Newqup Tablet 2mg (Ropinirole Hydrochloride)

Adult dose

1. An appropriate dose for each individual is recommended, taking efficacy and tolerability into consideration. (1) Idiopathic Parkinson's disease For improved gastrointestinal tolerability, it is preferable to take this medicine with food 3 times daily. Initial therapy: 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 therapy: After initial therapy, the dose may be increased at intervals of 1 week up to 3mg daily. Therapeutic effects occur at 3-9mg daily. 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 administering ropinirole. ③ As with other dopamine agonists, ropinirole should be discontinued gradually by reducing the number of daily administrations over the course of 1 week. (2) Primary restless legs syndrome Ropinirole should be taken once daily at bedtime, 1~3 hours before bedtime. Initial therapy (1 week): The initial 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 therapy (from week 2): After initial therapy, 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 administration of this medicine has been interrupted 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), as ropinirole clearance is unchanged. Administration of this medicine has not been studied in severe renal impairment (creatinine clearance ＜30mL/min); therefore, ropinirole is not recommended in 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 in these patients. 4. Administration to elderly patients: Ropinirole clearance is reduced in patients aged 65 years and older, but the dose for elderly patients may be adjusted in the usual manner according to the patient's clinical response.

Child dose

④ Pediatric use: 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 should be used with caution in patients with severe cardiovascular disease. When used in conjunction with antihypertensives or antiarrhythmics, it may cause hypotension, bradycardia, or arrhythmia. It should be used only when the benefits outweigh the risks in patients with severe mental illness. This drug may cause sudden drowsiness or sleepiness; therefore, activities such as driving or operating machinery should be avoided. Patients with hypersensitivity to this drug, pregnant or nursing women, and patients with lactose intolerance should not use it. During the course of taking this medication, side effects such as nausea, vomiting, drowsiness, dizziness, hypotension, edema, etc. may occur. Particularly, patients with Parkinson's disease need to be cautious as extrapyramidal symptoms or hallucinations, confusions may occur. Reducing or stopping the dosage suddenly can result in severe side effects and should be adjusted gradually. It is advisable not to use this medication in combination with other dopamine agonists, and there may be interactions with certain medications, so consultation with a physician is necessary. Pregnant or nursing individuals should not use this drug, and it is not recommended for children under the age of 18. In case of overdose, symptoms such as vomiting, dizziness, hallucinations, and heart problems may occur, requiring immediate medical attention. This medication should be kept out of reach of children and stored in a dry place below 25 degrees Celsius.

• Nausea
• drowsiness
• leg swelling
• abdominal pain
• vomiting
• fainting
• movement disorders
• hallucinations
• confusion
• dizziness

This drug should be stored in a cool place below 25 degrees Celsius, in a tightly sealed container protected from light and air. This will help maintain the effectiveness of the drug and prevent degradation.

Appearance

Pink pentagonal film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)