Lamotrigine Tablets 100 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 started 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 medicine being taken, or adding another antiepileptic medicine/other medicine to a treatment regimen that includes this medicine, the potential effect on the pharmacokinetics of this medicine should be considered. 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 Some patients have received doses of up to 500 mg/day 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 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 * For example, patients receiving glucuronidation inducers of this medicine such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir In patients receiving medicines for which pharmacokinetic interactions with lamotrigine are not currently known (see Interactions), dose increases should follow the recommended dose and rate of dose escalation for concomitant use of this medicine and valproate. 2. Bipolar disorder 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 started at the recommended dose. A careful dose-escalation schedule may reduce the severity of skin rash. This medicine is recommended for patients with bipolar disorder who are at risk of future depressive symptoms. Dose-escalation schedule to reach the maintenance stabilization dose (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 needed, 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 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, 200 mg (once daily or in 2 divided doses) In patients receiving antiepileptic medicines for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dosage for concomitant use of this medicine and valproate. The target stabilization dose may be adjusted according to clinical response. Patients receiving a glucuronidation inhibitor (e.g., valproate): Patients receiving a glucuronidation inhibitor such as valproate concomitantly should take 25 mg every other day for 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 clinical response, the dose may be increased to a maximum of 200 mg, administered once daily (or in 2 divided doses). Patients not receiving an inhibitor such as valproate and receiving a glucuronidation inducer (e.g., carbamazepine, phenobarbital): Patients receiving a glucuronidation inducer such as carbamazepine or phenobarbital without valproate should take 50 mg once daily for the first 2 weeks as the initial dose, 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 from week 7. Patients receiving other medicines that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this medicine as monotherapy: In patients concomitantly receiving medicines with which this medicine has no theoretical clinical pharmacokinetic interaction, 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; however, lamotrigine 400 mg/day provided no benefit over 200 mg/day. Dosage regimen after reaching the maintenance stabilization dose After discontinuing a glucuronidation inhibitor (e.g., valproate): Administer twice the stabilization dose. However, the dose increase must 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 in week 2 (200 mg/day) (once daily or in 2 divided doses) After discontinuing a glucuronidation inducer (e.g., carbamazepine): Select the dose according to the existing maintenance dose. For an existing maintenance dose of 400 mg: 300 mg in week 1 and 200 mg in week 2; for 300 mg: 225 mg in week 1 and 150 mg in week 2; for 200 mg: 150 mg in week 1 and 100 mg in week 2 After discontinuing a medicine 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) In patients receiving antiepileptic medicines for which pharmacokinetic interactions with lamotrigine are not currently known, it is recommended that the current dose initially be maintained and then adjusted according to clinical response. After discontinuing a glucuronidation inhibitor (e.g., valproate): After discontinuing valproate, increase this medicine to twice the existing target stabilization dose and continue to maintain this dose. After discontinuing a glucuronidation inducer (e.g., carbamazepine): Select the dose according to the existing maintenance dose. After discontinuing a glucuronidation inducer, gradually reduce the dose of this medicine over 3 weeks. After discontinuing a medicine that does not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion): Maintain the target dose reached through dose escalation. Daily dose adjustment in patients with bipolar disorder when adding another medicine When adding a glucuronidation inhibitor (e.g., valproate), select the dose according to the existing lamotrigine dose: Current lamotrigine stabilization dose of 200 mg/day: 100 mg* in week 1, then maintain this dose (100 mg/day)* from week 2 onward; 300 mg: 150 mg* in week 1, then maintain this dose (150 mg/day)* from week 2 onward; 400 mg: 200 mg* in week 1, then maintain this dose (200 mg/day)* from week 2 onward 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 of 200 mg/day: 200 mg** in week 1, 300 mg** in week 2, and 400 mg** from week 3 onward; 150 mg: 150 mg** in week 1, 225 mg** in week 2, and 300 mg** from week 3 onward; 100 mg: 100 mg** in week 1, 150 mg** in week 2, and 200 mg** from week 3 onward When adding a medicine that does not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): Target maintenance dose reached through dose escalation (200 mg/day)* In patients receiving antiepileptic medicines for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dosage for concomitant use of this medicine and valproate. * : Once daily or in 2 divided doses, ** : In 2 divided doses 3. Discontinuation of this medicine As with other antiepileptic medicines, 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 and exceeding the recommended dose escalation, the need for gradual dose escalation to the maintenance dose should be assessed when restarting treatment in patients who have discontinued this medicine. The longer the interval since the previous dose, the greater the consideration that should be given to gradual escalation to the maintenance dose. In general, when more than 5 half-lives have elapsed since discontinuing this medicine, 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 treatment unless the expected benefit clearly outweighs the risk. 5. Elderly patients The recommended dosage regimen for adults and adolescents aged 13 years and older may also be used in elderly patients (65 years and older). However, because adequate clinical data are generally unavailable for elderly patients, administer with caution and start at a low dose. Elderly patients are more likely to have comorbidities requiring treatment with other medicines; therefore, this medicine should be administered with caution and such patients should be monitored regularly. 6. Patients with hepatic impairment In general, the initial dose, dose increments, 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. Dose increments and the maintenance dose should be adjusted according to clinical response. 7. Patients with renal impairment Use with caution in 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 treatment regimen. A reduced maintenance dose may be effective in patients with severe renal impairment.

