Medication info
Bacron Tablet 10 mg (Baclofen)

Bacron Tablet 10 mg (Baclofen)

Prescription medicationTabletOral
Ingredient · strength
Baclofen›10mg / 1 tablet
Manufacturer / importer
Taejun Pharmaceutical Co., Ltd.
Appearance
White round tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 198701594 · Notified 1987.08.26 · Insurance code 650100390

Summary

Main use
Relief of muscle spasticity associated with nervous system disorders (spinal cord disorders, multiple sclerosis, cerebral palsy, etc.)
Who takes it
Adults · Children
Adult dose
Treatment with this drug should always be initiated at a low dose and increased gradually. The optimal dose should be determined individually for each patient at a level that reduces clonic convulsions, flexor and extensor rigidity, and spasms while avoiding adverse effects as much as possible. To prevent excessive muscle weakness and falls, use with caution when muscle tone is needed to maintain upright posture and balance during movement, as well as to maintain function. It is important to allow transient spasms that help maintain some muscle tone and support circulatory function. Administer this drug with a small amount of water during meals. The total daily dose should be administered orally in 3 divided doses in adults. Adults 1. Administer baclofen 5㎎ per dose 3 times daily by mouth, and increase by 5㎎ per dose 3 times daily at 3-day intervals until the optimal dose is determined. 2. In patients with hypersensitivity to this drug, it is advisable to start with a lower dose (5-10㎎ per day) and increase it slowly. 3. The optimal dose is usually 30-80㎎ per day. Hospitalized patients may receive 100-120㎎ per day under close supervision.
Child dose
Children (12 months~18 years): Treatment is generally initiated at a very low dose (0.3 mg/kg per day in 2~4 divided doses). The usual daily maintenance dose is 0.75~2mg/kg. Increase the dose cautiously at intervals of approximately 1-2 weeks until it is appropriate for the individual's needs. The total daily dose should be administered orally in 4 divided doses. Children under 8 years: The maximum daily dose is 40mg. Children aged 8 years and older (12 months~18 years): The maximum daily dose is 60mg. If no clear therapeutic effect is observed within 6-8 weeks after administration of the maximum dose, reconsider whether to continue treatment with this drug.

Ingredients

Manufacturer
Taejun Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of muscle spasticity associated with nervous system disorders (spinal cord disorders, multiple sclerosis, cerebral palsy, etc.)

  • Skeletal muscle spasticity due to multiple sclerosis
  • spasticity due to spinal cord disease
  • spastic spinal paralysis
  • amyotrophic lateral sclerosis
  • syringomyelia
  • transverse myelitis
  • traumatic paraplegia
  • spinal cord compression
  • other spinal diseases
  • cerebral origin spasticity
  • cerebral palsy
  • cerebrovascular accidents
View approved original text

This medication is effectively used for the treatment of skeletal muscle spasticity due to multiple sclerosis or spinocerebellar degeneration. It is also helpful for various forms of spasticity due to spinal cord disease, such as spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, and traumatic paraplegia. Additionally, it is used for the treatment of cerebral origin spasticity caused by cerebral palsy, cerebrovascular accidents, neoplastic brain diseases, and degenerative brain diseases. In summary, this drug is used to relieve muscle spasticity caused by various neurological diseases.

How to take

Adult dose

Treatment with this drug should always be initiated at a low dose and increased gradually. The optimal dose should be determined individually for each patient at a level that reduces clonic convulsions, flexor and extensor rigidity, and spasms while avoiding adverse effects as much as possible. To prevent excessive muscle weakness and falls, use with caution when muscle tone is needed to maintain upright posture and balance during movement, as well as to maintain function. It is important to allow transient spasms that help maintain some muscle tone and support circulatory function. Administer this drug with a small amount of water during meals. The total daily dose should be administered orally in 3 divided doses in adults. Adults 1. Administer baclofen 5㎎ per dose 3 times daily by mouth, and increase by 5㎎ per dose 3 times daily at 3-day intervals until the optimal dose is determined. 2. In patients with hypersensitivity to this drug, it is advisable to start with a lower dose (5-10㎎ per day) and increase it slowly. 3. The optimal dose is usually 30-80㎎ per day. Hospitalized patients may receive 100-120㎎ per day under close supervision.

Child dose

Children (12 months~18 years): Treatment is generally initiated at a very low dose (0.3 mg/kg per day in 2~4 divided doses). The usual daily maintenance dose is 0.75~2mg/kg. Increase the dose cautiously at intervals of approximately 1-2 weeks until it is appropriate for the individual's needs. The total daily dose should be administered orally in 4 divided doses. Children under 8 years: The maximum daily dose is 40mg. Children aged 8 years and older (12 months~18 years): The maximum daily dose is 60mg. If no clear therapeutic effect is observed within 6-8 weeks after administration of the maximum dose, reconsider whether to continue treatment with this drug.

