Zebinix 400 mg Tablets (Eslicarbazepine Acetate (Micronized))

Adult dose

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 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. Dose adjustment is required in patients with renal impairment according to creatinine clearance (CLCR). - CLCR > 60 ml/min: No dose adjustment is required. - CLCR 30-60 ml/min: Administer an initial dose of 200 mg once daily for 2 weeks, then administer 400 mg once daily. The dose may be adjusted according to individual response. No dose adjustment is required in older adults (aged 65 years or over) with normal renal function. Use of 1,600 mg as monotherapy is not recommended. Patients who have difficulty taking the medicine may crush it, mix it with soft food, and take it immediately. Do not store the mixture.

Child dose

For pediatric patients aged 6 years or over who weigh less than 60 kg, the recommended initial dose is 10 mg/kg once daily. 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 should receive the same dose as adults. For pediatric patients aged 6 years or over with renal impairment, adjust the dose according to creatinine clearance (CLCR). - CLCR > 60 ml/min: No dose adjustment is required. - CLCR 30-60 ml/min: Administer an initial dose of 5 mg/kg once daily or 10 mg/kg every 2 days for 2 weeks, then administer 10 mg/kg once daily. The dose may be adjusted according to individual response.

This medication is used in the treatment of epilepsy and may increase the risk of suicidal thoughts or behavior, so patients should be carefully monitored for depression or mood changes during treatment. This medication can cause serious skin reactions; if rash, red patches, or blisters appear on the skin, discontinue immediately and consult a doctor. Do not use if allergic to this medication or have certain heart conditions; women who are pregnant or planning to become pregnant should use this medication cautiously after consulting a physician. Side effects such as dizziness, drowsiness, headache, fatigue, and nausea may occur; caution should be exercised when driving or operating machinery. This medication may lower blood sodium levels; patients at risk for hyponatremia should have regular blood tests. Additionally, patients with liver or kidney function issues may require dosage adjustments, and should notify healthcare professionals if symptoms of liver damage occur. This medication may interact with other drugs, so patients should inform their healthcare providers of any other medications they are taking, particularly as it may reduce the effectiveness of oral contraceptives, thus additional contraceptive methods are recommended. Use during pregnancy may affect the fetus, so thorough consultation with a specialist is necessary before use, and it is recommended to discontinue breastfeeding if using this medication. In cases of overdose, symptoms such as dizziness or gait instability may occur, requiring immediate emergency treatment, as there are no specific antidotes, treatment should be symptom-based. Finally, this medication should be kept out of reach of children, and it is safe to avoid transferring it to another container.

suicidal ideation, 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, seizure worsening, confusion, decreased consciousness, lethargy, nausea, dizziness, decreased serum osmolality, vomiting, headache, state of confusion, neurological signs, prolonged PR interval, transaminase elevation, bilirubin elevation, thyroid dysfunction, pancytopenia, agranulocytosis, leukopenia, diplopia, drowsiness, vomiting, diarrhea, constipation, abdominal pain, gastritis, weakness, 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

This medication should be stored in a tightly sealed container to prevent air and moisture infiltration, at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance

White, round, biconvex tablet

Package unit

28 tablets/PTP (7 tablets/PTP x 4)