Dopafro Tablets 1.0 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

④ 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, and care should be taken when taken with other medications that may affect blood pressure or heart rhythm. Patients with psychiatric disorders should only use this drug when the therapeutic benefit outweighs the risks. Sudden drowsiness or sleep may occur during treatment with this drug, so activities requiring alertness such as driving or operating machinery should be avoided. This drug should not be administered to individuals with hypersensitivity to it, pregnant or nursing women, or patients with specific genetic lactose intolerance. Nausea, vomiting, drowsiness, dizziness, hypotension, and edema may occur; consult a physician if any abnormal symptoms arise. This drug is particularly used for patients with Parkinson's disease and restless legs syndrome, and symptoms may worsen or new abnormal symptoms may appear, so careful monitoring is necessary. Drug interactions may occur, so notify healthcare providers of any other medications being taken, particularly dopamine antagonists, should not be used together. During pregnancy or breastfeeding, this drug should not be used as it may be harmful to the fetus or newborn. It is not recommended for children as safety and efficacy have not been established. In case of overdose, severe drowsiness, hallucinations, hypotension, and movement disorders may occur, so contact medical institutions immediately. This drug should be stored out of the reach of children and kept in a cool, dry place away from direct sunlight.

• Area
• drowsiness
• leg edema
• abdominal pain
• vomiting
• syncope
• movement disorder
• hallucination
• confusion
• dizziness

This medication should be stored at a cool temperature below 25 degrees Celsius and kept in a tightly sealed container that is protected from light and well-ventilated. Storing it this way helps to maintain the drug's effectiveness and prevent degradation.

Appearance

Green pentagonal film-coated tablets

Package unit

21 tablets (21 tablets/PTP*1)