Frex Tablet 5 mg (Baclofen)

Adult dose

Treatment with this drug should always be initiated at a low dose and gradually increased. The optimal dose should be individualized for each patient to reduce clonic spasms, flexor and extensor rigidity, and convulsions 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 an upright posture and balance during movement, and to preserve function. It is important to allow temporary spasms that maintain some muscle tone and help support circulatory function. Take this drug with meals with a small amount of water. For adults, administer the daily dose orally in 3 divided doses. ○ Adults 1. Administer baclofen 5㎎ orally 3 times daily. Increase the dose by 5㎎ per dose, 3 times daily, at 3-day intervals until the optimal dose is established. 2. For patients who are hypersensitive to this drug, it is advisable to start at a lower dose (5-10㎎ per day) and increase it slowly. 3. The optimal dose is usually 30-80㎎ per day. Hospitalized patients may receive 100-120㎎ per day under close supervision.

Child dose

For children, administer the daily dose orally in 4 divided doses. ○ Children (12 months~18 years) 12 months~18 years: Treatment is generally initiated at a very low dose (0.3 mg/kg per day in 2~4 divided doses). 12 months~18 years: The usual maintenance dose is 0.75~2mg/kg per day. Children younger than 8 years: The maximum daily dose is 40mg. Children 8 years and older: The maximum daily dose is 60mg. 12 months~18 years: Increase the dose carefully at intervals of approximately 1-2 weeks until the individual requirement is met. If no clear therapeutic effect is observed within 6-8 weeks after administration of the maximum dose, reconsider whether treatment with this drug should be continued.

This medication should not be used in patients with specific allergic reactions. This medication contains lactose and should not be administered to patients with genetic disorders that prevent lactose digestion. Caution should be exercised in patients with mental disorders or neurological diseases, as symptoms may worsen, and they should be used with careful monitoring. In patients with epilepsy, seizures may be triggered; therefore, close monitoring is necessary along with appropriate treatment. Caution is also required when used in patients with peptic ulcers, heart failure, cardiovascular diseases, cerebrovascular diseases, respiratory diseases, liver impairment, and decreased renal function. Particularly in patients with severely impaired renal function, only very small doses should be administered with close observation. This drug may cause respiratory depression due to muscle relaxant effects, so patients with respiratory diseases should be careful. Children, especially those with a history of epilepsy, are at risk of seizures and therefore should be cautious. Symptoms such as drowsiness, sedation, and dizziness may occur during the administration of this drug, so driving or operating dangerous machinery should be avoided. Patients with liver disease or diabetes should regularly undergo liver function tests and blood sugar tests. Sudden withdrawal after long-term use may result in severe symptoms such as anxiety, confusion, hallucinations, and seizures; thus, dosage should be reduced gradually. This medication may have an additive effect and increase the risk of side effects when taken with other central nervous system depressants, alcohol, tricyclic antidepressants, and antihypertensive drugs. During pregnancy, there could be a potential risk to the fetus; hence it should only be used if deemed necessary. During breastfeeding, only a very small amount is secreted, resulting in a lower risk, but should still be used cautiously. The elderly may have decreased bodily functions, so they should start with low doses and be closely monitored. In cases of overdose, serious symptoms such as central nervous system depression, respiratory distress, blood pressure abnormalities, and seizures may occur, requiring immediate emergency treatment; since there is no antidote, symptom-specific treatments such as gastric lavage, activated charcoal administration, or artificial respiration are necessary.

• Sedation
• drowsiness
• respiratory depression
• dizziness
• malaise
• fatigue
• exhaustion
• altered mental status
• vertigo
• headache

This medication should be stored in a sealed container to prevent air and moisture from getting in. It is recommended to store it at room temperature between 1 and 30 degrees Celsius to maintain the effectiveness of the medication and prevent deterioration.

Appearance

White round tablet

Package unit

30 tablets/bottle, 1000 tablets/bottle