Ravisitin Tablet 25 mg (Lamotrigine)

Adult dose

Epilepsy — Adults and adolescents aged 13 years and older 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. In some patients, doses of up to 500 mg/day have been used to achieve the desired response. Adjunctive therapy — Patients not receiving valproate and receiving a glucuronidation-inducing drug: 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. Adjunctive therapy — Patients receiving 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. In patients receiving drugs for which pharmacokinetic interactions with lamotrigine are not known, dose increases should follow the recommended dosage and dose escalation schedule for concomitant use of this drug with valproate. Bipolar disorder — Adults aged 18 years and older Dose escalation schedule to reach the maintenance stabilization 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 another drug that does 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 (week 6): 200 mg (once daily or in 2 divided doses). Patients receiving a glucuronidation inhibitor (e.g., valproate): 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 the clinical response, the dose may be increased to a maximum of 200 mg once daily (or in 2 divided doses). Patients not receiving an inhibitor such as valproate and receiving a glucuronidation inducer (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. Patients receiving another drug that does not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this drug 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). Administer 200 mg once daily or in 2 divided doses. In clinical trials, doses of up to 400 mg/day were used as monotherapy, but a lamotrigine dose of 400 mg/day offered no benefit over a dose of 200 mg/day. After reaching the maintenance stabilization dose — After discontinuation of a glucuronidation inhibitor (e.g., valproate): Administer twice the stabilization dose. However, the dose increase should not exceed 100 mg/week. That is, if the target stabilization dose is 100 mg/day, administer 200 mg/day in week 1. In week 2, maintain the week 1 dose (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 previous maintenance dose. Previous maintenance dose of 400 mg: 300 mg in week 1, 200 mg in week 2; previous maintenance dose of 300 mg: 225 mg in week 1, 150 mg in week 2; previous maintenance dose of 200 mg: 150 mg in week 1, 100 mg in week 2. After discontinuation of a drug 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). After discontinuation of a glucuronidation inhibitor (e.g., valproate), increase this drug's dose to twice the previous target stabilization dose and continue at this dose. After discontinuation of a glucuronidation inducer (e.g., carbamazepine), gradually reduce this drug's dose over 3 weeks. After discontinuation of a drug that does not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), maintain the target dose reached through dose escalation. Dose adjustment for adjunctive treatment with other drugs — When adding a glucuronidation inhibitor (e.g., valproate): Previous dose 200 mg: 100 mg* in week 1, then maintain this dose (100 mg/day)*; previous dose 300 mg: 150 mg* in week 1, then maintain this dose (150 mg/day)*; previous dose 400 mg: 200 mg* in week 1, then maintain this dose (200 mg/day)*. When adding a glucuronidation inducer (e.g., carbamazepine) in patients not receiving valproate: Previous dose 200 mg: 200 mg** in week 1, 300 mg** in week 2, 400 mg** from week 3 onward; previous dose 150 mg: 150 mg** in week 1, 225 mg** in week 2, 300 mg** from week 3 onward; previous dose 100 mg: 100 mg** in week 1, 150 mg** in week 2, 200 mg** from week 3 onward. Adjunctive therapy with a drug that does not significantly inhibit or induce lamotrigine glucuronidation (e.g., lithium, bupropion): Target maintenance dose reached through dose escalation (200 mg/day)*. *: Once daily or in 2 divided doses, **: In 2 divided doses. Discontinuation of this drug: The dose of this drug should be gradually reduced over at least 2 weeks. Restarting treatment: If the period since discontinuation of this drug exceeds 5 half-lives, gradually increase the dose to the maintenance dose according to an appropriate schedule. Older adults: The recommended dosage schedule for adults and adolescents aged 13 years and older may also be used in older adults (aged 65 years and older). Start with a low dose. Patients with hepatic impairment: In patients with moderate (Child-Pugh grade B) and severe (Child-Pugh grade C) hepatic impairment, the initial dose, escalation dose, and maintenance dose should be reduced by approximately 50% and 75%, respectively. Patients with renal impairment: In patients with end-stage renal impairment, the initial dose of this drug 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

Epilepsy — children aged 2∼12 years, monotherapy: Adequate clinical data are not yet available to support a basic recommended dose for use of this medication as monotherapy in children 12 years of age or younger. Epilepsy — children aged 2∼12 years, adjunctive therapy: Patients not receiving valproate and receiving glucuronidation-inducing agents: Weeks 1 and 2, 0.6 mg/kg/day (divided into 2 doses); weeks 3 and 4, 1.2 mg/kg/day (divided into 2 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 (divided into 2 doses); maximum 400 mg/day. Epilepsy — children aged 2∼12 years, adjunctive therapy: Patients 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). 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 medication should not be administered. For patients aged 2 years or older but younger than 6 years, the upper end of the recommended dose range may become the maintenance dose. Epilepsy — children younger than 2 years: The safety and efficacy of this medication have not been established in children aged 1 month to younger than 2 years. 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 establish an accurate initial dose in patients younger than 2 years who are taking valproate. Bipolar disorder — children and adolescents younger than 18 years: This medication should not be administered to patients with bipolar disorder who are children or adolescents younger than 18 years.

This medication may cause severe skin rashes; therefore, if a rash appears on the skin, particularly within the first 8 weeks of treatment, discontinue use immediately and consult a physician. The risk of such skin rashes is higher in children, so care should be taken particularly if a rash occurs along with fever. This medicine may interact with other medications, so it is essential to inform the physician or pharmacist if other medications are being taken. There may be mental health issues such as suicidal thoughts or depression; thus, if there are significant mood changes or unusual behaviors, notify healthcare professionals immediately. Women who are pregnant or planning to become pregnant must consult their physician before taking this medication, and it is also advisable to avoid usage while breastfeeding. Abrupt cessation of this medication may worsen seizures; therefore, any dosage adjustments must be done gradually according to the healthcare provider's instructions. Caution is advised when driving or operating machinery as drowsiness or dizziness may occur.

• rash
• skin rash
• photosensitivity reaction
• skin-mucous membrane syndrome
• toxic epidermal necrolysis
• alopecia
• hematological abnormalities
• lymphadenopathy
• hemophagocytic lymphohistiocytosis
• hypersensitivity reaction

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Maintain storage temperature between 1°C and 30°C, and keep it in a dry place with low humidity.

Appearance

Pale yellowish-brown, rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle