Lioresal, Gablofen (baclofen) dosing, indications, interactions, adverse effects, and more.

Baclofen – StatPearls – NCBI Bookshelf

Continuing Education Activity

Baclofen is used to treat muscle spasticity; it is FDA-approved for the management of reversible spasticity, particularly for the relief of flexor spasms, clonus, and concomitant pain, common sequelae of spinal cord lesions, and multiple sclerosis. Baclofen also has several off-label uses. This activity outlines the indications, mechanism of action, safe administration, adverse effects, contraindications, toxicology, and monitoring of the broad array of physiological possibilities when using baclofen in the clinical setting.

Objectives:

• Identify the approved and off-label indications for baclofen.

• Summarize the mechanism of action of baclofen.

• 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 1960 to treat epilepsy. However, the result was not satisfactory. Baclofen was reintroduced in 1971 when it was found to treat muscle spasticity and has seen wide use since. Baclofen is FDA-approved for managing reversible spasticity, particularly for the relief of 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 who fail to respond to oral therapy. [1] Intrathecal baclofen administration is FDA-approved for the management of spasticity of cerebral origins, such as traumatic brain injury or severe spasticity of spinal cord origin that is unresponsive to treatment with maximum doses of oral baclofen, tizanidine, and/or dantrolene.

Baclofen is also 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.[2][3][2][4] Baclofen is also considered as a 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. 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. [3] 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.[5] 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 bioavailability of 70% to 85% and is therefore 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.

Administration

Baclofen is available for oral, transdermal, and intrathecal administration through pump infusion. Oral administration is initially 5 mg three times a day. The dose is increased every 3 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.[6]

Intrathecal administration of baclofen initiates via screening. 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. Daily dose adjustments will be made gradually on the order of 10% to 30% for spasticity of spinal cord origin and 5% to 15% for spasticity of cerebral origin until attaining a positive response. 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 703 mcg daily. Spasticity related to the spinal cord usually requires 300 to 800 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. Up to 10% of patients become resistant to dose titrations and may need a drug holiday. 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.  

Researchers have not established the safety and efficacy of baclofen in pediatric populations younger than 12 years old.

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.

The most common adverse effects are transient sedation, confusion, muscle weakness, vertigo, and nausea.

Less common adverse effects are neuropsychiatric impairment, hypotension, peripheral edema, dyspnea, hypoventilation, pneumonia, seizure, insomnia, pain, speech alteration, depression, agitation, constipation, diarrhea, urinary frequency, incontinence, acute urinary retention, impotence, tremor, weakness, amblyopia, urticaria, and pruritus.

The FDA requires a black box warning for baclofen. Abrupt withdrawal of intrathecal baclofen may occur in patients using the drug over 2 months. It may result in a hypermetabolic state with hyperpyrexia, impaired mental status, muscle rigidity, and severe rebound spasticity, potentially advancing to rhabdomyolysis and multi-organ system failure. The symptoms improve upon recommencing of baclofen by a similar dose as before the interruption. Withdrawal most commonly occurs because of a delivery system problem. The patient and caregiver must understand the importance of monitoring the pump to prevent withdrawal events.

Abrupt discontinuation of oral baclofen therapy might cause seizures and hallucinations. Gradual dose reduction is recommended to prevent withdrawal symptoms.

Contraindications

Baclofen is contraindicated in patients with hypersensitivity to baclofen or any component of its formulation.

Baclofen use requires caution in patients with impaired renal function, and it might be necessary to reduce the dose.[7]

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.[8] Sedation is less of a concern during the administration of low intrathecal doses, topical application, or if the nursing infant is older than 2 months.

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.

Monitoring

Administration of baclofen with any other central nervous system depressants requires close monitoring.

Patients with epilepsy should be monitored with a regular electroencephalogram due to deterioration in seizure control when receiving baclofen.

Toxicity

Overdose primarily arises from drug screening before pump implantation or human error during refilling and programming the pump. 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. [9]

Enhancing Healthcare Team Outcomes

Healthcare workers, including nurse practitioners who prescribe baclofen, should educate the patient on the safe use of this drug. It does work well as a muscle relaxant, but its use to manage low back pain is limited. The drug should not be combined with narcotics, sedatives, or hypnotics. Also, baclofen should not be prescribed for a prolonged duration.

An interprofessional healthcare team is the optimal strategy for baclofen use. The clinician will make the clinical decision to use baclofen, but the pharmacist should verify the appropriateness of the dose, mode of administration, and perform medication reconciliation to rule out drug interactions. Nursing will administer the drug in many cases, particularly intrathecally, and should be aware of the signs of adverse effects or excessive dosing. When the pharmacist or nurse encounters a reason for concern, they must be empowered to immediately communicate it to the treating clinicians. This type of interprofessional team approach will optimize baclofen therapy while minimizing adverse events. [Level 5]

References

1.

Ertzgaard P, Campo C, Calabrese A. Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen. J Rehabil Med. 2017 Mar 06;49(3):193-203. [PubMed: 28233010]

2.

Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D’Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. Lancet. 2007 Dec 08;370(9603):1915-22. [PubMed: 18068515]

3.

Albright AL. Baclofen in the treatment of cerebral palsy. J Child Neurol. 1996 Mar;11(2):77-83. [PubMed: 8881981]

4.

Guelaud C, Similowski T, Bizec JL, Cabane J, Whitelaw WA, Derenne JP. Baclofen therapy for chronic hiccup. Eur Respir J. 1995 Feb;8(2):235-7. [PubMed: 7758557]

5.

Gracies JM, Nance P, Elovic E, McGuire J, Simpson DM. Traditional pharmacological treatments for spasticity. Part II: General and regional treatments. Muscle Nerve Suppl. 1997;6:S92-120. [PubMed: 9826984]

6.

Montané E, Vallano A, Laporte JR. Oral antispastic drugs in nonprogressive neurologic diseases: a systematic review. Neurology. 2004 Oct 26;63(8):1357-63. [PubMed: 15505149]

7.

Vlavonou R, Perreault MM, Barrière O, Shink E, Tremblay PO, Larouche R, Pichette V, Tanguay M. Pharmacokinetic characterization of baclofen in patients with chronic kidney disease: dose adjustment recommendations. J Clin Pharmacol. 2014 May;54(5):584-92. [PubMed: 24414993]

8.

Eriksson G, Swahn CG. Concentrations of baclofen in serum and breast milk from a lactating woman. Scand J Clin Lab Invest. 1981 Apr;41(2):185-7. [PubMed: 7313501]

9.

May CR. Baclofen overdose. Ann Emerg Med. 1983 Mar;12(3):171-3. [PubMed: 6829997]

Baclofen tablets

What is this medicine?

BACLOFEN (BAK loe fen) helps relieve spasms and cramping of muscles. It may be used to treat symptoms of multiple sclerosis or spinal cord injury.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ED Baclofen, Lioresal

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• kidney disease
• seizures
• stroke
• an unusual or allergic reaction to baclofen, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Swallow it with a drink of water. Follow the directions on the prescription label. Do not take more medicine than you are told to take.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medication with any of the following medicines:

• narcotic medicines for cough

This medicine may also interact with the following medications:

• alcohol
• antihistamines for allergy, cough and cold
• certain medicines for anxiety or sleep
• certain medicines for depression like amitriptyline, fluoxetine, sertraline
• certain medicines for seizures like phenobarbital, primidone
• general anesthetics like halothane, isoflurane, methoxyflurane, propofol
• local anesthetics like lidocaine, pramoxine, tetracaine
• medicines that relax muscles for surgery
• narcotic medicines for pain
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.

Do not suddenly stop taking your medicine. If you do, you may develop a severe reaction. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects. Follow the advice of your doctor.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

If you are taking another medicine that also causes drowsiness, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in emotions or moods
• changes in vision
• chest pain
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• hallucinations
• loss of balance or coordination
• ringing of the ears
• seizures
• trouble passing urine or change in the amount of urine
• trouble walking
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in taste
• confusion
• constipation
• diarrhea
• dry mouth
• headache
• muscle weakness
• nausea, vomiting
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Baclofen – Injection | HealthLink BC

Pronunciation: BAK-loe-fen

Common Brand Name(s): Lioresal

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Warning

Do not stop using this medication without consulting your doctor. Serious (rarely fatal) withdrawal problems may occur if this medication is suddenly stopped. Get medical help right away if you have any signs of a withdrawal reaction, including: itching, numb/tingling skin, high fever, mental/mood changes (such as confusion), seizures, worsening muscle tightness/stiffness, signs of kidney problems (such as change in the amount of urine). Tell your doctor if you ever had a withdrawal reaction from baclofen.

Keep all appointments for refilling the pump to avoid any serious withdrawal problems. Your doctor or another health care professional will check that the pump is programmed and working properly during these appointments. If you must miss a refill appointment, contact your doctor right away to reschedule the appointment before you run out of medication. Also, learn what your pump alarm sounds like. If you hear the alarm, contact your doctor right away.

Uses

Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, cerebral palsy, spinal cord injury/disease). It works by helping to relax the muscles.

Baclofen injection is used by patients who do not respond to or who cannot tolerate the side effects of baclofen taken by mouth.

How To Use

This medication is given by injection into the space around the spinal cord (intrathecally). It is usually given using a drug pump implanted under your skin. A health care professional will fill and refill the pump with medication.

The dosage is based on your medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Do not stop treatment with this drug without consulting your doctor. If you suddenly stop using this medication, you may have serious withdrawal symptoms. See also Warning section. To prevent withdrawal, your doctor may lower your dose slowly. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition does not improve or if it worsens, or if you have any signs of infection (such as fever, chills, redness/swelling/pain/warmth at the pump site).

Side Effects

Drowsiness, dizziness, weakness, headache, constipation, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as confusion, depression, hallucinations)
• numb/tingling skin
• vision changes
• difficulty urinating

Get medical help right away if you have any very serious side effects, including:

• seizures
• trouble breathing

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using baclofen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• recent/current infection
• seizures
• mental/mood disorders (such as schizophrenia)
• kidney disease

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), other muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, seizures, severe muscle weakness, loss of consciousness.

Notes

Keep all regular medical and laboratory appointments.

Keep all of your appointments to refill the medication. If you plan to travel, talk with your doctor ahead of time about your refill schedule so you do not run out of medication while you are away from home.

Missed Dose

This drug is to be given continuously as an infusion. If your infusion is interrupted, contact your doctor or pharmacist right away. If you miss an appointment to refill the medication, contact your doctor right away to reschedule before the pump runs out of drug.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Lioresal Tablets (Baclofen) Drug / Medicine Information

Baclofen

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Lioresal.

It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine. You can also download the most up to date leaflet
from www. novartis.com.au.

Those updates may contain important information about the medicine and its use of
which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Lioresal against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Lioresal is used for

Lioresal belongs to a group of medicines called muscle relaxants. This medicine is
used to reduce the excessive stiffness and/or spasms in your muscles. These spasms
happen in various illnesses such as multiple sclerosis and diseases or injuries of
the spinal cord.

Because this medicine reduces spasms and the pain that goes with them, it helps to
make you more mobile and better able to manage your daily activities.

Ask your doctor if you have any questions about why Lioresal has been prescribed for
you.

Your doctor may have prescribed it for another purpose.

Lioresal is only available with a doctor’s prescription.

Before you take Lioresal

When you must not take it

Do not take Lioresal if you have ever had an allergic reaction after taking:

baclofen (the active ingredient in Lioresal)

any of the other ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.

Do not take Lioresal after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.

In that case, return it to your pharmacist.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you are pregnant or intend to become pregnant or you are breast-feeding.

There is very little information on the use of this medicine in pregnancy or while
breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have to take Lioresal during pregnancy your baby may have convulsions and other
symptoms related to sudden discontinuation of the medicine just after delivery.

Tell your doctor if you have, or have ever had, any of the following medical conditions:

a mental illness

Parkinson’s disease

seizures (fits) from any cause

stiffness and restriction of movement in a group of muscles

stomach ulcers

stroke or other blood circulation disease

heart disease

kidney disease

liver disease

lung problems which make breathing difficult

diabetes

porphyria, a rare disturbance in the production of porphyrin, a pigment important
for liver function and blood formation

history of alcoholism, drink alcohol to excess or you have a history of drug abuse
or dependence. Some people being treated with baclofen have had thoughts of harming
or killing themselves or have tried to kill themselves. Most of these people also
had depression, had been using alcohol excessively or were prone to having thoughts
of killing themselves. If you have thoughts of harming or killing yourself at any
time, speak to your doctor straightaway or go to a hospital. Also, ask a relative
or close friend to tell you if they are worried about any changes in your behaviour
and ask them to read this leaflet.

high blood pressure

Your doctor may want to take special precautions if you have any of the above conditions.These
precautions may include additional tests during or prior to taking Lioresal.

