Lamictal Chewable Tablets 5 mg (Lamotrigine)

Adult dose

Directions for use: This medicine may be swallowed whole, chewed, or taken after dispersing the tablet in a small amount of water. This medicine must be administered only as a whole-tablet dose; do not divide the tablet. 1. Epilepsy 1) Adults and adolescents aged 13 years and older (1) Monotherapy (daily dose) 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. (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 medications Weeks 1 and 2: 12.5 mg (25 mg every 2 days) 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 other medications that do not significantly inhibit or induce lamotrigine glucuronidation Weeks 1 and 2: 25 mg (once daily) Weeks 3 and 4: 50 mg (once daily) Maintenance dose: 100~200mg (once daily or in 2 divided doses) Increase by up to 50~100 mg every 1～2 weeks until the maintenance dose is reached. * For example, patients receiving inducers of this medicine's glucuronidation, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir For patients receiving medications for which pharmacokinetic interactions with lamotrigine are currently unknown (see Interactions), dose increases should follow the recommended dose and dose-increase schedule for concomitant administration of this medicine with valproate. 2. Bipolar disorder 1) Adults aged 18 years and older (1) Dose escalation schedule to reach the maintenance stabilization dose Patients receiving 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 receiving an inhibitor such as valproate and receiving 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) 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: 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 dose for concomitant administration of this medicine with valproate. The target stabilization dose may be changed according to clinical response. ① Patients receiving an inhibitor of glucuronidation (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 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 an inducer of glucuronidation (e.g., carbamazepine, phenobarbital): 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, administer 200 mg in 2 divided doses. In week 6, administer 300 mg in 2 divided doses. From 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 medicine as monotherapy: 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, administer 100 mg once daily (or in 2 divided doses). The target dose 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. (2) Dosing schedule after reaching the maintenance stabilization dose After discontinuation of an inhibitor of glucuronidation (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 in week 1. Week 2: Maintain the week 1 dose (200 mg/day) (once daily or in 2 divided doses) After discontinuation of an inducer of glucuronidation (e.g., carbamazepine): Select the dose according to the previous maintenance dose. Week 1: 400 mg / 300 mg / 200 mg Week 2: 300 mg / 225 mg / 150 mg Week 3 onward*: 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 currently unknown, 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): Increase the dose of this medicine to twice the previous target stabilization dose and continue to maintain this dose. ② After discontinuation of an inducer of glucuronidation (e.g., carbamazepine): Select the dose according to the previous maintenance dose. After discontinuation, 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 When adding an inhibitor of glucuronidation (e.g., valproate), select the dose according to the patient's 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 an inducer of glucuronidation (e.g., carbamazepine) in patients not receiving valproate, select the dose according to the previous 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** 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 currently unknown, dose increases should follow the recommended dose for concomitant administration of this medicine with valproate. * : Once daily or in 2 divided doses, ** : in 2 divided doses 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 at least 2 weeks. 4. Restarting treatment The longer the interval since the previous dose, the greater the consideration that should be given to gradually increasing the dose to the maintenance dose. In general, if the period after 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 dosing schedule for adults and adolescents aged 13 years and older may also be used in elderly patients (65 years and older). In general, elderly patients should be treated with caution, starting at a low dose. 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, increasing dose, and maintenance dose should be reduced by approximately 50% and 75%, respectively. Increasing and maintenance doses should be adjusted according to clinical response. 7. 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: Recommended dosage for epilepsy (total daily dose: mg/kg (body weight)/day) Monotherapy in children 12 years of age or younger: Adequate clinical data to support a basic recommended dose are not yet available. Children aged 2∼12 years who are not receiving valproate and are taking glucuronidation-inducing drugs: Weeks 1 and 2, 0.6 mg/kg/day (divided into 2 doses per day); weeks 3 and 4, 1.2 mg/kg/day (divided into 2 doses per day); increase by a maximum of 1.2 mg/kg/day every 1～2 weeks to a maintenance dose of 5∼15 mg/kg/day (divided into 2 doses per day), maximum 400 mg/day Children aged 2∼12 years who are 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 a maximum of 0.3 mg/kg/day every 1～2 weeks to a maintenance dose of 1∼5 mg/kg/day (administered once daily or divided into 2 doses per day). Maximum 200 mg/day Children aged 2∼12 years who are taking other drugs that do not significantly inhibit or induce lamotrigine glucuronidation: Weeks 1 and 2, 0.3 mg/kg/day (administered once daily or divided into 2 doses per day); weeks 3 and 4, 0.6 mg/kg/day (administered once daily or divided into 2 doses per day); increase by a maximum of 0.6 mg/kg/day every 1～2 weeks to a maintenance dose of 1∼10 mg/kg/day (administered once daily or divided into 2 doses per day). 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. Administer this drug only in whole-tablet doses; do not divide the tablets. If the calculated dose of this drug cannot be administered as a whole-tablet dose, reduce it to the nearest whole-tablet dose that does not exceed the calculated dose. In patients aged 2 years or older and younger than 6 years, the upper limit of the recommended dose 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. There are no data for neonates younger than 1 month. This drug is not recommended for patients younger than 2 years, particularly those younger than 2 years who are taking valproate. Children and adolescents younger than 18 years: Do not administer to patients with bipolar disorder.

