Lamotrigine 100 mg (Lamotrigine)

Adult dose

Epilepsy, adults and adolescents aged 13 years and older: Monotherapy: 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. Doses of up to 500 mg/day have been used in some patients to achieve the desired response. Epilepsy, adjunctive therapy in adults and adolescents aged 13 years and older (daily dose): For patients not receiving valproate and receiving 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. For 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. In patients receiving medications for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dosage and dose-escalation schedule for concomitant administration of this drug with valproate. Bipolar disorder, adults aged 18 years and older: For patients receiving a glucuronidation inhibitor (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). For patients not receiving an inhibitor such as valproate and receiving 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); 300 mg in week 6, with an increase to 400 mg in week 7 if needed (in 2 divided doses). For patients receiving 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). The target stabilization dose may be adjusted according to clinical response. For patients receiving concomitant glucuronidation inhibitors such as valproate, administer 25 mg every other day for the first 2 weeks, then 25 mg once daily for the next 2 weeks. The target dose 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). For patients not receiving valproate but receiving glucuronidation inducers such as carbamazepine or phenobarbital, administer 50 mg once daily for the first 2 weeks, then 100 mg in 2 divided doses for the next 2 weeks. In week 5, administer 200 mg in 2 divided doses. In week 6, administer 300 mg in 2 divided doses. From week 7, 400 mg may be administered in 2 divided doses. For patients receiving concomitant medications that do not significantly inhibit or induce glucuronidation, or receiving this drug as monotherapy, administer 25 mg once daily for the first 2 weeks, then 50 mg once daily (or in 2 divided doses) for the next 2 weeks. In week 5, administer 100 mg once daily (or in 2 divided doses). The target dose 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 benefit over 200 mg/day. Bipolar disorder, after reaching the maintenance stabilization dose: After discontinuing a glucuronidation inhibitor (e.g., valproate), administer twice the stabilization dose. However, the dose increase should not exceed 100 mg/week. For example, 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: for an existing maintenance dose of 400 mg, 300 mg in week 1 and 200 mg in week 2; for an existing maintenance dose of 300 mg, 225 mg in week 1 and 150 mg in week 2; for an existing maintenance dose of 200 mg, 150 mg in week 1 and 100 mg in week 2. After discontinuing a medication that does not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), maintain the target maintenance dose reached through dose escalation (200 mg/day) (in 2 divided doses). After discontinuing a glucuronidation inhibitor (e.g., valproate), increase the dose of this drug to twice the previous target stabilization dose and continue to maintain this dose. After discontinuing a glucuronidation inducer, gradually decrease the dose of this drug over 3 weeks. For patients receiving an antiepileptic drug for which pharmacokinetic interactions with lamotrigine are not currently known, initially maintain the current dose and adjust the dose according to clinical response. Bipolar disorder, adjunctive therapy with other medications: When adding a glucuronidation inhibitor (e.g., valproate), for an existing lamotrigine dose of 200 mg, administer 100 mg* in week 1 and maintain this dose (100 mg/day)* from week 2 onward; for 300 mg, administer 150 mg* in week 1 and maintain this dose (150 mg/day)* from week 2 onward; for 400 mg, administer 200 mg* in week 1 and maintain this dose (200 mg/day)* from week 2 onward. When adding a glucuronidation inducer (e.g., carbamazepine) in patients not receiving valproate, for an existing dose of 200 mg, administer 200 mg** in week 1, 300 mg** in week 2, and 400 mg** from week 3 onward; for 150 mg, administer 150 mg** in week 1, 225 mg** in week 2, and 300 mg** from week 3 onward; for 100 mg, administer 100 mg** in week 1, 150 mg** in week 2, and 200 mg** from week 3 onward. When adding a medication that does not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), use the target maintenance dose reached through dose escalation (200 mg/day)*. *: Once daily or in 2 divided doses; **: in 2 divided doses. Discontinuation of this drug: Unless immediate discontinuation is required for safety reasons (e.g., a serious skin rash), the dose of this drug should be reduced gradually over at least 2 weeks. Restarting treatment: If the period since discontinuation of this drug exceeds 5 half-lives, gradually increase the dose to the maintenance dose according to an appropriate regimen. Older adults: The recommended dosage schedule for adults and adolescents aged 13 years and older may also be used in older adults (65 years and older). Start older patients 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, 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 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, monotherapy: Adequate clinical data to support a basic recommended dose for use of this medicine as monotherapy in children aged 12 years or younger are not yet available. Children aged 2∼12 years, adjunctive therapy: 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 a maintenance dose of 5∼15 mg/kg/day (in 2 divided doses); maximum 400 mg/day. Children aged 2∼12 years, adjunctive therapy: Patients receiving valproate, regardless of other concomitant medicines: 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 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 medicine should not be administered. For patients aged 2 years or older and younger than 6 years, the upper limit of the recommended dose may be the maintenance dose. Children aged 1 month to under 2 years: The safety and efficacy of this medicine have not been established. It is not recommended for patients younger than 2 years, and use is particularly not recommended in patients younger than 2 years who are taking valproate. Neonates younger than 1 month: No data are available. Children and adolescents younger than 18 years, bipolar disorder: Do not administer.

This medication may cause severe skin rashes, so it should be discontinued immediately if a rash occurs, especially in children. Skin rashes commonly occur during the first 8 weeks, so if any rash or fever symptoms appear during this period, medical attention should be sought. Caution should be taken as using an initial dose too high or increasing the dosage too quickly may increase the risk of rashes. The risk of rashes may also increase when taken with other medications, so consultation with a doctor is necessary during concomitant use. Hypersensitivity reactions may occur with blood or systemic symptoms, and if there are symptoms such as fever or lymphadenopathy, administration should be stopped immediately. Treatment should be discontinued if symptoms of aseptic meningitis occur, and re-administration should be avoided. This medication may increase the risk of suicidal thoughts or behavior, so patients and caregivers should inform healthcare professionals immediately if such symptoms arise. During pregnancy, the use of this medication may affect the fetus, so women who are pregnant or planning to become pregnant must consult a doctor. During breastfeeding, this medication can be excreted into breast milk and may affect the baby, so it is advisable to avoid breastfeeding. This medication can interact with other drugs, so if you are taking other medications, be sure to inform healthcare professionals. Serious symptoms may occur in cases of overdose, so it is important to adhere to the prescribed dosage and frequency. It is important to recognize that this medication may cause drowsiness or dizziness before driving or operating machinery.

Rash, skin adverse reactions, skin and mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), fever, lymphadenopathy, facial edema, blood dyscrasia, liver dysfunction, aseptic meningitis, disseminated intravascular coagulation, multiple organ failure, hemophagocytic lymphohistiocytosis, seizure clustering, rhabdomyolysis, suicidal thoughts, suicidal behavior, depression, aggression, irritability, tics, hallucinations, confusion, nightmares, headache, drowsiness, insomnia, dizziness, ataxia, eyelid twitching, restlessness, instability, movement disorders, exacerbation of Parkinson's disease, extrapyramidal effects, chorea, increase in seizure frequency, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, pain, pharyngitis, flu-like syndrome, menstrual disorder, tremors, pulmonary disorders, depression, memory loss, abnormal thoughts, hematological abnormalities (neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), hypersensitivity reactions, elevated liver enzyme levels, liver dysfunction, liver failure, lupus-like reactions, fatigue, alopecia, dyspepsia, constipation, bloating, weight gain, edema, arthralgia, myalgia, emotional instability, movement disorders, sensory abnormalities, frequent urination, sweating, erythema multiforme, exfoliative dermatitis, mania, hypomania, mixed episodes, decreased bone density, osteopenia, osteoporosis, fractures, DRESS syndrome, eyelid twitching, ataxia, coma, altered consciousness, increased seizures, generalized seizures, headache, vomiting, loss of consciousness, comatose state

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be kept between 1 and 30 degrees Celsius, and it is best to keep it in a dry place with low humidity.

Appearance

Light yellowish-brown square tablet

Package unit

30 tablets/bottle, 100 tablets/bottle