Medication info
Baclan Tablet 10 mg (Baclofen)

Baclan Tablet 10 mg (Baclofen)

Prescription medicationTabletOral
Ingredient · strength
Baclofen›10mg / 1 tablet
Manufacturer / importer
Yuyoung Pharmaceutical Co., Ltd.
Appearance
Yellow round tablets
Packaging
For domestic use: 30 tablets/bottle, 500 tablets/bottle For export: 100 tablets (10 tablets/PTP package x 10)
Approval status
Active

MFDS item code 198501456 · Notified 1985.11.05 · Insurance code 648200500

Summary

Main use
Relief of spasticity caused by spinal cord disorders, cerebral disorders, multiple sclerosis, and spinocerebellar degeneration
Who takes it
Adults · Children
Adult dose
Treatment with this drug should always be started at a low dose, which is gradually increased. The optimal dose should be individualized for each patient to reduce clonus, flexor and extensor spasticity, and spasms while avoiding adverse effects as far as possible. Use with caution to prevent excessive muscle weakness and falls when muscle tone is needed to maintain balance in an upright posture and during movement, and to preserve function. It is important to allow transient spasms that help maintain some muscle tone and 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 baclofen 5㎎ orally 3 times daily, and increase the dose by 5㎎ per dose, 3 times daily, at 3-day intervals until the optimal dose is established. In patients who are hypersensitive to this drug, it is advisable to start at a lower dose (5-10㎎ daily) and increase it slowly. The optimal dose is usually 30-80㎎ daily. Hospitalized patients may receive 100-120㎎ daily under close supervision.
Child dose
Pediatric patients (12 months–18 years): The daily dose is administered orally in 4 divided doses. Pediatric patients (12 months–18 years): Treatment is generally initiated at a very low dose (0.3 mg/kg/day in 2–4 divided doses). Pediatric patients (12 months–18 years): The usual daily maintenance dose is 0.75–2 mg/kg. Children under 8 years: The maximum daily dose is 40mg. Children 8 years and older: The maximum daily dose is 60mg. Pediatric patients (12 months–18 years): Increase the dose cautiously at intervals of approximately 1-2 weeks until it is appropriate for the individual patient's needs. Pediatric patients (12 months–18 years): If no clear therapeutic effect is observed within 6-8 weeks after administration of the maximum dose, reconsider whether to continue this medicine.

Ingredients

Manufacturer
Yuyoung Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of spasticity caused by spinal cord disorders, cerebral disorders, multiple sclerosis, and spinocerebellar degeneration

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

This medication is used to relieve skeletal muscle spasticity caused by multiple sclerosis or spinal cerebellar degeneration. It is also effective for treating spasticity from spinal diseases such as spastic spinal paralysis, transverse myelitis, traumatic paraplegia, and various other causes. It helps with spasticity due to cerebral causes, particularly in conditions like cerebral palsy, sequelae from cerebrovascular accidents, and both neoplastic and degenerative brain diseases. This medication is used to improve the symptoms of muscle rigidity in these conditions, aiding patient movement and enhancing quality of life.

How to take

Adult dose

Treatment with this drug should always be started at a low dose, which is gradually increased. The optimal dose should be individualized for each patient to reduce clonus, flexor and extensor spasticity, and spasms while avoiding adverse effects as far as possible. Use with caution to prevent excessive muscle weakness and falls when muscle tone is needed to maintain balance in an upright posture and during movement, and to preserve function. It is important to allow transient spasms that help maintain some muscle tone and 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 baclofen 5㎎ orally 3 times daily, and increase the dose by 5㎎ per dose, 3 times daily, at 3-day intervals until the optimal dose is established. In patients who are hypersensitive to this drug, it is advisable to start at a lower dose (5-10㎎ daily) and increase it slowly. The optimal dose is usually 30-80㎎ daily. Hospitalized patients may receive 100-120㎎ daily under close supervision.

Child dose

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

Precautions

This medication should not be used in certain patients. For example, individuals allergic to this medication or its ingredients, or those with lactose intolerance, should not take it. Patients with mental illness, epilepsy, peptic ulcers, cardiovascular diseases, liver dysfunction, or renal impairment should use this medication cautiously, and their condition should be closely monitored. Special caution is needed for children with a history of epilepsy, as there is a risk of seizures. Taking this medication may result in CNS-related side effects such as drowsiness, sedation, and dizziness, which can be alleviated by adjusting the dose. Additionally, various side effects such as liver dysfunction, digestive issues, cardiovascular anomalies, and skin rashes have been reported; therefore, if any unusual symptoms occur, immediate consultation with a healthcare professional is necessary. Sudden discontinuation after long-term use can lead to serious symptoms such as anxiety, hallucinations, and seizures, so it is important to taper off gradually. During the course of this medication, one should avoid driving or operating hazardous machinery, and it is advisable to have regular liver function and blood glucose tests. Patients with renal dysfunction must be particularly careful, and those with a history of drug abuse should be carefully monitored for potential dependence. In pregnant or breastfeeding women, careful consideration should be given to the potential effects on the fetus or neonate prior to administration. Elderly patients may experience side effects more easily due to decreased body functions, so starting with a lower dose and monitoring their condition during treatment is recommended. In cases of overdose, symptoms such as CNS depression, respiratory distress, and seizures may appear, requiring immediate emergency treatment as there is no specific antidote; treatment should involve symptomatic care such as gastric lavage, activated charcoal administration, and artificial respiration. This medication may interact with other CNS depressants, alcohol, tricyclic antidepressants, and antihypertensives, potentially exacerbating side effects, so caution is advised.

Side effects

  • Calmness
  • drowsiness
  • respiratory depression
  • headache
  • fatigue
  • tiredness
  • mental confusion
  • dizziness
  • headache
  • insomnia
Show 57 more
  • anxiety
  • depression
  • muscle weakness
  • ataxia
  • tremors
  • hallucinations
  • nightmares
  • myalgia
  • nystagmus
  • thirst
  • sensory disturbance
  • dysarthria
  • seizures
  • encephalopathy
  • visual disturbances
  • visual impairment
  • strabismus
  • taste disturbances
  • tinnitus
  • nausea
  • mild gastrointestinal disturbances
  • nausea
  • involuntary vomiting
  • loss of appetite
  • abdominal discomfort
  • abdominal distension
  • heartburn
  • constipation
  • diarrhea
  • abdominal pain
  • occult blood in stool
  • hypotension
  • decreased cardiac output
  • impaired cardiovascular function
  • tachycardia
  • bradycardia
  • palpitations
  • syncope
  • chest pain
  • frequency of urination
  • polyuria
  • difficulty urinating
  • urinary retention
  • erectile dysfunction
  • hematuria
  • liver dysfunction
  • abnormal liver function tests
  • sweating
  • skin rash
  • increased rigidity
  • edema
  • chest tightness
  • sweating
  • dyspnea
  • elevated 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 closed container to prevent exposure to air or moisture. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius to ensure the effectiveness of the medication for an extended period.

Appearance and packaging

Appearance

Yellow round tablets

Package unit

For domestic use: 30 tablets/bottle, 500 tablets/bottle For export: 100 tablets (10 tablets/PTP package x 10)

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.