Precautions

This medication should not be used by patients who are allergic to this medication or any of its other components. Patients with conditions such as psychosis, schizophrenia, bipolar disorder, confusion, or Parkinson's disease may experience exacerbation of symptoms when using this medication and should use it very cautiously and be observed carefully. Patients with a history of epilepsy should monitor their condition carefully while maintaining anticonvulsant therapy, as this medication may pose a risk of inducing seizures. Patients with a history of peptic ulcers or current peptic ulcers must use this medication with caution. Patients with severe cardiac weakness and cardiovascular disease should also be cautious when using this medication. Patients with cerebrovascular disease and respiratory diseases need caution, as this medication may relax muscles and suppress respiration. Patients with poor liver function and impaired kidney function should use this medication in small amounts with caution, and patients undergoing dialysis should very carefully adjust the dosage to a much lower level. While this medication can improve neurogenic bladder dysfunction, acute urinary dysfunction may occur in patients with severe sphincter tension, so caution is necessary. Children, especially those with a history of epilepsy, may be at risk for seizures and should be monitored closely. Common side effects such as sedation and drowsiness may occur while taking this medication, and these symptoms mainly occur initially when significantly increasing the dosage or using high doses, and most are temporary and improve with dosage reduction. Patients with a history of mental disorders or cerebrovascular diseases, as well as the elderly, may experience more severe side effects, so caution is warranted. Sudden discontinuation of this medication after long-term use may lead to anxiety, agitation, hallucinations, and psychotic symptoms, so it is important to taper off gradually over 1-2 weeks. While taking this medication, dizziness, drowsiness, and decreased concentration may occur, so drivers and those operating hazardous machinery should avoid such activities. Patients with liver dysfunction or diabetes need regular monitoring as this medication may affect liver function or blood sugar levels. Patients with impaired kidney function require close observation to detect toxic symptoms of this medication early. There may be an increased risk of suicide among some patients using this medication, so patients and their families should closely monitor any changes in mental state and inform healthcare professionals immediately of any abnormalities. This medication has the potential for drug abuse or dependence, so patients with a history of substance abuse should be monitored carefully. If symptoms of encephalopathy occur while taking this medication, it should be stopped immediately. Using this medication alongside other central nervous system drugs or alcohol may increase sedation and the risk of respiratory depression, so patients with cardiopulmonary diseases need to exercise special caution. When used with tricyclic antidepressants, the muscle relaxant effect may be enhanced. When taken with antihypertensives, blood pressure may drop too low, requiring dose adjustments. Parkinson's disease patients taking this medication along with levodopa may experience side effects such as confusion, hallucinations, and headaches. During pregnancy, this medication crosses the placenta, so the risks to the fetus and the therapeutic effects must be carefully considered before use. In breastfeeding, this medication is secreted in small amounts into breast milk, which usually has no significant effect on the baby, but consultation with a specialist is advised if necessary. The elderly should start with a low dose and observe their condition carefully due to declining bodily functions.

Side effects

  • Sedation
  • drowsiness
  • respiratory function inhibition
  • dizziness
  • lethargy
  • fatigue
  • exhaustion
  • mental confusion
  • vertigo
  • headache
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  • insomnia
  • paranoia
  • depression
  • muscle weakness
  • ataxia
  • tremors
  • hallucinations
  • nightmares
  • myalgia
  • nystagmus
  • thirst
  • sensory disturbances
  • speech disorders
  • seizures
  • encephalopathy
  • visual adjustment disorders
  • visual impairment
  • strabismus
  • taste disorders
  • tinnitus
  • nausea
  • mild gastrointestinal disturbance
  • queasiness
  • involuntary vomiting
  • loss of appetite
  • discomfort in the stomach area
  • abdominal bloating
  • heartburn
  • constipation
  • diarrhea
  • abdominal pain
  • occult blood in stool
  • hypotension
  • decreased cardiac output
  • impaired cardiovascular function
  • tachycardia
  • bradycardia
  • palpitations
  • syncope
  • chest pain
  • urinary frequency
  • polyuria
  • dysuria
  • urinary retention
  • impotence
  • hematuria
  • liver function impairment
  • abnormal liver function test results
  • sweating
  • skin rash
  • increased rigidity
  • edema
  • chest tightness
  • perspiration
  • shortness of breath
  • elevated blood sugar levels
  • weight gain
  • congestion
  • anxiety
  • agitation
  • confusional state
  • psychosis
  • mania
  • paranoid state
  • status epilepticus
  • movement disorders
  • rhabdomyolysis
  • hyperthermia
  • akathisia
  • suicidal and suicide-related cases
  • drug abuse
  • misuse and dependence
  • drowsiness
  • decreased level of consciousness
  • confusion
  • myotonic dystrophy
  • coma
  • depression
  • consciousness disorder
  • coma
  • delirium
  • agitation
  • coordination disorder
  • loss of pupillary reflex
  • generalized muscle tone decrease
  • hyporeflexia
  • areflexia
  • peripheral vasodilation
  • hypothermia
  • vomiting
  • increased salivation
  • elevated liver enzyme levels
  • rhabdomyolysis
  • generalized slow waves on EEG

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent exposure to air, and it is recommended to store it at a temperature between 1 to 30 degrees Celsius at room temperature. This will help safely maintain the efficacy of the medication.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 500 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.