If you have not told your doctor about any of these things, tell him/her before you
take Lioresal.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you
buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Lioresal may interfere with each other. These include:

any medicine that tends to make you sleepy, such as medicines used to help you sleep
or calm you down, pain relievers and medicines for colds or allergies

medicines used to treat mood disorders, including tricyclic antidepressants, lithium
and monoamine oxidase inhibitors (MAOIs)

medicines used to treat diabetes

medicines for high blood pressure

medicines used to treat Parkinson’s disease, including selegiline and levodopa and
carbidopa

You may need to take different amounts of your medicines or you may need to take different
medicines.

Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking Lioresal.

Tell your doctor if you have an intolerance to gluten.

This medicine contains wheat starch.

How to take Lioresal

Follow all directions given to you by your doctor and pharmacist carefully.

These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist
for help.

How much to take

Treatment is usually started in hospital with small doses of Lioresal. The dose is
then gradually increased to an amount that works best for you. For example, Lioresal
may be started at a dose of 15 mg a day, then increased slowly to anywhere from 30
to 75 mg a day. Sometimes, doses up to 100 mg a day may be needed.

If you are under the age of 16 or over 65 or you have kidney disease, your doctor
may start you on a lower dose and increase it more gradually to prevent unwanted side
effects.

How to take it

Swallow the tablets during meals with a little liquid.

Lioresal is usually taken in at least 3 divided doses throughout the day. But your
doctor may tell you to take it more or less often, depending on your situation.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next
dose when you are meant to.

Otherwise, take it as soon as you remember and then go back to taking it as you would
normally.

Do not take a double dose to make up for the one that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.

How long to take it

Continue taking Lioresal for as long as your doctor recommends.

Your doctor will check your progress to make sure the medicine is working and will
discuss with you how long your treatment should continue.

If you take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26)
for advice, or go to Accident and Emergency at your nearest hospital if you think
that you may have taken too much Lioresal, even if there are no signs of discomfort
or poisoning.

The main symptoms of overdose are: drowsiness, breathing difficulties, consciousness
disorders and being unconscious (coma).

Other symptoms may include: feeling confused, hallucinations, agitation, convulsions,
blurred vision, unusual muscle slackness, sudden contraction of the muscles, poor
or absent reflexes, high or low blood pressure, slow, fast or irregular heartbeat,
low body temperature, nausea, vomiting, diarrhoea or excessive salivation, trouble
breathing during sleep (sleep apnoea), pain in muscles, fever and dark urine (rhabdomyolysis).

If you have kidney disease and have accidentally taken more tablets or more syrup
than your doctor has prescribed, you may experience neurological symptoms of overdose
(e.g. drowsiness, feeling confused, hallucinations)

While you are taking Lioresal

Things you must do

If you become pregnant while taking Lioresal, tell your doctor immediately.

Your doctor can discuss with you the risks of taking it while you are pregnant.

Be sure to keep all of your doctor’s appointments so that your progress can be checked.

To help prevent unwanted side effects from happening, your doctor may want to do some
tests from time to time during the course of your treatment.

If your muscle spasms come back, tell your doctor.

Your doctor may be able to change the dose of Lioresal to make it work better for
you.

If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Lioresal.

Tell any other doctor, dentist or pharmacist who treats you that you are taking Lioresal.

Things you must not do

Do not stop taking Lioresal suddenly.

This medicine is not habit-forming but stopping it suddenly may bring on severe spasms
and other unwanted symptoms, such as nervousness, feeling confused, hallucinations,
abnormal thinking or behaviour, convulsions, uncontrollable twitching, jerking or
writhing movements, fast heartbeat, high body temperature, pain in muscles, fever
and dark urine. The excessive stiffness (spasms) in your muscles may also get worse.

If Lioresal must be stopped, your doctor will reduce the dose gradually over a period
of 1 to 2 weeks so that these unwanted effects are avoided.

Do not use Lioresal to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if their symptoms seem to be similar
to yours.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you to be alert
while you are taking Lioresal until you know how it affects you.

This medicine may cause sleepiness and decreased alertness in some people, especially
at the start of treatment.

Be careful when drinking alcohol while you are taking Lioresal.

The combination may make you feel more sleepy and less alert than usual.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Lioresal.

All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.

Side effects happen mainly at the start of treatment or if the dose is too high or
is increased too rapidly. They can often be relieved by lowering the dose.

If you are over 65 years old, you should be especially careful while taking this medicine.
Report any side effects promptly to your doctor.

As people grow older, they are more likely to get side effects from medicines.

Do not be alarmed by this list of possible side effects. You may not experience any
of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

daytime sleepiness or drowsiness

lack of energy, tiredness

dizziness or light-headedness

spinning sensation (vertigo)

mental confusion

headache

difficulty sleeping or nightmares

nausea (feeling sick), retching or vomiting

constipation, stomach cramps or diarrhoea

loss of appetite

stuffy or blocked nose

dry mouth

change in sense of taste

misuse, abuse and dependence

suicide or suicide attempts

numbness or tingling in hands and feet

muscle weakness, spasms or pain

problems with coordination and balance

difficulty in speaking

swelling of ankles due to fluid build-up

blurred or double vision

ringing in the ears

frequent urination or bed wetting

excessive sweating

weight gain

impotence or inability to ejaculate

increased blood sugar

low body temperature

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of the following:

signs of allergy such as rash, itching or hives on the skin; swelling of the face,
lips, tongue or other parts of the body; shortness of breath or wheezing

slow or difficult breathing

irregular heart beat (fast or slow)

chest pain

uncontrollable muscle spasms affecting the eyes, head, neck or body

fainting or seizures (fits)

depression or other severe mood or mental changes

hallucinations (hearing or seeing things that are not there)

being unable to urinate or pain when urinating; blood in the urine

symptoms following sudden discontinuation of the medicine (drug withdrawal syndrome).
Refer to “Things you must not do” above

The above side effects could be serious. You may need medical attention.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may happen in some people.

After using Lioresal

Storage

Keep your tablets in the original container until it is time to take them

Store the tablets in a cool dry place

Do not store Lioresal or any other medicine in the bathroom or near a sink

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines. Lioresal will keep well if it is cool
and dry.

Keep the tablets where young children cannot reach them.

A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.

Disposal

If your doctor tells you to stop taking Lioresal or the expiry date on the medicine
has passed, ask your pharmacist what to do with any tablets you have left over.

Product description

What it looks like

Lioresal 10 mg: white, round, flat tablets marked with KJ and a score line on one
side and CG on the other side: packs of 100 tablets.

