Trileptal Suspension 6% (Oxcarbazepine)

Adult dose

This medicine is suitable for use either as monotherapy or as adjunctive therapy with other antiepileptic drugs. Whether used as monotherapy or adjunctive therapy, the clinically effective dose should be administered in 2 divided doses daily, and may be increased or decreased according to clinical symptoms. During combination therapy, the total antiepileptic drug burden increases, so it may be necessary to reduce the dose of the concomitant drug or increase the dose of this medicine more gradually. 1) 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/day (8∼10 mg/kg) in 2 divided doses. For patients switching from another antiepileptic drug to monotherapy with this medicine, discontinue the concomitant antiepileptic drug completely over 3∼6 weeks while increasing this medicine to the maximum dose over approximately 2∼4 weeks. To achieve an appropriate therapeutic effect, the dose may be increased from the initial dose at intervals of one week, by no more than 600 mg/day at a time; 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), administered in 2 divided doses. To achieve an appropriate therapeutic effect, the dose may be increased from the initial dose at intervals of one week, by no more than 600 mg/day at a time. 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, due primarily to 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 exceeding 2,400 mg/day have not been adequately evaluated. 3. Elderly patients (65 years and older) Adjust the therapeutic dose of this medicine for each individual. Pharmacokinetic studies showed that the AUC of MHD increased by approximately 30~60% in elderly patients compared with younger adults. In addition, close monitoring of sodium concentrations is required in patients at risk of hyponatremia, and dose adjustment is recommended in elderly patients 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, use caution when administering this medicine to patients with severe hepatic impairment. 5. 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 the dose at intervals of at least one week until the desired clinical response is achieved; monitor the patient closely during this time.

Child dose

1) Monotherapy (children 4 years of age and older) For patients switching from another antiepileptic drug to monotherapy with this medicine or patients not currently receiving treatment with an antiepileptic drug, the initial dose of this medicine is 8∼10 mg/kg/day in 2 divided doses. For patients switching from another antiepileptic drug to monotherapy with this medicine, begin reducing the dose of the concomitant antiepileptic drug when this medicine is started and discontinue it over 3∼6 weeks. To achieve an appropriate therapeutic effect, the dose may be increased from the initial dose at approximately one-week intervals, by no more than 10 mg/kg/day at a time; a maximum dose of 46 mg/kg/day is recommended. For patients not currently receiving treatment with an antiepileptic drug, increase the dose by 5 mg/kg/day every 3 days. 2) Adjunctive therapy (children 2 years of age and older) The initial dose of this medicine is 8∼10 mg/kg/day in 2 divided doses, not exceeding 600 mg/day. To achieve an appropriate therapeutic effect, the dose may be increased from the initial dose at approximately one-week intervals, by no more than 10 mg/kg/day at a time; up to a maximum of 60 mg/kg/day may be administered. The target maintenance dose of this medicine for adjunctive therapy is 30~46mg/kg/day. In children 4 years of age and older, the target dose of this medicine should be reached over 2 weeks and may be administered as follows according to the patient's body weight. 20∼29 kg : 900 mg/day 29.1∼39 kg : 1200 mg/day >39 kg : 1800 mg/day In a clinical trial using the target doses above, the median daily dose was 31 mg/kg (range : 6∼51 mg/kg). In infants 2∼4 years of age, the initial dose of this medicine is 8∼10 mg/kg/day in 2 divided doses, not exceeding 600 mg/day. For patients weighing 20kg or less, an initial dose of 16∼20 mg/kg may be considered. The maximum maintenance dose of this medicine should be reached over 2∼4 weeks and should not exceed 60 mg/kg/day. In a clinical trial in infants aged 2 to less than 4 years, the target dose was 60 mg/kg/day, and 56% of subjects reached a final dose of at least 55 mg/kg/day. Because the weight-normalized apparent clearance of MHD (L/hr/kg) decreases with increasing age during adjunctive therapy, the dose of this medicine per body weight may need to be 2 times the adult dose in infants aged 2 to less than 4 years and 1.5 times the adult dose in children aged 4 to 12 years. The effect of other enzyme-inducing antiepileptic drugs on the weight-normalized apparent clearance (apparent clearance, L/hr/kg) of this medicine is greater in infants aged 1 month to less than 4 years than in children 4 years of age and older. Therefore, in infants aged 2 to less than 4 years receiving adjunctive therapy with an enzyme-inducing antiepileptic drug, the dose of this medicine per body weight may need to be 1.6 times higher than with monotherapy or adjunctive therapy with a non-enzyme-inducing antiepileptic drug. In children 4 years of age and older, a slight dose increase may be needed compared with the dose used for monotherapy. The safety and efficacy of this medicine in infants and children under 2 years of age have not been established.

