otherwise known as alcohol use disorder. There is some evidence that baclofen can help reduce cravings for alcohol and overall alcohol consumption [15].

For example, a study of 67 patients found that oral baclofen may reduce alcohol cravings [16].

In another 2-year observational study of 100 patients, 92% of participants reported suppressed alcohol cravings after taking oral baclofen [17].

A meta-analysis of 12 clinical trials found that baclofen is associated with higher rates of abstinence than placebo. However, the researchers also determined that baclofen did not decrease heavy drinking, craving, anxiety, or depression [18].

Another systematic review of 12 clinical trials including 1,128 participants concluded that there was not enough strong clinical research to determine if baclofen is more effective than placebo for alcohol use disorder [15].

3) Alcohol Withdrawal

Besides alcohol dependence, baclofen is also sometimes used to help treat alcohol withdrawal symptoms. Some small studies suggest that oral baclofen may reduce the physical symptoms of withdrawal, such as sweating, tremors, anxiety, and agitation [19, 20, 21].

For example, a randomized trial of 37 patients found that baclofen may be as effective as diazepam for treating alcohol withdrawal syndrome [19].

However, a systematic review of 3 clinical trials including 141 patients concluded that the clinical evidence that supports the use of baclofen for alcohol withdrawal is of very low quality. According to the researchers, there is not enough information to determine the effectiveness and safety of baclofen for this use [22].

4) Acid Reflux

There is evidence that baclofen may help reduce the symptoms of acid reflux, also known as gastroesophageal reflux disease (GERD). According to research, baclofen may help prevent the lower esophagus from relaxing, which is one of the causes of acid reflux [23].

A meta-analysis of 9 clinical trials including 283 patients with acid reflux may help reduce the number and average length of reflux episodes [23].

5) Cerebral Palsy

Baclofen is sometimes used in children and adolescents to help treat muscle spasticity associated with cerebral palsy [24].

According to a systematic review of 6 clinical studies, spinal (intrathecal) injections of baclofen can reduce short-term muscle spasticity in children with cerebral palsy. However, there was not enough evidence to determine its long-term effectiveness [24].

Oral baclofen does not appear to be effective for this condition. A review of 6 clinical trials with a total of 130 patients concluded there was not enough evidence to support the use of oral baclofen for muscle spasticity associated with cerebral palsy in children or adolescents [25].

6) Hiccups

A hiccup is caused by an involuntary muscle contraction of the diaphragm. While almost everyone experiences hiccups, a small number of people experience persistent hiccups that continue for days or months [26].

As a muscle relaxant, baclofen is sometimes used to help treat severe cases of persistent hiccups.

A systematic review of 15 studies including 341 patients found that baclofen may help treat persistent hiccups, although the quality of evidence is low [26].

Baclofen Safety

Side Effects

Below are some reported side effects of baclofen. If any side effects persist or worsen, let your doctor know. This is also not a complete list of possible side effects. Tell your doctor if you experience any serious side effects or notice any effects not listed here.

Side effects can vary depending on the dose and how baclofen is administered (as an oral tablet, through an injection, or as a topical cream) [1].

Some common side effects include [1]:

  • Confusion
  • Muscle weakness
  • Sedation
  • Dizziness (vertigo)
  • Nausea

Some rare but serious side effects include [1]:

  • Swelling (edema)
  • Seizures
  • Depression
  • Agitation
  • Tremors
  • Pneumonia
  • Difficulty breathing

Fatigue and sleepiness often occur at the start of oral baclofen treatment, especially if the dosage is increased too quickly, if the initial dose is large, or in older people. These side effects typically go away with time and can be reduced by decreasing the dosage.

Withdrawal Risk

Baclofen can cause withdrawal symptoms if suddenly discontinued after long-term use. If you want to stop taking baclofen, let your doctor know first.

Some withdrawal symptoms include [27, 28]:

  • High fever
  • Altered mental status
  • Hallucinations
  • Seizures
  • Muscle rigidity
  • Delirium

There are several case reports where abrupt discontinuation of intrathecal baclofen has led to death [29].

In the majority of cases, baclofen withdrawal symptoms are due to malfunctions or errors associated with intrathecal pumps. As mentioned earlier, baclofen can be administered through implanted automatic pumps. This is why it is important for patients and caregivers to monitor the pump to make sure it is always working correctly [1].

Contraindications

Baclofen should not be taken by those that are allergic or hypersensitive to baclofen or any of its components [1].

Pregnancy and Breastfeeding

The safety of baclofen in pregnancy has not been established. Pregnant women should discuss potential baclofen risks with their doctor to determine if baclofen is still needed.

There is evidence that baclofen use during pregnancy may cause preterm delivery, low birth weight, birth defects and withdrawal in newborn babies [30].

In one case report, the newborn baby of a woman taking 90 mg oral baclofen during pregnancy had seizures shortly after birth. In another case, a newborn baby experienced feeding difficulties. These may be symptoms of baclofen withdrawal and require special medical treatment with baclofen itself or other drugs [31, 32].

Baclofen Abuse

Baclofen has a potential for abuse. And although rare, some people become addicted to baclofen, especially with high doses.

In one case report, baclofen initially helped a 36-year-old man with depression and alcohol abstinence. However, he developed baclofen abuse due to its mood-enhancing effects and started to take higher and higher doses of the drug [33].

In one other case, a 29-year-old man on a smoking cessation program was prescribed 20 mg/day of baclofen. But he took 30 times the prescribed dose, which added up to 600 mg/day. He described a sense of wellbeing and pleasure from baclofen and a craving for it. As his baclofen dose was reduced, he experienced insomnia, irritability, anger outbursts, and tremors [34].

Drug Interactions

The following drugs have been reported to interact with baclofen. However, this is not a complete list, let your doctor know of all the medications and supplements you are currently taking to avoid any unexpected interactions.

Baclofen can interact with the following drugs [30]:

  • Other muscle relaxants
  • Parkinson’s Disease drugs
  • Anti-seizure drugs
  • Antidepressants and lithium
  • Drugs for high blood pressure
  • Other drugs that affect kidney function, such as ibuprofen
  • Opioid drugs for pain relief
  • Drugs for insomnia or anxiety
  • Antihistamines and sedatives

It’s not recommended to consume alcohol while on baclofen, since this can cause additional sleepiness, dizziness, and may even lead to coma.

Baclofen Dosage

The dosing of baclofen can vary. Always take this medication as directed by a doctor.

Oral Baclofen

Oral baclofen is available as tablets with strengths of 5 mg, 10 mg, and 20 mg.

Patients are usually started at a low dosage, which is gradually increased until the desired effect is achieved. The lowest possible dosage needed to achieve the effect should be maintained.

Typical dosages range from 40 – 80 mg/day, while the maximum dosage should not exceed 80 mg/day.

When stopping baclofen, the dose should be gradually decreased over 1 – 2 weeks to avoid withdrawal symptoms.

Intrathecal Baclofen (Spinal Cord Injections)

Baclofen injections into the spinal cord (intrathecal) are indicated only in people with severe muscle spasticity from injury or multiple sclerosis who do not respond to oral baclofen [30].

The optimum dosage of intrathecal baclofen will individually vary depending on the disease type, symptoms, severity, side effects, and other factors. Patients are screened to determine if baclofen pumps should be implanted for continuous long-term baclofen infusions [30].

Initially, baclofen is administered in very small doses, which are gradually increased while side effects and clinical response are monitored by the healthcare team. Some people don’t respond to baclofen spinal injections. For those who do respond, daily doses are increased by 5 – 30% until a suitable maintenance dose is found [30].

The dose administration patterns can vary between individuals and include: simple continuous dosing, variable 24-hour flex dosing, or regularly scheduled administration [35].

Use of baclofen for withdrawal in a preterm infant

A 1.8-kg male infant was born at 33 2/7 weeks gestation, to a 33-year-old gravida 4 para 1 female. The maternal history was significant for a traumatic cervical spine fracture, resulting in paraplegia. The mother was referred to maternal–fetal medicine to evaluate the fetus for possible dwarfism. An amniocentesis was performed, revealing a normal 46 XY male karyotype. The mother was maintained on baclofen, 30 mg orally three times daily, for muscle spasms.

The mother presented with premature rupture of membranes. She was given intramuscular betamethasone and managed expectantly. Her labor progressed and she subsequently underwent repeat cesarean section. The infant required no resuscitation in the delivery room and was admitted to the intermediate care nursery due to prematurity. The admission exam was consistent with the estimated gestational age and, notable, only for bruising.

Because of the maternal history of baclofen use, NAS scoring (using the Modified Finnegan Scoring Tool) was begun on the first day of life. Urine and meconium toxicology screens were obtained from the infant and were negative for drugs of abuse. By the third day of life, the infant had NAS scores that ranged from 5 to 11, manifested as a high-pitched cry, tremor, hypertonicity, excessive sucking, disordered sleep, hyperthermia and mottling. Baclofen, concentrated at 5 mg ml−1, was begun at a dose of 0.5 mg kg−1 per day, divided into four doses. The infant demonstrated improvement in the symptoms of withdrawal, and a weaning schedule was devised based upon pharmacokinetics and compounding constraints associated with oral baclofen. NAS scoring was continued every 4 h during the weaning period. On the fourth day of treatment, dosage was halved to 0.25 mg kg−1 per day. Because of compounding constraints, a dosage of less than 0.12 mg (0.067 mg kg−1) could not be delivered, necessitating a reduction in the number of daily doses. On the seventh day of treatment, the dosage was halved again to 0.125 mg kg−1 per day, divided into two doses that were administered every 12 h. The infant demonstrated transient elevations in NAS scores on the ninth day of therapy, manifested by high pitched cry, hypertonicity, excessive sucking, disordered sleep, hyperthermia and loose stools. Weaning of baclofen was delayed until the 11th day, when the daily dosage was halved to 0.067 mg kg−1 per day as a single dose. The final dose of baclofen was given on the 13th day of treatment. The infant was discharged home to the parents on the 18th day of life after demonstrating NAS scores consistently less than 8 (range 4 to 7) for 48 h off of the oral baclofen. The infant’s neurological examination at the time of discharge was normal.

90,000 Spasticity Clinical Study: Baclofen – Clinical Trials Registry

Inclusion Criteria:

1. Men and women aged 2 to 16 years inclusive.

2. Triceps skinfold thickness between 5th and 95th percentiles for age (see Appendix 3).

3. General Motor Function Classification Scale (GMFCS) Level II – V (GMFCS classifies children according to functional mobility with level I minimal motor disability and V indicates whole body involvement and mobility dependence on others (Palisano et al.others, 1997).

4. Ashworth score of 2 or higher in at least one arm and one leg (knee + elbow flexors and / or extensors).

5. cerebral palsy: impaired motility due to static, non-progressive traumatic brain injury. a developmental defect that has arisen in utero or at any time before the age of 2 years.

6. No history of baclofen use within the last 4 months.

7. woman who has premature menstruation or is incapable of pregnancy due to hysterectomy or tubal ligation; or a female subject who is sexually active and capable of pregnancy has used an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier) for at least one month prior to the study and agrees to continue using one of them throughout the training period.the study; or a female subject who is abstaining from sex and able to become pregnant agrees to continue abstinence or to use an acceptable method of birth control (either an intrauterine device or spermicide and barrier) in the event of sexual intercourse.

8. Subject over 10 years of age has negative urine tests at screening and baseline for alcohol, non-medical prescription drugs, and no history of tobacco use.

Exclusion criterion:

1.Hypersensitivity to baclofen.

2. Selective dorsal rhizotomy.

3. Active intrathecal baclofen pump within the last 6 months.

4. Botulinum toxin use within the last 4 months or at any time during the study.

5. using tonicity medications (eg, baclofen, benzodiazepines, levodopa, trihexyphenidil) for> 3 consecutive days within the last 4 months.

6. Start taking any drug or product known to be a significant inducer of the cytochrome P450 enzyme.or an inhibitor within the past 30 days.

7. Orthopedic surgery during the last year or at any time during the study.

8. Abdominal surgery within the last six months or at any time during the study.

9. uncontrolled seizures (baseline frequency of seizures> 1 per month or history of more than 2 prolonged seizures lasting more than 5 minutes in the last year.

10. Serious behavioral or mental disorders.

11. Proven abnormal gastric motility: known history of abnormal gastric emptying and / or history of vomiting 3 or more times per week.

