Lamotrigine Tablet 50 Milligrams (Lamotrigine)

Adult dose

This medicine may be swallowed whole, chewed, or taken after dispersing the tablet in a small amount of water (chewable tablets only). 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 obtain the desired response. Epilepsy—Adults and adolescents aged 13 years and older, adjunctive therapy (daily dose), patients not receiving valproate and receiving glucuronidation-inducing agents: 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. Epilepsy—Adults and adolescents aged 13 years and older, 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 example, patients receiving glucuronidation-inducing agents such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, or ritonavir. In patients receiving medications for which pharmacokinetic interactions with lamotrigine are currently unknown (see Interactions), dose increases should follow the recommended dose and rate of dose escalation for concomitant use of this medicine with valproate. Bipolar disorder—Adults aged 18 years and older 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). Bipolar disorder—Adults aged 18 years and older 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); 300 mg in week 6, with an increase to 400 mg in week 7 if needed (in 2 divided doses). Bipolar disorder—Adults aged 18 years and older 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). In patients receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, 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 receiving glucuronidation inhibitors (e.g., valproate): Patients receiving a glucuronidation inhibitor such as valproate concomitantly should receive an initial dose of 25 mg every other day during 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 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): Patients receiving glucuronidation inducers such as carbamazepine or phenobarbital without valproate should receive an initial dose of 50 mg once daily during 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. The usual target dose for an optimal response may be 400 mg in 2 divided doses starting in week 7. Patients receiving other medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this medicine as monotherapy: Patients concomitantly receiving medications with which this medicine has no theoretical clinical pharmacokinetic interaction, or receiving this medicine as monotherapy, should receive an initial dose of 25 mg once daily during 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 offered no advantage over 200 mg/day. Adults with bipolar disorder after discontinuation of a glucuronidation inhibitor (e.g., valproate): Week 1: administer twice the stabilization dose. 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 in week 1. Week 2: maintain the week 1 dose (200 mg/day) (once daily or in 2 divided doses). Adults with bipolar disorder after discontinuation of a glucuronidation inducer (e.g., carbamazepine): Select the dose according to the previous maintenance dose. Previous dose 400 mg: 300 mg in week 1, 200 mg in week 2; previous dose 300 mg: 225 mg in week 1, 150 mg in week 2; previous dose 200 mg: 150 mg in week 1, 100 mg in week 2. Adults with bipolar disorder 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). In patients receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, it is recommended that the current dose initially be maintained and adjusted according to clinical response. After discontinuation of a glucuronidation inhibitor (e.g., valproate): After discontinuation of valproate, increase the dose of this medicine to twice the previous target stabilization dose and continue to maintain this dose. After discontinuation of a glucuronidation inducer (e.g., carbamazepine): Select the dose according to the previous maintenance dose. After discontinuation of a glucuronidation inducer, gradually reduce the dose of this medicine over 3 weeks. After discontinuation of a medication that does not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion): Maintain the target dose achieved through dose escalation. Lamotrigine dose adjustment in adults aged 18 years and older with bipolar disorder receiving adjunctive therapy with other medications (daily dose): When adding a glucuronidation inhibitor (e.g., valproate), select the dose according to the patient's previous lamotrigine dose—previous stabilization dose 200 mg/day: 100 mg* in week 1, then maintain this dose (100 mg/day)*; previous stabilization dose 300 mg/day: 150 mg* in week 1, then maintain this dose (150 mg/day)*; previous stabilization dose 400 mg/day: 200 mg* in week 1, then 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 previous dose: previous stabilization dose 200 mg/day: 200 mg** in week 1, 300 mg** in week 2, 400 mg** from week 3 onward; previous stabilization dose 150 mg/day: 150 mg** in week 1, 225 mg** in week 2, 300 mg** from week 3 onward; previous stabilization dose 100 mg/day: 100 mg** in week 1, 150 mg** in week 2, 200 mg** from week 3 onward. Adjunctive therapy with medications that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): target maintenance dose achieved through dose escalation (200 mg/day)*. In patients receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, 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 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. Restarting treatment: In general, if the period after discontinuation of this medicine 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). However, because adequate clinical data in elderly patients are generally unavailable, administer with caution and start at a low dose. Patients with hepatic impairment: In general, in patients with moderate (Child-Pugh grade B) and severe (Child-Pugh grade C) hepatic impairment, the initial, escalation, and maintenance doses should be reduced by approximately 50% and 75%, respectively. Escalation and maintenance doses should be adjusted according to clinical response. Patients with renal impairment: In patients with end-stage renal impairment, 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, epilepsy monotherapy: Adequate clinical data to support the basic recommended dose for administration of this drug as monotherapy in children aged 12 years or younger are not yet available. Children aged 2∼12 years, epilepsy adjunctive therapy (total daily dose: mg/kg (body weight)/day), patients not receiving valproate and receiving glucuronidation-inducing agents: Weeks 1 and 2, 0.6 mg/kg/day (in 2 divided doses); weeks 3 and 4, 1.2 mg/kg/day (in 2 divided doses); increase by a maximum of 1.2 mg/kg/day every 1～2 weeks to achieve a maintenance dose of 5∼15 mg/kg/day (in 2 divided doses), up to a maximum of 400 mg/day. Children aged 2∼12 years, epilepsy adjunctive therapy (total daily dose: mg/kg (body weight)/day), patients receiving valproate, regardless of other concomitant medications: Weeks 1 and 2, 0.15 mg/kg/day** (once daily); weeks 3 and 4, 0.3 mg/kg/day (once daily); increase by a maximum of 0.3 mg/kg/day every 1～2 weeks to achieve a maintenance dose of 1∼5 mg/kg/day (once daily or in 2 divided doses). Maximum 200 mg/day. * Patients receiving glucuronidation inducers of this drug, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir. For patients taking medications for which pharmacokinetic interactions with lamotrigine are currently unknown (see Interactions), the same dose escalation schedule recommended for concomitant administration of this drug and valproate should be used. ** 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. In patients aged 2 years to less than 6 years, the upper end of the recommended dose range is likely to be the maintenance dose. Children aged 1 month to less than 2 years: The safety and efficacy of this drug have not been established. It is not recommended for patients younger than 2 years. Neonates younger than 1 month: No data are available. Children and adolescents younger than 18 years, bipolar disorder: This drug should not be administered.

