Innovareon Film-Coated Tablet 200mg (Lupinamide)

Adult dose

Treatment with this medicine should be initiated by a pediatrician or neurologist experienced in the treatment of epilepsy. This medicine is for oral use and should be taken with water. Divide the daily dose into 2 equal doses, taken in the morning and evening approximately 12 hours apart. Taking this medicine with food is recommended. If the patient has difficulty swallowing, the tablet may be crushed and taken with half a glass of water. Alternatively, the tablet may be split in half along the score line. Information on the use of this medicine in elderly patients is limited. Since the pharmacokinetics of rufinamide are unchanged in elderly patients, dose adjustment is not necessary in patients aged 65 years and older. Studies in patients with severe renal impairment have shown that dose adjustment is not necessary in these patients. The use of this medicine in patients with hepatic impairment has not been studied. Careful and gradual dose titration is required when administering it to patients with mild to moderate hepatic impairment. Therefore, use in patients with severe hepatic impairment is not recommended. This medicine should be administered with food. When discontinuing this medicine, it should be withdrawn gradually. In clinical trials, treatment was discontinued by reducing the dose by approximately 25% every two days. If one or more doses are missed, an individual clinical assessment is required. Although no controlled trials have been conducted for longer than 3 months, uncontrolled open-label studies have shown sustained long-term efficacy.

Child dose

Children aged 1 year and older but younger than 4 years, patients not receiving valproate: Start treatment at a dose of 10mg/kg/day. Depending on clinical response and tolerability, the dose may be increased by up to 10mg/kg/day at 3-day intervals to a target dose of 45mg/kg/day. The maximum recommended dose in this patient group is 45mg/kg/day. Children aged 1 year and older but younger than 4 years, patients receiving valproate: Start treatment at a dose of 10mg/kg/day. Depending on clinical response and tolerability, the dose may be increased by up to 10mg/kg/day at 3-day intervals to a target dose of 30mg/kg/day. The maximum recommended dose in this patient group is 30mg/kg/day. Children aged 4 years and older weighing less than 30kg, patients weighing less than 30kg who are not receiving valproate: Start treatment at a dose of 200mg/day. Depending on clinical response and tolerability, the dose may be increased by 200mg/day every two days up to the maximum recommended dose of 1,000mg. Doses of up to 3,600mg/day have been studied in a limited number of patients. Children aged 4 years and older weighing less than 30kg, patients weighing less than 30kg who are receiving valproate: Start treatment at 200mg/day. Depending on clinical response and tolerability, the dose may be increased by 200mg/day at intervals of at least two days up to the maximum recommended dose of 600mg/day. Children aged 4 years and older weighing 30kg or more, patients weighing 30kg or more who are not receiving valproate: Start treatment at a dose of 400mg/day. Depending on clinical response and tolerability, the dose may be increased by 400mg/day every two days up to the maximum recommended dose listed in the following table. 30.0 - 50.0 kg: maximum recommended dose 1,800mg/day. 50.1 - 70.0 kg: maximum recommended dose 2,400mg/day. 70.1 kg or more: maximum recommended dose 3,200mg/day. Doses of up to 4,000mg/day (for the 30-50kg weight range) or 4,800mg/day (over 50kg) have been studied in a limited number of patients. Children aged 4 years and older weighing 30kg or more, patients weighing 30kg or more who are receiving valproate: Start treatment at a dose of 400mg/day. Depending on clinical response and tolerability, the dose may be increased by 400mg/day every two days up to the maximum recommended dose listed in the following table. 30.0 - 50.0 kg: maximum recommended dose 1,200mg/day. 50.1 - 70.0 kg: maximum recommended dose 1,600mg/day. 70.1 kg or more: maximum recommended dose 2,200mg/day. The safety and efficacy of this medicine have not been established in newborns and infants younger than 1 year.

This medication may increase the risk of suicidal thoughts or behavior; therefore, patients taking it should be carefully monitored for symptoms of depression or mood changes. It is important for the patient, their guardians, and family to immediately inform healthcare providers if such mental changes occur. Additionally, this medication may cause side effects such as drowsiness, fatigue, and dizziness; caution should be taken when performing hazardous activities such as driving or operating machinery. Patients with allergies to this medication or specific genetic disorders should not take it. Various adverse reactions such as headaches, vomiting, and rashes may occur; if severe skin reactions appear, discontinue use immediately and consult healthcare providers. Abrupt discontinuation of this medication may worsen seizures, so the dosage should be gradually reduced per the doctor's instructions. Women of childbearing age must use effective contraception while taking this medication, and the decision to use it during pregnancy should be made with caution. Additionally, this medication can interact with other drugs; therefore, it is essential to inform healthcare providers of any other medications being taken. In the event of an overdose, prompt medical treatment should be sought, as there is no specific antidote; supportive treatment based on symptoms is required.

• suicidal ideation
• suicidal behavior
• depression
• abnormal changes in emotions or behavior
• drowsiness
• fatigue
• cooperation disorder
• dizziness
• gait disorder
• ataxia

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly closed container. The storage temperature should be kept between 1 and 30 degrees Celsius at room temperature.

Appearance

A pink, oval film-coated tablet that is convex on both sides and has a score line.

Package unit

30 tablets per bottle