Lioresal 25 mg: white, round, flat tablets marked with UR and a score line on one
side and CG on the other side: packs of 100 tablets.

Ingredients

Lioresal tablets contain either 10 mg or 25 mg of baclofen, the active ingredient.
They also contain:

colloidal anhydrous silica

microcrystalline cellulose

magnesium stearate

povidone

wheat starch

Lioresal tablets do not contain lactose, sucrose, tartrazine or any other azo dyes.
 

Excipient with known effect: wheat starch. Wheat starch may contain gluten, but only
in trace amounts.

Sponsor

Lioresal is supplied in Australia by:

NOVARTIS Pharmaceuticals Australia Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Telephone 1 800 671 203

®= Registered Trademark

This leaflet was prepared in November 2019.

Australian Registration Number.

Lioresal 10 mg bottle: AUST R 11038

Lioresal 25 mg bottle: AUST R 11039

Lioresal 25 mg blister: AUST R 68365

Internal document code

(lrst071119c) based on PI (lrst071119i)

What is a baclofen pump?

Learn>Living with NBIA

What is a baclofen pump?

Image Courtesy of Royal Children’s Hospital Melbourne, Dept of Developmental Medicine

• Baclofen is one of the most effective drugs for dystonia (involuntary muscle spasms) and spasticity (stiff or rigid muscles) in NBIA
• A baclofen pump is surgically placed inside the body and continuously delivers baclofen
• When and how much baclofen gets delivered is programed into the pump by a doctor
• Baclofen is injected into the intrathecal space (fluid-filled area surrounding the spinal cord) through a catheter

When should a baclofen pump be considered?

• When oral baclofen medication can no longer control the dystonia/spasticity symptoms
  • The oral form typically loses its effectiveness over time
  • Side effects often develop before the oral drug reaches its full potential
• A baclofen pump should be considered as a alternate treatment earlier rather than later

What can be expected from the procedure?

• Before having baclofren pump surgery, individuals should first get a few test doses of baclofen
  • They can be injected by a trained nurse in the hospital and kept overnight for observation
  • The test doses will allow the doctor to see how a patient responds to the medication
• The baclofen pump can be placed either high or low depending on the surgeon
  • Dr. A Leland Albright, a neurosurgeon at the University of Wisconsin, has developed a method to place the pump’s catheter tip high in the ventricle (fluid filled cavity) of the brain
• After the pump is implanted, regular doctor visits should be scheduled
  • To re-evaluate the effectiveness of the treatment
  • To adjust the level of medication as needed and how it is released from the pump to optimize results
• Other therapies such as oral medication, Botox injections and DBS (Deep Brain Stimulation) can be used along with a baclofen pump when appropriate/needed

What effect will it have on quality of life?

Image Courtesy of Royal Children’s Hospital Melbourne, Dept of Developmental Medicine

• The pump can sometimes be seen under clothing
• The pump needs to be refilled when the baclofen medication runs low
• However, it is generally discrete and has little effect on daily activities

Are there any side effects or cons?

Cons

• The surgical incision site can get infected
• Baclofen withdrawal or overdose
  • Withdrawal is more likely than an overdose
  • Something as simple as a kink in the tubing can lead to a lack of medication, causing withdrawal symptoms
  • Human error can occur rarely, such as the medication dosage being programmed incorrectly into the pump and causing an overdose (vigilant parents can help reduce this risk)

Pros

• The baclofen pump is usually more effective than oral baclofen
• The baclofen pump is effective at a lower dose
  • Lower dosage means fewer side effects and less harm to the body
• The baclofen pump can deliver medication in multiple ways:
  • Continuous mode
  • Flexible mode
  • Or a combination of both based on trial and error
• The pump is less invasive than treatments like deep brain stimulation (DBS)
  • DBS is probably the next best option for managing dystonia
• Treatment is potentially reversible because the pump can be removed if needed

Copyright © 2014 by NBIAcure. org. All rights reserved.

Baclofen Pump – Treatments – For Patients – UR Neurosurgery

For more information, please visit our Center for Neuromodulation

What is it?

Baclofen pump implantation is a surgical procedure performed to permanently implant a pump that delivers baclofen to the spinal fluid to treat severe to moderate-severe spasticity that is refractory to oral medications. It continuously delivers baclofen in small doses directly to the spinal fluid, increasing the therapeutic benefits, and causing fewer and less severe side effects compared to the oral medicine.

What is its goal?

The aim of the operation is to decrease spasticity related to multiple sclerosis, spinal cord injuries, or other neurological diseases.

How is it done?

During a pre-operative trial, baclofen is injected into the spinal canal (using a small needle) and you are assessed by the treatment team over several hours to determine how well the medicine treats the spasticity. If a positive effect is observed then you may be a candidate for implantation of a permanent pump to delver the drug.

The pump is inserted under the covering of the abdominal muscles while the patient is under a general anesthetic. A small catheter is then inserted through a needle into the spinal fluid space and is threaded upward. The catheter is then tunneled under the skin to the abdomen and is connected to the pump. The pump is filled with the drug baclofen and is programmed by a computer to continuously release a specified dose that is determined by the physician.

The operation is completed when the incision is closed with suture material (stitches) or surgical staples. If the outer incision is closed with staples or non-absorbable sutures, they will have to be removed after the incision has healed. The procedure usually lasts 1-2 hours.

What are the risks?

There are always risks with any surgery. Potential complications may include:

• Pain, numbness, weakness or paralysis due to nerve damage (rare)
• Cerebrospinal fluid leak
• Bleeding/injury to blood vessels
• Infections
• General anesthetic complications

Hardware related complications during surgery is rare but can include catheter migration. After surgery though, the potential hardware complications include: catheter fracture or migration, infection or pump malfunction.

What is the success rate?

The success rate of baclofen pump implantation for delivery of baclofen to the spinal fluid is generally favorable. Patients tend to have had a good response from pre-operative trials of intrathecal (delivery to the spinal fluid) baclofen and this is the permanent implantation phase.

How long will I stay in the hospital?

After the surgery, patients are in the hospital for a few days. Each individual patient’s return to normal activity is largely dependent on his/her pre-operative condition and age. Typically you will be able to go home once your vital signs are stable and you are back to baseline functioning. Follow-up will be needed as the pump will need to be refilled every couple of months, depending on the pump size, concentration and dose. Refills are done in the office using a syringe and needle and take approximately fifteen minutes to complete. At that time, baclofen doses are adjusted depending on the effects that are being seen.

Intrathecal baclofen for the treatment of spasticity in children with cerebral palsy

Spasticity, which is manifested by increased muscle tone, is the most common condition impairing movement in children with cerebral palsy. Baclofen is a medication that acts on receptors in the brain and spinal cord to reduce abnormal muscle tone. It has been used as an oral medicine for many years. The disadvantages of oral administration are that only a small amount of the drug crosses the blood-brain barrier, after which it can exert its effect, and that the dose is limited by the undesirable effect of excessive sedation [excessive sedation].Injecting baclofen into the fluid surrounding the spinal cord overcomes these problems. This treatment is called intrathecal baclofen therapy. Baclofen is administered using a pump placed under the skin connected to a catheter that penetrates the membranes that cover the spinal cord to deliver the baclofen directly into the fluid surrounding the spinal cord and brain.

The conclusion of this review is that there is little evidence from studies to date that intrathecal baclofen is an effective treatment for reducing spasticity in children with cerebral palsy in the short term.The long-term effect of intrathecal baclofen on spasticity in children with cerebral palsy is less clear.

Two short-term studies (by the same investigators) showed a reduction in spasticity, but the single, longer-term study showed minimal evidence for a reduction in spasticity with intrathecal baclofen. Two further short-term studies showed a decrease in spasticity with intrathecal baclofen, but the authors used inappropriate data analysis methods, so it is not known if these results are valid.All of these studies had a small number of participants, making the conclusions less reliable.

Evidence from one short-term study and one longer study (again by the same researchers) is presented that intrathecal baclofen therapy improves comfort, care and some aspects of quality of life in children with cerebral palsy. However, the results of the longer study may have been influenced by the fact that both participants and researchers knew whether they were receiving treatment or were assigned to a control group.The same study showed that intrathecal baclofen slightly improved gross motor [motor function] in children with cerebral palsy, but again, the way in which this study was conducted may have influenced these results.

Further evidence of the efficacy of intrathecal baclofen for the treatment of spasticity from other investigators is needed to confirm these results.

There is little evidence from short-term randomized controlled trials regarding the safety and economic consequences of this treatment when long-term therapy is given through implanted devices.For the same reasons, we were unable to conclude whether the need for further orthopedic surgery is changing in children receiving intrathecal baclofen therapy.

What is Baclofen Trip? | RESTART

Baclofen – what are these tablets? What is the medicine for, and what is it? It is a centrally acting muscle relaxant developed in the 60s of the last century. Baclofen is prescribed by the attending physician if there is an indication for its use. This drug acts as a sedative and pain reliever.It will also help with diseases of the heart and blood vessels.

However, in addition to benefits, it can be harmful, depending on what you are using Baclofen for. It is ranked among powerful and rather dangerous pharmaceutical drugs, if the dosage is violated, it causes persistent dependence. The drug gained its popularity due to its easy availability and low cost. The chemical formula of the substance is C10h22ClNO2, it is impossible to create it yourself at home.

What is Baclofen used for today?

Initially, the drug was created for the treatment of epilepsy, but it did not give positive results.However, when the drug began to be injected through the spinal cord, it began to help people with TBI, spasms, after strokes. Today, the medicine has a fairly widespread use in medicine. Baclofen tablets are used to treat tumors, cerebral palsy, withdrawal symptoms for alcoholism, meningitis, and strokes. When administered by another method, the drug helps in the treatment of sclerosis, brain damage.

Baclofen as a drug

Baclofen is the active substance of Baklosan, which is also used by addicts as a drug.Depending on how you use it, Baklosan can have a narcotic effect. Most often this is done intentionally, by increasing the dosage allowed in the instructions (up to 15 tablets). Young people in nightclubs take Baclofen and alcohol, which leads not only to drug but also alcohol intoxication.

Baclofen-trip – as a “pret” pharmaceutical drug?

After taking the drug, a person very soon begins to feel a surge of energy, strength, vigor, his mood increases, the desire to move and communicate.Hyperactivity and excessive joy make the addict’s behavior strange and inadequate, although he feels that everything is in order. In a burst of energy, a person can not only rest, but also work. However, after a couple of hours, the opposite effect of Baclofen is observed: weakness, loss of strength, dizziness, drowsiness.

Side Effects of Baclofen

With continued use, the addict’s behavior changes. He becomes irritable, apathetic, sleepy, he is constantly thirsty, his pupils dilate, and his hands tremble and do not obey.But the worst thing is that the drug causes persistent psychological dependence. And in the absence of the required dose of the drug, narcotic withdrawal occurs. Often, young people take another dose of the drug after several hours to prolong the effect, thus very often an overdose of Baclofen occurs. This condition is dangerous to human life and health. In case of withdrawal symptoms, urgently call a narcologist.

Many drug addicts are switching from the widespread amphetamine to the cheaper and more affordable Baclofen.However, today Baclofen is also used in bodybuilding, actively promoting it as a muscle relaxant that restores joints, relieves muscle spasms, and reduces back pain. Like Phenibut, which is a pharmacy drug, Baclofen is very dangerous when taken uncontrolled. You should not believe such an advertisement if you have not been prescribed it by your doctor.

Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the necessary information about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

Gablofen; Lioresal; Ozobax

Trade names: Canada

APO-Baclofen; Baclofen-10; Baclofen-20; DOM-Baclofen; Lioresal DS [DSC]; Lioresal Intrathecal; Lioresal [DSC]; MYLAN-Baclofen; PMS-Baclofen; RATIO-Baclofen [DSC]; RIVA-Baclofen

Warning

Infusion:

• Hazardous side effects have happened when this drug is stopped abruptly. These side effects included high fever, mental changes, increased seizures, and muscle stiffness.In rare cases, such side effects led to very severe disruptions in the work of muscles, organs and became the cause of death. Do not stop taking this drug abruptly without talking to your doctor. Be sure to refill your pump in a timely manner and become familiar with its alarms and what to do when they are triggered. Tell your doctor if you have ever experienced withdrawal symptoms while taking baclofen tablets or injections. If you have signs of withdrawal, contact your doctor immediately.
• See package insert for details.

What is this drug used for?

• Used to relax muscles.
• Used to treat multiple sclerosis spasms or spinal cord diseases.
• This medicinal product can be used for other indications. Consult your doctor.

What do I need to tell my doctor BEFORE taking this drug?

All forms of issue:

• If you are allergic to this drug, any of its ingredients, other drugs, foods or substances.Tell your doctor about your allergy and how it manifested itself.

Infusion:

• In case of infection.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems.You need to make sure that this drug is safe for your medical conditions and in combination with other drugs you are already taking. Do not start or stop taking any drug or change the dosage without your doctor’s approval.

What do I need to know or do while taking this drug?

• Tell all healthcare providers that you are taking this drug.These are doctors, nurses, pharmacists and dentists.
• Avoid driving or other activities that require increased attention until you see how this drug affects you.
• Do not stop taking this drug abruptly without talking to your doctor. This can increase the risk of side effects. If necessary, this drug should be stopped gradually as directed by your doctor.
• Consult your doctor before using alcohol, marijuana, or other forms of cannabis, or prescription and over-the-counter medications that may slow you down.
• Use with caution in children. Consult your doctor.
• Use of this drug during pregnancy may cause withdrawal in the newborn.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. The benefits and risks for you and your child will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can have serious and sometimes deadly side effects. Call your doctor or get medical help right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

All forms of issue:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Severe dizziness or fainting.
• Confusion of consciousness.
• Changes in the frequency of urination.
• The appearance or aggravation of mental disorders, mood swings, or changes in behavior.

Infusion:

• Convulsions.
• Change in vision.
• Chest pain.
• Muscle pain or weakness.
• Muscle stiffness.
• Unusual burning, numbness, or tingling sensations.
• Difficulty breathing, slow or shallow breathing.
• Difficulty urinating or a change in the amount of urine excreted.
• Blood in the urine.
• Hallucinations (a person sees or hears something that is not in reality).
• Uncontrolled body movements, convulsive movements, imbalance, difficulty swallowing or speaking.
• Loss of control over eye movements.
• Feeling of an abnormal heartbeat.

What are some other side effects of this drug?

Any medicine can have side effects.However, many people have little or no side effects. Call your doctor or get medical help if these or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Sleep disorders.
• Nausea or vomiting.
• Headache.
• Constipation.

This list of potential side effects is not exhaustive.If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Office.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your healthcare practitioner.Read all the information provided to you. Follow all instructions strictly.

Pills:

• Take this medication with or without food.

Liquid (solution):

• Doses of liquid preparation should be measured with caution. Use the dispenser that comes with the medicine. If a dispenser is not included in the package, ask your pharmacist for a dosing product for this drug.

Infusion:

• For insertion into the spine.

What should I do if a dose of a drug is missed?

Solution or tablets:

• Take the missed dose as soon as you can.
• If it is time for your next dose, do not take the missed dose and then return to your normal dose schedule.
• Do not take 2 doses at the same time or an additional dose.

Infusion:

• Call your doctor for further instructions.

How do I store and / or discard this drug?

Pills:

• Store at room temperature in a dry place. Do not store in the bathroom.
• If you split the tablets, you may need to throw them away after some time. You need to know how long split tablets can be stored. If you are unsure, call your pharmacist.

Liquid (solution):

• Store in refrigerator. Do not freeze.

Infusion:

• If you need to store this drug at home, ask your doctor, nurse, or pharmacist for information about how it is stored.

All forms of issue:

• Store all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your health does not improve or even worsens, see your doctor.
• You should not give your medicine to anyone and take other people’s medicines.
• Some medicines may have different patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• Some medicines may come with other patient information sheets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient.This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional.Check with your doctor for complete information on the possible risks and benefits of taking this drug. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

90,000 BACLOFENE is … What is BACLOFENE?

Baclofen

Active ingredient

›› Baclofen * (Baclofen *)

Latin name

Baclofen

ATX:

›› M03BX01 Drugs affecting the neurotransmission
Pharmaceuticals

Composition and release form

in a polypropylene can 50 pcs .; in a pack of cardboard 1 can.

Route of administration and dosage

Inside, during meals. For adults and children, the initial dose is 5 mg (1/2 table, 10 mg each) 3 times a day. Gradually, with caution, every 3 days, the dose is increased until the onset of a therapeutic effect (for adults, usually up to 30–75 mg per day).For higher doses (75-100 mg per day), 25 mg tablets should be used. The maximum daily dose is 100 mg.
Usually recommended doses for children: 1-2 years old – 10-20 mg / day; 2-6 years – 20-30 mg / day; 6-10 years old – 30-60 mg / day. For children over 10 years of age, the maximum dose is 1.5–2 mg / kg.

Shelf life

5 years

Storage conditions

List B.: In a dry, dark place at temperatures below 25 ° C.

* * *

BACLOFEN *.4-Amino-3- (para-chlorophenyl) -butyric acid Synonyms: Lioresal, Baclon, Gabalon, Lioresal, Spastin. In structure, baclofen is similar to the derivatives of g – aminobutyric acid aminolone and phenibut (see). It differs from the latter by the presence of a chlorine atom in the para-position of the phenyl nucleus. The pharmacological properties of baclofen are different than those of phenibut and other nootropic drugs (see). It is an agonist of GABA-B receptors, and the main manifestation of its pharmacological activity is antispastic action.It inhibits spinal and visceral reflexes, reduces muscle tension, clonus. It also has an analgesic effect. Baclofen is used to reduce spasticity in multiple sclerosis and other types of spasticity (mainly of spinal origin), but not in muscle rigidity in patients with parkinsonism. Baclofen is prescribed orally (with meals), starting with 5 mg 3 times a day, then the dose is increased (every 3 days by 5 mg 3 times a day) to a maximum daily dose of 60 – 75 mg.The drug should be withdrawn gradually. When taking baclofen, nausea, vomiting, and dizziness are possible. Like other muscle relaxants, it can impair your ability to walk normally. Contraindications: psychosis, epilepsy, Parkinson’s disease. Caution is needed for impaired renal function. Release form: tablets of 10 and 25 mg in a package of 50 pieces. Storage: List B.

Dictionary of Medicines.
2005.

Baclofen – strong psychoactive drug

Baclofen is a drug that causes euphoria thanks to its potent ingredients.It is also called a drugstore drug. Officially, the drug is prescribed for strokes, meningitis, head injuries and other ailments. It has analgesic and sedative effects.

Muscle relaxant contains a number of potent components: magnesium stearate, lactose, gelatin and, directly, baclofen in a volume of 10 or 25 mg. The formula is exclusively reproduced in the laboratory. It was first invented in Switzerland. A famous chemist in 1962 planned to use it to treat an epileptic disease.But it was ineffective, but it had a positive effect on the condition of patients who survived a stroke, muscle spasms and traumatic brain injury.

Baclofen is a drug and its signs of use

Baclofen is an affordable drug that young drug addicts like. A strong intoxicating effect from an overdose is achieved by taking 6-14 tablets at a time. Strengthen the effect of alcoholic beverages. After 30-40 minutes, euphoria is felt, and you may also experience:

• nausea and vomiting;
• dry mouth;
• hallucinations;
• tremors;
• apathy;
• dilated pupils;
• dizziness;
• Loss of motor coordination.

People who are addicted to amphetamine can also take baclofen, the drug enhances the effect, converting 1 dose into 2. This mixture increases euphoria, a surge of energy and hallucinations.

Baclofen and narcotic effect

The first thing that comes under attack is the central nervous system and the work of internal organs. An hour later, unnatural amusement and hyperactivity develop. A person can work without rest for 1.5-2 hours. Then the activity is replaced by drowsiness, pain, tremors, headaches.A person feels hidden opportunities, becomes self-confident. Fears, nervousness and depression disappear. Energy comes to replace, but only for the duration of exposure. Baclofen, the narcotic effect of which is expressed in the development of psychological attraction, does not cause chemical dependence. After the formation of a persistent habit, the person feels bad. He needs to take another dose.

The effect is achieved mainly by exceeding the dose. But the result of this approach is sometimes fatal – depression of the respiratory center or death.Those who managed to survive acquire:

• manic-depressive syndrome;
• lose contact with the outside world;
• become sociopaths.

In case of overdose, act decisively. It is necessary to call an ambulance, rinse the stomach, give an abundant drink. After that, you need to seek help. It is impossible to get out of the trap of illusions on your own. Available baclofen is a predominantly youth drug. Getting it is not a problem. Don’t waste your time.The specialists of the Mayak Health rehabilitation center will help your loved ones return to real life, where there is no place for drugs.

90,000 how to stop drinking baklosan

how to stop drinking baklosan

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Baklosan is one of the most common drugs. It is addictive, so patients become addicted easily. The drug enhances the effect of alcohol or other drugs. An hour after taking the pills, efficiency increases, mood improves, and a surge of strength occurs.Why is baklosan dangerous? In such cases, urgent hospitalization of the drug addict is necessary. How to stop baclofen? Can i stop using baclofen on my own? Yes, only if: less than two months of use. When taking Baklosan, undesirable reactions may occur in the form of drowsiness, depression, confusion, euphoria, tremors and weight gain. Independent use of the drug in arbitrary quantities is dangerous by the development of addiction, seizures, respiratory disorders and an increase in body temperature up to 40 degrees.In the absence of specific help and severe intoxication in connection with an overdose of the drug, a shock condition occurs, threatening coma and death of a person. Features of the drug. Narcologists emphasize that the uncontrolled intake of Baklosan provokes effects similar to that. Under what pathologies is Baklosan dangerous? Baklosan: side effects. Addiction. Withdrawal symptoms. Overdose. Many drugs that are produced for the treatment of various pathologies have a pronounced narcotic effect.These include baklosan – dependence on it (first mental, then physical) develops quickly enough. This must be taken into account when prescribing it so that an ordinary patient does not turn into a drug addict. General information. Baclosan is the trade name for the muscle relaxant baclofen. It is a stimulant of GABA – gamma-aminobutyric acid, the presence of which depends on How to quit baclosan and restore the quality of life after it – doctors answer Ask a Doctor. Baklosan is such a specific drug and it could help you only if you have muscle hypertension syndrome, cerebral palsy, spastic paralysis, or paresis, multiple sclerosis.But then his reception is shown for life. Save. + 1. Margarita, I drank plenty of water and milk + Furosemide diuretic for a week. In some part, I think it helped, but the bottom line is that there is not much time left. Save. How to quit baklosan. I have been taking this stuff for 5 years. I started with 3 tablets of 25 ml and finished with 7-8 25 ml tablets. Today is the first Day as the pills are over. Maybe you can advise some kind of spice to alleviate the condition. While I quit I feel it will be very hard. I ask for advice, I started throwing baklosan, slowed down from 125 to 110, I plan to remove 5 mg every 3 days, before taking it there is a strong panic and depression, tell me how to alleviate the condition and normalize it.Baklosan. Good afternoon, since January 2019, I systematically began to use baklosan 25mg, now the dosage is 6 tablets per day, 3 in the morning and 3 in the evening, sometimes it is more rare. Tried to. Baclofen (baklosan) is one of the most readily available drugs. If you use the drug in large quantities, while simultaneously using alcoholic beverages or other drugs, you can fall into a psychedelic state. Because of this, a serious mental addiction arises, which is not so easy to get rid of.After taking a dose, a person begins to experience various experiences of a rather strange nature, there is a persecution mania, increased nervousness and other similar problems. Baclofen (baklosan) is a medication from the group of centrally acting muscle relaxants, which is dispensed in pharmacies by prescription, since it causes drug addiction when used uncontrollably. It belongs to the category of soft drugs, popular among the younger generation. Addiction manifests itself quickly, while more often it is of a psychological nature.Treatment of dependence on Baclofen, Baklosan is recommended to be carried out in a hospital or a rehabilitation center. [us_image image = 15128 ″ size = full] [us_separator size = small]. Features of the drug. Baclosan (Baclofen) is a synthetic drug that belongs to the group of muscle relaxants. It is used in traditional medical practice to relieve epileptic seizures, correct spastic reactions in various muscle groups, which are provoked by various diseases. But, unfortunately, baclofen is a drug that is widely popular in the criminal world.Some drugs that drug addicts are hunting for are widely used in traditional medicine for the treatment and correction of various pathological conditions. Baclofen – Treatment Pills or Drug? Baclosan (Baclofen) is a synthetic drug that belongs to the group of muscle relaxants. Baclofen (baklosan) is a medicine that can be purchased over the counter. It provokes addiction, which is difficult to get rid of. Tablets are classified as light narcotic drugs, therefore they have gained popularity among young people.As a medical preparation, baclofen is suitable for the treatment of craniocerebral injuries, spasmodic and spastic conditions. It should be taken strictly under the supervision of a physician. Addiction to Baklosan (baclofen). Baclofen (baklosan) is a medicine that can be purchased over the counter. It provokes addiction, which is difficult to get rid of. Tablets are classified as light narcotic drugs, therefore they have gained popularity among young people. Hello, I have been using baklosan for a long time, I really want to quit, but I can’t go to the doctor, they recognize as a drug addict, what to do? Please help me, I can’t do this anymore.I’m afraid, I don’t know what to do, there was a break in saline glucose panangin and askarbinka works 100%, you need to find a medicine for intravenous instillation, and everything has been packed up a few days ago and everything will be in order, and before going to bed I need 4po25mg amitriptyline. impression, I was lying dying from alcohol poisoning and finibut sharply raised me to my feet, lifted my spirits thereby making me feel life. After a while I tried baklosan, not understanding the effect of expecting something from him.

