Lamosital 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 (for chewable tablets only). 1. Epilepsy 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 (1) Monotherapy (daily dose) In some patients, doses of up to 500 mg/day have been used to achieve the desired response. (2) Adjunctive therapy (daily dose) Patients not taking valproate and taking an inducer of glucuronidation* 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 Patients taking 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 taking inducers of lamotrigine glucuronidation such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, or ritonavir In patients taking medications for which pharmacokinetic interactions with lamotrigine are not currently known (see Interactions), dose increases should follow the recommended dosage and dose-increase schedule for concomitant administration of this medicine and valproate. 2. Bipolar disorder 1) Adults aged 18 years and older: Recommended dosage for the prevention of recurrence of depressive episodes in patients with bipolar I disorder (1) Dose-increase schedule for reaching the maintenance stabilization dose Recommended dose escalation (daily dose) to reach the maintenance stabilization dose in adults aged 18 years and older Patients taking an inhibitor of glucuronidation (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 taking an inhibitor such as valproate and taking an inducer of glucuronidation (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) The dose may be increased to 300 mg in week 6 and, if necessary, to 400 mg in week 7 (in 2 divided doses). Patients taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion), or taking lamotrigine alone 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) In patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dosage for concomitant administration of this medicine and valproate. The target stabilization dose may be changed according to clinical response. ① Patients taking an inhibitor of glucuronidation (e.g., valproate): Patients receiving concomitant treatment with an inhibitor of glucuronidation such as valproate should take an initial dose of 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 to a maximum of 200 mg once daily (or in 2 divided doses). ② Patients not taking an inhibitor such as valproate and taking an inducer of glucuronidation (e.g., carbamazepine, phenobarbital): Patients taking an inducer of glucuronidation such as carbamazepine or phenobarbital, without valproate, should take an initial dose of 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. From week 7, the usual target dose for an optimal response may be 400 mg in 2 divided doses. ③ Patients taking other medications that do not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion), or taking this medicine alone: Patients receiving concomitant medications with which this medicine theoretically has no clinically significant pharmacokinetic interaction, or receiving this medicine as monotherapy, should take an initial dose of 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 offered no benefit over 200 mg/day. (2) Medication schedule after reaching the maintenance stabilization dose 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 an inhibitor of glucuronidation (e.g., valproate) Week 1: 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. Week 2: Maintain the week 1 dose (200 mg/day) (once daily or in 2 divided doses) Week 3 onward*: Maintain the week 1 dose (200 mg/day) After discontinuation of an inducer of glucuronidation (e.g., carbamazepine): Select the dose according to the existing maintenance dose 400 mg: 300 mg in week 1, 200 mg in week 2 300 mg: 225 mg in week 1, 150 mg in week 2 200 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) Maintain the target maintenance dose reached through dose escalation (200 mg/day) (in 2 divided doses) In patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, it is recommended to initially maintain the current dose and adjust the dose according to clinical response. ① After discontinuation of an inhibitor of glucuronidation (e.g., valproate): After discontinuing valproate, increase this medicine to twice the existing target stabilization dose and continue maintaining this dose. ② After discontinuation of an inducer of glucuronidation (e.g., carbamazepine): Select the dose according to the existing maintenance dose. After discontinuing the inducer of glucuronidation, gradually reduce the dose of this medicine 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. (3) Daily dose adjustment in patients with bipolar disorder when adding other medications Lamotrigine dose adjustment in adults aged 18 years and older with bipolar disorder according to adjunctive medication (daily dose) When adding an inhibitor of glucuronidation (e.g., valproate), select the dose according to the existing 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 an inducer of glucuronidation (e.g., carbamazepine) in patients not taking 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 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)* In patients taking antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, 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 2) Children and adolescents under 18 years of age This medicine should not be administered to children and adolescents under 18 years of age with bipolar disorder. 3. 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 gradually reduced over a period of at least 2 weeks. 4. 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. 5. 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, elderly patients should generally be treated with caution and started at a low dose because sufficient clinical data are not available. 6. Patients with hepatic impairment In general, in patients with moderate (Child-Pugh grade B) and severe (Child-Pugh grade C) hepatic impairment, the initial dose, dose increments, and maintenance dose should be reduced by approximately 50% and 75%, 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 drug regimen. A reduced maintenance dose may be effective in patients with severe renal impairment.

Child dose

Pediatric patients aged 2∼12 years: Recommended dosage for epilepsy (total daily dose: mg/kg (body weight)/day) Pediatric patients aged 2∼12 years, monotherapy: Adequate clinical data to support a basic recommended dose for use of this medicine as monotherapy in children aged 12 years or younger are not yet available. Pediatric patients aged 2∼12 years who are not receiving valproate and are receiving glucuronidation-inducing agents: 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. Pediatric patients aged 2∼12 years who are 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), up to a maximum of 200 mg/day. * Patients receiving glucuronidation-inducing agents for this medicine, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir. ** 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. For patients aged 2 years or older and younger than 6 years, the upper end of the recommended dose range may be required as the maintenance dose. Pediatric patients aged 1 month to younger than 2 years: Use of this medicine is not recommended, particularly in patients younger than 2 years who are taking valproate, because it is difficult to determine an accurate initial dose. Patients younger than 2 years: Not recommended.

This medication can cause severe skin rashes, which can be particularly dangerous in children, so if a rash appears, discontinue use immediately. This medication can induce a serious immune response called hemophagocytic lymphohistiocytosis, so if symptoms such as fever or rash appear, seek medical attention immediately. Seizures may worsen, so consult medical personnel if seizure symptoms exacerbate. Other lamotrigine formulations should not be taken concurrently with this medication, and close observation is required as suicidal thoughts or behavioral changes may occur. Women who are pregnant or planning to become pregnant should consult a doctor before taking this medication, and it is advisable to avoid taking this medication while breastfeeding. This medication may interact with other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. Drowsiness, dizziness, blurry vision, and other symptoms may occur during treatment, so caution is needed when driving or operating machinery. Serious symptoms may manifest in case of overdose, so follow the dosage exactly and do not discontinue or increase the dosage without a doctor's instructions. Store in a cool, dry place below 30 degrees Celsius, and keep out of reach of children.

• rash
• skin rash
• photosensitivity reaction
• mucocutaneous syndrome
• toxic epidermal necrolysis
• alopecia
• hematological abnormalities
• lymphadenopathy
• histiocytic necrotizing lymphadenitis
• hypersensitivity reaction

This medication may be vulnerable to air or moisture, so it must be stored in a tightly sealed container. Additionally, avoid extreme temperatures, and it is best to store in a dry place at room temperature between 1 and 30 degrees Celsius.

Appearance

Light yellowish-brown square tablet

Package unit

30 tablets/bottle, 200 tablets/bottle