Lamiat Tablet 25 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 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. Monotherapy (daily dose): In some patients, doses of up to 500 mg/day have been used to achieve the desired response. Adjunctive therapy (daily dose): For 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 up to 100 mg every 1～2 weeks until the maintenance dose is reached. For patients taking 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 taking inducers of lamotrigine glucuronidation such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, or ritonavir. For patients taking medicines for which pharmacokinetic interactions with lamotrigine are not currently known (see Interactions), dose increases should follow the recommended dosage and titration schedule for concomitant use of this medicine with 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 Recommended dose escalation to reach the maintenance stabilization dose in adults aged 18 years and older (daily dose) 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); week 6, 300 mg; if necessary, the dose may be increased to 400 mg in week 7 (in 2 divided doses). Patients taking 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 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 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 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 once daily (or in 2 divided doses). Patients not taking an inhibitor such as valproate and taking an inducer of glucuronidation (e.g., carbamazepine, phenobarbital): As the initial dose, 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, 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 medicines that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this medicine as monotherapy: As the initial dose, 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, 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. 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 an inhibitor of glucuronidation (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 discontinuation of an inducer of glucuronidation (e.g., carbamazepine): Select the dose according to the previous maintenance dose. Administer 300 mg for a previous dose of 400 mg, 225 mg for 300 mg, and 150 mg for 200 mg. After discontinuation of 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). 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 then adjusted according to clinical response. After discontinuation of valproate, increase this medicine to twice the previous target stabilization dose and continue to maintain that dose. After discontinuation of an inducer of glucuronidation, gradually reduce the dose of this medicine over 3 weeks. After discontinuation of a medicine that does not significantly inhibit or induce lamotrigine glucuronidation, maintain the target dose reached through dose escalation. Lamotrigine dose adjustment in adults aged 18 years and older with bipolar disorder when other medicines are added as adjunctive therapy (daily dose) When adding an inhibitor of glucuronidation (e.g., valproate): For a previous lamotrigine stabilization dose of 200 mg/day, administer 100 mg* in week 1 and maintain this dose thereafter (100 mg/day)*; for 300 mg, administer 150 mg* in week 1 and maintain this dose thereafter (150 mg/day)*; for 400 mg, administer 200 mg* in week 1 and maintain this dose thereafter (200 mg/day)*. When adding an inducer of glucuronidation (e.g., carbamazepine) in patients not taking valproate: For a previous dose of 200 mg, administer 200 mg** in week 1, 300 mg** in week 2, and 400 mg** from week 3 onward; for 150 mg, administer 150 mg** in week 1, 225 mg** in week 2, and 300 mg** from week 3 onward; for 100 mg, administer 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): Maintain the target maintenance dose reached 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. Abrupt discontinuation of this medicine should be avoided whenever possible because it may cause rebound seizures. Unless immediate discontinuation is required for safety reasons (e.g., a serious skin rash), the dose of this medicine should be gradually reduced over at least 2 weeks. When restarting treatment in a patient who has discontinued this medicine, assess the need to gradually increase the dose to the maintenance dose. 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, 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 plan. The recommended dosing schedule for adults and adolescents aged 13 years and older may also be used in elderly patients (aged 65 years and older). In general, because clinical data in elderly patients are limited, administer with caution and start at a low dose. In patients with moderate (Child-Pugh grade B) or severe (Child-Pugh grade C) hepatic impairment, the initial dose, escalation dose, and maintenance dose should each be reduced by approximately 50% and 75%, respectively. The escalation and maintenance doses should be adjusted according to clinical response. 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

Recommended dosage for epilepsy in children aged 2∼12 years (total daily dose: mg/kg (body weight)/day) Monotherapy in children aged 2∼12 years: There are currently insufficient adequate clinical data to support a basic recommended dose for use of this drug as monotherapy in children aged 12 years or younger. Children aged 2∼12 years who are not receiving valproate and are receiving glucuronidation inducers*: 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 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 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 up to 0.3 mg/kg/day every 1～2 weeks to a maintenance dose of 1∼5 mg/kg/day (administered once daily or in 2 divided doses), up to a maximum of 200 mg/day * Patients receiving glucuronidation inducers of this drug, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir Patients taking medications for which pharmacokinetic interactions with lamotrigine are not currently known (see Interactions) should have the same dosage escalation rate as recommended when this drug is administered concomitantly with valproate. ** 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. For patients aged 2 years and older but 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 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, use is not recommended in patients younger than 2 years, and use of this drug is particularly not recommended in patients younger than 2 years who are taking valproate because of the difficulty in determining an accurate initial dose. Children and adolescents younger than 18 years: This drug should not be administered to patients younger than 18 years with bipolar disorder.

This medication may cause severe skin rashes, so if a rash appears, especially in children, the medication should be discontinued immediately and a physician should be consulted. Skin rashes typically appear within 8 weeks of starting treatment and can range from mild rashes to life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis. Early symptoms may include fever, lymphadenopathy, and facial swelling, so if these symptoms occur, immediate medical attention should be sought. This medication may provoke seizures, so abrupt discontinuation is to be avoided; the dosage should be gradually reduced under a physician's direction. Suicidal thoughts or changes in behavior have been reported, and patients and caregivers should closely monitor for such symptoms and inform medical personnel of any unusual signs. Women taking hormonal contraceptives may have decreased contraceptive efficacy due to changes in the drug level, so the use of non-hormonal contraceptive methods is recommended. Patients with liver or kidney dysfunction may experience delayed metabolism of this medication, so caution is warranted. Women who are pregnant or planning to become pregnant should consult a physician before taking this medication, and folic acid supplementation is recommended during pregnancy. Breastfeeding mothers are advised not to breastfeed as this medication may pass into breast milk and affect the newborn. Caution is needed when driving or operating machinery due to possible drowsiness and dizziness.

Rash, skin rash, photosensitivity reaction, skin and mucous membrane syndrome, toxic epidermal necrolysis, alopecia, hematological abnormalities (including neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), lymphadenopathy, hypersensitivity reactions (including fever, lymphadenopathy, facial swelling, blood abnormalities, liver abnormalities, disseminated intravascular coagulation, multiple organ failure), headache, drowsiness, insomnia, dizziness, ataxia, tremor, aseptic meningitis, agitation, instability, movement disorders, exacerbation of Parkinson's disease, extrapyramidal effects, chorea-like twisting movements, increased seizure frequency, nightmares, tics, hallucinations, confusion, aggression, irritability, double vision, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, gastrointestinal disturbances, pharyngitis, flu-like syndrome, menstrual disorders, tremors, pulmonary disorders, depression, amnesia, abnormal thinking, fatigue, pain, sore throat, abdominal pain, dyspepsia, constipation, bloating, weight gain, edema, arthralgia, myalgia, polyuria, sweating, DRESS syndrome, hemophagocytic lymphohistiocytosis, seizure clustering, rhabdomyolysis, multiple organ failure, disseminated intravascular coagulation, suicidal ideation, suicidal behavior

This medication is sensitive to air and moisture and should be stored in a tightly sealed container. It is best kept in a cool, dry place at room temperature, avoiding areas that are too hot or too cold.

Appearance

Light yellow-brown square tablet

Package unit

30 tablets/bottle