Child dose

Children aged 2∼12 years: Recommended dosage for epilepsy (total daily dose: mg/kg (body weight)/day) Adequate clinical data to support a basic recommended dose for use of this medicine as monotherapy in children 12 years and younger are not yet available. Adjunctive therapy in children aged 2∼12 years (daily dose): Patients not receiving valproate and receiving glucuronidation-inducing medicines*: 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 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); 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); maintenance dose: 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. * For example, patients receiving glucuronidation-inducing medicines such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir. For patients taking medicines for which pharmacokinetic interactions with lamotrigine are currently unknown (see Interactions), the same dose escalation schedule as recommended for concomitant administration of this medicine with 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. Children's body weight should be monitored to ensure that the therapeutic dose is maintained, and the dose should be reconsidered if body weight changes. In patients aged 2 years or older and younger than 6 years, the upper end of the recommended dose range is likely to be the maintenance dose. The safety and efficacy of this medicine in children aged 1 month to under 2 years have not been established. There are no data for neonates younger than 1 month. Therefore, use is not recommended in patients younger than 2 years, particularly because it is difficult to determine an accurate initial dose in patients younger than 2 years who are taking valproate. Children and adolescents younger than 18 years: This medicine should not be administered to patients younger than 18 years with bipolar disorder. Clinical trials in children and adolescents younger than 18 years with bipolar disorder did not demonstrate significant efficacy and showed an increased number of reports of suicidal behavior.

This medication may cause severe skin rashes, so if a rash occurs, discontinue use immediately and consult a doctor. In particular, the risk of skin rash is higher in children, so if a rash occurs along with fever, the medication response should be checked quickly. The risk of skin rash increases with higher initial doses or rapid dose escalation beyond the recommended dose, and when used in combination with certain medications. If systemic symptoms such as fever, lymphadenopathy, or facial swelling occur during treatment, discontinue use immediately. Symptoms of aseptic meningitis may appear, so if symptoms such as headache, fever, vomiting, or neck stiffness occur, notify medical personnel. Suicidal thoughts or changes in behavior have been reported, so patients and caregivers should report any such symptoms to a doctor immediately. Administration during pregnancy may affect the fetus, so women who are pregnant or planning to become pregnant must consult a doctor first. If breastfeeding, it is recommended to avoid breastfeeding as this drug may pass into breast milk and affect the newborn. There may be interactions with other medications, so inform medical personnel of any other medications being taken. Serious symptoms may occur with overdose, so strictly adhere to the dosage and visit a hospital immediately if abnormal symptoms occur. This drug should be stored in a cool, dry place below 30 degrees Celsius and kept out of reach of children.

Rash, mucocutaneous syndrome, toxic epidermal necrolysis, 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, multi-organ failure), aseptic meningitis, photosensitivity reactions, aggression, hypersensitivity, tics, hallucinations, confusion, nightmares, headache, drowsiness, insomnia, dizziness, ataxia, tremor, agitation, instability, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, chorea-like movements, increased seizure frequency, double vision, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, pharyngitis, flu-like syndrome, menstrual disorders, tremors, lung disorders, depression, amnesia, abnormal thoughts, fatigue, pain, 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, fracture, DRESS syndrome, hemophagocytic lymphohistiocytosis

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

Appearance

Pale yellow quadrilateral tablet with rounded edges

Package unit

30 tablets/bottle, 100 tablets/bottle