Oxcarbazepine Tablet 600 mg (Oxcarbazepine)

Adult dose

This medicine is suitable for use either as monotherapy or as adjunctive therapy with other antiepileptic drugs. In either case, the clinically effective dose is administered in 2 divided doses daily, and the dose may be adjusted according to clinical symptoms. During adjunctive therapy, the total antiepileptic drug burden increases, so it may be necessary to reduce the dose of concomitant medicines or increase the dose of this medicine more gradually. This medicine may be taken with or without food. In these cases, adjust the dose of this medicine to maintain the MHD plasma concentration below 35mg/L. (Based on the plasma concentration measured 2~4 hours after taking this medicine) 1. Adults 1) Monotherapy For patients switching from another antiepileptic drug to monotherapy with this medicine, or patients not receiving antiepileptic drug treatment, the initial dose of this medicine is 600 mg/day (8∼10 mg/kg) in 2 divided doses. For patients switching from another antiepileptic drug to monotherapy with this medicine, completely discontinue the concomitant antiepileptic drug over 3∼6 weeks while increasing this medicine to the target dose over approximately 2∼4 weeks. To achieve an appropriate therapeutic effect, the initial dose may be increased at weekly intervals by no more than 600 mg/day; the maintenance dose is 600∼2,400 mg/day. In one clinical trial, a dose of 1,200 mg/day was shown to be effective in subjects who began treatment with this medicine as monotherapy. In a controlled clinical trial of monotherapy in patients previously treated with antiepileptic drugs, a dose of 1,200 mg/day was effective. In patients who were difficult to treat or who switched from another antiepileptic drug to monotherapy with this medicine, a dose of 2,400 mg/day was effective. 2) Adjunctive therapy The initial dose of this medicine is 600 mg/day (8∼10 mg/kg) in 2 divided doses. To achieve an appropriate therapeutic effect, the initial dose may be increased at weekly intervals by no more than 600 mg/day. The maintenance dose is 600∼2,400 mg/day. In controlled clinical trials of adjunctive therapy, doses of 600∼2,400 mg/day of this medicine were effective. However, primarily because of adverse reactions related to the central nervous system, most patients did not tolerate a dose of 2,400 mg/day without a reduction in the dose of the other concomitant antiepileptic drug. Doses above 2,400 mg/day have not been adequately evaluated. 3. Older adults (65 years and older) Adjust the therapeutic dose of this medicine individually. Pharmacokinetic studies showed that the MHD AUC in older adults increased by approximately 30~60% compared with younger adults. In addition, close monitoring of sodium levels is required in patients at risk of hyponatremia, and dose adjustment is recommended in older adults with renal impairment (creatinine clearance<30ml/min). 4. Patients with hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. This medicine has not been studied in patients with severe hepatic impairment. Therefore, caution is required when administering it to patients with severe hepatic impairment. 5. Patients with renal impairment In patients with renal impairment (creatinine clearance<30 mL/min), initiate this medicine at half the usual dose (300 mg/day) and increase it at intervals of at least 1 week until the desired clinical response is achieved. These patients should be monitored carefully.

Child dose

Use in children 3 years of age or younger is preferably avoided.

This medication is used for treating epilepsy and may increase the risk of suicidal thoughts or behaviors during use, so any unusual changes in mood or behavior should be reported to a healthcare professional immediately. Blood sodium levels may decrease during treatment, so regular blood tests should be done if renal function is impaired or if certain medications are taken concurrently. Patients with weak kidney, liver, or heart function, or elderly patients are at higher risk for side effects and should be cautious. If there is an allergy to other drugs that are structurally similar to this one, there may be a risk of cross-allergic reactions, so caution is advised. Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur rarely, so if any skin rash or other unusual symptoms appear, discontinue the medication immediately and consult a healthcare professional. As with all antiepileptic drugs, stopping this medication abruptly can worsen seizures, so any discontinuation should be done gradually under a doctor's guidance. This drug carries a higher risk of severe skin reactions in some Asians with certain genotypes, so genetic testing is recommended before use. Women who are pregnant or planning to become pregnant should consult a doctor before using this medication, as its use may increase the risk of fetal malformations, and taking folic acid supplements is advisable. Breastfeeding women should monitor their babies for any adverse symptoms, as this medication may pass into breast milk. Drowsiness, dizziness, and blurred vision may occur, so caution should be taken when driving or operating machinery during treatment. This medication may interact with other drugs; therefore, inform your doctor or pharmacist of any other medications being taken, especially hormonal contraceptives, as their effectiveness may be reduced, and non-hormonal methods of contraception are recommended. In case of overdose, there is no specific antidote, so appropriate treatment should be sought immediately, ensuring close monitoring of the heart, respiration, and electrolyte status. Store out of reach of children and do not transfer to another container for safety.

Drowsiness, headache, dizziness, diplopia, nausea, vomiting, fatigue, leukopenia, bone marrow suppression, aplastic anemia, agranulocytosis, pancytopenia, thrombocytopenia, neutropenia, anaphylactic reaction, rash, fever, eosinophilia, lymphadenopathy, splenomegaly, hepatitis, abnormal liver function tests, joint swelling, myalgia, arthralgia, hepatic encephalopathy, renal failure, interstitial nephritis, proteinuria, pulmonary edema, asthma, bronchospasm, interstitial lung disease, dyspnea, angioedema, hypothyroidism, seizures, encephalopathy, cognitive decline, confusion, hazy vision, visual impairment, anxiety, hyperesthesia, emotional instability, neurosis, confusional state, depression, amnesia, emotional blunting, ataxia, tremor, nystagmus, attentional deficits, memory impairment, cloudy vision, dizziness, tinnitus, atrioventricular block, arrhythmia, hypertension, diarrhea, abdominal pain, constipation, pancreatitis, increased lipase, hepatitis, rash, alopecia, acne, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, angioedema, erythema multiforme, systemic lupus erythematosus, fatigue, weakness, increased liver enzyme levels, increased amylase, increased lipase, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, ataxia, agitation, somnolence, decreased appetite, increased serum uric acid, weakness, pain, anorexia, altered perception, pruritus, polyuria, seizures, polyuria, facial flushing, suicidal thoughts, suicidal behavior, depression, abnormal mood and behavior changes, decreased serum osmolality, falls, speech impairment, decreased bone density, osteopenia, osteoporosis, fractures, weight gain, cholestatic hepatitis, sleep disturbances, hypersomnia, hyperactivity, coordination disorders, comatose state, loss of consciousness, movement disorders, aggression, hypotension, dyspnea

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1 and 30 degrees Celsius. This storage method helps to safely maintain the medication's efficacy.

Appearance

Bright pink oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle