Zebinix 200 mg (Eslicarbazepine Acetate (Micronized))

Adult dose

This medicine may be taken with or without food. Do not use this medicine as adjunctive therapy in patients receiving oxcarbazepine. 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 and pediatric patients aged 6 years or over 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) Pediatric patients 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. Pediatric patients weighing 60 kg or more: Administer the same dose as for adults. 4. Patients with renal impairment CLCR 30-60 ml/min: Administer an initial dose of 5 mg/kg once daily for pediatric patients aged 6 years or over, or 10 mg/kg every 2 days for pediatric patients aged 6 years or over, for 2 weeks; then administer 400 mg (10 mg/kg for pediatric patients aged 6 years or over) once daily. The dose may be adjusted according to individual response.

This medication is used for the treatment of epilepsy. During treatment with this medication, there may be an increased risk of suicidal thoughts or behavior, so patients and caregivers should closely monitor for such symptoms. Additionally, this medication can cause serious skin reactions that may be life-threatening; therefore, if any symptoms such as a rash, blisters, or red spots appear, the patient should immediately stop taking the medication and consult healthcare professionals. Patients with hypersensitivity to this medication or those with certain cardiovascular conditions (2nd or 3rd degree atrioventricular block) should not take this medication. Women who are pregnant or planning to become pregnant should carefully consider the use of this medication and should ideally use the minimum effective dose for monotherapy. Breastfeeding women should discontinue breastfeeding, as this medication may be excreted in breast milk. This medication may cause dizziness, drowsiness, or ataxia, so it is advisable to avoid driving or operating hazardous machinery. While taking this medication, various adverse reactions such as decreased blood sodium levels, liver function abnormalities, and thyroid function changes may occur, necessitating regular laboratory tests. Furthermore, this medication may interact with other drugs, so it is essential to inform healthcare providers of any other medications being taken. Abrupt discontinuation of this medication may worsen seizures; hence, it should be tapered gradually under the guidance of a physician when discontinuing. Special caution is required while using this medication in children, the elderly, or patients with impaired renal or liver function. In the case of overdose, symptoms such as dizziness or gait instability may occur, and immediate medical attention should be sought. Finally, this medication should be stored out of reach of children and should not be transferred to other containers.

suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms, rash, urticaria, angioedema, hyponatremia, exacerbation of seizures, confusion, decreased consciousness, drowsiness, nausea, dizziness, decreased serum osmolality, vomiting, headache, state of confusion, neurological symptoms, PR interval prolongation, transaminase elevation, bilirubin elevation, decreased serum T3 and T4, pancytopenia, agranulocytosis, leukopenia, diplopia, drowsiness, nausea, vomiting, diarrhea, constipation, abdominal pain, gastritis, asthenia, gait disturbance, peripheral edema, urinary tract infection, falls, dizziness, drowsiness, headache, ataxia, balance disorder, tremor, stuttering, memory impairment, eye twitching, depression, insomnia, cough, hypertension, anxiety, abdominal pain, allergic dermatitis, vertigo, abnormal cooperation

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, ideally at room temperature between 1 degree and 30 degrees Celsius. Storing it this way can help maintain its effectiveness for a longer period.

Appearance

White, elongated tablet

Package unit

30 tablets/bottle, 60 tablets/bottle, 90 tablets/bottle, 20 tablets/PTP (10 tablets/PTP x 2)