Unilep Tablet (Oxcarbazepine)

Adult dose

This medicine is suitable for use either as monotherapy or as adjunctive therapy to other antiepileptic drugs. In either case, divide the clinically effective dose into 2 doses per day and adjust the dose according to clinical symptoms. During adjunctive therapy, the total antiepileptic drug burden increases, so 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. Plasma drug concentration monitoring The therapeutic effect of oxcarbazepine is mainly produced by 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 verify adherence or when changes in MHD clearance are expected, as in the following cases: · Changes in renal function (see Dosage Adjustment in Patients with Renal Impairment) · Pregnancy (see Pregnancy and Breastfeeding) · Use of enzyme-inducing drugs (see Interactions) In these cases, adjust the dose of this medicine to maintain the MHD plasma concentration below 35 mg/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), divided into 2 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 adequate therapeutic response, the dose may be increased from the initial dose at weekly intervals by no more than 600 mg/day. The maintenance dose is 600–2,400 mg/day. One clinical trial demonstrated efficacy at a dose of 1,200 mg/day in subjects who started treatment with this medicine as monotherapy. A controlled clinical trial of monotherapy in patients previously treated with antiepileptic drugs demonstrated efficacy at a dose of 1,200 mg/day. A dose of 2,400 mg/day was effective in patients whose condition was difficult to treat or who switched to monotherapy with this medicine from another antiepileptic drug. 2) Adjunctive therapy The initial dose of this medicine is 600 mg/day (8–10 mg/kg), divided into 2 doses. To achieve an adequate therapeutic response, the dose may be increased from the initial dose at weekly intervals 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, primarily because of 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 above 2,400 mg/day have not been adequately evaluated. 3. Older adults (65 years and older) Adjust the therapeutic dose of this medicine for each patient. Pharmacokinetic studies showed that the MHD AUC in older adults was approximately 30–60% higher than in younger adults. In addition, close monitoring of sodium concentrations is required in patients at risk of hyponatremia, and dose adjustment is recommended for older adults with renal impairment (creatinine clearance <30ml/min). 4. Patients with hepatic impairment No dose adjustment is needed 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. Monitor these patients closely.

Child dose

2. Children Experience with this medicine in children is limited, particularly clinical experience in children under 3 years of age. Use in infants is not recommended because it is difficult to administer tablets in 2–3 divided doses according to the individual dose. It is preferable to avoid use in children under 3 years of age.

This medication is used for the treatment of epilepsy, and there may be an increased risk of suicidal thoughts or behavior during treatment. Therefore, it is important for patients or caregivers to immediately inform healthcare professionals if there are changes in mood or unusual behavior. Sodium levels in the blood may decrease, so patients with poor renal function or low sodium levels should undergo regular blood tests, and if symptoms of hyponatremia (nausea, headache, drowsiness, confusion, etc.) occur, medical consultation should be sought immediately. Patients with renal or liver dysfunction, or heart disease, as well as elderly patients, are at higher risk of adverse reactions and should take caution. If there is an allergy to this medication or other medications with a similar structure, cross-reactivity may occur, so it is essential to confirm allergy status before use. Rarely, serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, etc.) may occur, so if skin rashes or mucosal abnormalities develop, the medication should be stopped immediately and healthcare providers informed. Like all antiepileptic medications, abrupt discontinuation may worsen seizures, so when stopping the medication, the dosage should be gradually reduced under the guidance of healthcare professionals. This medication carries a higher risk of serious skin reactions in patients with specific genotypes (HLA-B*1502, HLA-A*3101), so genetic testing is recommended before administration in Asian patients or specific ethnic groups. Women who are pregnant or planning to become pregnant should consider the potential effects of this medication on the fetus and discuss the need for treatment and associated risks with healthcare professionals. During breastfeeding, this medication may pass into breast milk and affect the infant, so it is advisable to consult healthcare providers regarding breastfeeding. This medication may interact with various other drugs, so if taking other medications, it is essential to inform healthcare providers, particularly regarding the concomitant use of MAO inhibitors, antiepileptic drugs, calcium channel blockers, and hormonal contraceptives. Drowsiness, dizziness, and visual disturbances may occur while taking this medication, so caution is advised when driving or operating machinery. Additionally, alcohol consumption may enhance sedation, so it is advisable to avoid it. Overdosage may lead to severe symptoms, so it is important to adhere to the prescribed dosage and seek emergency treatment if abnormal symptoms occur. Keep out of reach of children and do not transfer to other containers for safety.

suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, hyponatremia, nausea, lethargy, headache, somnolence, confusion, insensitivity, increase in the 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, respiratory distress, angioedema, hypothyroidism, convulsions, encephalopathy, cognitive decline, confusion, blurred vision, visual impairment, folate deficiency, anxiety, irritability, emotional instability, neurosis, confusional state, depression, memory loss, emotional blunting, ataxia, tremor, nystagmus, attention disorders, memory disorders, 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, weakness, decreased T4, increased liver enzyme levels, increased amylase, increased lipase, syndrome of inappropriate antidiuretic hormone secretion, drug rash, systemic symptoms, acute generalized exanthematous pustulosis, falls, speech impairment, decreased bone density, osteopenia, osteoporosis, fractures, weight gain, cholestatic hepatitis, sleep disturbances, aggression, confusional state, hypotension, respiratory distress, drowsiness, stupor, loss of consciousness, movement disorders

This medication may be sensitive to air or moisture and should be stored in a sealed container. It is best stored at room temperature between 1 and 30 degrees Celsius to maintain effectiveness and prevent degradation.

Appearance

Yellow elongated film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle