Lamictal Tablet 25 Milligrams, 50 Milligrams, 100 Milligrams (Lamotrigine)

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-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. 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. Adjunctive therapy (daily dose): Patients receiving other medications that do not significantly inhibit or induce lamotrigine glucuronidation: Weeks 1 and 2: 25 mg (once daily); Weeks 3 and 4: 50 mg (once daily); maintenance dose: 100~200mg (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 patients taking medications for which pharmacokinetic interactions with lamotrigine are currently unknown (see Interactions), dose increases should follow the recommended dose and dose escalation rate for concomitant administration of this medication with valproate. 2. Bipolar disorder Adults aged 18 years and older: Prevention of recurrence of depressive episodes in patients with bipolar I disorder 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). Dose escalation schedule to reach the maintenance stabilization dose (daily dose): 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, which may be increased to 400 mg in Week 7 if needed (in 2 divided doses). Dose escalation schedule to reach the maintenance stabilization dose (daily dose): 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). In patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, dose increases should follow the recommended dose for concomitant administration of this medication with valproate. The target stabilization dose may be changed 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, then 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 and administered 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, then 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, 400 mg in 2 divided doses daily may be administered as the usual target dose for an optimal response. Patients receiving other medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this medication as monotherapy: As the initial dose, 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, 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. Medication schedule after reaching the maintenance stabilization dose: After discontinuation of a glucuronidation inhibitor (e.g., valproate): Week 1: administer twice the stabilization dose. 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 in Week 1. 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 previous 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 medications that do 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). For patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, it is recommended that the current dose initially be maintained and then adjusted according to clinical response. After discontinuation of a glucuronidation inhibitor (e.g., valproate), increase the dose of this medication to twice the previous target stabilization dose and continue to maintain that 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 medication over 3 weeks. After discontinuation of medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), maintain the target dose achieved through dose escalation. Lamotrigine dose adjustment when adding other medications (daily dose): When adding a glucuronidation inhibitor (e.g., valproate): Current lamotrigine stabilization dose of 200 mg/day: Week 1, 100 mg*; Week 2, maintain this dose (100 mg/day)*; 300 mg/day: Week 1, 150 mg*; Week 2, maintain this dose (150 mg/day)*; 400 mg/day: 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: Current lamotrigine stabilization dose of 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 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 taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, dose increases should follow the recommended dose for concomitant administration of this medication with valproate. *: Once daily or in 2 divided doses, **: In 2 divided doses. 3. Discontinuation of this medication: Unless immediate discontinuation is required for safety reasons (e.g., serious skin rash), the dose of this medication should be gradually reduced over a minimum of 2 weeks. 4. Restarting treatment: The longer the interval since the previous dose, the greater the consideration that should be given to gradual escalation to the maintenance dose. In general, if the period after discontinuation of this medication exceeds 5 times the half-life, 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 (65 years and older). However, in general, elderly patients should be treated cautiously and started at a low dose because sufficient clinical data are unavailable. 6. Patients with hepatic impairment: In general, in patients with moderate (Child-Pugh grade B) and severe (Child-Pugh grade C) hepatic impairment, the initial dose, escalation dose, and maintenance dose should each be reduced by approximately 50% and 75%, respectively. Escalation and maintenance doses should be adjusted according to clinical response. 7. Patients with renal impairment: In patients with end-stage renal impairment, the initial dose of this medication 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: There are currently insufficient adequate clinical data to support a basic recommended dose for monotherapy with this drug in children 12 years and under. Children aged 2∼12 years, adjunctive therapy: Patients not receiving valproate and receiving glucuronidation-inducing drugs: 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 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 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. Children aged 2∼12 years, adjunctive therapy: Patients receiving other drugs that do not significantly inhibit or induce lamotrigine glucuronidation: Weeks 1 and 2, 0.3 mg/kg/day (once daily or in 2 divided doses); weeks 3 and 4, 0.6 mg/kg/day (once daily or in 2 divided doses); increase by a maximum of 0.6 mg/kg/day every 1～2 weeks to a maintenance dose of 1∼10 mg/kg/day (once daily or in 2 divided doses). Maximum 200 mg/day. Children aged 2∼12 years: If the calculated dose of this drug cannot be administered as a whole-tablet dose, reduce it to the nearest whole-tablet dose that does not exceed the calculated dose. The child's weight should be monitored to ensure that the therapeutic dose is maintained, and the dose should be reviewed if weight changes occur. In patients aged 2 years or older but under 6 years, the upper end of the recommended dose range may be the maintenance dose. Children under 2 years: The safety and efficacy of this drug in children aged 1 month to under 2 years have not been established. There are no data in neonates under 1 month of age. Therefore, use is not recommended in patients under 2 years of age; in particular, use is not recommended in patients under 2 years who are taking valproate because of the difficulty of determining an accurate initial dose. Children and adolescents under 18 years: This drug should not be administered to patients under 18 years of age with bipolar disorder.

This medication may cause severe skin rashes during use, so caution is particularly necessary in children. If a rash appears, the medication must be stopped immediately and a doctor should be consulted. Also, this medication can induce hypersensitivity reactions accompanied by systemic symptoms such as fever, lymphadenopathy, facial swelling, etc., so these symptoms should be reported to healthcare professionals immediately. Increased seizures or severe seizures may occur, so if symptoms worsen, immediate medical attention is necessary. There may be an increased risk of suicidal thoughts or behavior during treatment, so patients and caregivers should closely monitor for changes in mental status. Women who are pregnant or planning to become pregnant should consult with a doctor before taking this medication, and during pregnancy, the minimum effective dose should be used. If breastfeeding, this medication may be secreted in breast milk and affect the baby, so breastfeeding should be stopped or a doctor should be consulted. This medication has many drug interactions, so any other medications being taken must be reported to healthcare professionals. Sudden discontinuation can worsen seizures, so dosage adjustments should be made gradually according to a doctor's instructions. Care should be taken when driving or operating machinery as this medication may cause drowsiness or dizziness.

Rash, skin rash, photosensitive reactions, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), alopecia, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), aseptic meningitis, hematological abnormalities (neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), lymphadenopathy, hemophagocytic lymphohistiocytosis, pseudo-lymphoma, fever, facial edema, liver abnormalities, kidney abnormalities, aggression, hypersensitivity, tics, hallucinations, confusion, nightmares, headache, drowsiness, insomnia, dizziness, tremors, eye twitching, restlessness, instability, movement disorders, exacerbation of Parkinson's disease, extrapyramidal effects, chorea-like slow twisting movements, increased seizure frequency, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, gastrointestinal disturbances, elevated liver function tests, liver dysfunction, liver failure, lupus-like reactions, fatigue, interstitial nephritis, abdominal pain, indigestion, constipation, bloating, weight gain, edema, arthralgia, myalgia, amnesia, emotional instability, movement disorders, sensory abnormalities, increased urination, sweating

This medication should be stored in a tightly sealed container that is well-ventilated and kept at room temperature in a dry place. This helps maintain the effectiveness of the medication and prevents degradation.

Appearance

Pale yellow-brown square tablet

Package unit

90 tablets/box [10 tablets/PTP X 9], 90 tablets/box [15 tablets/PTP X 6]