Rikiroldimin Tablets 8mg (Ropinirole Hydrochloride)

Adult dose

Adults The appropriate dose should be determined individually, taking efficacy and tolerability into consideration. This medicine should be taken once daily at the same time each day. It may be taken with or without food. Swallow this medicine whole. Do not chew, crush, or split it. 1) Initial therapy For the first week, administer 2mg of this medicine (extended-release tablet) once daily. Starting in the second week of treatment, increase the dose to 4mg once daily. A treatment response may occur starting at 4mg daily. 2) Maintenance therapy When administering this medicine (extended-release tablet), continue treatment at the lowest dose that controls symptoms. If symptoms are not adequately controlled or control is not maintained with 4mg once daily, gradually increase the dose by 2mg each week (or over a longer period) until the daily dose reaches 8mg. If symptoms are not adequately controlled or control is not maintained with 8mg once daily, gradually increase the daily dose by 2mg or 4mg at intervals of 2 weeks or longer. The maximum daily dose of this medicine is 24mg. If treatment is interrupted for 1 day or more, restarting treatment should be considered according to the initial therapy dosing schedule. When ropinirole is administered concomitantly with levodopa, the levodopa dose may be gradually reduced according to the clinical response. In clinical trials, the levodopa dose was gradually reduced by up to approximately 30% in patients receiving this medicine (extended-release tablet) concomitantly with levodopa. Dyskinesia may occur early in treatment with this medicine (extended-release tablet) when administered with levodopa in patients with advanced Parkinson's disease. 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 instructions 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 tablets to this medicine (extended-release tablet) Immediate-release ropinirole tablets may be replaced with this medicine (extended-release tablet) overnight. The dose of this medicine should be selected based on the patient's total daily dose of immediate-release ropinirole tablets, according to the following dosage table. Total daily dose of immediate-release ropinirole tablets (mg) → Total daily dose of ropinirole extended-release tablets (mg) 0.75-2.25 → 2 3-4.5 → 4 6 → 6 7.5-9 → 8 12 → 12 15-18 → 16 21 → 20 24 → 24 After switching from immediate-release ropinirole tablets to this medicine (extended-release tablet), adjust the dose according to the treatment response. 2. Administration to elderly patients Since ropinirole clearance is decreased in patients aged 65 years and older, the dose should be increased 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 in patients with mild or moderate renal impairment (creatinine clearance 30-50mL/min), as ropinirole clearance is unchanged.

This medication should be used cautiously in patients with severe cardiovascular diseases. This medication may cause hypotension or arrhythmia when used in combination with antihypertensive or antiarrhythmic medications, so caution is needed in such cases. It should only be used in patients with significant mental disorders when the therapeutic benefits are judged to outweigh the risks. While taking this medication, sudden drowsiness or sleep may occur, so risky activities such as driving or operating machinery should be avoided. It should not be administered to patients with hypersensitivity to this medication, severe renal or hepatic impairment, pregnant or lactating women, and patients with lactose intolerance. Patients with cardiovascular conditions should monitor their blood pressure closely due to the risk of hypotension, especially during initial treatment. This medication contains specific yellow pigments, which should be used cautiously in patients with a history of allergies. Patients may experience various side effects such as hallucinations, confusion, drowsiness, dizziness, orthostatic hypotension, gastrointestinal disturbances, and should consult healthcare providers if they notice any abnormal symptoms. Patients with a history of mental illness should thoroughly consider the risks when administering this medication and should minimize side effects by adjusting the dosage. Behavioral changes such as impulse control disorders may occur, so patients and guardians should closely monitor for these symptoms. This medication should be titrated slowly, and abrupt discontinuation may trigger severe symptoms similar to neuroleptic malignant syndrome. It should not be used with other dopamine agonists, and it may interact with certain medications, so consult a healthcare provider before starting new medications. Dose adjustments may be necessary if smoking is started or stopped. Pregnant or lactating women should not use this medication, and women who may become pregnant should also exercise caution. It is not recommended for children or adolescents under 18 years of age as safety and effectiveness have not been established. In overdose situations, side effects related to dopamine activity may occur, and appropriate treatment and cardiovascular monitoring are necessary. Keep out of the reach of children, and avoid transferring to other containers.

Hallucinations, drowsiness, akathisia, dizziness, sudden sleep, orthostatic hypotension, hypotension, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, and pruritus), confusion, delusions, illusions, psychosis (other than hallucinations), impulse control disorder, hypersexuality, pathological gambling, compulsive buying, binge eating, aggression, syncope, excessive daytime sleepiness, vomiting, heartburn, abdominal pain, liver reactions, elevated liver enzymes, lower limb edema

This medication should be stored in a tightly closed container to prevent air and moisture exposure. It is best to store it at room temperature, between 1 and 30 degrees Celsius.

Appearance

Biconvex rectangular film-coated sustained-release tablet, reddish-brown in color

Package unit

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