Medication info
Frex Tablet (Baclofen)

Frex Tablet (Baclofen)

Prescription medicationTabletOral
Ingredient · strength
Baclofen›20mg / 1 tablet
Manufacturer / importer
Korea United Pharmaceutical Co., Ltd.
Appearance
Light blue round tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 199001340 · Notified 1990.10.13 · Insurance code 644304550

Summary

Main use
Relief of spasticity associated with central nervous system disorders (such as multiple sclerosis and spinal cord or cerebral disorders)
Who takes it
Adults · Children
Adult dose
Treatment with this drug should always be initiated at a low dose and gradually increased. The optimal dose should be individualized for each patient to reduce clonus, flexor and extensor rigidity, and spasms while avoiding adverse effects as far as possible. Use with caution when muscle tone is needed to maintain balance in an upright posture and during movement, as well as to preserve function, in order to prevent excessive muscle weakness and falls. It is important to allow transient spasms that maintain some degree of muscle tone and help support circulatory function. Take this drug with a small amount of water during meals. The daily dose should be administered orally in 3 divided doses in adults. Administer 5㎎ of baclofen per dose orally 3 times daily, and increase by 5㎎ per dose 3 times daily at 3-day intervals until the optimal dose is determined. For patients who are hypersensitive to this drug, it is advisable to start with a lower dose (5-10㎎ per day) and increase it slowly. The optimal dose is usually 30-80㎎ per day. In hospitalized patients, 100-120㎎ per day may be administered under close supervision.
Child dose
12 months to 18 years: 0.3 mg/kg per day in 2~4 divided doses; the usual maintenance daily dose is 0.75~2mg/kg. Under 8 years: The maximum daily dose is 40mg. 8 years and older: The maximum daily dose is 60mg. The daily dose should be administered orally in 4 divided doses in children. Increase the dose carefully at intervals of approximately 1-2 weeks until it meets the individual patient's requirements. If no clear therapeutic effect is seen within 6-8 weeks after reaching the maximum dose, reconsider whether to continue this drug.

Ingredients

Manufacturer
Korea United Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of spasticity associated with central nervous system disorders (such as multiple sclerosis and spinal cord or cerebral disorders)

  • Muscle stiffness due to multiple sclerosis
  • muscle stiffness due to spinocerebellar degeneration
  • stiffness from spinal disorders
  • spastic spinal paralysis
  • amyotrophic lateral sclerosis
  • syringomyelia
  • transverse myelitis
  • traumatic paraplegia
  • spinal compression
  • other spinal diseases
  • rigidity caused by cerebral origin
  • cerebral palsy
View approved original text

This medication helps relieve muscle stiffness due to multiple sclerosis and spinocerebellar degeneration. It is also effective for stiffness caused by various spinal disorders, including spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia, and spinal compression, among others. Additionally, it is used to alleviate cerebral causes of rigidity caused by cerebral palsy, cerebrovascular accidents, neoplastic, and degenerative brain diseases. This drug improves muscle stiffness symptoms caused by various neurological disorders, thereby helping enhance the patient's motor function.

How to take

Adult dose

Treatment with this drug should always be initiated at a low dose and gradually increased. The optimal dose should be individualized for each patient to reduce clonus, flexor and extensor rigidity, and spasms while avoiding adverse effects as far as possible. Use with caution when muscle tone is needed to maintain balance in an upright posture and during movement, as well as to preserve function, in order to prevent excessive muscle weakness and falls. It is important to allow transient spasms that maintain some degree of muscle tone and help support circulatory function. Take this drug with a small amount of water during meals. The daily dose should be administered orally in 3 divided doses in adults. Administer 5㎎ of baclofen per dose orally 3 times daily, and increase by 5㎎ per dose 3 times daily at 3-day intervals until the optimal dose is determined. For patients who are hypersensitive to this drug, it is advisable to start with a lower dose (5-10㎎ per day) and increase it slowly. The optimal dose is usually 30-80㎎ per day. In hospitalized patients, 100-120㎎ per day may be administered under close supervision.

Child dose

12 months to 18 years: 0.3 mg/kg per day in 2~4 divided doses; the usual maintenance daily dose is 0.75~2mg/kg. Under 8 years: The maximum daily dose is 40mg. 8 years and older: The maximum daily dose is 60mg. The daily dose should be administered orally in 4 divided doses in children. Increase the dose carefully at intervals of approximately 1-2 weeks until it meets the individual patient's requirements. If no clear therapeutic effect is seen within 6-8 weeks after reaching the maximum dose, reconsider whether to continue this drug.

