Trileptal Film-coated Tablets 150 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 of plasma drug concentrations The therapeutic effect of oxcarbazepine is primarily due to MHD (10-monohydroxy derivative), the pharmacologically active metabolite of oxcarbazepine. 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

2. Pediatrics 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 the risk of suicidal thoughts or behaviors during treatment. Therefore, patients and their caregivers should closely monitor for changes in mood or behavior. Hyponatremia, a condition in which serum sodium levels become low, may occur, so sodium levels must be regularly checked through blood tests before and during treatment. Patients with impaired liver, kidney, or heart function, as well as the elderly, are at higher risk for adverse reactions and should be particularly cautious. Patients with an allergy to this medication should avoid its use, especially if they have an allergy to similar structural medications, due to the possibility of cross-reactivity. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis may rarely occur, so if skin rashes or mucosal abnormalities appear, the medication should be discontinued immediately and medical consultation sought. This medication should not be stopped abruptly as it may worsen seizures; gradual tapering of the dosage is important. Women who are pregnant or may become pregnant should consult a doctor before taking this medication, as there is an increased risk of fetal malformations, and folic acid supplements may be necessary. Breastfeeding mothers should be aware that this medication may be excreted in breast milk and could affect the infant, so thorough consultation with healthcare professionals regarding breastfeeding is necessary. Caution is required when driving or operating machinery as symptoms like dizziness and drowsiness may occur. This medication may interact with other drugs; caution is particularly advised when used in combination with antiepileptic drugs, hormonal contraceptives, and MAO inhibitors, and all medications being taken should be informed to healthcare professionals. There is no specific antidote for overdose, so immediate medical attention should be sought for appropriate treatment. Store in a place out of reach of children, and do not transfer to a different container for safety.

Suicidal thoughts, suicidal behavior, depression, abnormal changes in mood and behavior, hyponatremia, nausea, lethargy, headache, drowsiness, confusion, numbness, increased frequency or severity of seizures, skin and mucous membrane syndrome, toxic epidermal necrolysis, 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, muscle pain, arthralgia, hepatic encephalopathy, renal failure, interstitial nephritis, proteinuria, pulmonary edema, asthma, bronchospasm, interstitial lung disease, dyspnea, angioedema, hypothyroidism, seizures, encephalopathy, cognitive decline, confusion, visual disturbances, visual impairment, folate deficiency, anxiety, irritability, emotional instability, neurosis, states of confusion, amnesia, emotional blunting, ataxia, tremors, nystagmus, attention deficit, memory impairment, blurred vision, dizziness, tinnitus, atrioventricular block, arrhythmia, hypertension, diarrhea, abdominal pain, constipation, pancreatitis, increased lipase, alopecia, acne, urticaria, angioedema, polymorphous erythema, systemic lupus erythematosus, weakness, decreased T4, increased liver enzyme levels, increased amylase, clinically significant hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, agitation, drowsiness, decreased appetite, increased serum uric acid, weakness, pain, anorexia, paresthesia, itching, polyuria, seizures, urinary incontinence, facial flushing, suicidal thoughts or suicidal behavior, sleep disturbances, rash, itching, urticaria, angioedema, anaphylaxis, laryngeal edema, multi-organ hypersensitivity, fever, lymphadenopathy, hepatitis, hematological abnormalities, itching, nephritis, decreased urine output, nephrotic syndrome, arthralgia, weakness, exacerbation of seizures, electrocardiogram abnormalities, hypothyroidism, hepatic failure, hepatitis, decreased renal function, decreased bone density, osteopenia, osteoporosis, fractures, weight gain, falls, aggression, states of confusion, hypotension, dyspnea

This medication should be stored in a sealed container to prevent contact with air and kept at room temperature that is neither too hot nor too cold to maintain its efficacy and safety for a longer period.

Appearance

Pale green oval film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)