Lamotrigine 25 mg (Lamotrigine)

Adult dose

1. 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. 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. For patients receiving medications with no known pharmacokinetic interaction with lamotrigine, dose increases should follow the recommended dosage and dose escalation schedule for concomitant use of this drug with valproate. 2. Bipolar disorder Adults aged 18 years and older: Weeks 1 and 2, weeks 3 and 4, week 5, and target stabilization dose (week 6), in that order. Patients receiving glucuronidation inhibitors (e.g., valproate): 12.5 mg (25 mg every other day), 25 mg (once daily), 50 mg (once daily or in 2 divided doses), 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): 50 mg (once daily), 100 mg (in 2 divided doses), 200 mg (in 2 divided doses), 300 mg in week 6; if necessary, the dose may be increased to 400 mg in week 7 (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: 25 mg (once daily), 50 mg (once daily or in 2 divided doses), 100 mg (once daily or in 2 divided doses), 200 mg (once daily or in 2 divided doses). For patients receiving antiepileptic drugs with no known pharmacokinetic interaction with lamotrigine, dose increases should follow the recommended dosage 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): The initial dose is 25 mg every other day for the first 2 weeks, followed by 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). Patients not receiving inhibitors such as valproate and receiving glucuronidation inducers (e.g., carbamazepine, phenobarbital): 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, 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. Patients receiving other medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this drug as monotherapy: 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, administer 100 mg once daily (or in 2 divided doses). Administer 200 mg once daily or in 2 divided doses. In clinical trials, doses of up to 400 mg/day were used as monotherapy; however, lamotrigine 400 mg/day provided no benefit over 200 mg/day. After reaching the maintenance stabilization dose: After discontinuation of a glucuronidation inhibitor (e.g., valproate), administer twice the stabilization dose. However, dose increases should not exceed 100 mg/week. For example, if the target stabilization dose is 100 mg/day, administer 200 mg/day in week 1. Maintain the week 1 dose (200 mg/day) in week 2 (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. In order of week 1, week 2, and week 3 onward: existing maintenance dose of 400 mg: 300 mg, 200 mg; existing maintenance dose of 300 mg: 225 mg, 150 mg; existing maintenance dose of 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 reached through dose escalation (200 mg/day) (in 2 divided doses). After discontinuation of a glucuronidation inhibitor (e.g., valproate), increase this drug's dose to twice the existing target stabilization dose and continue to maintain this dose. After discontinuation of a glucuronidation inducer (e.g., carbamazepine), select the dose according to the existing maintenance dose. After discontinuation of a glucuronidation inducer, gradually reduce this drug's dose over 3 weeks. After discontinuation of a medication that does not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), maintain the target dose reached through dose escalation. Dose adjustment with adjunctive therapy with other medications: When adding a glucuronidation inhibitor (e.g., valproate), select the dose according to the existing lamotrigine dose: current stabilization dose 200 mg/day: 100 mg* in week 1, then maintain this dose (100 mg/day)*; 300 mg: 150 mg*, then maintain this dose (150 mg/day)*; 400 mg: 200 mg*, 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 existing dose: current stabilization dose 200 mg: 200 mg** in week 1, 300 mg** in week 2, 400 mg** from week 3 onward; 150 mg: 150 mg**, 225 mg**, 300 mg**; 100 mg: 100 mg**, 150 mg**, 200 mg**. Adjunctive therapy with medications that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): target maintenance dose reached through dose escalation (200 mg/day)*. *: Once daily or in 2 divided doses, **: In 2 divided doses. For patients receiving antiepileptic drugs with no known pharmacokinetic interaction with lamotrigine, dose increases should follow the recommended dosage for concomitant use of this drug with valproate. Do not administer to pediatric patients or adolescents under 18 years of age with bipolar disorder. 3. Discontinuation of this drug: Unless immediate discontinuation is required for safety reasons (e.g., serious skin rash), the dose of this drug should be gradually reduced over at least 2 weeks. 4. 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. 5. Elderly patients: The recommended dosing regimen for adults and adolescents aged 13 years and older may also be used in elderly patients (65 years and older). Administer with caution and start at a low dose. 6. 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 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 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, adjunctive therapy (daily dose): Patients not receiving valproate and receiving an inducer of glucuronidation: 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 until a maintenance dose of 5∼15 mg/kg/day (in 2 divided doses) is reached; maximum 400 mg/day. Children aged 2∼12 years, adjunctive therapy (daily dose): 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 until a maintenance dose of 1∼5 mg/kg/day (once daily or in 2 divided doses) is reached. Maximum 200 mg/day. Children aged 2∼12 years, monotherapy: There are currently insufficient clinical data to support a basic recommended dose for use of this medicine as monotherapy in children 12 years of age or younger. Children aged 2∼12 years: 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. The child's weight should be monitored to confirm that the therapeutic dose is maintained, and the dose should be reviewed if weight changes occur. In patients aged 2 years or older but younger than 6 years, the upper end of the recommended dose range is likely to be the maintenance dose. Children aged 1 month to younger than 2 years: The safety and efficacy of this medicine have not been established. There are no data in neonates younger than 1 month. Use is not recommended in patients younger than 2 years, particularly in those taking valproate. Children and adolescents younger than 18 years: Do not administer to patients with bipolar disorder.

