Lamosital Tablet 50 mg (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). 1. Epilepsy It is recommended that treatment with this medicine be initiated at the recommended dose. A careful dose-escalation schedule may reduce the severity of skin rash. The initial dose and rate of dose escalation must not be exceeded because of the risk of rash. When discontinuing an antiepileptic drug currently being taken or adding another antiepileptic drug/another medicine to a treatment regimen that includes this medicine, it should be taken into consideration that this may affect the pharmacokinetics of this medicine. 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 up to 50∼100 mg every 1∼2 weeks until the maintenance dose is reached (1) Monotherapy (daily dose) In some patients, doses up to 500 mg/day have been used to achieve the desired response. (2) 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 up to 100 mg every 1～2 weeks until the maintenance dose is reached Patients receiving valproate, regardless of other concomitant medicines 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 * Patients receiving glucuronidation inducers of this medicine, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir For patients receiving medicines for which pharmacokinetic interactions with lamotrigine are currently unknown (see Interactions), dose increases should follow the recommended dosage and dose-escalation schedule for concomitant administration of this medicine 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 It is strongly recommended that treatment with this medicine be initiated at the recommended dose. A careful dose-escalation schedule may reduce the severity of skin rash. This medicine is recommended for use in patients with bipolar disorder who are at risk of future depressive symptoms. (1) Dose-escalation schedule to reach the maintenance stabilization dose To prevent recurrence of depressive episodes, the following transition regimen should be used: increase the dose of this medicine over 6 weeks until the maintenance stabilization dose is reached, after which other psychotropic medicines or antiepileptic drugs may be discontinued at the clinician's discretion. Recommended dose escalation to 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 medicines 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 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 with valproate. The target stabilization dose may be changed according to clinical response. ① Patients receiving a glucuronidation inhibitor (e.g., valproate): Patients receiving a glucuronidation inhibitor such as valproate concomitantly should take 25 mg every other day during the first 2 weeks as the initial dose, 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 the clinical response, the dose may be increased to a maximum of 200 mg and administered 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): Patients who are not receiving valproate and are receiving a glucuronidation inducer such as carbamazepine or phenobarbital should take 50 mg once daily during the first 2 weeks as the initial dose, followed by 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. The usual target dose for an optimal response may be 400 mg in 2 divided doses daily from week 7. ③ Patients receiving other medicines that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion), or receiving this medicine as monotherapy: Patients receiving concomitant medicines with which this medicine is theoretically not expected to have a clinical pharmacokinetic interaction, or receiving this medicine as monotherapy, should take 25 mg once daily during the first 2 weeks as the initial dose, 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 up to 400 mg/day were used as monotherapy; however, lamotrigine 400 mg/day offered no benefit over 200 mg/day. (2) Dosage regimen after reaching the maintenance stabilization dose Once the target maintenance stabilization dose has been reached, other psychotropic medicines may be discontinued according to the following dosage regimen. Daily maintenance stabilization dose in adults aged 18 years and older with bipolar disorder after discontinuation of concomitant psychotropic medicines or antiepileptic drugs (daily dose) After discontinuation of a glucuronidation inhibitor (e.g., valproate) Week 1 Administer twice the stabilization dose. However, the dose increase must not exceed 100 mg/week. That is, if the target stabilization dose is 100 mg/day, administer 200 mg/day during week 1. Week 2 Maintain the dose used in week 1 (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 400 mg: Week 1 300 mg, week 2 200 mg 300 mg: Week 1 225 mg, week 2 150 mg 200 mg: Week 1 150 mg, week 2 100 mg After discontinuation of medicines that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion) Maintain the target maintenance dose reached through dose escalation during weeks 1 and 2 and thereafter (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 initially be maintained and then adjusted according to clinical response. ① After discontinuation of a glucuronidation inhibitor (e.g., valproate): After discontinuing valproate, increase the dose of this medicine to twice the existing 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 existing maintenance dose. After discontinuation of a glucuronidation inducer, gradually reduce the dose of this medicine over 3 weeks. ③ After discontinuation of medicines that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): Maintain the target dose reached through dose escalation. (3) Daily dose adjustment in patients with bipolar disorder when adding another medicine There is no clinical experience regarding adjustment of the daily dose of this medicine when another medicine is added. However, based on drug interaction studies, the following dosage regimen is recommended. Lamotrigine dose adjustment in adults aged 18 years and older with bipolar disorder when adding another medicine (daily dose) 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*, week 2 maintain this dose (100 mg/day)* Current lamotrigine stabilization dose 300 mg/day: Week 1 150 mg*, week 2 maintain this dose (150 mg/day)* Current lamotrigine stabilization dose 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, select the dose according to the existing dose Current lamotrigine stabilization dose 200 mg/day: Week 1 200 mg**, week 2 300 mg**, week 3 onward 400 mg** Current lamotrigine stabilization dose 150 mg/day: Week 1 150 mg**, week 2 225 mg**, week 3 onward 300 mg** Current lamotrigine stabilization dose 100 mg/day: Week 1 100 mg**, week 2 150 mg**, week 3 onward 200 mg** When adding medicines that do 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 with valproate. * : Once daily or in 2 divided doses, ** : In 2 divided doses 3. Discontinuation of this medicine As with other antiepileptic drugs, abrupt discontinuation of this medicine should be avoided whenever possible because it may cause rebound seizures. Unless immediate discontinuation is required for safety reasons (for example, a serious skin rash), the dose of this medicine should be gradually reduced over at least 2 weeks. 4. Restarting treatment Because the risk of serious rash is associated with a high initial dose of this medicine and exceeding the recommended dose escalation, when restarting treatment in patients who have discontinued this medicine, the need to gradually increase the dose to the maintenance dose should be assessed. The longer the interval since the previous dose, the more consideration should be given to gradually increasing the dose to the maintenance dose. In general, when 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. However, in patients who discontinued treatment because of a rash, it is preferable not to restart this treatment unless the expected benefit greatly outweighs the risk. 5. Elderly patients To date, there is no evidence suggesting that drug response in elderly patients differs from that in adults. The recommended dosage schedules for adults and adolescents aged 13 years and older may also be used in elderly patients (aged 65 years and older). However, in general, because sufficient clinical data are not available in elderly patients, this medicine should be used with caution and started at a low dose. Elderly patients are more likely to have comorbidities that may require treatment with other medicines; therefore, this medicine should be used with caution and patients should be monitored regularly. 6. Patients with hepatic impairment In general, the initial dose, escalation dose, and maintenance dose 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. The escalation and maintenance doses should be adjusted according to clinical response. 7. Patients with renal impairment Caution should be exercised when administering this medicine to patients with renal impairment. In patients with end-stage renal disease, 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 administration of this drug as monotherapy in children aged 12 years or younger are not yet available. 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); Maintenance dose: Increase by up to 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—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); Maintenance dose: Increase by up to 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. The weight of children should be monitored to ensure that the therapeutic dose is maintained, and the dose should be reviewed if a change in weight occurs. 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. 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 of determining an accurate initial dose in patients younger than 2 years who are taking valproate. 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. Significant efficacy was not demonstrated in clinical trials in children and adolescents younger than 18 years with bipolar disorder, and reports of suicidal behavior were increased.

This medication may cause serious side effects such as severe skin rash, so it is crucial to discontinue use and consult a doctor immediately if a rash or fever occurs, especially during the first 8 weeks. There is a higher risk of skin rash in pediatric patients, thus extra caution is needed, and if it is unclear whether a rash is related to the medication, it should be stopped. This medication should not be administered to patients with certain genetic disorders, and those with a history of hypersensitivity should be given it cautiously. Women who are pregnant, planning to become pregnant, or breastfeeding should consult a healthcare professional before taking this medication, and it is advisable to avoid it while breastfeeding. Abrupt discontinuation may worsen seizures, so any dosage adjustments should be made slowly and gradually. Additionally, this medication may exacerbate suicidal thoughts or behaviors, as well as depressive symptoms, so patients and guardians should report any such symptoms to healthcare providers immediately. Interactions with other medications may occur; therefore, it is essential to inform healthcare providers about any other medications being taken, especially if antiepileptics or hormonal contraceptives are used concurrently, as dosage adjustments may be necessary. Patients should exercise caution when driving or operating machinery while on this medication, and if symptoms such as rash, fever, headache, vomiting, or neck stiffness occur, they should consult a healthcare professional immediately. Overdose may increase the risk of consciousness disturbances or seizures, so it is vital to adhere strictly to prescribed dosages and seek appropriate medical treatment if an overdose occurs. This medication should be stored in a dry place below 30 degrees Celsius and kept out of reach of children, ideally in its original container.

Skin rash, photosensitivity reaction, skin and mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell 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, hypersensitivity, tics, hallucinations, confusion, nightmares, headache, drowsiness, insomnia, dizziness, tremors, ataxia, eye twitching, unease, instability, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, dyskinesia, increased seizure frequency, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, decreased appetite, gastrointestinal disturbances, pharyngitis, flu-like syndrome, menstrual disorders, depression, amnesia, abnormal thoughts, fatigue, pain, pharyngitis, hematologic abnormalities, elevated liver function tests, liver dysfunction, liver failure, lupus-like reactions, abdominal pain, dyspepsia, 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, coma, consciousness disorders, increased seizures, generalized seizures, QRS prolongation (ventricular conduction delay)

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

Appearance

Light yellowish-brown square tablet

Package unit

30 tablets/bottle, 200 tablets/bottle