Ravicti 100mg (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). Epilepsy (seizures), adults and adolescents aged 13 years and older: 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 the dose by up to 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 (daily dose), patients not receiving valproate and receiving glucuronidation-inducing drugs: 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 the dose by up to 100 mg every 1～2 weeks until the maintenance dose is reached. Adjunctive therapy (daily dose), 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 the dose by up to 25～50 mg every 1～2 weeks until the maintenance dose is reached. * For example, patients receiving drugs that induce glucuronidation of this medicine, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir In patients receiving drugs 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 with valproate. Bipolar disorder, adults aged 18 years and older: 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, which may be increased to 400 mg in week 7 if needed (in 2 divided doses). Patients receiving other drugs 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 (week 6)**: 200 mg (once daily or in 2 divided doses). In patients receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dose for concomitant use of this medicine with valproate. The target stabilization dose may be adjusted according to clinical response. ① Patients receiving a glucuronidation inhibitor (e.g., valproate): Patients receiving a glucuronidation inhibitor such as valproate should take an initial dose of 25 mg every other day during the first 2 weeks, followed by 25 mg once daily for the next 2 weeks. The target dose to achieve 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 receiving an inhibitor such as valproate and receiving a glucuronidation inducer (e.g., carbamazepine, phenobarbital): Patients who are not receiving valproate but are receiving a glucuronidation inducer such as carbamazepine or phenobarbital should take an initial dose of 50 mg once daily during the first 2 weeks, followed by 100 mg in 2 divided doses daily for the next 2 weeks. In week 5, increase the dose to 200 mg in 2 divided doses daily. In week 6, increase the dose to 300 mg in 2 divided doses daily. The usual target dose to achieve an optimal response may be 400 mg in 2 divided doses daily from week 7. ③ Patients receiving other drugs that do not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion), or receiving this medicine as monotherapy: Patients receiving concomitant drugs that theoretically have no clinically significant pharmacokinetic interaction with this medicine, or receiving this medicine as monotherapy, should take an initial dose of 25 mg once daily during 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 to achieve an optimal response is 200 mg once daily or in 2 divided doses. Doses of up to 400 mg/day were used as monotherapy in clinical trials, but lamotrigine 400 mg/day provided no benefit over 200 mg/day. Drug regimen after reaching the maintenance stabilization dose, following discontinuation of a glucuronidation inhibitor (e.g., valproate): Week 1: 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. Week 2: maintain the week 1 dose (200 mg/day) (once daily or in 2 divided doses). Following discontinuation of a glucuronidation inducer (e.g., carbamazepine): Select the dose according to the previous maintenance dose. Week 1/week 2/from week 3 onward: for 400 mg/day, 300 mg, 200 mg, 200 mg; for 300 mg/day, 225 mg, 150 mg, 150 mg; for 200 mg/day, 150 mg, 100 mg, 100 mg. Following 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). In patients receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, it is recommended that the current dose initially be maintained and adjusted according to clinical response. ① Following discontinuation of a glucuronidation inhibitor (e.g., valproate): After discontinuing valproate, increase the dose of this medicine to twice the previous target stabilization dose and maintain this dose. ② Following discontinuation of a glucuronidation inducer (e.g., carbamazepine): Select the dose according to the previous maintenance dose. After discontinuing the glucuronidation inducer, gradually reduce the dose of this medicine over 3 weeks. ③ Following discontinuation of a drug that does not significantly inhibit or induce glucuronidation (e.g., lithium, bupropion): Maintain the target dose reached through dose escalation. Lamotrigine dose adjustment in adults aged 18 years and older with bipolar disorder receiving adjunctive therapy with other drugs (daily dose): With adjunctive therapy using a glucuronidation inhibitor (e.g., valproate), for a previous dose of 200 mg/day: week 1, 100 mg*; maintain this dose (100 mg/day)* in week 2 and from week 3 onward; for a previous dose of 300 mg/day: week 1, 150 mg*; maintain this dose (150 mg/day)* in week 2 and from week 3 onward; for a previous dose of 400 mg/day: week 1, 200 mg*; maintain this dose (200 mg/day)* in week 2 and from week 3 onward. With adjunctive therapy using a glucuronidation inducer (e.g., carbamazepine) in patients not receiving valproate, for a previous dose of 200 mg/day: week 1, 200 mg**; week 2, 300 mg**; from week 3 onward, 400 mg**; for a previous dose of 150 mg/day: week 1, 150 mg**; week 2, 225 mg**; from week 3 onward, 300 mg**; for a previous dose of 100 mg/day: week 1, 100 mg**; week 2, 150 mg**; from week 3 onward, 200 mg**. 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)*. In patients receiving antiepileptic drugs for which pharmacokinetic interactions with lamotrigine are not currently known, dose increases should follow the recommended dose for concomitant use of this medicine with valproate. * : Once daily or in 2 divided doses, ** : in 2 divided doses Discontinuation of this medicine: As with other antiepileptic drugs, 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. Restarting treatment: When restarting treatment in a patient who has discontinued this medicine, assess the need to gradually increase the dose to the maintenance dose. In general, if the time since discontinuation of this medicine exceeds 5 half-lives, the dose should be gradually increased to the maintenance dose according to an appropriate schedule. 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). However, since clinical data in elderly patients are generally insufficient, administer with caution and start at a low dose. Patients with hepatic impairment: In general, in patients with moderate (Child-Pugh grade B) and severe (Child-Pugh grade C) hepatic impairment, the initial, escalation, and maintenance doses should be reduced by approximately 50% and 75%, respectively. Escalation and maintenance doses should be adjusted according to clinical response. Patients with renal impairment: A reduced maintenance dose may be effective in patients with severe renal impairment.

