Medication info
Samsung Baclofen Tablets

Samsung Baclofen Tablets

Prescription medicationTabletOral
Ingredient · strength
Baclofen›10mg / 1 tablet
Manufacturer / importer
Samsung Pharm Co., Ltd.
Appearance
White round tablets
Packaging
30 tablets/bottle, 300 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200000452 · Notified 2000.03.02 · Insurance code 642301360

Summary

Main use
Relief of muscle stiffness associated with spinal cord disorders, cerebral disorders, multiple sclerosis, and other conditions
Who takes it
Adults · Children
Adult dose
Treatment with this medication 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 clonic spasms, flexor and extensor rigidity, and spasms 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 balance while standing and moving, and to preserve function. It is important to allow transient spasms that help maintain some muscle tone and perform circulatory function. Take this medication with a small amount of water during meals. The daily dose should be administered orally in divided doses 3 times daily in adults and 4 times daily in children. Administer baclofen orally at a dose of 5㎎ 3 times daily, increasing the dose by 5㎎ per dose 3 times daily at 3-day intervals until the optimal dose is established. Patients with hypersensitivity to this medication should preferably 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
12 months to 18 years: Treatment is generally given at a very low dose (0.3 mg/kg daily in 2 to 4 divided doses). 12 months to 18 years: The usual maintenance dose is 0.75~2mg/kg daily. Under 8 years: The maximum daily dose is 40mg. 8 years and older: The maximum daily dose is 60mg. Increase the dose carefully at intervals of approximately 1-2 weeks until it is appropriate for the individual patient's needs. If no clear therapeutic effect is seen within 6-8 weeks after administration of the maximum dose, reconsider whether to continue this medication.

Ingredients

Manufacturer
Samsung Pharm Co., Ltd.

Efficacy & effects

Relief of muscle stiffness associated with spinal cord disorders, cerebral disorders, multiple sclerosis, and other conditions

  • Spasticity of skeletal muscles caused by multiple sclerosis
  • spasticity due to spinocerebellar degeneration
  • spasticity from spinal disorders
  • spastic paraplegia
  • 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 helps to relieve skeletal muscle spasticity caused by multiple sclerosis or spinocerebellar degeneration. It is also effective for spasticity resulting from spinal diseases, such as spastic paraplegia or amyotrophic lateral sclerosis. It is used in cases of spasticity due to cerebral disorders, especially in neurological diseases such as cerebral palsy or cerebrovascular accidents. In summary, this medication is used to improve muscle spasticity caused by several central nervous system disorders.

How to take

Adult dose

Treatment with this medication 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 clonic spasms, flexor and extensor rigidity, and spasms 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 balance while standing and moving, and to preserve function. It is important to allow transient spasms that help maintain some muscle tone and perform circulatory function. Take this medication with a small amount of water during meals. The daily dose should be administered orally in divided doses 3 times daily in adults and 4 times daily in children. Administer baclofen orally at a dose of 5㎎ 3 times daily, increasing the dose by 5㎎ per dose 3 times daily at 3-day intervals until the optimal dose is established. Patients with hypersensitivity to this medication should preferably 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

12 months to 18 years: Treatment is generally given at a very low dose (0.3 mg/kg daily in 2 to 4 divided doses). 12 months to 18 years: The usual maintenance dose is 0.75~2mg/kg daily. Under 8 years: The maximum daily dose is 40mg. 8 years and older: The maximum daily dose is 60mg. Increase the dose carefully at intervals of approximately 1-2 weeks until it is appropriate for the individual patient's needs. If no clear therapeutic effect is seen within 6-8 weeks after administration of the maximum dose, reconsider whether to continue this medication.

Precautions

This medication should not be used by patients with allergies to specific ingredients. Since it contains lactose, patients with genetic diseases that prevent lactose digestion should also avoid using it. Patients with mental or neurological disorders should use it cautiously as their symptoms may worsen. Patients with epilepsy should be monitored closely as seizures may occur with this medication. Patients with peptic ulcers, heart failure, cardiovascular and cerebrovascular diseases, respiratory diseases, liver dysfunction, and renal impairment should take it with caution. In particular, patients with very poor kidney function should take a small dose and carefully monitor blood concentration. This medication may affect urination, causing acute urinary retention in patients with related neural disorders, therefore caution is advised. Children, especially those with a history of epilepsy, should be careful due to the risk of seizures. Sedation or relaxation effects are common in the early stages of administration or when the dosage is increased rapidly, but these are usually temporary. Elderly patients with mental illnesses or cerebrovascular disorders may have more severe side effects. It is advisable to avoid driving or operating hazardous machinery while taking this medication. Liver function abnormalities or changes in blood glucose may occur, necessitating regular check-ups for patients with liver disease or diabetes. Patients with a history of drug abuse should be closely monitored for misuse or dependency risks. Abrupt discontinuation of this medication can lead to serious symptoms such as anxiety, confusion, or seizures, thus it should be reduced gradually. During pregnancy, it should only be used when necessary considering the risks to the fetus, and during breastfeeding, very small amounts may be secreted, so it should be administered cautiously. Elderly patients may experience side effects easily due to declining bodily functions, so they should start with a low dosage and observe their condition. In case of overdose, severe central nervous system depression, respiratory distress, seizures, and changes in blood pressure may occur, requiring immediate emergency treatment. This medication, when taken with other central nervous system depressants or alcohol, can enhance sedative effects and increase the risk of respiratory depression. Additionally, co-administration with certain antidepressants or antihypertensives can either enhance drug effects or cause side effects, so consultation with the prescribing physician is important.

Side effects

  • Sedation
  • drowsiness
  • respiratory depression
  • dizziness
  • lethargy
  • fatigue
  • exhaustion
  • mental confusion
  • vertigo
  • headache
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  • insomnia
  • melancholia
  • depression
  • muscular weakness
  • ataxia
  • tremors
  • hallucinations
  • nightmares
  • myalgia
  • oscillopsia
  • thirst
  • sensory disturbances
  • speech disorders
  • seizures
  • encephalopathy
  • visual disturbances
  • visual impairment
  • strabismus
  • taste disturbances
  • tinnitus
  • nausea
  • mild gastrointestinal disturbances
  • nausea
  • involuntary vomiting
  • loss of appetite
  • abdominal discomfort
  • bloating
  • heartburn
  • constipation
  • diarrhea
  • abdominal pain
  • occult blood in stool
  • hypotension
  • decreased cardiac output
  • impaired cardiovascular function
  • tachycardia
  • bradycardia
  • palpitations
  • syncope
  • chest pain
  • frequent urination
  • polyuria
  • dysuria
  • urinary retention
  • erectile dysfunction
  • hematuria
  • liver dysfunction
  • abnormal liver function tests
  • hyperhidrosis
  • skin rash
  • increased rigidity
  • edema
  • chest tightness
  • sweating
  • dyspnea
  • increased blood sugar 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 avoid exposure to air and moisture, and it should ideally be kept at a temperature between 1 degrees and 30 degrees Celsius. Proper storage helps to maintain the effectiveness of the medication over time.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 300 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.