This medication may cause skin rashes and has a higher risk of developing into serious skin disorders, especially in children, so if a rash occurs, immediate discontinuation is necessary. Rashes primarily occur within the first 8 weeks, which may be mild but can be severe enough to require hospitalization. The risk of rash increases when this medication is initially prescribed or when the dosage is increased rapidly, or when used in conjunction with certain other medications. Hypersensitivity reactions may manifest as fever, lymph node swelling, facial swelling, etc., and in the presence of such symptoms, immediate consultation with a healthcare professional and discontinuation of the medication is required. This medication may worsen seizures, thus if seizure symptoms deteriorate, immediate medical attention is required. There may be an increased risk of suicidal thoughts or behaviors, so it is essential for patients and caregivers to closely monitor for changes in mental state and notify healthcare professionals of any abnormal signs. Women using hormonal contraceptives should consult their doctor when starting or stopping this medication, as it may reduce the contraceptive effect and may require adjustments in contraceptive methods. This medication should be used cautiously during pregnancy due to risks to the fetus, and women planning to become pregnant or who are pregnant must consult their doctor. Breastfeeding women should discuss with their doctor whether the medication passes into breast milk and can affect the newborn. This medication is not recommended for use in children under 2 years of age, and it is not approved for treating bipolar disorder in individuals under 18 years old. Severe symptoms may arise from overdose, so it is crucial to adhere strictly to the prescribed dosage and seek immediate medical attention in case of overdose. During use, symptoms such as drowsiness, dizziness, and blurred vision may occur, so caution is required when driving or operating machinery. This medication may interact with other drugs, so individuals taking other medications must inform their physician or pharmacist.

Rash, skin adverse reactions, skin mucosal syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), fever, lymphadenopathy, facial edema, blood abnormalities, liver abnormalities, aseptic meningitis, photosensitive reactions, hematological abnormalities (neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), erythrophagocytic lymphohistiocytosis, hypersensitivity reactions, disseminated intravascular coagulation, multiple organ failure, aggressiveness, hypersensitivity, tics, hallucinations, confusion, nightmares, headaches, drowsiness, insomnia, dizziness, ataxia, eye twitching, aseptic meningitis, agitation, instability, movement disorders, exacerbation of Parkinson's disease, extrapyramidal effects, dyskinetic movements, increased frequency of seizures, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, gastrointestinal disorders, loss of appetite, pain, pharyngitis, flu-like syndrome, menstrual disorders, tremors, pulmonary disorders, depression, amnesia, abnormal thoughts, abdominal pain, indigestion, constipation, bloating, weight gain, edema, arthralgia, myalgia, emotional instability, sensory disturbances, frequent urination, sweating, alopecia, lupus-like reactions, fatigue, pain, back pain, DRESS syndrome, suicidal impulses, suicidal behavior, suicidal tendencies, suicidal thoughts, coma, consciousness disturbances, increased seizures, grand mal seizures, QRS prolongation, ventricular conduction delay, eye twitching, ataxia, dizziness, drowsiness, blurred vision, headaches, vomiting

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The proper storage temperature is between 1 degree and 30 degrees Celsius, and it is advisable to keep it in a cool, dry place.

Appearance

Light yellowish-brown square tablets

Package unit

30 tablets/bottle, 100 tablets/bottle