Ropinirole Tablets 0.25 mg (Ropinirole Hydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease In all clinical trials, treatment was initiated at a subtherapeutic dose to avoid excessive adverse effects and orthostatic hypotension. This medicine should be gradually titrated in all patients. The dose should be increased to the level that provides maximum therapeutic effect while balancing the principal adverse effects of dyskinesia, hallucinations, somnolence, and dry mouth. 1. Patients with normal renal function 1) Initiation The initial total daily dose is 0.375mg/day, divided into 3 doses daily, and gradually increased. Week 1: 0.125mg 3 times daily, total daily dose 0.375mg Week 2: 0.25mg 3 times daily, total daily dose 0.75mg Week 3: 0.5mg 3 times daily, total daily dose 1.50mg Week 4: 0.75mg 3 times daily, total daily dose 2.25mg Week 5: 1.0mg 3 times daily, total daily dose 3.0mg Week 6: 1.25mg 3 times daily, total daily dose 3.75mg Week 7: 1.5mg 3 times daily, total daily dose 4.50mg Dose increases should be made approximately once every 5-7 days and not more frequently. The increases recommended based on clinical trials are as follows. 2) Maintenance therapy This medicine was effective and well tolerated when administered alone at a total daily dose of 1.5~4.5mg/day divided into 3 doses, or in combination with levodopa (approximately 800mg/day). In clinical trials in patients with early Parkinson's disease, administration of this medicine at total daily doses of 3mg, 4.5mg, and 6mg did not show a significant benefit compared with administration at 1.5mg/day. At doses of 3mg/day or higher, the incidence of these adverse reactions was generally approximately twice that with placebo. The incidence of somnolence reported at a dose of 1.5mg/day was similar to that with placebo. When this medicine is administered in combination with levodopa, a reduction in the levodopa dose should be considered. In clinical trials in patients with advanced Parkinson's disease, the levodopa dose was reduced by an average of 27% compared with the dose immediately before initiation of this medicine (baseline). 2. Patients with renal impairment creatinine CL>50ml/min: No adjustment of daily dose or dosing frequency is necessary. creatinine CL=20~50ml/min: Initial dose 0.125mg tablet 2 times daily, maximum dose 2.25mg daily creatinine CL<20ml/min: Initial dose 0.125mg tablet once daily, maximum dose 1.5mg daily 3. Discontinuation Reduce the daily dose of this medicine by 0.75 mg/day until it reaches 0.75 mg, then reduce it by 0.375 mg/day. Idiopathic restless legs syndrome 1. The recommended initial dose is 0.125mg once daily, taken 2~3 hours before bedtime. If additional symptom relief is needed, the dose may be increased every 4~7 days according to the following schedule. In long-term open-label clinical trials of this medicine, the dose was increased to 0.75mg in a few patients; however, there is no evidence demonstrating additional benefit with 0.75mg compared with 0.5mg. The lowest effective dose should be used. Dose level 1: Daily dose 0.125mg Dose level 2*: Daily dose 0.25mg Dose level 3*: Daily dose 0.50mg *If needed 2. Patients with renal impairment In patients with restless legs syndrome and severe or moderate renal impairment (creatinine clearance 20~60mL/min), the dose should be increased at intervals of 14 days. 3. Discontinuation of treatment In clinical trials in patients with restless legs syndrome who received up to 0.75mg once daily, this medicine was discontinued without dose reduction.

This drug is a dopamine agonist used to treat Parkinson's disease and restless legs syndrome, which may cause drowsiness or sudden onset of sleep, hence caution should be taken when driving a vehicle or operating hazardous machinery. Additionally, there may be mental abnormalities such as hallucinations or confusion, particularly in elderly patients, and if such symptoms occur, it is crucial to consult a physician immediately. This medication can lower blood pressure, leading to symptoms of orthostatic hypotension, such as dizziness upon standing, so blood pressure should be monitored frequently, especially when starting the treatment. Patients with impaired kidney function or cardiovascular diseases may require dosage adjustments and blood pressure monitoring while using this medication. This medication may interact with other sedatives, sleeping pills, or blood pressure medications, so patients should inform their physician of any other medications they are taking. Women who are pregnant or breastfeeding should consult a physician before taking this medication, as its safety has not been established. Elderly patients require careful observation due to a higher risk of side effects such as hallucinations. Sudden cessation of this medication may lead to withdrawal symptoms; therefore, the dosage should be gradually reduced under the supervision of a physician, and if unusual behaviors or impulse control disorders occur, a physician should be consulted. This medication should be kept out of reach of children, and it is safest not to transfer it to another container.

• Drowsiness
• hallucination
• confusion
• orthostatic hypotension
• nausea
• dizziness
• insomnia
• constipation
• weakness
• headache

This medication may be sensitive to air and light, so it should be kept in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature, and it is advisable to store it in a dark place away from direct sunlight.

Appearance

White oval-shaped tablet

Package unit

For domestic use - 100 tablets/box [10 tablets/PTP x 10 packs]