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necke KD, Hellweg R., Heinz A. High-dose baclofen for the treatment

of alcohol dependence (BACLAD study ): a randomized, placebo-con-

trolled trial. Eur Neuropsychopharmacol. 2015; 25: 1167-1177. PMID:

26048580. DOI: 10.1016 / j.euroneuro.2015.04.002

31. Rigal L., Legay Hoang L., Alexandre-Dubroeucq C., Pinot J., Le Jeunne

C., Jaury P. Tolerability of high-dose baclofen in the treatment of pa-

tients with alcohol disorders: a retrospective study.Alcohol Alcohol.

2015; 50: 551-557. DOI: 10.1093 / alcalc / agv052

32. Léger M., Brunet M., Le Roux G., Lerolle N., Boels D. Baclofen self-poi-

soning in the era of changing indication: multicentric reports to a

French poison control center. Alcohol Alcohol. 2017; 52: 665-670.

DOI: 10.1093 / alcalc / agx072

33. Franchitto N., De Haro L., Pélissier F. Focusing solely on the e ff ect of

the medication without taking a holistic view of the patient does not

seem very constructive …Clin Toxicol. 2018; 56: 309. DOI:

10.1080 / 15563650.2017.1373781

34. Beck A., Pelz P., Lorenz R.C., Charlet K., Geisel O., Heinz A., Wüstenberg

T., Müller C.A. E ects of High-Dose Baclofen on Cue Reactivity in Al-

cohol Dependence: A Randomized, Placebo-Controlled pharmaco-

fMRI Study. Eur Neuropsychopharmacol. 2018; 28 (11): 1206-1216

PMID: 30217552. DOI: 10.1016 / j.euroneuro.2018.08.507

35. Vourc’h M., Feuillet F., Mahe P.-J., Sebille V., Asehnoune K., BACLOREA

trial group. Baclofen to Prevent Agitation in Alcohol-Addicted Pa-

tients in the ICU: Study Protocol for a Randomized Controlled Trial.

Trials. 2016; 17 (1): 415. PMID: 27542731. PMCID: PMC4992221. DOI:

10.1186 / s13063-016-1539-2

36. Dixit D., Endicott J., Burry L., Ramos L., Yeung SYA, Devabhakthuni

S., Chan C., Tobia A., Bulloch MN Management of Acute Alcohol

Withdrawal Syndrome in Critically Ill Patients.Pharmacotherapy.

2016; 36 (7): 797-822. PMID: 27196747. DOI: 10.1002 / phar. 1770

37. Beraha EM, Salemink E., Goudriaan AE, Bakker A., ​​de Jong D., Smits

N., Zwart JW, Geest DV, Bodewits P., Schiphof T., Defourny H., van

Tricht M., van den Brink W., Wiers RW E ffi cacy and safety of high-

dose baclofen for the treatment of alcohol dependence: A multicen-

tre, randomized, double-blind controlled trial. European Neuropsy-

chopharmacology.2016; 26 (12): 1950-1959. DOI: 10.1016 / j.

euroneuro.2016.10.006. PMID 27842939.

38. Minozzi S., Saulle R., Rösner S. Baclofen for alcohol use disorder.

Cochrane Database Syst Rev. 2018; 26 (11): CD012557. PMID: 30484285.

PMCID: PMC6517285. DOI: 10.1002 / 14651858.CD012557.pub2

39. Girish K., Vikram Reddy K., Pandit LV, Pundarikaksha HP, Vijen-

dra R., Vasundara K., Manjunatha R., Nagraj M., Shruthi R A ran-

domized, open-label, standard controlled, parallel group study of

efficacy and safety of baclofen, and chlordiazepoxide in uncom-

plicated alcohol withdrawal syndrome.Biomed J. 2016; 39 (1):

72-80. DOI: 10.1016 / j.bj.2015.09.002. PMID: 27105601. PMCID:

PMC6138810

40. Simon N., Franchitto N., Rolland B. Pharmacokinetic Studies of Ba-

clofen Are Not Su cient to Establish an Optimized Dosage for Man-

agement of Alcohol Disorder. Front Psychiatry. 2018; 9: 485. PMID:

30349489. PMCID: PMC6186984. DOI: 10.3389 / fpsyt.2018.00485

41. Schiess M.C., Eldabe S., Konrad P., Molus L., Spencer R., Stromberg K.,

Weaver T., Punkett R. Intrathecal Baclofen for Severe Spasticity: Lon-

gitudinal Data From the Product Surveillance Registry. Neuromodu-

lation. 2020. DOI: 10.1111 / ner.13097. [Epub ahead of print] PMID:

31989725

42. van den Brink W. Baclofen: A Game Changer in the Treatment of Al-

cohol Dependence. Alcohol Alcohol. 2020; 55 (1): 46–47. Doi:

10.1093 / alcalc / agz085. PMID: 32031207

43.Krupickij E.M., Rybakova K.V., Kiselev A.S., Alekseeva Yu.V., Berncev

V.A., Chekhlatyj E.I., Zubova E. Yu., Popov Yu.V., Neznanov N.G. E ffi-

cacy and safety of baclofen in the treatment of alcohol dependence

(double-blind randomized placebo-controlled pilot study). Zhurnal

nevrologii i psikhiatrii im. S.S. Korsakova. 2015; 115 (6): 53–62. [In

Russ.]. DOI: 10.17116 / jnevro20151156153-62

44. McLaughlin M.J., He Y., Brunstrom-Hernandez J., Thio L.L., Carleton

B.C., Ross C.J.D., Gaedigk A., Lewandowski A., Dai H., Jusko W.J., Leeder

J.S. Response in Children With Cerebral Palsy. PM R. 2018; 10 (3):

235-243. DOI: 10.1016 / j.pmrj.2017.08.441.

45. Navarrete-Opazo A.A., Gonzalez W., Nahuelhual P. E ectiveness of

Oral Baclofen in the Treatment of Spasticity in Children and Adoles –

cents With Cerebral Palsy. Arch Phys Med Rehabil 2016; 97 (4):

604-618.DOI: 10.1016 / j.apmr.2015.08.417. PMID: 26321489

46. Furr-Stimming E.