This medication may cause serious rashes on the skin, so if a rash develops in children during the first 8 weeks, treatment should be discontinued immediately. Rashes can sometimes progress to life-threatening conditions, so caution is needed unless it is confirmed that the rash is unrelated to the medication. When starting this medication, the dosage should be increased slowly, and the recommended dosage should not be exceeded. Additionally, the blood concentration of this medication may change when taken with certain other medications, so consulting with a doctor is necessary. This medication may increase the risk of suicidal thoughts or behaviors, so patients and caregivers should closely monitor mental health status and report any abnormal signs to healthcare professionals promptly. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and special care is required during pregnancy to minimize impacts on the fetus. If breastfeeding, healthcare professionals should be consulted regarding the potential transfer of this medication to breast milk. Sudden discontinuation of this medication may worsen seizures, so dosage should be reduced gradually under a doctor's guidance. Caution is needed when driving or operating machinery, as drowsiness or dizziness may occur. This medication should not be used in patients with certain genetic disorders, and it should be used cautiously in patients with heart disease or those taking specific medications. In case of overdose, immediate visit to a medical institution for appropriate treatment is necessary, and there is no specific antidote, so supportive care based on symptoms is required. This medication should be stored in a dry place below 30 degrees Celsius, safely out of reach of children.

Rash, skin adverse reactions, skin mucosal syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), 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 reactions, hematologic abnormalities (neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), hemophagocytic lymphohistiocytosis, hypersensitivity reactions, aggressiveness, hyperactivity, tics, hallucinations, confusion, nightmares, headache, drowsiness, insomnia, dizziness, ataxia, eye twitching, agitation, instability, movement disorders, exacerbation of Parkinson's disease, extrapyramidal effects, chorea-like movements, increased seizure frequency, double vision, blurry vision, conjunctivitis, nausea, vomiting, diarrhea, appetite loss, pain, pharyngitis, influenza-like syndrome, menstrual disorders, tremors, pulmonary disorders, depression, amnesia, abnormal thoughts, blood deficiency, lymphadenopathy, lupus-like reactions, fatigue, sweating, abdominal pain, dyspepsia, constipation, bloating, weight gain, edema, arthralgia, myalgia, emotional instability, sensory abnormalities, frequent urination, alopecia, mania, hypomania, mixed episodes, decreased bone density, osteopenia, osteoporosis, fractures, DRESS syndrome, eye twitching, ataxia, coma, altered consciousness, increased seizures, grand mal seizures, QRS prolongation, loss of consciousness

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The appropriate storage temperature is between 1 and 30 degrees Celsius, and it is best kept in a cool, dry place.

Appearance

Light yellow, rounded square tablets

Package unit

30 tablets/bottle, 100 tablets/bottle