Lamia Tablet 50 Milligrams (Lamotrigine)

Adult dose

This medicine may be swallowed whole, chewed, or taken after dispersing the tablet in a small amount of water (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 the dose 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. Epilepsy, adults and adolescents aged 13 years and older: Adjunctive therapy in patients not receiving valproate and taking glucuronidation-inducing drugs: 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 the dose by up to 100 mg every 1～2 weeks until the maintenance dose is reached. Epilepsy, adults and adolescents aged 13 years and older: Adjunctive therapy in 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 the dose by up to 25～50 mg every 1～2 weeks until the maintenance dose is reached. For patients taking 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 medicine with valproate. Bipolar disorder, adults aged 18 years and older: Patients taking 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). Bipolar disorder, adults aged 18 years and older: Patients not taking inhibitors such as valproate and taking 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); 300 mg in week 6, with an increase to 400 mg in week 7 if needed (in 2 divided doses). Bipolar disorder, adults aged 18 years and older: Patients taking 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). For patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dosage for concomitant use of this medicine with valproate. The target stabilization dose may be adjusted according to clinical response. Patients taking glucuronidation inhibitors (e.g., valproate): As the initial dose, take 25 mg every other day for the first 2 weeks, then 25 mg once daily for the next 2 weeks. The target dose for 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 taking inhibitors such as valproate and taking glucuronidation inducers (e.g., carbamazepine, phenobarbital): As the initial dose, take 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. The usual target dose for optimal response may be 400 mg in 2 divided doses starting in week 7. Patients taking other medications that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving monotherapy with this medicine: As the initial dose, take 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 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 offered no benefit over 200 mg/day. After discontinuation of a glucuronidation inhibitor (e.g., valproate) in adults with bipolar disorder: 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) in adults with bipolar disorder: Select the dose according to the previous maintenance dose. Previous maintenance dose 400 mg: 300 mg in week 1, 200 mg in week 2; previous maintenance dose 300 mg: 225 mg in week 1, 150 mg in week 2; previous maintenance dose 200 mg: 150 mg in week 1, 100 mg in week 2. After discontinuation of a medication that does not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion) in adults with bipolar disorder: 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 not currently known, it is recommended that the current dose initially be maintained and adjusted according to clinical response. After discontinuation of a glucuronidation inhibitor (e.g., valproate), double the existing target stabilization dose of this medicine and continue at 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 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 achieved through dose escalation. Adults aged 18 years and older with bipolar disorder receiving adjunctive therapy with another medication: When adding a glucuronidation inhibitor (e.g., valproate), select the dose according to the current lamotrigine dose. Current lamotrigine stabilization dose 200 mg/day: week 1, 100 mg*, then maintain this dose (100 mg/day)*; 300 mg: week 1, 150 mg*, then maintain this dose (150 mg/day)*; 400 mg: week 1, 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 current dose. Current lamotrigine stabilization dose 200 mg: 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**. Adjunctive therapy with medications that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): target maintenance dose achieved through dose escalation (200 mg/day)*. For patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dosage for concomitant use of this medicine with valproate. * : once daily or in 2 divided doses, ** : in 2 divided doses. Discontinuation of this medicine: Unless immediate discontinuation is required for safety reasons (for example, a serious skin rash), the dose of this medicine should be reduced gradually over at least 2 weeks. Restarting treatment: In general, if the period since discontinuation of this medicine exceeds 5 half-lives, the dose should be gradually increased to the maintenance dose according to an appropriate schedule. Elderly patients: The recommended dosage schedule for adults and adolescents aged 13 years and older may also be used in elderly patients (65 years and older). However, because sufficient clinical data are generally unavailable for elderly patients, administer with caution and start 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 dose, dose increases, and maintenance dose should be reduced by approximately 50% and 75%, respectively. Dose increases and the maintenance dose 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: Monotherapy. Adequate clinical data to support a basic recommended dose for this drug as monotherapy in children 12 years of age 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 (administered in 2 divided doses); weeks 3 and 4: 1.2 mg/kg/day (administered in 2 divided doses); increase by up to 1.2 mg/kg/day every 1～2 weeks to reach a maintenance dose of 5∼15 mg/kg/day (administered in 2 divided doses), up to a maximum of 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** (administered once daily); weeks 3 and 4: 0.3 mg/kg/day (administered once daily); increase by up to 0.3 mg/kg/day every 1～2 weeks to reach a maintenance dose of 1∼5 mg/kg/day (administered 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. 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. The safety and efficacy of this drug in children aged 1 month to younger than 2 years have not been established. No data are available for neonates younger than 1 month. Therefore, this drug is not recommended for patients younger than 2 years, particularly because of the difficulty in determining an accurate initial dose in patients younger than 2 years who are taking valproate. Do not administer to pediatric and adolescent patients younger than 18 years of age with bipolar disorder.

This medication may cause skin rashes; therefore, it should be discontinued immediately if a rash appears and a doctor should be consulted. Particularly, severe skin rashes may occur more frequently in children, so caution is needed. The risk of rash may increase when starting this medication or significantly increasing the dose. Furthermore, inform your doctor if you are taking other medications, as this may alter the risk of skin rash. This medication can cause hypersensitivity reactions with systemic symptoms, so notify medical personnel immediately if unusual symptoms such as fever or lymphadenopathy occur. Convulsions may worsen, so consult medical personnel if seizure symptoms worsen or new symptoms appear. During the treatment with this medication, suicidal thoughts or depressive symptoms may emerge, so it is crucial to inform a doctor if mood changes occur. Women taking hormonal contraceptives should consult their doctor when starting or stopping this medication due to potential interactions. Caution is required when used in patients with impaired liver or kidney function, and women who are pregnant or planning to become pregnant must consult a doctor before taking this medication. If breastfeeding, it is recommended to discontinue breastfeeding as this medication may be transmitted through breast milk. This medication is not recommended for children, especially under 2 years of age, where safety and efficacy are not established. Stopping this medication suddenly may worsen seizures, so the dosage should be gradually adjusted according to the doctor’s instructions. When driving or operating machinery, caution is necessary as side effects such as dizziness or drowsiness may occur. Serious symptoms may arise from overdose, so adherence to the prescribed dosage is essential, and if unusual symptoms occur, visit a medical institution immediately.

Skin rash, photosensitivity reaction, skin mucosal syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), alopecia, hematological abnormalities (including neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), lymphadenopathy, hemophagocytic lymphohistiocytosis, hypersensitivity reactions (including fever, lymphadenopathy, facial edema, blood abnormalities, liver abnormalities, disseminated intravascular coagulation, multiple organ failure), aggression, hyperactivity, tics, hallucinations, confusion, nightmares, headaches, drowsiness, insomnia, dizziness, ataxia, eye twitching, aseptic meningitis, restlessness, instability, motor disturbances, exacerbation of Parkinson's disease, extrapyramidal effects, chorea and dystonia, increased seizure frequency, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, pain, pharyngitis, flu-like syndrome, menstrual disorders, tremors, pulmonary disorders, depression, memory loss, abnormal thoughts, abdominal pain, dyspepsia, constipation, bloating, weight gain, edema, arthralgia, myalgia, emotional instability, movement disorders, sensory abnormalities, frequent urination, sweating, lupus-like reactions, fatigue, pain, back pain, mania, hypomania, mixed episodes, decreased bone density, osteopenia, osteoporosis, fractures, DRESS syndrome, eye twitching, ataxia, dizziness, drowsiness, diplopia, blurred vision, nausea, increased seizures, grand mal seizures, coma, consciousness disturbances

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to keep it away from direct sunlight and store it in a cool, dry room at room temperature.

Appearance

Light yellowish-brown rectangular tablet

Package unit

30 tablets/bottle