Medication info
Daewoo Baclofen Tablet 10 mg

Daewoo Baclofen Tablet 10 mg

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

MFDS item code 199400569 · Notified 1994.09.27 · Insurance code 649600190

Summary

Main use
Relief of spasticity due to spinal cord disorders, skeletal muscle spasticity, and cerebral spasticity
Who takes it
Adults · Children
Adult dose
Treatment with this product should always be started at a low dose and increased gradually. The optimal dose should be determined individually for each patient as the dose 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 balance in an upright posture and during movement, as well as to preserve function. It is important to allow transient spasms that help maintain some muscle tone and support circulatory function. Take this product with meals and a small amount of water. In adults, the daily dose should be administered orally in 3 divided doses. Administer baclofen 5㎎ per dose orally 3 times daily, and increase by 5㎎ per dose, 3 times daily, at 3-day intervals until the optimal dose is established. For patients with hypersensitivity to this product, it is advisable to start at a lower dose (5-10㎎ per day) and increase slowly. 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 to 18 years): Treatment is generally started at a very low dose (0.3 mg/kg per day in 2~4 divided doses). Children (12 months to 18 years): The usual maintenance daily dose is 0.75~2mg/kg. Children under 8 years: The maximum daily dose is 40mg Children aged 8 years and older: The maximum daily dose is 60mg Children (12 months to 18 years): Increase the dose cautiously at intervals of approximately 1-2 weeks until it meets the individual patient's requirements. If no clear therapeutic effect is observed within 6-8 weeks after administration of the maximum dose, reconsider whether to continue this product. In children, administer orally in 4 divided doses per day.

Ingredients

Manufacturer
Daewoo Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of spasticity due to spinal cord disorders, skeletal muscle spasticity, and cerebral spasticity

  • Skeletal muscle stiffness due to multiple sclerosis
  • spinocerebellar degeneration
  • stiffness due to spinal diseases
  • spastic paraplegia
  • amyotrophic lateral sclerosis
  • syringomyelia
  • transverse myelitis
  • traumatic paraplegia
  • spinal compression
  • other spinal diseases
  • stiffness due to cerebral causes
  • cerebral palsy
View approved original text

This medication is used to relieve skeletal muscle stiffness caused by multiple sclerosis or spinocerebellar degeneration. It is also effective for stiffness due to various spinal diseases caused by inflammatory, degenerative, traumatic, or neoplastic origins, such as spastic paraplegia and transverse myelitis. It is also utilized to treat stiffness resulting from cerebral causes, particularly stiffness associated with cerebral palsy or cerebrovascular accidents. In summary, this drug is used to improve muscle stiffness due to neurological disorders.

How to take

Adult dose

Treatment with this product should always be started at a low dose and increased gradually. The optimal dose should be determined individually for each patient as the dose 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 balance in an upright posture and during movement, as well as to preserve function. It is important to allow transient spasms that help maintain some muscle tone and support circulatory function. Take this product with meals and a small amount of water. In adults, the daily dose should be administered orally in 3 divided doses. Administer baclofen 5㎎ per dose orally 3 times daily, and increase by 5㎎ per dose, 3 times daily, at 3-day intervals until the optimal dose is established. For patients with hypersensitivity to this product, it is advisable to start at a lower dose (5-10㎎ per day) and increase slowly. 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 to 18 years): Treatment is generally started at a very low dose (0.3 mg/kg per day in 2~4 divided doses). Children (12 months to 18 years): The usual maintenance daily dose is 0.75~2mg/kg. Children under 8 years: The maximum daily dose is 40mg Children aged 8 years and older: The maximum daily dose is 60mg Children (12 months to 18 years): Increase the dose cautiously at intervals of approximately 1-2 weeks until it meets the individual patient's requirements. If no clear therapeutic effect is observed within 6-8 weeks after administration of the maximum dose, reconsider whether to continue this product. In children, administer orally in 4 divided doses per day.

