Medication info
Frex Tablet 10 mg (Baclofen)

Frex Tablet 10 mg (Baclofen)

Prescription medicationTabletOral
Ingredient · strength
Baclofen›10mg / 1 tablet
Manufacturer / importer
Korea United Pharmaceutical Co., Ltd.
Appearance
Round tablets of pale yellow to light green
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 199101449 · Notified 1991.10.28 · Insurance code 644304560

Summary

Main use
Relief of spasticity due to spinal cord and cerebral disorders, multiple sclerosis, and spinocerebellar degeneration
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 clonic spasms, flexor and extensor rigidity, and convulsions while avoiding adverse effects as much as possible. Use with caution to prevent excessive muscle weakness and falls when muscle tone is needed to maintain an upright posture and balance during movement, and to preserve function. It is important to allow temporary spasms that maintain some muscle tone and help support circulatory function. Take this drug with meals with a small amount of water. For adults, administer orally in 3 divided doses per day. Administer baclofen 5㎎ orally 3 times daily. Increase the dose by 5㎎ per dose, 3 times daily, at 3-day intervals until the optimal dose is established. For patients who are hypersensitive to this drug, it is advisable to start at a lower dose (5-10㎎ per day) and increase it slowly. The optimal dose is usually 30-80㎎ per day. Hospitalized patients may receive 100-120㎎ per day under close supervision.
Child dose
For children, administer orally in 4 divided doses per day. 12 months~18 years: Treatment is generally initiated at a very low dose (0.3 mg/kg per day in 2~4 divided doses). 12 months~18 years: The usual maintenance dose is 0.75~2mg/kg per day. Children younger than 8 years: The maximum daily dose is 40mg. Children 8 years and older: The maximum daily dose is 60mg. Increase the dose carefully at intervals of approximately 1-2 weeks until the individual requirement is met. If no clear therapeutic effect is observed within 6-8 weeks after administration of the maximum dose, reconsider whether treatment with this drug should be continued.

Ingredients

Manufacturer
Korea United Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of spasticity due to spinal cord and cerebral disorders, multiple sclerosis, and spinocerebellar degeneration

  • Skeletal muscle stiffness
  • rigidity
  • spastic paraplegia
  • amyotrophic lateral sclerosis
  • syringomyelia
  • transverse myelitis
  • traumatic limb paralysis
  • spinal compression
  • other spinal diseases
  • cerebral cause rigidity
View approved original text

This medication helps relieve skeletal muscle stiffness caused by multiple sclerosis or spinocerebellar degeneration. It is also used for improving stiffness symptoms due to spinal diseases such as spastic paraplegia or transverse myelitis, which occur due to various causes. In addition, it is effective for muscle stiffness caused by cerebral reasons such as cerebral palsy and cerebrovascular accidents. By alleviating muscle stiffness that appears in various neurological disorders, it helps improve patients' 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 clonic spasms, flexor and extensor rigidity, and convulsions while avoiding adverse effects as much as possible. Use with caution to prevent excessive muscle weakness and falls when muscle tone is needed to maintain an upright posture and balance during movement, and to preserve function. It is important to allow temporary spasms that maintain some muscle tone and help support circulatory function. Take this drug with meals with a small amount of water. For adults, administer orally in 3 divided doses per day. Administer baclofen 5㎎ orally 3 times daily. Increase the dose by 5㎎ per dose, 3 times daily, at 3-day intervals until the optimal dose is established. For patients who are hypersensitive to this drug, it is advisable to start at a lower dose (5-10㎎ per day) and increase it slowly. The optimal dose is usually 30-80㎎ per day. Hospitalized patients may receive 100-120㎎ per day under close supervision.

Child dose

For children, administer orally in 4 divided doses per day. 12 months~18 years: Treatment is generally initiated at a very low dose (0.3 mg/kg per day in 2~4 divided doses). 12 months~18 years: The usual maintenance dose is 0.75~2mg/kg per day. Children younger than 8 years: The maximum daily dose is 40mg. Children 8 years and older: The maximum daily dose is 60mg. Increase the dose carefully at intervals of approximately 1-2 weeks until the individual requirement is met. If no clear therapeutic effect is observed within 6-8 weeks after administration of the maximum dose, reconsider whether treatment with this drug should be continued.

