Lamotrigine Tablet 50 mg (Lamotrigine)

Adult dose

1) Adults and adolescents aged 13 years and older: Recommended dosage for epilepsy 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. 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 inducers* — 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. * For example, patients receiving inducers of glucuronidation of this drug, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir. For patients receiving medications for which pharmacokinetic interactions with lamotrigine are not currently known (see Interactions), dose increases should follow the recommended dosage and dose-escalation schedule for concomitant use of this drug with valproate. 2. Bipolar disorder 1) Adults aged 18 years and older: Recommended dosage for prevention of recurrence of depressive episodes in patients with bipolar I disorder Recommended dose escalation to reach the maintenance stabilization dose in adults aged 18 years and older (daily dose) 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; 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: 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 not currently known, dose increases should follow the recommended dosage for concomitant use of this drug with valproate. ① Patients receiving a glucuronidation inhibitor (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 is 100 mg once daily or in 2 divided doses. Depending on the clinical response, the dose may be increased to a maximum of 200 mg once daily (or in 2 divided doses). ② Patients not receiving an inhibitor such as valproate and receiving a glucuronidation inducer (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 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. Starting in week 7, 400 mg may be administered in 2 divided doses. ③ Patients receiving other medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this drug 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). Administer 200 mg once daily or in 2 divided doses. In clinical trials, doses of up to 400 mg/day were used as monotherapy, but a dose of lamotrigine 400 mg/day offered no benefit over 200 mg/day. Daily maintenance stabilization dose in adults aged 18 years and older with bipolar disorder after discontinuation of concomitant psychotropic drugs or antiepileptic drugs (daily dose) After discontinuation of a glucuronidation inhibitor (e.g., valproate): Administer twice the stabilization dose. However, dose increases should not exceed 100 mg/week. That is, if the target stabilization dose is 100 mg/day, administer 200 mg/day in week 1. Maintain the week 1 dose in week 2 (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 — 400 mg, 300 mg, 200 mg; 300 mg, 225 mg, 150 mg; 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). For patients receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, it is recommended to initially maintain the current dose and adjust it according to the clinical response. ① After discontinuation of a glucuronidation inhibitor (e.g., valproate): After discontinuing valproate, increase the dose of this drug to twice the previous target stabilization dose and continue to maintain this dose. ② 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 drug over 3 weeks. ③ 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 in adults aged 18 years and older with bipolar disorder according to adjunctive therapy with other medications (daily dose) When adding a glucuronidation inhibitor (e.g., valproate): Current lamotrigine stabilization dose 200 mg/day — week 1: 100 mg*, maintain this dose (100 mg/day)*; 300 mg — week 1: 150 mg*, maintain this dose (150 mg/day)*; 400 mg — week 1: 200 mg*, maintain this dose (200 mg/day)*. When adding a glucuronidation inducer (e.g., carbamazepine) in patients not receiving valproate: Current lamotrigine stabilization dose 200 mg/day — week 1: 200 mg**, week 2: 300 mg**, week 3 onward: 400 mg**; 150 mg — week 1: 150 mg**, week 2: 225 mg**, week 3 onward: 300 mg**; 100 mg — 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 not currently known, dose increases should follow the recommended dosage for concomitant use of this drug with valproate. * : Once daily or in 2 divided doses, ** : in 2 divided doses. The dose of this drug should be gradually reduced over at least 2 weeks. The recommended dosing schedule for adults and adolescents aged 13 years and older may also be used in elderly patients (aged 65 years and older). In general, because sufficient clinical data are not available in elderly patients, administer with caution and start at a low dose. In general, in patients with moderate (Child-Pugh grade B) or severe (Child-Pugh grade C) hepatic impairment, the initial, escalation, and maintenance doses should be reduced by approximately 50% and 75%, respectively. The escalation and maintenance doses should be adjusted according to the clinical response. Use with caution in 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

2) Children aged 2∼12 years: Recommended dosage for epilepsy (total daily dose: mg/kg body weight/day) Monotherapy in children aged 2∼12 years: 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. Adjunctive therapy in children aged 2∼12 years (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. Adjunctive therapy in children aged 2∼12 years (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. * For example, patients receiving inducers of glucuronidation of this medicine, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir. For patients taking medicines for which pharmacokinetic interactions with lamotrigine are not currently known (see Interactions), the same dose escalation schedule recommended for concomitant administration of this medicine 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 medicine should not be administered. 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 younger than 2 years: The safety and efficacy of this medicine have not been established in children aged 1 month to younger than 2 years. There are no data in neonates younger than 1 month. Therefore, use is not recommended in patients younger than 2 years; in particular, use is not recommended in patients younger than 2 years who are taking valproate because of the difficulty of determining an accurate starting dose. Children and adolescents younger than 18 years: This medicine should not be administered to patients younger than 18 years with bipolar disorder.

This medication may cause severe skin rashes during treatment; therefore, if a rash appears, the medication should be discontinued immediately, and a doctor should be consulted. Particularly in children, the risk of severe skin rash is higher, so it is important to promptly notify medical personnel if rash and fever symptoms occur. In addition to rash, systemic symptoms such as fever, lymphadenopathy, and facial swelling may also indicate hypersensitivity reactions; therefore, if any of these symptoms occur, administration must be stopped immediately. Serious side effects such as hematological abnormalities, aseptic meningitis, worsening of seizures, and suicidal thoughts or behaviors have been reported, necessitating caution. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and nursing mothers should also exercise caution, as the drug may be transmitted through breast milk. This medication can interact with other drugs, so if you are taking other medications, you should inform your doctor or pharmacist and seek advice. Drowsiness and dizziness may occur during treatment, making it necessary to take caution when driving or operating machinery. In the case of overdose, immediate medical attention is necessary, as there is no specific antidote. This medication should be stored out of the reach of children and in a cool, dry place below 30 degrees Celsius.

Rash, skin rash, photosensitive reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), alopecia, hematological abnormalities (including neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), lymphadenopathy, hypersensitivity reactions (including fever, lymphadenopathy, facial edema, blood abnormalities, liver abnormalities, disseminated intravascular coagulation, multiple organ failure), aseptic meningitis, aggression, hyperactivity, tics, hallucinations, confusion, nightmares, headache, drowsiness, insomnia, dizziness, tremors, ataxia, eye twitching, agitation, instability, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, slow twisting movements, increased seizure frequency, double vision, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, gastrointestinal disturbances, pharyngitis, flu-like syndrome, menstrual disorders, tremors, lung disorders, depression, amnesia, abnormal thoughts, blood system abnormalities, lupus-like reactions, fatigue, pain, back pain, abdominal pain, indigestion, constipation, bloating, weight gain, edema, arthralgia, myalgia, emotional instability, movement disorders, sensory abnormalities, frequent urination, sweating, mania, hypomania, mixed episodes, decreased bone density, osteopenia, osteoporosis, fractures, DRESS syndrome, eye twitching, ataxia, double vision, blurred vision, nausea, drowsiness

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. The storage temperature should maintain room temperature between 1 and 30 degrees Celsius, and it is preferable to store it in a dry location with low humidity.

Appearance

Light yellowish-brown square tablet

Package unit

30 tablets/bottle, 100 tablets/bottle