Dopafro Tablet 0.25 mg (Ropinirole Hydrochloride)

Adult dose

1. An appropriate dose should be selected individually based on efficacy and tolerability. (1) Idiopathic Parkinson's disease It is preferable to take the medicine with food 3 times daily to improve gastrointestinal tolerability. Initial treatment: Take 0.25mg 3 times daily. The treatment schedule for the first 4 weeks is as follows: Week 1: Single dose 0.25mg, daily dose 0.75mg Week 2: Single dose 0.5mg, daily dose 1.5mg Week 3: Single dose 0.75mg, daily dose 2.25mg Week 4: Single dose 1.0mg, daily dose 3.0mg Maintenance treatment: After initial treatment, the daily dose may be increased at weekly intervals up to 3mg. Therapeutic effects are seen at daily doses of 3-9mg. If symptoms are not adequately controlled or control cannot be maintained, the ropinirole dose may be increased until a clear therapeutic effect is achieved, but should not exceed 24mg per day. ① When administered as an adjunct to levodopa, the levodopa dose may be gradually reduced by up to approximately 20% of the total dose. ② When switching from another dopamine agonist to ropinirole, follow the manufacturer's guidelines for discontinuation before starting ropinirole. ③ As with other dopamine agonists, ropinirole should be discontinued gradually by reducing the number of daily doses over the course of 1 week. (2) Primary restless legs syndrome Ropinirole should be taken once daily before bedtime, 1~3 hours before bedtime. Initial treatment (1 week): The recommended initial dose is 0.25mg once daily for 2 days, taken 1~3 hours before bedtime. If this dose is well tolerated, it may be increased to 0.5mg once daily from the 3rd day through the last day of the first week of treatment (day 7). Maintenance treatment (from week 2): After initial treatment, the daily dose may be increased according to the following schedule until an optimal therapeutic response is achieved. Week 2: Single dose 1mg Week 3: Single dose 1.5mg Week 4: Single dose 2mg Week 5: Single dose 2.5mg Week 6: Single dose 3mg Week 7: Single dose 4mg The safety and efficacy of doses greater than 4mg/day have not been established in patients with restless legs syndrome. As with other dopamine agonists, treatment with this medicine should be discontinued gradually by reducing the daily dose. If administration of this medicine has been interrupted for a significant period, it is recommended that treatment be restarted using the dose titration described above. 2. 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. Administration of this medicine has not been studied in patients with severe renal impairment (creatinine clearance ＜30mL/min); therefore, ropinirole is not recommended for these patients. 3. Patients with hepatic impairment: Administration of this medicine has not been studied in patients with hepatic impairment; therefore, ropinirole is not recommended for these patients. 4. Use in older adults: Ropinirole clearance is reduced in patients 65 years of age and older, but the dose for older adults may be adjusted in the usual manner according to the patient's clinical response.

Child dose

Use in children: Parkinson's disease does not occur in children. Therefore, no studies of ropinirole use in this population have been reported, and it should not be administered to children.

This drug should be used with caution in patients with severe cardiovascular disease. Caution is required when taken with antihypertensive agents or antiarrhythmics, as it may result in hypotension or arrhythmia. It should be used only when the benefits outweigh the risks in patients with severe mental illnesses. Patients should be careful when driving or operating machinery as they may suddenly become very drowsy or fall asleep unexpectedly during the day while taking this medication. Patients who are allergic to this drug, pregnant or breastfeeding women, and individuals with lactose intolerance should not take this medication. Side effects such as nausea, vomiting, drowsiness, dizziness, hypotension, and edema may occur, and patients should consult their physician if symptoms are severe. Especially, Parkinson's disease patients may experience movement disorders, hallucinations, and confusion, so caution is required. Discontinuing this medication abruptly may lead to severe side effects, so the dosage should be reduced gradually. It should not be taken with other dopamine drugs, and dose adjustments may be necessary when taken with certain antibiotics or hormone therapies. Pregnant or breastfeeding women should not take this drug, and it is not recommended for children under 18 years old as safety and efficacy have not been established. In case of overdose, symptoms such as nausea, dizziness, hallucinations, and hypotension may occur, and immediate medical attention is required. This drug should be stored away from direct sunlight in a cool and dry place, out of reach of children.

• nausea
• drowsiness
• leg edema
• abdominal pain
• vomiting
• syncope
• dyskinesia
• hallucinations
• confusion
• dizziness

This medication should be stored at a cool temperature below 25 degrees Celsius, and it is important to store it in a tightly sealed container that is protected from light and air. Storing it this way will prevent the degradation of its components and maintain its effectiveness over time.

Appearance

White pentagonal film-coated tablet

Package unit

21 tablets (21 tablets/PTP*1)