Precautions

This medicine should not be used in patients who are allergic to this drug or any of its components. This drug contains lactose, and should not be administered to patients with hereditary diseases that cause lactose intolerance. Caution is needed for patients with psychiatric disorders or neurological disorders, as symptoms may worsen; their condition should be closely monitored. Patients with a history of epilepsy should be treated and monitored appropriately, as this drug may trigger seizures. Patients with peptic ulcers, heart failure, cardiovascular, cerebrovascular, respiratory, liver or kidney problems should be administered with caution. Especially in patients with severely impaired kidney function, drug concentration may increase, thus requiring adjustment to a very low dose. This drug can suppress respiration due to its muscle relaxant effect, so patients with respiratory diseases should be cautious. Children, especially those with epilepsy, should be used with caution due to the risk of seizures. Patients allergic to the dye included in this drug should be careful. During initial treatment, side effects such as drowsiness or sedation may commonly occur, but these symptoms are usually temporary and can be alleviated by adjusting the dosage. Elderly patients with a history of psychiatric disorders or strokes may experience more severe side effects, so caution is necessary. During the course of this medication, dizziness or drowsiness may occur, so driving or operating dangerous machinery should be avoided. There may be changes in liver function or blood sugar levels, so patients with liver disease or diabetes should have regular check-ups. Patients with a history of substance abuse should be closely monitored for the risk of drug dependence or misuse. The risks to the fetus during pregnancy have not been completely clarified, so it should be used cautiously only if necessary. Although small amounts of the drug's components are secreted during breastfeeding, it should be administered carefully considering the possibility of adverse reactions. Elderly patients may experience side effects easily due to diminished bodily functions, so they should start at a low dose and be monitored for their condition. In cases of overdose, severe symptoms such as central nervous system depression, respiratory impairment, and blood pressure changes may occur, requiring immediate emergency treatment. There is no specific antidote for overdose, and treatment may require gastric lavage, administration of adsorbents, or artificial respiration.

Side effects

  • Sedation
  • drowsiness
  • respiratory function suppression
  • headache
  • fatigue
  • exhaustion
  • mental confusion
  • dizziness
  • headache
  • insomnia
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  • apathy
  • depression
  • muscle weakness
  • ataxia
  • tremors
  • hallucinations
  • nightmares
  • myalgia
  • nystagmus
  • dry mouth
  • sensory disturbances
  • dysarthria
  • convulsions
  • encephalopathy
  • visual disturbances
  • visual impairment
  • strabismus
  • taste disturbances
  • tinnitus
  • nausea
  • mild gastrointestinal disorders
  • nausea
  • involuntary vomiting
  • loss of appetite
  • upper abdominal discomfort
  • abdominal bloating
  • heartburn
  • constipation
  • diarrhea
  • abdominal pain
  • occult blood in stool
  • hypotension
  • decreased cardiac output
  • cardiovascular dysfunction
  • tachycardia
  • bradycardia
  • palpitations
  • syncope
  • chest pain
  • increased urinary frequency
  • nocturia
  • dysuria
  • urinary retention
  • erectile dysfunction
  • hematuria
  • liver dysfunction
  • abnormal liver function tests
  • hyperhidrosis
  • skin rash
  • increased rigidity
  • edema
  • chest tightness
  • sweating
  • shortness of breath
  • elevated blood glucose levels
  • weight gain
  • congestion
  • anxiety
  • agitation
  • confused state
  • psychosis
  • mania
  • paranoid state
  • status epilepticus
  • movement disorders
  • tachycardia
  • rhabdomyolysis
  • high fever
  • paradoxical reactions
  • dizziness
  • decreased attention span
  • increased serum AST
  • increased ALP
  • increased blood glucose levels
  • confusion
  • loss of sense of direction
  • depressed consciousness
  • suicide and suicide-related cases
  • substance abuse
  • misuse
  • dependence
  • drowsiness
  • decreased level of consciousness
  • hepatic myoclonus
  • coma
  • depression
  • consciousness disorder
  • coma
  • confusion
  • agitation
  • coordination disorder
  • loss of pupillary reflex
  • generalized muscle tone decrease
  • hyporeflexia
  • areflexia
  • peripheral vasodilation
  • hypothermia
  • nausea
  • vomiting
  • diarrhea
  • increased saliva secretion
  • elevated liver enzymes
  • rhabdomyolysis

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

Storage

This drug should be stored in a tightly sealed container to prevent air exposure, and it is recommended to keep it at a temperature between 1 degree and 30 degrees Celsius at room temperature. This way of storage can help maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Round tablets of pale yellow to light green

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.