Oxycarbazepine Tablets 150 mg (Oxycarbazepine)

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 2 divided doses per day, and may be increased or decreased according to clinical symptoms. During adjunctive therapy, because the patient's total antiepileptic drug burden increases, it may be necessary to reduce the dose of concomitant drugs or increase the dose of this medicine more gradually. In such 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 dose may be increased at weekly intervals from the initial dose, by no more than 600 mg/day at each increase; the maintenance dose is 600∼2,400 mg/day. One clinical study demonstrated efficacy at a dose of 1,200 mg/day in subjects who began treatment with this medicine as monotherapy. In a controlled monotherapy clinical study in patients previously treated with antiepileptic drugs, efficacy was demonstrated at a dose of 1,200 mg/day. In patients whose treatment was difficult or who switched from another antiepileptic drug to monotherapy with this medicine, efficacy was demonstrated at a dose of 2,400 mg/day. 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 dose may be increased at weekly intervals from the initial dose, by no more than 600 mg/day at each increase. The maintenance dose is 600∼2,400 mg/day. In controlled clinical studies of adjunctive therapy, this medicine was effective at doses of 600∼2,400 mg/day. However, most patients could not tolerate a dose of 2,400 mg/day without a reduction in the dose of the other concomitant antiepileptic drug, primarily because of adverse reactions related to the central nervous system. Doses above 2,400 mg/day have not been adequately evaluated. 3. Older adults (65 years of age 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 concentrations is required in patients at risk of hyponatremia, and dosage adjustment is recommended in older adults with renal impairment (creatinine clearance<30ml/min). 4. Patients with hepatic impairment No dosage 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 with caution in 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 at intervals of at least 1 week until the desired clinical response is achieved. Monitor patients carefully.

Child dose

2. Children Experience with this medicine in children is limited, and clinical experience in infants 3 years of age and younger is particularly limited. Use in infants is not recommended because it is difficult to divide tablets into 2∼3 doses according to the individual dose for children. It is preferable to avoid use in infants 3 years of age and younger.

This medication is used for treating epilepsy, and there is an increased risk of suicidal thoughts or behavior during treatment, so patients and caregivers should closely monitor for mood changes or symptoms of depression. Blood sodium levels should be regularly tested before and during treatment, particularly in patients with impaired kidney function or those at risk of hyponatremia. Patients with decreased kidney, liver, or heart function, and the elderly are at a higher risk of adverse reactions and require special caution. If there is an allergy to this medication, cross-reactivity may occur; therefore, it is essential to check for allergies before administration. Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may occur, so if skin rashes or mucosal abnormalities develop, discontinue the medication immediately and consult a healthcare professional. This medication may increase the frequency of seizures, so it should not be abruptly discontinued but rather gradually tapered off. If hypersensitivity reactions or severe allergic reactions occur, discontinue administration immediately and consider alternative treatment. Pregnant women or women planning to become pregnant should consult a doctor before taking this medication, as there may be an increased risk of congenital defects in the fetus, and appropriate testing should be conducted if necessary. Lactating women should be cautious as this medication may be excreted in breast milk and should decide on its use by observing the infant's condition. Drowsiness, dizziness, and visual disturbances may occur during treatment, necessitating caution when driving or operating machinery. This medication may interact with other drugs; therefore, patients should inform their doctor, particularly if taking antiepileptic drugs, oral contraceptives, or MAO inhibitors. Overdosing may result in severe symptoms, requiring immediate medical treatment at a hospital. This medication should be stored out of reach of children, and it is advisable not to transfer it to other containers.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hyponatremia, nausea, lethargy, headache, drowsiness, confusion, numbness, increased frequency or severity of seizures, mucocutaneous syndrome, toxic epidermal necrolysis, drowsiness, headache, dizziness, diplopia, 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, blurred vision, visual impairment, agitation, nervousness, emotional instability, neurosis, confused state, depression, amnesia, emotional blunting, ataxia, tremor, nystagmus, attention deficit, memory impairment, blurred vision, dizziness, tinnitus, heart block, arrhythmia, hypertension, diarrhea, abdominal pain, constipation, pancreatitis, increased lipase, hepatitis, rash, alopecia, acne, urticaria, mucocutaneous syndrome, toxic epidermal necrolysis, angioedema, erythema multiforme, systemic lupus erythematosus, fatigue, asthenia, increased liver enzyme levels, increased amylase, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, drowsiness, excitement, drowsiness, decreased appetite, increased uric acid levels, weakness, pain, anorexia, perceptual disturbances, itching, polyuria, convulsions, nocturia, facial flushing, aggression, confused state, hypotension, dyspnea, speech disturbance, decreased bone density, osteopenia, osteoporosis, fracture, weight gain, cholestatic hepatitis, sleep disorders, anaphylaxis, angioedema, hypersensitivity reaction, multisystem hypersensitivity reaction, fever, lymphadenopathy, hepatitis, thrombocytopenia, neutropenia, itching, nephritis, decreased urine output, nephrotic syndrome, arthralgia, asthenia, falls, hypersomnia, hyperactivity, coma, loss of consciousness, movement disorders

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at room temperature between 1°C and 30°C. Proper storage will help maintain the efficacy of the medication for a longer period.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle