Bacrafon Tablet 10 mg (Baclofen)

Adult dose

Treatment with this medicine 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 clonic spasms, flexor and extensor rigidity, and convulsions while avoiding adverse effects as far as possible. Use with caution to prevent excessive muscle weakness and falls, particularly 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. Administer this medicine with a small amount of water during meals. The total daily dose should be divided into 3 doses for adults and 4 doses for children and administered orally. ○ Adults 1. Administer 5 mg of baclofen orally 3 times daily, increasing the dose by 5 mg per dose 3 times daily at 3-day intervals until the optimal dose is established. 2. In patients who are hypersensitive to this medicine, it is advisable to start with a lower dose (5-10 mg per day) and increase it slowly. 3. The usual optimal dose is 30-80 mg per day. Hospitalized patients may receive 100-120 mg 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, divided into 2~4 doses). ○ Children (12 months to 18 years): The usual maintenance dose is 0.75~2mg/kg per day. ○ Children under 8 years: The maximum daily dose is 40mg. ○ Children 8 years and older: The maximum daily dose is 60mg. ○ Children (12 months to 18 years): Increase the dose cautiously at intervals of about 1-2 weeks until it meets the individual patient's needs. ○ 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 this medicine.

This medication should not be administered to certain patients. Patients who are allergic to this medication or its ingredients should not use it. Additionally, since it contains lactose, it should not be given to patients with hereditary lactose intolerance or related diseases. Caution should be exercised when using this medication in patients with symptoms of psychosis, schizophrenia, bipolar disorder, confusion, or Parkinson's disease, as it may worsen symptoms, and their condition should be closely monitored. In patients with a history of epilepsy, this medication may lower the seizure threshold, increasing the risk of seizures, so appropriate antiepileptic medication should be maintained, and their condition should be well-monitored. This medication should also be administered carefully to patients with peptic ulcers, heart failure, cardiovascular and cerebrovascular diseases, respiratory diseases, liver disorders, and renal impairment. In particular, patients with severely impaired renal function should be given only a small amount, and caution is needed as the drug concentration may increase in dialysis patients. This medication can affect urination, potentially leading to acute urinary retention in patients with neurological disorders, so caution is warranted. In young children, especially those with a history of epilepsy, care should be taken due to the risk of seizures. When taking this medication, side effects such as sedation or drowsiness may occur, primarily when the dosage is rapidly increased or at high doses. Most are temporary and can be alleviated by dosage adjustment. Patients with a history of mental illness or cerebrovascular disorders and the elderly may experience more severe side effects, so they must be cautious. Discontinuing this medication abruptly after long-term use may lead to symptoms such as anxiety, confusion, hallucinations, and psychosis; thus, the dosage should be gradually reduced when discontinuing treatment. Dizziness, drowsiness, and decreased attention may occur during treatment, so avoid driving or operating dangerous machinery. Patients with liver diseases or diabetes should undergo regular liver function tests and blood glucose tests. Patients with renal impairment should be carefully monitored to detect any drug toxicity symptoms early. The risk of suicide may increase during the use of this medication, so both patients and caregivers should closely observe for mood changes or abnormal behavior, and immediately inform healthcare professionals if any unusual symptoms arise. Caution should be exercised when using this medication with other central nervous system-active drugs or alcohol, as it may enhance sedative effects and increase the risk of respiratory depression. When used in conjunction with tricyclic antidepressants or antihypertensives, the drug effect may be intensified, necessitating dosage adjustments. During pregnancy, it should only be administered if absolutely necessary, considering the risk to the fetus. During breastfeeding, it is expected that a small amount is excreted in breast milk, but adverse reactions are rare. Elderly patients should start with low doses and be monitored closely due to potential decreased physiological functions.

• calmness
• drowsiness
• respiratory depression
• dizziness
• lethargy
• fatigue
• exhaustion
• mental confusion
• vertigo
• headache

This medication should be stored in a sealed container to prevent air from entering and maintained at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the drug.

Appearance

[For domestic use] Yellow round tablet [For export] Yellow round film-coated tablet

Package unit

[For domestic use] 30 tablets/bottle, 300 tablets/bottle [For export] 10 tablets/PTP packaging, 30 tablets (10 tablets/PTP × 3), 100 tablets (10 tablets/PTP × 10)