Baclofen 10 mg Tablet

Adult dose

Treatment with this drug should always be started at a low dose, which should be increased gradually. The optimal dose should be determined individually for each patient at a level that reduces clonus, flexor and extensor rigidity, and spasms while avoiding adverse effects as much as possible. Take this drug with a small amount of water during meals. For adults, administer orally in 3 divided doses daily. Administer baclofen orally at 5㎎ per dose 3 times daily, and increase by 5㎎ per dose 3 times daily at 3-day intervals until the optimal dose is determined. For patients who are hypersensitive to this drug, it is advisable to start with a lower dose (5-10㎎ daily) and increase it slowly. The usual optimal dose is 30-80㎎ daily. Hospitalized patients may receive 100-120㎎ daily under close supervision.

Child dose

For children, administer orally in 4 divided doses daily. Children (12 months to 18 years): Treatment is generally started at a very low dose (0.3 mg/kg daily in 2 to 4 divided doses). Children (12 months to 18 years): The usual daily maintenance dose is 0.75~2mg/kg. Children under 8 years: Maximum daily dose is 40mg Children 8 years and older: Maximum daily dose is 60mg Children (12 months to 18 years): Increase the dose carefully at intervals of approximately 1-2 weeks until it is appropriate for the individual patient's requirements. Children (12 months to 18 years): 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.

This medication should not be used in certain patients. Individuals allergic to this drug or its components should not take it. Additionally, as it contains lactose, patients with lactose intolerance or certain genetic metabolic disorders should not take it. Patients with mental disorders, Parkinson's disease, epilepsy, peptic ulcers, heart failure, cardiovascular and cerebrovascular diseases, respiratory diseases, liver dysfunction, and impaired kidney function should use this drug cautiously. In particular, patients with severely impaired renal function should receive only small amounts, and their condition should be closely monitored. Patients with neurogenic bladder dysfunction may also need attention due to the risk of acute urinary retention. Children, especially those with a history of epilepsy, should be careful due to the risk of seizures. This medication primarily acts on the central nervous system and may cause side effects such as sedation and drowsiness, which typically occur when the dose is suddenly increased or when high doses are taken. Most side effects are temporary and resolve upon dose reduction. Side effects may be more severe in individuals with psychiatric disorders, cerebrovascular diseases, or elderly patients. Abruptly stopping this medication after long-term use can lead to severe symptoms such as anxiety, confusion, hallucinations, and seizures, so dosage should be gradually reduced over 1 to 2 weeks when discontinuing. Dizziness and drowsiness may occur during treatment, so it is advisable to avoid driving or operating hazardous machinery. Since this drug can affect liver function and blood sugar levels, regular monitoring is necessary for patients with liver disease or diabetes. Patients with a history of drug abuse should be carefully observed for misuse or dependence. Furthermore, there may be an increased risk of suicide, so patients and their families should closely monitor for changes in symptoms. This drug may enhance effects or exacerbate side effects when taken with other central nervous system depressants, alcohol, tricyclic antidepressants, blood pressure medications, etc., so consultation with a physician is required. During pregnancy, its use should be limited to necessary cases considering the risks to the fetus, and during lactation, although only small amounts are secreted, caution is advised. Elderly patients may experience side effects more easily due to declining bodily functions; thus, treatment should start with a low dose while monitoring their condition closely. In case of overdose, serious symptoms such as central nervous system depression, respiratory distress, seizures, and blood pressure changes may occur. Immediate medical attention is required, along with appropriate emergency treatment.

Calmness, drowsiness, respiratory depression, headache, lethargy, fatigue, exhaustion, mental confusion, dizziness, headache, insomnia, hyperdormia, depression, muscle weakness, ataxia, tremors, hallucinations, nightmares, myalgia, nystagmus, thirst, sensory distortion, speech disturbances, convulsions, encephalopathy, visual disturbances, visual impairment, strabismus, taste disturbance, tinnitus, nausea, mild gastrointestinal disturbances, nausea, involuntary vomiting, loss of appetite, discomfort in the stomach, abdominal bloating, heartburn, constipation, diarrhea, abdominal pain, occult blood in stool, hypotension, decreased cardiac output, cardiovascular dysfunction, tachycardia, bradycardia, palpitations, syncope, chest pain, frequent urination, polyuria, urinary difficulty, urinary retention, erectile dysfunction, hematuria, liver dysfunction, abnormal liver function tests, hyperhidrosis, skin rash, increased rigidity, edema, chest tightness, sweating, dyspnea, elevated blood glucose levels, weight gain, congestion, anxiety, agitation, confusion, psychosis, mania, delirium, status epilepticus, movement disorders, tachycardia, rhabdomyolysis, hyperthermia, frequent movements, dizziness, decreased attention span, elevated serum AST, increased ALP, increased blood sugar levels, confusion, loss of spatial orientation, depressed consciousness, cases of suicide and suicide-related incidents, substance abuse, misuse, dependence, drowsiness, decreased level of consciousness, confusion, hepatic myoclonus, coma, depression, consciousness disorders, coma, confusion, agitation, coordination disorders, loss of pupillary reflex, generalized muscle hypotonia, hepatic myoclonus, hyporeflexia, areflexia, peripheral vasodilation, hypothermia, nausea, vomiting, diarrhea, increased salivation, elevated liver enzymes, rhabdomyolysis

This medication is sensitive to light and should be stored in a dark container that does not allow light in. It should also be stored at room temperature between 1°C and 30°C, avoiding excessively hot or cold places.

Appearance

White, round tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 300 tablets/bottle, For export - 100 tablets/box [(10 tablets/PTP) × 10]