Child dose

Children aged 2–12 years, epilepsy (seizures), monotherapy: Adequate clinical data are not yet available to support a basic recommended dose for administration of this drug as monotherapy in children aged 12 years or younger. Children aged 2–12 years, adjunctive therapy (daily dose), patients not receiving valproate and receiving glucuronidation-inducing drugs: 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 until the maintenance dose of 5–15 mg/kg/day (in 2 divided doses) is reached. Maximum: 400 mg/day. Children aged 2–12 years, adjunctive therapy (daily dose), patients 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 until the maintenance dose of 1–5 mg/kg/day (once daily or in 2 divided doses) is reached. Maximum: 200 mg/day. * Patients receiving drugs that induce glucuronidation of this drug, such as phenytoin, carbamazepine, phenobarbital, primidone, rifampicin, lopinavir, and ritonavir. Patients taking drugs for which pharmacokinetic interactions with lamotrigine are not known (see Interactions) should use the same dose escalation schedule recommended for concomitant use of this drug 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. Children's body weight should be monitored to ensure that the therapeutic dose is maintained, and the dose should be reviewed if there is a change in body weight. 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. No data are available for neonates younger than 1 month. Therefore, this drug is not recommended for patients younger than 2 years; in particular, its use is not recommended in patients younger than 2 years who are taking valproate because of the difficulty of determining an accurate starting dose. Children and adolescents younger than 18 years: This drug should not be administered to patients with bipolar disorder who are younger than 18 years.

This medication is primarily used for the treatment of epilepsy and bipolar disorder. During treatment, close observation for skin rashes is essential. If a rash occurs, discontinue the medication immediately and consult a physician. The risk of rash is particularly higher in pediatric patients, and if significant rash occurs, it may be life-threatening, necessitating prompt action at the onset of initial symptoms. This medication may interact with other drugs, so dose adjustments may be necessary, especially when taken together with valproate or hormonal contraceptives. Additionally, patients receiving this medication should be closely monitored for changes in mental symptoms such as suicidal impulses or depression, and any unusual symptoms should be reported to medical staff immediately. Women who are pregnant or planning to become pregnant should consult with healthcare providers before taking this medication, and breastfeeding should be avoided, as the medication may be passed through breast milk. This medication should be administered with caution in patients with kidney or liver function issues, and those with a history of hypersensitivity to this medication or similar drugs should not be given this medication. Careful attention is required when driving or operating machinery as this medication may cause drowsiness, dizziness, and should be avoided. Abrupt discontinuation of the drug may exacerbate seizures, so doses should be gradually reduced. In case of overdose, consciousness disturbances, seizures, and cardiac abnormalities may occur, and immediate medical attention should be sought. This medication should be stored in a tightly closed container below 30 degrees Celsius in a dry place, out of reach of children.

Skin rash, photosensitivity reactions, skin and mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), alopecia, hematological abnormalities (including neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, aplastic anemia, agranulocytosis), lymphadenopathy, hemophagocytic lymphohistiocytosis, hypersensitivity reactions (including fever, lymphadenopathy, facial edema, blood abnormalities, liver abnormalities, disseminated intravascular coagulation, multi-organ failure), aggression, hypersensitivity, tics, hallucinations, confusion, nightmares, headaches, drowsiness, insomnia, dizziness, ataxia, ocular tremor, aseptic meningitis, restlessness, instability, movement disorders, aggravation of Parkinson's disease, extrapyramidal effects, choreoathetoid movements, increased seizure frequency, diplopia, blurred vision, conjunctivitis, nausea, vomiting, diarrhea, loss of appetite, gastrointestinal disorders, pharyngitis, flu-like syndrome, menstrual disturbances, tremors, pulmonary disorders, depression, amnesia, abnormal thinking, fatigue, pain, abdominal pain, indigestion, constipation, bloating, weight gain, edema, arthralgia, myalgia, emotional instability, movement disorders, sensory disturbances, frequent urination, sweating, lupus-like reactions, elevated liver function tests, liver dysfunction, liver failure, DRESS syndrome, ocular tremor, drowsiness, ataxia, headaches, dizziness

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the drug's efficacy and safety over time.

Appearance

Pale yellowish-brown rectangular tablet

Package unit

30 tablets/bottle, 100 tablets/bottle