12. Severe gastroesophageal reflux disease: known history of esophagitis (documented by abnormal endoscopy or biopsy).

13. Malnutrition: Defined as the thickness of the skinfold of the triceps less than the 5th percentile or more than the 95th percentile for age.

14. Kidney or liver disease: Elevated bilirubin, LFT more than double the upper limit of normal, decreased AMK / Cr ratio (<5), or abnormal creatinine clearance that is clinically significant as determined by the investigator.

15. Abnormal CBC: anemia, polycythemia, neutropenia, leukocytosis, thrombocytopenia, or clinically significant thrombocytosis as determined by the investigator.

16. Pregnancy or lactation.

17. Severe respiratory or heart disease: need for continued supplemental oxygen. (> 7 days), history of clinically significant congenital heart disease, congestive heart failure or cardiomegaly, and / or hospitalization within the past 6 months for cardiac symptoms or respiratory distress.

18. Previous Baclofen Failure: No Response to Baclofen or Unacceptable Side Effects: If previous baclofen therapy was used more than 4 months prior to the study and discontinued, the decision to enroll the subject will be at the discretion of the Investigator’s website and the reason for discontinuation of baclofen will be recorded.

19. use of drugs that interfere with the measurement of serum creatinine levels. the last 14 days (for example, trimethoprim-sulfamide, fibric acid derivatives, except for gemfibrizol, keto acid, salicylates, some cephalosporins, cimetidine, phenacemide).

20. Subject tested positive for hepatitis B or hepatitis C surface antigen antibodies or tested positive for one of these tests.

21. Subject is known to have seropositive for Human Immunodeficiency Virus. (HIV) or the subject is concurrently receiving antiretroviral therapy.

22. any serious unstable physical illness or clinically significant laboratory abnormalities. assessment that could adversely affect scientific interpretability or unduly increase the risks of the protocol.

23. The subject is suffering from a disorder or has a history of a non-CP related condition that may interfere with drug absorption, distribution, metabolism, or excretion.

24. Any condition in which the patient,

ASSA

Currently not an employee of the Institute

Publications

2011 Depressive-like psychoemotional state versus acute stresses enhances Lewis lung carcinoma metastasis in C57Bl / 6J mice.
Amikishieva A.V., Ilnitskaya S.I., Nikolin V.P., Popova N.A., Kaledin V.I.
[Experimental oncology]
Effect of vasopressin V1 receptor antagonist, SSR149415, on anxiety-like behavior and Lewis lung carcinoma metastasis in mice.

Amikishieva A. V. Ilnitskaya S.I., Nikolin V. P., Popova N. A.
[Experimental oncology]
Effect of intranasal dopamine administration on anxiety and locomotor activity in two strains of mice.
Kholodar A.V., Amikishieva A.V., Anisimov M.P.
[]
2009 Behavioral phenotyping: modern methods and equipment

Amikishieva A.V.
[VOGIS Newsletter]
2007 Effects of baclofen on anxiety, sexual motivation, and olfactory perception in male mice in different psychoemotional states

Amikishieva A.V. & Semendyaeva S.N.
[Neuroscience Behavioral Physiology]
GABA in the regulation of communication and sexual motivation in male mice with different psychoemotional status

Amikishieva A.B.
[B EXP BIOL MED +]
Testosterone and Behavior: Hormone Involvement in the Psychotropic Effects of Baclofen

Amikishieva A.V.
[B EXP BIOL MED +]
2006 Effect of dehydroepiandrosterone sulfate on sexual motivation in male mice with different psychoemotional statuses

Amikishieva A.V., Ovsyukova M.V.
[]
Features of the psychotropic effects of diazepam in male mice with different psychoemotional status

Amikishieva A.V., Semendyaeva S.N.
[]
Effects of baclofen on anxiety, sexual motivation and olfactory perception in male mice with different psychoemotional status.

Amikishieva A.V., Semendyaeva S.N.
[]

Conferences

2010 Behavioral effects of intranasal dopamine administration

Amikishieva A.V., Cholodar A.V.
[23rd ECNP Congress.]
Bioethical guidelines in Russian higher education: the requirements of the time and realities

Amikishieva A.B.
[1st International Becker Readings.]
2009 Psychoemotional state and cancerous growth metastases: possible roles of vasopressin.

