Tevaramotrine Chewable Tablets 25 Milligrams

Adult dose

1. Epilepsy Adults and adolescents aged 13 years and older Monotherapy (daily dose): Weeks 1 and 2: 25 mg (once daily); weeks 3 and 4: 50 mg (once daily); maintenance dose: 100∼200 mg (once daily or in 2 divided doses). Increase by up to 50∼100 mg every 1∼2 weeks until the maintenance dose is reached. In some patients, doses of up to 500 mg/day have been used to achieve the desired response. Adjunctive therapy (daily dose): Patients not receiving valproate and receiving glucuronidation inducers: Weeks 1 and 2: 50 mg (once daily); weeks 3 and 4: 100 mg (in 2 divided doses); maintenance dose: 200∼400 mg (in 2 divided doses). Increase by up to 100 mg every 1～2 weeks until the maintenance dose is reached. Adjunctive therapy (daily dose): Patients receiving valproate, regardless of other concomitant medications: Weeks 1 and 2: 12.5 mg (25 mg every other day); weeks 3 and 4: 25 mg (once daily); maintenance dose: 100∼200 mg (once daily or in 2 divided doses). Increase by up to 25～50 mg every 1～2 weeks until the maintenance dose is reached. For patients taking medications for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dose and dose-escalation schedule for concomitant use of this drug with valproate. 2. Bipolar disorder Adults aged 18 years and older Dose-escalation schedule to reach the maintenance stabilization dose (daily dose): Patients receiving glucuronidation inhibitors (e.g., valproate): Weeks 1 and 2: 12.5 mg (25 mg every other day); weeks 3 and 4: 25 mg (once daily); week 5: 50 mg (once daily or in 2 divided doses); target stabilization dose (week 6): 100 mg (once daily or in 2 divided doses) (maximum daily dose: 200 mg). Patients not receiving inhibitors such as valproate and receiving glucuronidation inducers (e.g., carbamazepine, phenobarbital): Weeks 1 and 2: 50 mg (once daily); weeks 3 and 4: 100 mg (in 2 divided doses); week 5: 200 mg (in 2 divided doses); week 6: 300 mg, with an increase to 400 mg in week 7 if needed (in 2 divided doses). Patients receiving other medications that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion), or receiving lamotrigine as monotherapy: Weeks 1 and 2: 25 mg (once daily); weeks 3 and 4: 50 mg (once daily or in 2 divided doses); week 5: 100 mg (once daily or in 2 divided doses); target stabilization dose (week 6): 200 mg (once daily or in 2 divided doses). For patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dose for concomitant use of this drug with valproate. The target stabilization dose may be adjusted according to clinical response. Patients receiving glucuronidation inhibitors (e.g., valproate): As the initial dose, administer 25 mg every other day for the first 2 weeks, followed by 25 mg once daily for the next 2 weeks. The target dose for optimal response is 100 mg once daily or in 2 divided doses. Depending on clinical response, the dose may be increased to a maximum of 200 mg once daily (or in 2 divided doses). Patients not receiving inhibitors such as valproate and receiving glucuronidation inducers (e.g., carbamazepine, phenobarbital): As the initial dose, administer 50 mg once daily for the first 2 weeks, followed by 100 mg in 2 divided doses daily for the next 2 weeks. In week 5, increase the dose to 200 mg in 2 divided doses daily. In week 6, increase the dose to 300 mg in 2 divided doses daily. From week 7, the usual target dose for optimal response may be 400 mg in 2 divided doses daily. Patients receiving other medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this drug as monotherapy: As the initial dose, administer 25 mg once daily for the first 2 weeks, followed by 50 mg once daily (or in 2 divided doses) for the next 2 weeks. In week 5, increase the dose to 100 mg once daily (or in 2 divided doses). The usual target dose for optimal response is 200 mg once daily or in 2 divided doses. In