Trileptal Film-Coated Tablets 300 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. 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) · Enzyme-inducing drugs (see Interactions) 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 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. 2) 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. 3. 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). 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 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. Carefully monitor the patient during this time.

Child dose

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

This medication is used for the treatment of epilepsy and may increase suicidal thoughts or behaviors during use, so both the patient and caregivers should closely observe for mood changes or abnormal behaviors. Hyponatremia, characterized by low sodium levels in the blood, may occur, thus regular blood tests should be conducted to check sodium levels before and during treatment. Special caution is required for patients with weak kidney, liver, or heart functions and for the elderly due to a higher risk of adverse reactions. Those allergic to carbamazepine should be cautious as cross-allergic reactions may occur when taking this medication. Severe skin reactions may occur; if symptoms such as rash, blisters, or sloughing skin appear, discontinue use and consult a doctor immediately. As with all antiepileptic drugs, suddenly stopping this medication may worsen seizures, so it should be gradually reduced. This medication should not be administered to patients with certain heart diseases, and women who are pregnant or planning to become pregnant and nursing mothers should consult a doctor before use. Common side effects may include drowsiness, headache, dizziness, nausea, vomiting, and fatigue, so caution is needed when driving or operating machinery. This medication may reduce the effectiveness of hormonal contraceptives, so women of childbearing age are advised to use non-hormonal contraceptive methods. There is no specific antidote for overdose, and treatment should be symptomatic, with careful monitoring of heart function and electrolyte status. Keep out of reach of children and do not transfer to other containers for safety. Taking this medication with alcohol may enhance sedative effects, so it is advisable to avoid drinking. Taking this medication during pregnancy may increase the risk of birth defects, so women who plan to become pregnant or who are pregnant should definitely consult a specialist before use. Regular monitoring of thyroid function and liver and kidney function tests is recommended during use. If any unusual symptoms or side effects occur while taking this medication, notify healthcare professionals immediately.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hyponatremia, nausea, lethargy, headache, drowsiness, confusion, numbness, increased frequency or severity of seizures, Stevens-Johnson syndrome, toxic epidermal necrolysis, 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, convulsions, encephalopathy, cognitive decline, confusion, blurred vision, visual impairment, folate deficiency, anxiety, emotional instability, confusion 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, Stevens-Johnson 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, ataxia, excitement, drowsiness, decreased appetite, increased serum uric acid, weakness, pain, anorexia, perceptual disturbances, itching, polyuria, convulsions, nocturia, facial flushing, suicidal thoughts, suicidal behavior, depression, state of confusion, anaphylaxis, rash, itching, urticaria, angioedema, laryngeal edema, multiorgan hypersensitivity, fever, lymphadenopathy, hepatitis, thrombocytopenia, neutropenia, nephritis, decreased urine output, hepatorenal syndrome, arthralgia, asthenia, exacerbation of seizures, drowsiness, nausea, dizziness, decreased serum osmolality, vomiting, headache, state of confusion, falls, speech impairment, decreased bone density, osteopenia, osteoporosis, fractures, weight gain, cholestatic hepatitis, sleep disturbances

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is advisable to avoid extremely hot or cold environments, and to store it at normal room temperature.

Appearance

Yellow oval film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging X 10)