Lamotrigine Chewable Tablet 50 mg

Adult dose

Swallow this medicine whole, chew it, or disperse the tablet in a small amount of water before taking it (applies to chewable tablets only). 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 taking a glucuronidation-inducing agent: 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 (see Interactions), dose increases should follow the recommended dose and dose-increase schedule for concomitant use of this medicine with valproate. 2. Bipolar disorder Adults aged 18 years and older Dose-escalation schedule to reach the maintenance stabilization dose (daily dose): Patients taking an inhibitor of glucuronidation (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). Dose-escalation schedule to reach the maintenance stabilization dose (daily dose): Patients not taking an inhibitor such as valproate and taking a glucuronidation inducer (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; if needed, the dose may be increased to 400 mg in Week 7 (in 2 divided doses). Dose-escalation schedule to reach the maintenance stabilization dose (daily dose): Patients taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion), or receiving lamotrigine 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 medicine with valproate. The target stabilization dose may be adjusted according to clinical response. Patients taking an inhibitor of glucuronidation (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 an optimal response is 100 mg once daily or in 2 divided doses. Depending on the clinical response, the dose may be increased to a maximum of 200 mg once daily (or in 2 divided doses). Patients not taking an inhibitor such as valproate and taking a glucuronidation inducer (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 for the next 2 weeks. In Week 5, increase the dose to 200 mg in 2 divided doses. In Week 6, increase the dose to 300 mg in 2 divided doses. From Week 7, the usual target dose for an optimal response may be 400 mg in 2 divided doses. Patients taking other medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this medicine 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 an 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. Dosing schedule after reaching the maintenance stabilization dose: After discontinuing an inhibitor of glucuronidation (e.g., valproate), administer twice the stabilization dose during Week 1. However, the dose increase should not exceed 100 mg/week. That is, if the target stabilization dose is 100 mg/day, administer 200 mg/day during Week 1. Maintain the Week 1 dose (200 mg/day) during Week 2 (once daily or in 2 divided doses). After discontinuing 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 discontinuing a medication that does not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): Maintain the target maintenance dose reached through dose escalation (200 mg/day) (in 2 divided doses). For patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, it is recommended that the current dose initially be maintained and adjusted according to clinical response. Daily dose adjustment when adding another medication: When adding an inhibitor of glucuronidation (e.g., valproate), select the dose according to the patient's existing lamotrigine dose: current stabilization dose 200 mg/day: Week 1, 100 mg*; maintain this dose (100 mg/day)* from Week 2 onward; 300 mg/day: Week 1, 150 mg*; maintain this dose (150 mg/day)* from Week 2 onward; 400 mg/day: Week 1, 200 mg*; maintain this dose (200 mg/day)* from Week 2 onward. When adding a glucuronidation inducer (e.g., carbamazepine) in patients not taking 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 reached through dose escalation (200 mg/day)*. 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 medicine with valproate. *: Once daily or in 2 divided doses, **: In 2 divided doses. 3. Discontinuation of this medicine Unless immediate discontinuation is required for safety reasons (e.g., a serious skin rash), the dose of this medicine should be gradually reduced over at least 2 weeks. 4. Restarting treatment If the period since discontinuation of this medicine exceeds 5 half-lives, the dose should be gradually increased to the maintenance dose according to an appropriate schedule. 5. Elderly patients The recommended dosing schedule for adults and adolescents aged 13 years and older may also be used in elderly patients (aged 65 years and older). In general, elderly patients should be treated with caution and started at a low dose because sufficient clinical data are not available. 6. Patients with hepatic impairment In general, the initial dose, dose increments, and maintenance dose should each be reduced by approximately 50% and 75% in patients with moderate (Child-Pugh grade B) and severe (Child-Pugh grade C) hepatic impairment, respectively. Dose increments and maintenance doses should be adjusted according to clinical response. 7. Patients with renal impairment In patients with end-stage renal disease, the initial dose of this medicine 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: Monotherapy: Adequate clinical data to support a basic recommended dose for administration of this drug as monotherapy in children aged 12 years or younger are not yet sufficient. Children aged 2∼12 years: Adjunctive therapy (daily dose), patients not receiving valproate and receiving glucuronic acid conjugation inducers: 0.6 mg/kg/day during weeks 1 and 2 (in 2 divided doses), 1.2 mg/kg/day during weeks 3 and 4 (in 2 divided doses), increase by up to 1.2 mg/kg/day every 1～2 weeks to reach a maintenance dose of 5∼15 mg/kg/day (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: 0.15 mg/kg/day** during weeks 1 and 2 (once daily), 0.3 mg/kg/day during weeks 3 and 4 (once daily), increase by up to 0.3 mg/kg/day every 1～2 weeks to reach a maintenance dose of 1∼5 mg/kg/day (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. Patients aged 2 years to under 6 years: The upper end of the recommended dose range may be the maintenance dose. Children aged 1 month to under 2 years: The safety and efficacy of this drug have not been established. Neonates under 1 month: No data are available. Children and adolescents under 18 years: Do not administer to patients with bipolar disorder.