clinical trials, doses of up to 400 mg/day were used as monotherapy, but lamotrigine 400 mg/day provided no benefit over 200 mg/day. Medication schedule after reaching the maintenance stabilization dose: After discontinuation of a glucuronidation inhibitor (e.g., valproate), administer twice the stabilization dose during week 1. However, the dose increase must not exceed 100 mg/week. For example, if the target stabilization dose is 100 mg/day, administer 200 mg/day during week 1. During week 2, maintain the week 1 dose (200 mg/day) (once daily or in 2 divided doses). After discontinuation of a glucuronidation inducer (e.g., carbamazepine): Select the dose according to the existing maintenance dose. Week 1/week 2/week 3 onward: 400 mg/300 mg/200 mg; 300 mg/225 mg/150 mg; 200 mg/150 mg/100 mg. After discontinuation of a medication that does not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): Maintain the target maintenance dose achieved through dose escalation (200 mg/day) (in 2 divided doses). After discontinuation of valproate, increase the dose of this drug to twice the previous target stabilization dose and continue at this dose. After discontinuation of a glucuronidation inducer, gradually reduce the dose of this drug over 3 weeks. After discontinuation of a medication that does not significantly inhibit or induce glucuronidation, maintain the target dose achieved through dose escalation. Daily dose adjustment when adding other medications: When adding a glucuronidation inhibitor (e.g., valproate), select the dose according to the existing dose of lamotrigine: Current stabilization dose 200 mg/day: week 1, 100 mg*; week 2, maintain this dose (100 mg/day)*; 300 mg: week 1, 150 mg*; week 2, maintain this dose (150 mg/day)*; 400 mg: week 1, 200 mg*; week 2, maintain this dose (200 mg/day)*. When adding a glucuronidation inducer (e.g., carbamazepine) in patients not receiving valproate, select the dose according to the existing dose: Current stabilization dose 200 mg/day: week 1, 200 mg**; week 2, 300 mg**; week 3 onward, 400 mg**; 150 mg/day: week 1, 150 mg**; week 2, 225 mg**; week 3 onward, 300 mg**; 100 mg/day: week 1, 100 mg**; week 2, 150 mg**; week 3 onward, 200 mg**. When adding a medication that does not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): target maintenance dose achieved through dose escalation (200 mg/day)*. *: once daily or in 2 divided doses, **: in 2 divided doses. As with other antiepileptic drugs, sudden discontinuation of this drug should be avoided whenever possible because it may cause rebound seizures. Unless immediate discontinuation is required for safety reasons (e.g., a serious skin rash), the dose of this drug should be gradually reduced over at least 2 weeks. Restarting treatment: The longer the interval since the previous dose, the more consideration should be given to gradual dose escalation to the maintenance dose. In general, if the period since discontinuation of this drug exceeds 5 half-lives, the dose should be gradually increased to the maintenance dose according to an appropriate schedule. Elderly patients: The recommended dosing schedule for adults and adolescents aged 13 years and older may also be used in elderly patients (65 years and older). Use with caution and start at a low dose. Patients with hepatic impairment: In patients with moderate (Child-Pugh grade B) and severe (Child-Pugh grade C) hepatic impairment, the initial dose, dose increments, and maintenance dose should be reduced by approximately 50% and 75%, respectively. Dose increments and the maintenance dose should be adjusted according to clinical response. Patients with renal impairment: In patients with end-stage renal impairment, the initial dose of this drug should be based on the patient's antiepileptic drug regimen. A reduced maintenance dose may be effective in patients with severe renal impairment.

Child dose

Children aged 2∼12 years: Total daily dose: mg/kg (body weight)/day. There are not yet sufficient adequate clinical data to support a basic recommended dose for administration of this drug as monotherapy in children aged 12 years or younger. Children aged 2∼12 years, adjunctive therapy (daily dose), patients not receiving valproate and receiving glucuronidation-inducing agents: Weeks 1 and 2: 0.6 mg/kg/day (administered in 2 divided doses); Weeks 3 and 4: 1.2 mg/kg/day (administered in 2 divided doses); increase by a maximum of 1.2 mg/kg/day every 1～2 weeks to reach a maintenance dose of 5∼15 mg/kg/day (administered in 2 divided doses); maximum 400 mg/day. Children aged 2∼12 years, adjunctive therapy (daily dose), patients receiving valproate regardless of other concomitant medications: Weeks 1 and 2: 0.15 mg/kg/day** (administered once daily); Weeks 3 and 4: 0.3 mg/kg/day (administered once daily); increase by a maximum of 0.3 mg/kg/day every 1～2 weeks to reach a maintenance dose of 1∼5 mg/kg/day (administered once daily or in 2 divided doses). Maximum 200 mg/day. ** If the calculated daily dose is 1∼2 mg, 2 mg may be administered every other day during the first 2 weeks. If the calculated daily dose is less than 1 mg, this drug should not be administered. For patients aged 2 years or older and younger than 6 years, the upper end of the recommended dose range may be required as the maintenance dose. Children younger than 2 years: The safety and efficacy of this drug in children aged 1 month to younger than 2 years have not been established. There are no data for neonates younger than 1 month. Therefore, this drug is not recommended for patients younger than 2 years, and its use is particularly not recommended in patients younger than 2 years who are taking valproate because of the difficulty of determining an accurate initial dose. Children and adolescents younger than 18 years: This drug should not be administered to patients with bipolar disorder who are children or adolescents younger than 18 years.

This medication can cause severe rashes, especially in children, and if a rash appears, treatment should be discontinued immediately. During the use of this medication, systemic symptoms such as fever, lymphadenopathy, and facial swelling may occur, and if these symptoms appear, patients should consult a doctor immediately. There may be rare symptoms of aseptic meningitis, and if symptoms such as headache, fever, or neck stiffness occur, medical personnel should be notified immediately. This medication may increase suicidal thoughts or actions; therefore, patients and caregivers should inform medical personnel promptly if mood changes or suicidal thoughts develop. Women taking hormonal contraceptives are advised to use alternative birth control methods, as this medication may reduce the effectiveness of contraceptives. Patients with poor kidney or liver function should use this medication with caution, and pregnant women or those planning to become pregnant must consult a doctor. Sudden discontinuation of this medication may worsen seizures, so the dosage should be reduced gradually according to the doctor's instructions. Patients should be careful while driving or operating machinery, as side effects such as drowsiness or dizziness may occur. This medication may interact with other drugs, so if patients are taking other medications, they should inform their doctor or pharmacist.

Rash, skin adverse reactions, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), fever, lymphadenopathy, facial swelling, blood abnormalities, liver abnormalities, aseptic meningitis, photosensitivity reactions, hemophagocytic lymphohistiocytosis, exacerbation of seizures, rhabdomyolysis, multiple organ failure, disseminated intravascular coagulation, suicidal tendencies, suicidal impulses, suicidal behavior, aggressiveness, hypersensitivity, tics, hallucinations, confusion, nightmares, headache, drowsiness, insomnia, dizziness, ataxia, tremors, restlessness, instability, movement disorders, exacerbation of Parkinson's disease, extrapyramidal effects, chorea-like movements, increased seizure frequency, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, elevated liver function tests, liver dysfunction, liver failure, lupus-like reactions, fatigue, alopecia, abdominal pain, dyspepsia, constipation, bloating, weight gain, edema, arthralgia, myalgia, memory loss, emotional instability, movement disorders, sensory abnormalities, frequent urination, sweating, erythema multiforme, exfoliative dermatitis, DRESS syndrome, gastrointestinal disturbances, hematological abnormalities, leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis

This medication may be sensitive to air and light, so it should be stored in a tightly sealed container. Additionally, it is recommended to store it at room temperature between 1 to 30 degrees Celsius in a dry place with low humidity.

Appearance

White egg-shaped chewable or dispersible tablet imprinted with '93' on one side and '132' on the other side

Package unit

30 tablets (10 tablets/PTP X 3)