Medication info

Celic Baclofen Tablet 10mg

Prescription medicationTabletOralExpired
Ingredient · strength
Baclofen›10mg / 1 tablet
Manufacturer / importer
Celic Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Expired

MFDS item code 199901718 · Notified 1999.07.21 · Insurance code 646200290

This product's status changed to Expired on 2025.10.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of spinal cord disease-related spasticity, skeletal muscle spasticity (e.g., multiple sclerosis), and cerebral spasticity
Who takes it
Adults · Children
Adult dose
Treatment with this medicine should always be started at a low dose, which is gradually increased. The optimal dose should be determined individually for each patient at a level that reduces myoclonic seizures, 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 balance while standing and moving, and to preserve function. It is important to allow transient spasms that help maintain some muscle tone and support circulatory function. Take this medicine with a small amount of water during meals. The daily dose for adults should be administered orally in 3 divided doses. ○ Adults 1. Administer 5㎎ of baclofen orally 3 times daily. Increase each dose by 5㎎, 3 times daily, at 3-day intervals until the optimal dose is determined. 2. For patients who are hypersensitive to this medicine, it is advisable to start with a lower dose (5-10㎎ per day) and increase it slowly. 3. The usual optimal dose is 30-80㎎ per day. Hospitalized patients may receive 100-120㎎ per day under close supervision.
Child dose
○ Children (12 months to 18 years) 1. Treatment is generally started at a very low dose (0.3 mg/kg per day in 2~4 divided doses). 2. The usual daily maintenance dose is 0.75~2mg/kg. 3. The maximum daily dose for children under 8 years is 40mg. 3. The maximum daily dose for children aged 8 years and older is 60mg. 4. Increase the dose carefully at intervals of about 1-2 weeks until it is appropriate for the individual patient'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 medicine. The daily dose for children should be administered orally in 4 divided doses.

Ingredients

Manufacturer
Celic Co., Ltd.

Efficacy & effects

Relief of spinal cord disease-related spasticity, skeletal muscle spasticity (e.g., multiple sclerosis), and cerebral spasticity

  • Spasticity of skeletal muscles due to multiple sclerosis and spinocerebellar degeneration
  • spasticity caused by 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
  • stroke
View approved original text

This medication is used to alleviate spasticity of skeletal muscles caused by multiple sclerosis or spinocerebellar degeneration. It is also effective for various types of spasticity due to spinal diseases, such as spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia, and spinal compression. It is also used to treat spasticity due to cerebral conditions, especially after cerebral palsy or stroke, as well as spasticity caused by neoplastic and degenerative brain diseases. This medication helps improve symptoms by reducing excessive muscle tension.

How to take

Adult dose

Treatment with this medicine should always be started at a low dose, which is gradually increased. The optimal dose should be determined individually for each patient at a level that reduces myoclonic seizures, 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 balance while standing and moving, and to preserve function. It is important to allow transient spasms that help maintain some muscle tone and support circulatory function. Take this medicine with a small amount of water during meals. The daily dose for adults should be administered orally in 3 divided doses. ○ Adults 1. Administer 5㎎ of baclofen orally 3 times daily. Increase each dose by 5㎎, 3 times daily, at 3-day intervals until the optimal dose is determined. 2. For patients who are hypersensitive to this medicine, it is advisable to start with a lower dose (5-10㎎ per day) and increase it slowly. 3. The usual optimal dose is 30-80㎎ per day. Hospitalized patients may receive 100-120㎎ per day under close supervision.

Child dose

○ Children (12 months to 18 years) 1. Treatment is generally started at a very low dose (0.3 mg/kg per day in 2~4 divided doses). 2. The usual daily maintenance dose is 0.75~2mg/kg. 3. The maximum daily dose for children under 8 years is 40mg. 3. The maximum daily dose for children aged 8 years and older is 60mg. 4. Increase the dose carefully at intervals of about 1-2 weeks until it is appropriate for the individual patient'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 medicine. The daily dose for children should be administered orally in 4 divided doses.