This medication may cause severe skin rashes, which can be life-threatening, especially in children. If a rash occurs, discontinue use immediately and consult a doctor. Rashes are most commonly seen within the first 8 weeks of starting this medication, so skin condition should be monitored carefully during this period. The risk of rash may increase when starting this medication in high doses or increasing the dose rapidly, or when taken with certain other medications. This medication can exacerbate mental health issues such as suicidal thoughts and depression, and patients and caregivers should inform medical personnel immediately if these symptoms occur. Women who are pregnant or planning to become pregnant should consult with a doctor before taking this medication and carefully consider its potential effects on the fetus. If breastfeeding, consult a doctor about the potential for this medication to transfer to the baby through breast milk. Stopping this medication suddenly can worsen seizures, so it should be reduced gradually according to a physician's instructions. Caution is needed while driving or operating machinery, as drowsiness, dizziness, and blurred vision may occur. This medication can interact with other drugs, so if taking other medications, be sure to inform a doctor or pharmacist. Serious side effects may occur in cases of overdose, so the prescribed dosage must be adhered to, and emergency care should be sought immediately in overdose situations. This medication should be stored below 30 degrees Celsius in a dry place, out of reach of children.

Skin rash, photoallergic reaction, polymorphous erythema, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), alopecia, dizziness, ataxia, headache, weakness, nausea, drowsiness, vomiting, respiratory disorders, pain, pharyngitis, flu syndrome, insomnia, menstrual disorders, tremors, lung disorders, depression, amnesia, abnormal thinking, hematological abnormalities (neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), lymphadenopathy, hemophagocytic lymphohistiocytosis, pseudolymphoma, fever, facial edema, liver abnormalities, kidney abnormalities, aseptic meningitis, hypogammaglobulinemia, aggressiveness, hypersensitivity, tics, hallucinations, confusion, nightmares, eye twitching, agitation, instability, movement disorders, exacerbation of Parkinson's disease, extrapyramidal effects, hypokinetic dyskinetic movements, increased seizure frequency, diplopia, blurry vision, conjunctivitis, diarrhea, elevated liver function tests, liver dysfunction, liver failure, lupus-like reactions, fatigue, interstitial nephritis, dry mouth, weight gain, edema, arthralgia, myalgia, emotional instability, sensory abnormalities, frequent urination, abdominal pain, mania, hypomania, mixed episodes, reduced bone density, osteopenia, osteoporosis, fractures, gastrointestinal disturbances, loss of appetite, sweating, suicidal impulse, suicidal behavior, suicidal tendencies, suicidal thoughts, suicide attempts, coma, consciousness disorders, increased seizures, grand mal seizures, QRS prolongation, eye twitching, ataxia, dizziness, drowsiness, blurry vision, headache, vomiting, loss of consciousness, fever, lymphadenopathy, facial edema, blood abnormalities, liver abnormalities, kidney abnormalities, aseptic meningitis, rash, photoallergic reaction, drowsiness, confusion

This medication should be stored in a closed container that protects it from light, ideally at a temperature between 1 degree and 30 degrees Celsius. It should also be stored in a dry place with low humidity to maintain its effectiveness.

Appearance

White to grayish-white rectangular tablets

Package unit

30 tablets/bottle