Trileptal Film-coated 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 should be administered in two divided doses per day and may be increased or decreased according to clinical symptoms. During adjunctive therapy, the patient’s total antiepileptic drug burden increases, so it may be necessary to reduce the dose of concomitant medications 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) Adults Monotherapy For patients switching from another antiepileptic drug to monotherapy with this medicine, or patients not receiving treatment with an antiepileptic drug, the initial dose of this medicine is 600 mg per day (8∼10 mg/kg) in two 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 titrating this medicine to the maximum dose over approximately 2∼4 weeks. To achieve an adequate therapeutic effect, the dose may be increased from the initial dose at weekly intervals by no more than 600 mg per day; the maintenance dose is 600∼2,400 mg per day. In one clinical trial, a dose of 1,200 mg per 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 per day was effective. A dose of 2,400 mg per day was effective in patients who were difficult to treat or who switched from another antiepileptic drug to monotherapy with this medicine. Adjunctive therapy The initial dose of this medicine is 600 mg per day (8∼10 mg/kg) in two divided doses. To achieve an adequate therapeutic effect, the dose may be increased from the initial dose at weekly intervals by no more than 600 mg per day. The maintenance dose is 600∼2,400 mg per day. In controlled clinical trials of adjunctive therapy, doses of 600∼2,400 mg per day of this medicine were effective. However, primarily because of adverse reactions associated with the central nervous system, most patients did not tolerate a dose of 2,400 mg per day without reducing the dose of the other concomitant antiepileptic drug. Doses exceeding 2,400 mg per day have not been adequately evaluated. Older adults (65 years and older) Adjust the therapeutic dose of this medicine for each individual. Pharmacokinetic studies showed that MHD AUC values were approximately 30~60% higher in older adults than in younger adults. In addition, close monitoring of sodium concentrations is required in patients at risk of hyponatremia, and dose adjustment is recommended in older adults with renal impairment (creatinine clearance<30ml/min). 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, use caution when administering it to patients with severe hepatic impairment. Patients with renal impairment In patients with renal impairment (creatinine clearance<30 mL/min), start 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. Carefully monitor the patient during this time.

Child dose

Infants 3 years of age or younger: It is preferable to avoid use.

This medication is used for the treatment of epilepsy, and there is an increased risk of suicidal thoughts, suicidal behavior, and mental health issues such as depression during treatment. Therefore, patients and guardians should carefully observe for these symptoms and inform medical personnel immediately in case of any abnormal signs. This medication can cause hyponatremia, which is a low sodium concentration in the blood, so regular blood tests to check sodium levels should be conducted before and during treatment. Special caution is required for patients with poor kidney function or those at high risk for hyponatremia. Elderly patients and those with weakened kidney, liver, or cardiac function have a higher risk of side effects from this medication, so it should be used with caution. Patients with allergies to similar medications may experience cross-reactivity, requiring close monitoring. Severe skin reactions may occur, and if a rash or mucosal damage, severe skin peeling occurs, the medication should be stopped immediately and medical advice should be sought. Sudden discontinuation of this medication may worsen seizures, so it is safe to gradually reduce the dosage when stopping. Women who are pregnant or planning to become pregnant and nursing mothers should consult a doctor before taking this medication, as it may affect the fetus or newborn, and regular check-ups may be required if necessary. Additionally, this medication may reduce the effectiveness of certain oral contraceptives, so it is recommended that women of childbearing age use non-hormonal contraceptive methods concurrently. Drowsiness, dizziness, and vision problems may occur while taking this medication, so caution is needed when driving or operating machinery. In cases of overdose, serious neurological and cardiovascular symptoms may arise, requiring immediate emergency treatment. This medication should be kept out of reach of children and should not be transferred to other containers. Finally, there may be interactions with other medications while taking this drug, so it is important to inform medical personnel of all medications being taken and to undergo regular check-ups.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hyponatremia, nausea, lethargy, headache, drowsiness, confusion, numbness, increased frequency or severity of seizures, drowsiness, headache, dizziness, double vision, 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, convulsions, encephalopathy, cognitive decline, confusion, visual impairment, visual disturbances, anxiety, irritability, emotional instability, neurosis, confusion state, depression, amnesia, emotional blunting, ataxia, tremors, nystagmus, attention disorders, memory disorders, blurred vision, dizziness, tinnitus, heart block, arrhythmias, hypertension, diarrhea, abdominal pain, constipation, pancreatitis, increased lipase, alopecia, acne, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme, systemic lupus erythematosus, asthenia, increased liver enzyme levels, increased amylase, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, agitation, drowsiness, reduced appetite, increased serum uric acid, weakness, pain, anorexia, paresthesia, pruritus, polyuria, convulsions, nocturia, facial flushing, rash, pruritus, urticaria, angioedema, anaphylaxis, multi-organ hypersensitivity, fever, lymphadenopathy, hepatitis, thrombocytopenia, neutropenia, nephritis, reduced urine output, hepatorenal syndrome, arthralgia, exacerbation of seizures, electrocardiogram abnormalities, hypothyroidism, liver failure, hepatitis, decreased bone density, osteopenia, osteoporosis, fractures, weight gain, sleep disorders, falls, speech disorders, aggressiveness, confusion state, hypotension, dyspnea, somnolence, hyperactivity, coma, loss of consciousness, movement disorders

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It should also be protected from direct sunlight and stored at room temperature.

Appearance

Light pink oval film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)