Medication info
Baclon Tablet 5 mg (Baclofen)

Baclon Tablet 5 mg (Baclofen)

Prescription medicationTabletOral
Ingredient · strength
Baclofen›5mg / 1 tablet
Manufacturer / importer
Taijun Pharmaceutical Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 198701585 · Approved 1987.01.17 · Insurance code 650100400

Summary

Main use
Relief of spasticity caused by nervous system disorders (multiple sclerosis, etc.), spinal cord disorders, and cerebral disorders
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) The total daily dose should be administered orally in 4 divided doses in 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). 12 months~18 years: The usual daily maintenance 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. Increase the dose cautiously at intervals of approximately 1-2 weeks until it is appropriate for the individual's needs. 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
Taijun Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of spasticity caused by nervous system disorders (multiple sclerosis, etc.), spinal cord disorders, and cerebral disorders

  • Spasticity of skeletal muscles due to multiple sclerosis
  • spinocerebellar degeneration
  • spasticity due to spinal disorders
  • spastic spinal paralysis
  • amyotrophic lateral sclerosis
  • syringomyelia
  • transverse myelitis
  • traumatic paraplegia
  • spinal cord compression syndrome
  • other spinal diseases
  • spasticity due to cerebral causes
  • cerebral palsy
View approved original text

This medication is primarily used to relieve skeletal muscle spasticity caused by multiple sclerosis or spinocerebellar degeneration. It is also effective for spasticity due to spinal disorders, such as inflammatory, degenerative, and traumatic causes. These include spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, and traumatic paraplegia. Spasticity due to cerebral causes, particularly muscle stiffness resulting from cerebral palsy or cerebrovascular accidents, is also treated. In summary, it is used to alleviate muscle spasticity symptoms resulting from various neurological disorders.

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) The total daily dose should be administered orally in 4 divided doses in 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). 12 months~18 years: The usual daily maintenance 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. Increase the dose cautiously at intervals of approximately 1-2 weeks until it is appropriate for the individual's needs. 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 with specific allergic reactions or genetic lactose intolerance. Patients with mental disorders, epilepsy, peptic ulcers, cardiovascular and respiratory diseases should use this medication very cautiously and monitor their condition closely. During the use of this drug, side effects such as sedation, drowsiness, and dizziness may occur, so it is advisable to avoid driving or operating dangerous machinery. Patients with weakened liver or kidney function may require dosage adjustment, and sudden discontinuation after long-term use can lead to various severe side effects, so it should be tapered gradually. Concomitant use with other central nervous system-affecting drugs or alcohol may exacerbate side effects. Women who are pregnant or breastfeeding should consult a physician before taking this medication and consider its effects on the fetus or newborn. Older adults may have reduced physical function, so they should start with a lower dose and monitor their condition closely. In case of overdose, severe symptoms such as central nervous system depression, respiratory distress, and abnormal blood pressure may occur, necessitating immediate emergency care and treatment as directed by medical personnel.

Side effects

  • Sedation
  • drowsiness
  • respiratory depression
  • dizziness
  • lethargy
  • fatigue
  • exhaustion
  • confusion
  • vertigo
  • headache
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  • insomnia
  • anxiety
  • depression
  • muscle weakness
  • ataxia
  • tremors
  • hallucinations
  • nightmares
  • myalgia
  • nystagmus
  • thirst
  • sensory disturbance
  • dysarthria
  • seizures
  • encephalopathy
  • visual disturbances
  • vision impairment
  • strabismus
  • taste disturbance
  • tinnitus
  • nausea
  • mild gastrointestinal disturbance
  • emesis
  • involuntary vomiting
  • anorexia
  • 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
  • polyuria
  • nocturia
  • dysuria
  • urinary retention
  • erectile dysfunction
  • hematuria
  • liver dysfunction
  • abnormal liver function tests
  • hyperhidrosis
  • skin rash
  • increased rigidity
  • edema
  • chest tightness
  • sweating
  • respiratory distress
  • increased blood sugar levels
  • weight gain
  • nasal congestion

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

Storage

This medication does not require special refrigeration and can be safely stored at room temperature. Normal room temperature refers to between 15 degrees and 25 degrees, and it is advisable to keep it away from direct sunlight and in a dry place.

Appearance and packaging

Appearance

White 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.