Innovaron Film-Coated Tablet 400mg (Lopinavir)

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 twice daily in the morning and evening, approximately 12 hours apart. Since food has been observed to affect this medicine, it is recommended that it be taken with food. If the patient has difficulty swallowing, the tablet may be crushed and taken with half a glass of water. Alternatively, the tablet may be divided in half along the score line. Initiate treatment at a dose of 400mg/day. Depending on clinical response and tolerability, the dose may be increased by 400mg/day every 2 days up to the maximum recommended dose listed in the following table. Weight range 30.0 - 50.0 kg: Maximum recommended dose (mg/day) 1,800 Weight range 50.1 - 70.0 kg: Maximum recommended dose (mg/day) 2,400 Weight range 70.1 kg or more: Maximum recommended dose (mg/day) 3,200 A limited number of patients have been studied at doses of up to 4,000mg/day (30-50kg range) or 4,800mg/day (over 50kg). Initiate treatment at a dose of 400mg/day. Depending on clinical response and tolerability, the dose may be increased by 400mg/day every 2 days up to the maximum recommended dose listed in the following table. Weight range 30.0 - 50.0 kg: Maximum recommended dose (mg/day) 1,200 Weight range 50.1 - 70.0 kg: Maximum recommended dose (mg/day) 1,600 Weight range 70.1 kg or more: Maximum recommended dose (mg/day) 2,200 Information on the use of this medicine in older adults is limited. Since the pharmacokinetics of rufinamide are unchanged in older adults, dose adjustment is not required in patients aged 65 years or older. Studies in patients with severe renal impairment have shown that dose adjustment is not required in these patients. The use of this medicine in patients with hepatic impairment has not been studied. Careful and cautious dose titration is required when administering this medicine 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. If treatment with this medicine is discontinued, it should be withdrawn gradually. In clinical trials, treatment was discontinued by reducing the dose by approximately 25% every 2 days. If one or more doses are missed, an individual clinical assessment is required. Although no controlled trials lasted longer than 3 months, long-term sustained efficacy was demonstrated in uncontrolled open-label studies.

Child dose

Children aged 1 year to under 4 years who are 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 reach the target dose of 45mg/kg/day. The maximum recommended dose in this patient group is 45mg/kg/day. Children aged 1 year to under 4 years who are 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 reach the 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, and 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 2 days, up to the maximum recommended dose of 1,000mg. The drug has been studied at doses of up to 3,600mg/day in a limited number of patients. Children aged 4 years and older weighing less than 30kg, and 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 2 days, up to the maximum recommended dose of 600mg/day. Children aged 4 years and older and adults weighing 30kg or more who are not receiving valproate: Weight range 30.0 - 50.0 kg, maximum recommended dose (mg/day) 1,800 Children aged 4 years and older and adults weighing 30kg or more who are not receiving valproate: Weight range 50.1 - 70.0 kg, maximum recommended dose (mg/day) 2,400 Children aged 4 years and older and adults weighing 30kg or more who are not receiving valproate: Weight range 70.1 kg or more, maximum recommended dose (mg/day) 3,200 Children aged 4 years and older and adults weighing 30kg or more who are receiving valproate: Weight range 30.0 - 50.0 kg, maximum recommended dose (mg/day) 1,200 Children aged 4 years and older and adults weighing 30kg or more who are receiving valproate: Weight range 50.1 - 70.0 kg, maximum recommended dose (mg/day) 1,600 Children aged 4 years and older and adults weighing 30kg or more who are receiving valproate: Weight range 70.1 kg or more, maximum recommended dose (mg/day) 2,200 The safety and efficacy of this drug in neonates and infants under 1 year of age have not been established.

This medication is used as an anticonvulsant to control seizures in epilepsy patients. During treatment, there may be suicidal thoughts, suicidal behavior, depression, or changes in mood or behavior, so patients and their caregivers should closely monitor for these symptoms. It may cause symptoms such as drowsiness, fatigue, dizziness, and motor control disorders due to its effect on the central nervous system, so caution is needed when driving or operating machinery. Patients allergic to the active ingredient or excipients, or those with congenital short QT syndrome or lactose intolerance should not use this medication. Common adverse reactions such as headache, dizziness, fatigue, drowsiness, vomiting, and rash may occur, and if these symptoms are severe, consult a doctor. During treatment, changes in seizure patterns or new types of seizures may occur, so careful monitoring of symptom changes is essential. This medication may interact with other anticonvulsants, and particularly when used with valproate, monitoring of blood concentration may be necessary, requiring dose adjustments. Women of childbearing age should use effective contraception during treatment and should discuss the use of this medication during pregnancy with their healthcare provider. While breastfeeding, it is recommended to avoid breastfeeding as this medication may be excreted in breast milk. In case of overdose, there is no specific antidote, so it is important to seek medical attention immediately for appropriate treatment, which may include gastric lavage or dialysis.

• suicidal thoughts
• suicidal behavior
• depression
• drowsiness
• fatigue
• cooperative disorder
• dizziness
• gait disorder
• ataxia
• headache

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is best stored at room temperature between 1°C and 30°C. Avoid excessively hot or cold places to help maintain the medication's efficacy.

Appearance

Pink oval film-coated tablet with a biconvex shape and a score line on both sides

Package unit

100 tablets/bottle