Hyundai Ropinirole Sustained Release Tablet 2 mg (Ropinirole Hydrochloride)

Adult dose

The optimal dose should be individualized, taking efficacy and tolerability into consideration. This medication should be taken once daily at the same time each day. It may be taken with or without food. Swallow this medication whole; do not chew, crush, or split it. 1) Initial therapy During the first week, administer this medication (extended-release tablet) 2mg once daily. Starting in the second week of treatment, increase the dose to 4mg once daily. A treatment response may occur starting at 4mg/day. 2) Maintenance therapy When administering this medication (extended-release tablet), continue treatment at the minimum dose that controls symptoms. If symptoms are inadequately controlled or not maintained with 4mg once daily, increase the dose in 2mg increments each week (or over a longer period) until the daily dose reaches 8mg. If symptoms are inadequately controlled or not maintained with 8mg once daily, increase the daily dose in increments of 2mg or 4mg at intervals of 2 weeks or longer. The maximum daily dose of this medication is 24mg. If treatment is interrupted for 1 day or longer, restarting treatment at the initial therapy dose should be considered. When ropinirole is administered concomitantly with levodopa, the levodopa dose may be reduced gradually according to the clinical response. In clinical trials, the levodopa dose was gradually reduced by up to approximately 30% in patients receiving this medication (extended-release tablet) concomitantly with levodopa. In patients with advanced Parkinson’s disease receiving concomitant levodopa, dyskinesia may occur early in treatment with this medication (extended-release tablet). In such cases, the levodopa dose should be reduced. If ropinirole is to be used as a substitute for another dopamine agonist, the other dopamine agonist should be discontinued according to its recommended method before starting ropinirole. As with other dopamine agonists, ropinirole should be discontinued by gradually reducing the daily dose over 1 week. 3) Switching from immediate-release ropinirole to this medication (extended-release tablet) Immediate-release ropinirole may be replaced with this medication (extended-release tablet) overnight. The dose of this medication should be selected according to the following dosage table, based on the patient’s total daily dose of immediate-release ropinirole. Total daily dose of immediate-release ropinirole (mg) 0.75-2.25: Total daily dose of extended-release ropinirole (mg) 2 Total daily dose of immediate-release ropinirole (mg) 3-4.5: Total daily dose of extended-release ropinirole (mg) 4 Total daily dose of immediate-release ropinirole (mg) 6: Total daily dose of extended-release ropinirole (mg) 6 Total daily dose of immediate-release ropinirole (mg) 7.5-9: Total daily dose of extended-release ropinirole (mg) 8 Total daily dose of immediate-release ropinirole (mg) 12: Total daily dose of extended-release ropinirole (mg) 12 Total daily dose of immediate-release ropinirole (mg) 15-18: Total daily dose of extended-release ropinirole (mg) 16 Total daily dose of immediate-release ropinirole (mg) 21: Total daily dose of extended-release ropinirole (mg) 20 Total daily dose of immediate-release ropinirole (mg) 24: Total daily dose of extended-release ropinirole (mg) 24 After switching from immediate-release ropinirole to this medication (extended-release tablet), adjust the dose according to the treatment response. 2. Use in elderly patients Ropinirole clearance is reduced in patients aged 65 years or older; therefore, increase the dose more gradually according to the clinical response. In very elderly patients, consider increasing the dose even more gradually during the initial period of treatment. 3. Patients with renal impairment No dose adjustment is necessary because ropinirole clearance is unchanged in patients with mild or moderate renal impairment (creatinine clearance 30-50mL/min).

This drug should be used with caution in patients with severe cardiovascular disease due to its peripheral dopamine action. Additionally, when used in conjunction with antihypertensive medications or antiarrhythmic agents, hypotension, bradycardia, or arrhythmias may occur, so care should be taken. In patients with significant mental illness, this drug should only be used if its therapeutic benefits outweigh the risks. While taking this medication, sudden drowsiness or sleep may occur, and it is advisable to avoid hazardous activities such as driving or operating machinery. Patients with a history of allergy or severe renal or liver dysfunction, pregnant or nursing women, and individuals with lactose intolerance should not use this medication. Patients with cardiovascular disease are at risk of hypotension and should frequently monitor their blood pressure. This drug contains certain dyes, so caution is warranted in those with a history of allergies. Various side effects such as hallucinations, drowsiness, dizziness, hypotension, constipation, edema, confusion, delusions, illusions, paranoia, impulse control disorders, hypersexuality, compulsive buying, binge eating, aggression, fainting, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, increased liver enzymes, and lower limb edema may occur, necessitating careful observation of symptoms. Particularly, Parkinson's patients may experience abnormal movements during initial dosage adjustments. Patients with a history of mental illness should carefully evaluate risks and benefits before administration of this medication. If severe drowsiness occurs, the dosage should be reduced, and regular observation is necessary as symptoms of impulse control disorders may develop. This drug may exacerbate side effects caused by neuroleptics and should not be used concurrently. There may be drug interactions, so if taking other medications, always consult with a doctor or pharmacist. During pregnancy, it should not be used as it can harm the fetus, and if nursing, avoid using it as it can be secreted into breast milk and affect the baby. It is not recommended for children or adolescents under 18 years of age, as safety and efficacy have not been established.

• hallucination
• drowsiness
• movement disorders
• dizziness
• sudden sleep
• orthostatic hypotension
• hypotension
• nausea
• constipation
• peripheral edema

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best kept in a cool place below 25 degrees Celsius.

Appearance

Pink, biconvex, rectangular film-coated sustained release tablet

Package unit

28 tablets/box [14 tablets/PTP*2]