This medication may cause skin rashes, so if a severe skin rash occurs, especially in children, discontinue use immediately. Rashes typically appear within 8 weeks of starting the medication and can rarely progress to life-threatening skin conditions. If a rash develops, seek medical attention immediately, and avoid re-administration if a rash had occurred previously with this medication. If systemic symptoms such as fever, swollen lymph nodes, or facial swelling occur during treatment, consult a healthcare provider immediately. Meningitis symptoms may occur; therefore, if symptoms such as headache, fever, or neck stiffness arise, inform medical staff quickly. This medication may increase the risk of suicidal thoughts or behaviors; inform medical staff immediately if mood changes or suicidal thoughts arise. Women taking hormonal contraceptives need to consult a doctor about possible dosage adjustments due to altered drug concentrations with this medication. Interactions may occur with other antiepileptic medications or drugs, so inform healthcare providers about all medications being taken. Women who are pregnant or planning to become pregnant must consult a doctor prior to taking this medication, and it is advisable to avoid use during breastfeeding. Sudden discontinuation of this medication may worsen seizures, so dosage should be gradually reduced as directed by a physician. In case of overdose, seek immediate hospital care as there is no specific antidote. Caution should be exercised during driving or operating machinery due to possible drowsiness or dizziness during treatment. Keep out of reach of children and store in a dry place below 30 degrees Celsius.

Rash, skin adverse reactions, mucocutaneous syndrome, toxic epidermal necrolysis, severe rash requiring hospitalization and discontinuation of administration, fever, lymphadenopathy, facial edema, blood abnormalities, liver abnormalities, aseptic meningitis, disseminated intravascular coagulation, multiple organ failure, photosensitivity reaction, hematological abnormalities, hemophagocytic lymphohistiocytosis, hypersensitivity, aggression, hyperreactivity, tics, hallucinations, confusion, nightmares, headaches, drowsiness, insomnia, ataxia, eye twitching, restlessness, instability, movement disorder, exacerbation of Parkinson's disease, extrapyramidal effects, bradykinetic chorea, increased seizure frequency, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, gastrointestinal disturbances, pain, pharyngitis, flu-like symptoms, menstrual disorders, tremors, pulmonary disorders, depression, memory loss, abnormal thinking, hematological abnormalities, lymphadenopathy, hypersensitivity, suicidal impulses, suicidal behavior, fatigue, abdominal pain, dyspepsia, constipation, bloating, weight gain, edema, arthralgia, myalgia, emotional instability, movement disorders, sensory disturbances, increased urination, sweating, alopecia, lupus-like reactions, elevated liver function tests, liver dysfunction, liver failure, DRESS syndrome, eye twitching, aseptic meningitis, chorea without athetosis, coma, altered consciousness, increased seizures, generalized seizures, QRS prolongation, unconsciousness

This medication should be stored in a tightly closed container to protect it from air and light exposure. It is best stored at room temperature between 1 and 30 degrees Celsius, in a dry area with low humidity.

Appearance

White round chewable or dispersible tablet engraved with 50 on one side and DLT on the other side

Package unit

30 tablets (10 tablets/PTP × 3)