Lamotrigine 25 mg (Lamotrigine)

Adult dose

This medicine should be swallowed whole, chewed, or dispersed in a small amount of water before taking (for chewable tablets only). 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 a maximum of 50∼100 mg every 1∼2 weeks until the maintenance dose is reached. Monotherapy (daily dose): 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 a glucuronidation inducer: 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 a maximum of 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 a maximum of 25～50 mg every 1～2 weeks until the maintenance dose is reached. Patients receiving glucuronidation inducers of this medicine, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir. For patients receiving medications for which pharmacokinetic interactions with lamotrigine are currently unknown (see Interactions), dose increases should follow the recommended dose and dose-escalation schedule for concomitant administration of this medicine and valproate. Bipolar disorder, adults aged 18 years and older: Recommended dosage for preventing recurrence of depressive episodes in patients with bipolar I disorder. 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). 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); week 6: 300 mg, with an increase to 400 mg in week 7 if needed (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: 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 receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, dose increases should follow the recommended dosage for concomitant administration of this medicine and valproate. The target stabilization dose may be adjusted according to clinical response. Patients receiving a glucuronidation inhibitor (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 for an optimal response is 100 mg once daily or in 2 divided doses. Depending on clinical response, the dose may be increased up to 200 mg once daily (or in 2 divided doses). Patients not receiving an inhibitor such as valproate and receiving a glucuronidation inducer (e.g., carbamazepine, phenobarbital): The initial dose is 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. The usual target dose for an optimal response may be 400 mg in 2 divided doses starting from week 7. Patients receiving other medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this medicine as monotherapy: The initial dose is 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. After discontinuation of 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 in week 1. In 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 existing maintenance dose. Existing maintenance dose of 400 mg: week 1, 300 mg; week 2, 200 mg. Existing maintenance dose of 300 mg: week 1, 225 mg; week 2, 150 mg. Existing maintenance dose of 200 mg: week 1, 150 mg; week 2, 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). For patients receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, it is recommended that the current dose be maintained initially and adjusted according to clinical response. After discontinuation of a glucuronidation inhibitor (e.g., valproate): After valproate is discontinued, double the existing target stabilization dose of this medicine and continue at 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 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 reached through dose escalation. Lamotrigine dose adjustment (daily dose) in adults aged 18 years and older with bipolar disorder when adding other medications: When adding a glucuronidation inhibitor (e.g., valproate), for a 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, for a 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 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 receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are currently unknown, dose increases should follow the recommended dosage for concomitant administration of this medicine and 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 reduced gradually over at least 2 weeks. Restarting treatment: The longer the interval since the previous dose, the more consideration should be given to gradual dose escalation to the maintenance dose. 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. In patients who discontinued treatment because of a rash, restarting treatment is not advisable unless the expected benefits clearly outweigh the risks. Elderly patients: The recommended dosage schedules for adults and adolescents aged 13 years and older may also be used in elderly patients (65 years and older). In general, because sufficient clinical data are not available in elderly patients, use with caution and start at a low dose. Patients with hepatic impairment: In general, the initial, escalation, and maintenance doses 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. 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: There are insufficient clinical data to support an appropriate basic recommended dose for administration of this drug as monotherapy in children aged 12 years or younger. Children aged 2–12 years, adjunctive therapy (daily dose), 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), up to a maximum of 400 mg/day. Children aged 2–12 years, adjunctive therapy (daily dose), 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. Patients receiving glucuronidation-inducing drugs that interact with this drug, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir. For patients taking drugs for which pharmacokinetic interactions with lamotrigine are currently unknown (see Interactions), the same dose-escalation schedule recommended for concomitant administration of this drug with valproate should be applied. ** 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’s body weight should be monitored to ensure that the therapeutic dose is maintained, and the dose should be reviewed if body weight changes. In patients aged 2 years or older and younger than 6 years, the upper end of the recommended dose range may be the maintenance dose. Children younger than 2 years: The safety and efficacy of this drug have not been established in children aged 1 month to younger than 2 years. There are no data for neonates younger than 1 month. Therefore, this drug is not recommended for patients younger than 2 years; in particular, use in patients younger than 2 years who are taking valproate is not recommended because of the difficulty of determining an accurate initial dose. Children and adolescents younger than 18 years: This drug should not be administered to patients with bipolar disorder who are children or adolescents younger than 18 years.

This medication may cause skin rashes during use; therefore, if a rash appears, especially in children, treatment should be discontinued immediately. Severe skin rashes can be life-threatening, so if a rash is suspected, consult a doctor quickly. This medication can also cause hypersensitivity reactions accompanied by systemic symptoms such as fever, lymphadenopathy, and facial swelling; if any of these symptoms occur, treatment should be stopped immediately and medical personnel should be informed. Symptoms of aseptic meningitis may occur, so if symptoms such as headache, fever, or neck stiffness arise, notify medical personnel immediately. This medication may increase the risk of suicidal ideation or behavior; therefore, patients and caregivers should inform a doctor if any signs of depression or suicidal thoughts appear. Women taking hormonal contraceptives should discuss with their doctor, as this medication may affect contraceptive effectiveness, before starting or discontinuing use. Patients with a history of allergies to this medication or components, past aseptic meningitis, or certain genetic lactose intolerance should not use it. Patients with impaired renal or liver function should use this medication with caution, and women who are pregnant or potentially pregnant, as well as nursing mothers, must consult a doctor before use. This medication may interact with other anticonvulsants, so anyone taking other medications must inform their doctor. While taking this medication, dizziness, drowsiness, or headaches may occur; caution should be exercised when driving or operating machinery. This medication should not be abruptly discontinued as it may worsen seizures; the dosage should be gradually reduced according to the doctor's instructions. Severe symptoms may occur in the case of overdose, so adhere strictly to the prescribed dosage, and visit a medical institution immediately if any abnormal symptoms arise. Store this medication in a dry place away from children's reach, in its original container, and in a sealed container as it is sensitive to air and moisture.

Skin rash, photosensitivity reaction, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), alopecia, hematological abnormalities (neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), lymphadenopathy, hypersensitivity reactions (fever, lymphadenopathy, facial swelling, blood abnormalities, liver abnormalities, disseminated intravascular coagulation, multiple organ failure), aseptic meningitis, aggression, hypersensitivity, tics, hallucinations, confusion, nightmares, headache, drowsiness, insomnia, dizziness, tremors, ataxia, eye twitching, restlessness, instability, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, chorea, increased frequency of seizures, suicidal thoughts, suicidal behavior, depression, amnesia, abnormal thoughts, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, gastrointestinal disorders, gastrointestinal disorders, elevated liver function tests, liver dysfunction, liver failure, lupus-like reaction, fatigue, abdominal pain, dyspepsia, constipation, abdominal distension, weight gain, edema, arthralgia, myalgia, emotional instability, sensory disturbance, increased urination, sweating, menstrual disturbances, pain, back pain

This medication is sensitive to air and moisture and must be stored in a sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature, preferably in a dry place with low humidity.

Appearance

Pale yellow, rounded square tablets

Package unit

30 tablets/bottle, 100 tablets/bottle