This medication is used to treat epilepsy, and during treatment, there may be an increase in suicidal thoughts or behavior, so patients and caregivers should closely monitor for changes in mood or unusual behavior. During treatment, sodium levels in the blood may decrease, so regular blood tests are needed, and caution is especially necessary in patients with impaired kidney function or symptoms of hyponatremia. Patients with weakened kidney, liver, or heart function, as well as the elderly, are at higher risk of adverse reactions, so careful administration is required. Caution should be exercised in patients with a known allergy to carbamazepine, as cross-allergic reactions may occur when using this medication. Severe skin reactions may rarely occur, so if symptoms such as skin rash or mucosal irregularities appear, the medication should be discontinued immediately, and medical consultation should be sought. Due to the risk of increased seizure frequency, it is important not to suddenly stop the medication, but to gradually reduce the dosage. This medication may interact with specific drugs, so if other medications are being taken, it is essential to inform the doctor or pharmacist. Women who are pregnant or may become pregnant should consult a specialist before taking the medication, and caution should also be taken during breastfeeding as it may affect the baby. Safety in children, especially infants under 2 years old, has not been established, so caution is advised in use. In case of overdose, there is no specific antidote, so immediate medical attention is required. After opening, it is recommended to finish the medication within 7 weeks and to store it out of reach of children. This medication contains ingredients that may cause allergic reactions and may affect sugar metabolism, so consulting a specialist before intake is necessary if related conditions exist. During the initial period of medication, symptoms such as dizziness, drowsiness, and visual disturbances may occur, so caution is advised when driving or operating machinery. During the use of this medication, closely monitor for mental health changes such as depression or suicidal thoughts and report any unusual symptoms to a healthcare provider immediately.

Suicidal impulses, 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 reactions, 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, blurred vision, visual impairment, folate deficiency, anxiety, nervousness, emotional instability, neurosis, confusional state, depression, amnesia, emotional blunting, ataxia, tremors, nystagmus, attention deficit, memory impairment, blurred vision, tinnitus, atrioventricular block, arrhythmia, hypertension, diarrhea, abdominal pain, constipation, pancreatitis, increased lipase, alopecia, acne, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme, systemic lupus erythematosus, weakness, increased liver enzyme levels, increased amylase, syndrome of inappropriate antidiuretic hormone secretion, ataxia, agitation, drowsiness, decreased appetite, increased serum uric acid, weakness, pain, loss of appetite, sensory disturbances, itching, frequent urination, convulsions, polyuria, facial flushing, aggressiveness, hypotension, dyspnea, speech impairment, decreased bone density, osteopenia, osteoporosis, fracture, weight gain, cholestatic hepatitis, sleep disturbances, falls, decreased serum osmolality, decreased serum sodium, pupillary constriction, hyperactivity, somnolence, coma, loss of consciousness, movement disorders

This medication should be stored in a tightly closed container that can block light, and the storage temperature should be maintained between 1 and 25 degrees Celsius. Additionally, it is safe to consume all of it within 7 weeks after opening.

Appearance

A nearly white to pale brown or pale red suspension in a brown glass bottle

Package unit

1 bottle/box [(100 milliliters/bottle)]