Precautions

This drug should not be used in patients who are allergic to this drug or any of its other components. Additionally, this drug contains lactose and should not be administered to patients with certain genetic disorders that impair lactose digestion. Patients with psychiatric disorders such as psychosis, schizophrenia, bipolar disorder, confusion, or Parkinson’s disease should be closely monitored and use this drug cautiously as it may exacerbate symptoms. Patients with a history of epilepsy should maintain appropriate treatment and closely observe their condition, as this drug may induce seizures. Patients with peptic ulcers, heart failure, cardiovascular diseases, cerebrovascular diseases, respiratory diseases, liver impairment, and renal function impairment should also use this drug with caution. Especially patients with severely impaired renal function should use very low doses, and patients undergoing prolonged dialysis should be more cautious as the blood concentration of this drug may increase. This drug may have muscle relaxant properties that can suppress respiration, so caution is needed in patients with respiratory diseases. Additionally, this drug may trigger seizures in children, especially those with a history of epilepsy, so it should be used cautiously. While taking this medication, side effects such as sedation, drowsiness, and dizziness may occur, and these symptoms generally appear during the initial treatment and decrease over time. Patients with a history of mental illness or cerebrovascular diseases, as well as the elderly, may experience more severe side effects and should be cautious. Patients who have been using this drug for a long time may experience serious symptoms such as anxiety, confusion, hallucinations, and seizures if they discontinue it suddenly, so dosage should be reduced gradually. During treatment, drowsiness or decreased attention may occur, so it is advisable to avoid dangerous activities such as driving or operating machinery. Patients with liver issues or diabetes should undergo regular blood tests to monitor changes in liver function or blood sugar levels. This drug should be used with special caution in patients with impaired renal function, and any neurological abnormalities should be reported to medical personnel immediately. Moreover, there may be an increased risk of suicidal thoughts or behaviors while taking this drug, so patients and caregivers should closely observe for symptoms. Caution should be exercised when this drug is taken with other medications that act on the central nervous system or alcohol, as it may enhance sedation effects and increase the risk of respiratory depression. During pregnancy, this drug should only be used when absolutely necessary, considering risks to the fetus, and during breastfeeding, it is only secreted in small amounts with a low possibility of adverse reactions, but caution is still warranted. Elderly patients should start with lower doses and observe their condition, as their bodily functions may be weakened. In cases of overdose, serious symptoms such as central nervous system depression, respiratory distress, seizures, and blood pressure anomalies may occur, requiring immediate medical attention.

Side effects

  • Sedation
  • drowsiness
  • respiratory depression
  • dizziness
  • fatigue
  • tiredness
  • mental confusion
  • vertigo
  • headache
  • insomnia
Show 99 more
  • anxiety
  • depression
  • muscle weakness
  • ataxia
  • tremors
  • hallucinations
  • nightmares
  • myalgia
  • nystagmus
  • thirst
  • sensory abnormalities
  • dysarthria
  • convulsions
  • encephalopathy
  • visual disturbances
  • visual impairment
  • strabismus
  • taste disorders
  • tinnitus
  • nausea
  • mild gastrointestinal disturbances
  • nausea
  • involuntary vomiting
  • loss of appetite
  • stomach discomfort
  • abdominal distension
  • heartburn
  • constipation
  • diarrhea
  • abdominal pain
  • occult blood in stool
  • hypotension
  • decreased cardiac output
  • cardiovascular dysfunction
  • tachycardia
  • bradycardia
  • palpitations
  • syncope
  • chest pain
  • frequency of urination
  • polyuria
  • dysuria
  • urinary retention
  • erectile dysfunction
  • hematuria
  • hepatic dysfunction
  • abnormal liver function tests
  • hyperhidrosis
  • skin rash
  • increased rigidity
  • edema
  • chest tightness
  • sweating
  • dyspnea
  • elevated blood sugar levels
  • weight gain
  • congestion
  • anxiety
  • agitation
  • confusion state
  • psychosis
  • mania
  • ataxia state
  • status epilepticus
  • movement disorders
  • tachycardia
  • rhabdomyolysis
  • fever
  • somnolence
  • confusion
  • consciousness depression
  • suicide and suicide-related cases
  • drug abuse
  • misuse
  • dependence
  • drowsiness
  • decreased level of consciousness
  • confusion
  • dystonic reaction
  • coma
  • depression
  • consciousness disturbance
  • coma
  • delusion
  • agitation
  • coordination disorder
  • loss of pupillary reflex
  • generalized muscle tone reduction
  • dystonic muscle spasms
  • reflex hypotonia
  • areflexia
  • peripheral vasodilation
  • hypothermia
  • nausea
  • vomiting
  • diarrhea
  • hypersalivation
  • increased liver enzyme levels
  • 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 avoid contact with air and moisture. It is important to maintain storage temperature between 1 degree and 30 degrees Celsius at room temperature.

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.