Precautions

This medication should not be used by patients with specific allergic reactions or hypersensitivity to any of the ingredients in this medication. Additionally, because it contains lactose, it should not be taken by patients with genetic diseases affecting lactose digestion. Patients with mental conditions or brain disorders should exercise caution when using this medication, as symptoms may worsen. Patients with a history of seizures should use this medication with caution due to the risk of seizures and should be closely monitored with appropriate treatment. Patients with peptic ulcers or diseases of the heart, blood vessels, or respiratory system should also use this medication with care. Patients with impaired liver or kidney function may require dosage adjustments or should use only small amounts due to increased medication concentration. This medication can affect urinary-related nerve problems and may cause acute urinary retention, so caution is advised. Particular care should be taken in children or those with a history of epilepsy, as there is an increased risk of seizures. Taking this medication may result in central nervous system adverse reactions such as drowsiness or sedation, usually appearing at the start of treatment and may improve with dosage adjustments. Elderly patients with mental disorders or cerebrovascular diseases may experience worsened reactions, requiring additional caution. Rapid discontinuation after long-term use may lead to severe symptoms like anxiety, confusion, and hallucinations, so the dosage should be gradually reduced. During treatment, there is a risk of accidents due to dizziness or drowsiness, so it is advised to avoid driving or operating dangerous machinery. Patients with liver disease or diabetes should undergo regular liver function tests and blood sugar monitoring. Patients with severely impaired kidney function may exhibit toxic symptoms during treatment, requiring close observation. This medication may increase the risk of suicide, so patients with depression or a history of suicidal thoughts need to be monitored thoroughly by healthcare professionals. Caution should be exercised when taking this medication with other central nervous system depressants, alcohol, or opioids as it may potentiate sedation and increase the risk of respiratory depression. When used with tricyclic antidepressants or antihypertensives, this medication may enhance effects leading to side effects, necessitating dosage adjustments. During pregnancy, it is only to be used when absolutely necessary due to potential risks to the fetus, and while breastfeeding, only small quantities are secreted into breast milk, with a low risk of adverse reactions. Elderly patients may experience side effects more easily due to decreased physical function, so treatment should start with lower doses and close observation is essential. In the event of overdose, severe symptoms such as central nervous system depression, respiratory difficulty, blood pressure changes, and seizures may occur, requiring immediate emergency treatment and appropriate therapies such as gastric lavage, activated charcoal administration, and artificial respiration.

Side effects

  • Calming
  • drowsiness
  • respiratory depression
  • dizziness
  • lethargy
  • fatigue
  • exhaustion
  • mental confusion
  • light-headedness
  • headache
Show 101 more
  • insomnia
  • anxiety
  • depression
  • muscle weakness
  • ataxia
  • tremors
  • hallucinations
  • nightmares
  • myalgia
  • nystagmus
  • thirst
  • sensory disturbances
  • speech disturbances
  • convulsions
  • visual disturbances
  • visual impairment
  • strabismus
  • taste disorders
  • tinnitus
  • nausea
  • mild gastrointestinal disturbances
  • nausea
  • involuntary vomiting
  • loss of appetite
  • discomfort in the stomach
  • abdominal bloating
  • heartburn
  • constipation
  • diarrhea
  • abdominal pain
  • fecal occult blood
  • hypotension
  • decreased cardiac output
  • cardiovascular dysfunction
  • tachycardia
  • bradycardia
  • palpitations
  • syncope
  • chest pain
  • frequent urination
  • polyuria
  • dysuria
  • urinary retention
  • erectile dysfunction
  • hematuria
  • liver dysfunction
  • abnormal liver function test results
  • sweating
  • skin rash
  • increased stiffness
  • edema
  • chest tightness
  • perspiration
  • respiratory distress
  • elevated blood sugar levels
  • weight gain
  • congestion
  • encephalopathy
  • anxiety
  • agitation
  • confusion
  • psychosis
  • mania
  • paranoid states
  • status epilepticus
  • movement disorders
  • tachycardia
  • rhabdomyolysis
  • hyperthermia
  • phenomena of emptiness
  • dizziness
  • decreased attention
  • increased serum AST
  • increased ALP
  • increased blood sugar levels
  • confusion
  • disorientation
  • depressed consciousness
  • suicide and suicide-related cases
  • drug abuse
  • misuse
  • dependence
  • depression
  • consciousness disorder
  • coma
  • respiratory impairment
  • agitation
  • cooperative movement disorders
  • loss of pupillary reflex
  • generalized muscle tone reduction
  • generalized muscle cramps
  • decreased reflexes
  • areflexia
  • peripheral vasodilation
  • hypothermia
  • nausea
  • vomiting
  • diarrhea
  • increased salivation
  • elevated liver enzyme levels
  • rhabdomyolysis

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 exposure to air or moisture. It is recommended to keep it at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness and safety.

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.

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.