Prakin Tablet 0.25 mg (Ropinirole Hydrochloride)

Adult dose

1. An appropriate dose should be determined individually, taking efficacy and tolerability into consideration. (1) Idiopathic Parkinson's disease It is preferable to take this medicine with food 3 times daily to improve gastrointestinal tolerability. Initial treatment: Take 0.25mg 3 times daily. The treatment regimen for the first 4 weeks is as follows: Week 1: Dose per administration 0.25mg, daily dose 0.75mg Week 2: Dose per administration 0.5mg, daily dose 1.5mg Week 3: Dose per administration 0.75mg, daily dose 2.25mg Week 4: Dose per administration 1.0mg, daily dose 3.0mg Maintenance treatment: After initial treatment, the dose may be increased at 1-week intervals up to 3mg daily. Therapeutic effects are seen at daily doses of 3-9mg. If symptoms are not adequately controlled or symptom control is not maintained, the ropinirole dose may be increased until a clear therapeutic effect is achieved, but should not exceed 24mg daily. ① When administered as adjunctive therapy to levodopa, the levodopa dose may be gradually reduced by 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 (week 1): The initially recommended 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 day 3 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: Dose per administration 1mg Week 3: Dose per administration 1.5mg Week 4: Dose per administration 2mg Week 5: Dose per administration 2.5mg Week 6: Dose per administration 3mg Week 7: Dose per administration 4mg The safety and efficacy of doses above 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 while reducing the daily dose. If this medicine has been discontinued for a significant period, it is recommended that treatment be restarted using the dose-adjustment schedule above. 2. Patients with renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance 30-50mL /min), since ropinirole clearance is unchanged. Use of this medicine in severe renal impairment (creatinine clearance ＜30mL/min) has not been studied; therefore, ropinirole is not recommended in these patients. 3. Patients with hepatic impairment: Use of this medicine in patients with hepatic impairment has not been studied; therefore, ropinirole is not recommended in these patients. 4. Use in the elderly: Ropinirole clearance is decreased in patients 65 years of age or older, but the dose for elderly patients 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 on the use of ropinirole in this population have been reported, and it should not be administered to children.

This drug is a dopamine agonist and should be used with caution in patients with severe cardiovascular diseases. Caution is necessary when taken with antihypertensive drugs or antiarrhythmics, as hypotension and bradycardia or arrhythmia may occur. Patients with significant mental illnesses should only use this drug after careful consideration of its therapeutic effects and risks. Sudden drowsiness or sleepiness may occur during treatment, so dangerous activities such as driving or operating machinery should be avoided. This drug should not be used in patients with hypersensitivity to it, pregnant or breastfeeding women, and those with lactose intolerance. Side effects such as nausea, vomiting, drowsiness, dizziness, hallucinations, confusion, and edema may occur, so if unusual symptoms arise, consult a doctor. This drug may lower blood pressure, which may lead to orthostatic hypotension, so caution is advised for dizziness or fainting. Psychological symptoms or impulse control disorders (e.g., pathologic gambling, increased sexual desire, compulsive shopping) may occur, so regular monitoring is needed. Taking it with other dopamine agonists may increase the risk of side effects, so co-administration should be avoided. Some antibiotics, hormone therapies, and smoking can affect the blood concentration of this drug, possibly requiring dose adjustments. This drug should not be used during pregnancy or breastfeeding as it may harm the fetus or newborn. It is not recommended for children under 18 as safety and efficacy have not been established. In case of overdose, symptoms such as nausea, dizziness, hallucinations, and heart problems may occur, so contact a medical institution immediately. This drug should be stored out of reach of children, kept away from direct sunlight, and stored in a cool, dry place.

• Area
• drowsiness
• leg swelling
• abdominal pain
• vomiting
• syncope
• dyskinesia
• hallucinations
• confusion
• dizziness

This drug should be stored in a cool place below 25 degrees Celsius, preferably in a tightly sealed container that is protected from light and well-ventilated.

Appearance

White pentagonal film-coated tablet

Package unit

21 tablets (21 tablets/PTPX1)