Triptal 300 mg (Oxcarbazepine)

Adult dosage

This medicine is suitable for use as monotherapy or as adjunctive therapy with other antiepileptic drugs. In either case, administer the clinically effective dose in 2 divided doses daily, and adjust the dose 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 medicines or increase the dose of this medicine more gradually. This medicine may be taken with or without food. Monitoring plasma concentrations of oxcarbazepine or MHD is generally not recommended. However, plasma concentration monitoring during treatment with this medicine may be considered to confirm adherence or when changes in MHD clearance are expected, as follows: · Changes in renal function (see Dosage adjustment in patients with renal impairment) · Pregnancy (see Pregnancy and lactation) · Concomitant use of enzyme-inducing drugs (see Drug interactions) In these cases, adjust the dose of this medicine to maintain MHD plasma concentrations below 35mg/L. (Based on plasma concentrations 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 is 600 mg/day (8∼10 mg/kg), administered 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 the dose of this medicine to the target dose over approximately 2∼4 weeks. To achieve an adequate therapeutic effect, the dose may be increased at weekly intervals from the initial dose by no more than 600 mg/day; the maintenance dose is 600∼2,400 mg/day. In one clinical study, 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 study of monotherapy in patients previously treated with antiepileptic drugs, a dose of 1,200 mg/day was effective. A dose of 2,400 mg/day was effective in patients who were difficult to treat or who switched from another antiepileptic drug to monotherapy with this medicine. 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 adequate therapeutic effect, the dose may be increased at weekly intervals from the initial dose 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, most patients did not tolerate a dose of 2,400 mg/day without reducing the dose of other concomitant antiepileptic drugs, primarily because of adverse reactions related to the central nervous system. Doses greater than 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 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). 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 should be exercised when administering it 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 it at intervals of at least 1 week until the desired clinical response is achieved. Monitor patients closely.

Children's dosage

2. Children Experience with the use of this medicine in children is limited, particularly in children 3 years of age and younger, for whom there is no clinical experience. Use in infants is not recommended because it is difficult to administer the tablets in 2∼3 divided doses according to the individual dose. It is preferable to avoid use in children 3 years of age and younger.

This medication may increase the risk of suicidal thoughts and behavior, so if any changes in mood or behavior occur during treatment, it is essential to consult a healthcare professional immediately. Sodium levels in the blood may decrease, so regular serum sodium tests should be conducted before and during treatment. Particular caution is needed for patients with impaired kidney function or a risk of hyponatremia. Patients with impaired kidney, liver, or heart function, as well as the elderly, are at higher risk of adverse effects and should use the medication cautiously. Caution should be exercised in cases of allergies to structurally similar drugs as cross-reactions may occur. Severe skin reactions, although rare, can occur, so if skin rashes or mucosal symptoms appear, the medication should be discontinued, and healthcare professionals should be consulted immediately. Since this is a seizure treatment medication, discontinuation should not be sudden as it may worsen seizures; the dosage should be gradually reduced. The use of this medication is contraindicated in patients with certain heart diseases, and interactions with other medications may occur, therefore it is crucial to inform the prescribing physician about other medications being taken. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication as it may affect the fetus. During breastfeeding, the medication may pass into breast milk, so it is important to observe the baby's condition and decide whether to continue use. Safety has not been established for children, especially infants under 2 years old, so caution should be exercised. In the case of overdose, severe symptoms may occur, requiring immediate emergency treatment as there is no specific antidote, and treatment should be symptomatic. Taking this medication with alcohol may increase sedation effects, so avoiding alcohol is advisable. Dizziness or drowsiness may occur while driving or operating machinery, so caution is needed. While taking this medication, regular blood tests and liver and kidney function tests should be conducted to monitor for adverse reactions. This medication may reduce the effectiveness of hormonal contraceptives, so it is recommended that women of childbearing age use alternative contraceptive methods. This medication should be kept out of the reach of children, and after opening, it should be used within the designated time frame.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hyponatremia, nausea, fatigue, headache, drowsiness, confusion, numbness, increased frequency or severity of seizures, Stevens-Johnson 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, cloudy vision, visual impairment, anxiety, nervousness, emotional instability, neurosis, state of confusion, depression, amnesia, emotional blunting, ataxia, tremor, nystagmus, attention deficit, memory impairment, tinnitus, atrioventricular block, arrhythmia, hypertension, diarrhea, abdominal pain, constipation, pancreatitis, increased lipase, hepatitis, rash, alopecia, acne, urticaria, angioedema, erythema multiforme, systemic lupus erythematosus, myasthenia, decreased T4, increased liver enzyme levels, increased amylase, falls, speech impairment, decreased bone density, osteopenia, osteoporosis, fractures, cholestatic hepatitis, sleep disorders, weight gain, decreased serum osmolality, decreased serum sodium, increased uric acid in the blood, decreased appetite, multi-organ hypersensitivity reactions, lymphadenopathy, hepatorenal syndrome, arthralgia, myasthenia, worsening of seizures, hypotension, dyspnea, somnolence, coma, loss of consciousness, movement disorders, aggression, anxiety, state of confusion

This medication should be stored in a sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature.

Appearance

Yellow oval film-coated tablet

Package unit

10 tablets ((10 tablets/PTP) X 1), 100 tablets ((10 tablets/PTP) X 10)