Zebrinix 600 mg (Eslicarbazepine Acetate (Micronized))

Adult dose

1. Adults This medicine may be administered as monotherapy or as adjunctive therapy with other antiepileptic drugs. The recommended initial dose is 400 mg once daily, increased to 800 mg once daily after 1 or 2 weeks. The usual maintenance dose is 800 mg once daily, and the dose may be increased to 1,200 mg once daily according to individual response. Some patients receiving monotherapy may benefit from a dose of 1,600 mg once daily. 3. Older adults (aged 65 years or over) No dose adjustment is required in older adults with normal renal function. Use of 1,600 mg as monotherapy is not recommended because clinical experience in older adults is very limited. 4. Patients with renal impairment Caution should be exercised when treating adults with renal impairment, and the dose should be adjusted according to creatinine clearance (CLCR) as follows: - CLCR >60 ml/min: No dose adjustment is required. - CLCR 30-60 ml/min: Administer an initial dose of 200 mg once daily or 400 mg every 2 days for 2 weeks, then administer 400 mg once daily. The dose may be adjusted according to individual response. - CLCR <30 ml/min: Use is not recommended in patients with severe renal impairment. 5. Patients with hepatic impairment No dose adjustment is required in patients with mild to moderate hepatic impairment. Use of this medicine is not recommended in patients with severe hepatic impairment because it has not been evaluated in this population. 6. For patients who have difficulty swallowing this medicine whole, immediately before taking it, crush the entire dose, mix it with soft food (such as applesauce), and take it immediately, followed by water. Do not store the mixture for later use.

Child dose

2. Pediatric patients (aged 6 years or over) weighing less than 60 kg The recommended initial dose is 10 mg/kg once daily. Depending on individual response, the dose may be increased by 10 mg/kg once daily at 1- or 2-week intervals, up to a maximum of 30 mg/kg. The maximum dose is 1,200 mg once daily. 2. Pediatric patients (aged 6 years or over) weighing 60 kg or more Pediatric patients weighing 60 kg or more should receive the same dose as adults. 4. Patients with renal impairment, pediatric patients aged 6 years or over, CLCR >60 ml/min No dose adjustment is required. 4. Patients with renal impairment, pediatric patients aged 6 years or over, CLCR 30-60 ml/min Administer an initial dose of 200 mg once daily (5 mg/kg for pediatric patients aged 6 years or over) or 400 mg every 2 days (10 mg/kg for pediatric patients aged 6 years or over) for 2 weeks, then administer 400 mg once daily (10 mg/kg for pediatric patients aged 6 years or over). The dose may be adjusted according to individual response. 4. Patients with renal impairment, pediatric patients aged 6 years or over, CLCR <30 ml/min Use is not recommended in patients with severe renal impairment.

This medication may increase the risk of suicidal thoughts or suicidal behavior, thus careful monitoring of changes in mental state is essential during treatment. Patients taking this drug may experience serious skin reactions that can be life-threatening; if any rash or red spots appear, they should stop taking it immediately and consult a physician. Patients with hypersensitivity to this medication or certain heart diseases should not take it. Women who are pregnant, planning to become pregnant, or breastfeeding should take this medication cautiously and should determine whether to take it after consulting a physician. Central nervous system side effects such as dizziness, drowsiness, and fatigue may occur, so caution should be taken when driving or operating machinery. This medication can interact with other drugs, thus any other medications being taken should be reported to a physician or pharmacist. Blood sodium levels may decrease, so regular blood tests are necessary, and if symptoms of hyponatremia occur, the medical staff should be consulted immediately. This drug may affect liver and kidney function, so patients with liver or kidney disease should consult a physician before taking it. Serious central nervous system symptoms may occur in the event of overdose, thus it is important to adhere to the prescribed dosage and avoid overdosing. Keep out of reach of children, and do not transfer to other containers for safety.

suicidal thoughts, suicidal behavior, depression, abnormal mood and behavior changes, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction accompanied by eosinophilia and systemic symptoms, skin reactions, rash, hives, angioedema, hyponatremia, worsening of seizures, confusion, decreased consciousness, drowsiness, nausea, dizziness, decreased serum osmolality, vomiting, headache, state of confusion, neurological signs, prolonged PR interval, elevated transaminases, increased bilirubin, jaundice, thyroid dysfunction, pancytopenia, agranulocytosis, leukopenia, double vision, drowsiness, ataxia, balance disorder, gait disturbance, tremors, cognitive impairment, visual impairment, weakness, stuttering, memory impairment, vertigo, falls, abdominal pain, diarrhea, hypertension, urinary tract infection

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to ensure the drug's efficacy and safety over time.

Appearance

White rectangular tablet

Package unit

30 tablets/PTP (10 tablets/PTP x 3)