N.A. Popova, V.P. Nikolin, S.I.Ilnitskaya, M.D. Belyaev, A.V. Amikishieva, A.A.Kolobov, V.I. Kaledin
[10th ECNP Regional Meeting]
Vasopressin as stimulator of the cancerous methastases growth

Amikishieva A.V., Ilnitskaya S.I., Popova N.A., Nikolin V.P., Belyaev M.D., Tolstikova S.G., Kaledin V.I.
[22th ECNP Congress.]
Bioethical aspects of the use of animals in the experiment

Amikishieva A.V.
[Scientific and Practical Conference “Laboratory Animals as the Basis of Experimental Medicine”]
Bioethical analysis of animal rights used by humans

Amikishieva A.V.
[II International Symposium “Ecology and Human and Animal Rights”]
2008 Behavioral phenotyping: up-to-date methods and equipments

Amikishieva A.V.
[6th international conference on bioinformatics of genome regulation and structure BGRS’2008.]
Olfactory perception test is necessary in sociobiobehavioral researches

Amikishieva A.V., Semendyaeva S.N.
[21st ECNP Congress]
Bioethics – a new look at human interaction with the world

Amikishieva A.V.
[School-conference on animal and human behavior: psychological, evolutionary and genetic-physiological aspects]
2007 GABA receptors can play diverse roles at the beginning and development of sexual motivation

Amikishieva A.V.
[9th ECNP Regional Meeting]
2006 Different roles of A and B types of GABA receptors in control of sexual motivation in male mice

Amikishieva A.V.
[19th ECNP Congress]

Scientific guidance

2010 Investigation of a number of physiological effects of vasopressin and thyroxin in different genotypes of mice

[Shuvaeva Lyudmila Yurievna]

Training courses

2007 Anatomy and Physiology of the Central Nervous System

Amikishieva A.B.

Higher nervous activity

Amikishieva A.V.

© 2010-2021 ICG SB RAS. All rights reserved.

FSUE “Nizhny Novgorod Prosthetic and Orthopedic Enterprise”

FSUE “Nizhny Novgorod Prosthetic and Orthopedic Enterprise”

from December 22, 2016 renamed

“NIZHEGORODSKY” BRANCH

Federal State Unitary Enterprise “Moscow Prosthetic and Orthopedic Enterprise”

The company provides prosthetic and orthopedic assistance to the population suffering from diseases and disorders of the musculoskeletal system.

“Nizhegorodsky” branch of FSUE “Moscow Prosthetic and Orthopedic Enterprise” – one of the leading state enterprises in Russia for the production of prostheses, prosthetic and orthopedic products and orthopedic footwear.

“Nizhny Novgorod” branch of FSUE “Moscow Prosthetic and Orthopedic Enterprise” is the largest manufacturer of prostheses in the Nizhny Novgorod region: hand, forearm, shoulder, after the shoulder, lower leg, thigh, with congenital underdevelopment of the limbs; orthopedic apparatus; tutor; corsets; bandages, etc.technical means of rehabilitation; complex orthopedic shoes, including those with diabetic foot syndrome. The range of products manufactured by the enterprise is extremely diverse: more than 500 different basic standard models, designs, fixtures. At the enterprise you can purchase and order modern technical means of rehabilitation.

The “Nizhny Novgorod” branch of the FSUE “Moscow Prosthetic and Orthopedic Enterprise” operates Medical Rehabilitation Center .

This is one of the best rehabilitation centers in the region for a comprehensive, individual, intensive recovery after:

  • injuries of the musculoskeletal system and nervous system,
  • surgical interventions (incl.h. about onco-pathology),
  • acute and chronic diseases of the joints and spine.

The Center is headed by Doctor of Medical Sciences, Professor of Nizhny Novgorod State Medical Academy Builova Tatyana Valentinovna –

Traumatologist-orthopedist of the highest category, chief specialist in rehabilitation of the Volga Federal District.

The company includes:

Reorganization of FSUE “Nizhegorodskoe PrOP” Ministry of Labor of Russia

.