Precautions

This medication should not be used in patients who are allergic to it or any of its other components. This medication contains lactose, so it should not be administered to patients with genetic issues that impair lactose digestion. Patients with conditions such as psychosis, schizophrenia, bipolar disorder, confusion, or Parkinson's disease should use this medication cautiously, as it may worsen symptoms, and their condition should be monitored closely. Patients with a history of epilepsy may have an increased risk of seizures due to this medication, so appropriate treatment should be maintained, and their condition carefully monitored. Patients with peptic ulcers or a history of such, heart failure, cardiovascular diseases, cerebrovascular diseases, or respiratory diseases should also exercise caution when using this medication. Patients with liver or kidney function impairment should receive this medication in small amounts with caution, especially those undergoing dialysis, who should only use very low doses. This medication can improve nerve-related urinary disorders, but acute urinary retention may occur in patients with high sphincter tone, so caution is necessary. Children with a history of epilepsy are at risk of seizures, so this medication should be used judiciously. Taking this medication may result in side effects such as sedation and drowsiness, which usually alleviate when the dosage is increased gradually. Patients with mental disorders or cerebrovascular disorders, as well as the elderly, may experience severe side effects, so careful monitoring is required. If this medication is suddenly discontinued after long-term use, severe symptoms such as anxiety, confusion, hallucinations, and seizures may occur, so the dosage should be tapered off gradually. During treatment with this medication, dizziness and drowsiness may occur, so driving or operating dangerous machinery should be avoided. This medication may affect liver function or blood sugar levels; thus, patients with liver disease or diabetes should undergo regular check-ups. Patients taking this medication may exhibit toxic symptoms if they have impaired kidney function, so careful observation is essential. Some patients receiving this medication may have an increased risk of suicide; therefore, patients and caregivers should closely monitor mood changes or unusual behavior and report any abnormalities to the healthcare provider immediately. This medication may have enhanced sedative effects and increase the risk of respiratory depression when taken with other central nervous system drugs or alcohol, so caution is advised. Pregnant patients should carefully consider the risks to the fetus and the benefits of this medication before use, and very small amounts may be secreted in breast milk during breastfeeding, which is not expected to have a significant impact on the baby. The elderly may have reduced physiological functions, so low doses should be initiated while monitoring their condition. In the case of overdose, severe symptoms such as central nervous system depression, breathing difficulties, blood pressure changes, and seizures can occur, and immediate medical treatment should be sought. There is no specific antidote, so appropriate treatment tailored to the symptoms should be implemented, including gastric lavage, activated charcoal, or artificial respiration, and dialysis may be helpful in cases of impaired kidney function.

Side effects

  • Sedation
  • drowsiness
  • respiratory function suppression
  • dizziness
  • lethargy
  • fatigue
  • exhaustion
  • mental confusion
  • vertigo
  • headache
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  • insomnia
  • joylessness
  • depression
  • muscle weakness
  • ataxia
  • tremors
  • hallucinations
  • nightmares
  • myalgia
  • ocular myoclonus
  • thirst
  • sensory disturbances
  • speech disorders
  • convulsions
  • encephalopathy
  • visual impairment
  • visual field disorders
  • diplopia
  • taste disorders
  • tinnitus
  • nausea
  • mild gastrointestinal disturbances
  • queasiness
  • involuntary vomiting
  • decreased appetite
  • gastric discomfort
  • abdominal bloating
  • heartburn
  • constipation
  • diarrhea
  • abdominal pain
  • occult blood in stool
  • hypotension
  • decreased cardiac output
  • cardiovascular dysfunction
  • tachycardia
  • bradycardia
  • palpitations
  • syncope
  • chest pain
  • frequent urination
  • polyuria
  • dysuria
  • urinary retention
  • erectile dysfunction
  • hematuria
  • liver function impairment
  • abnormal liver function tests
  • hyperhidrosis
  • skin rash
  • increased rigidity
  • edema
  • chest tightness
  • sweating
  • dyspnea
  • increased blood glucose levels
  • weight gain
  • congestion

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the medication's efficacy and prevents it from deteriorating.

Appearance and packaging

Appearance

Light blue round tablet

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.