Newqup 1mg (Ropinirole Hydrochloride)

Adult dose

(1) Idiopathic Parkinson's disease It is preferable to take this medication 3 times daily with food to improve gastrointestinal tolerability. 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 weekly intervals up to 3mg per day. Therapeutic effects occur 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 per day. ① When administered as an adjunct 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 discontinuing the other medication 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 therapy (week 1): 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 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 treatment 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 medication should be discontinued gradually while reducing the daily dose. If treatment with this medication 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 required in patients with mild or moderate renal impairment (creatinine clearance 30-50mL /min), because ropinirole clearance is unchanged. Use of this medication has not been studied in patients with severe renal impairment (creatinine clearance ＜30mL/min); therefore, ropinirole is not recommended in these patients. 3. Patients with hepatic impairment: Use of this medication has not been studied in patients with hepatic impairment; therefore, ropinirole is not recommended in these patients. 4. Use in older adults: Ropinirole clearance is reduced in patients 65 years of age and older, but the dose for older patients 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 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 diseases. Especially, caution should be exercised when taken with blood pressure-lowering medications or antiarrhythmic agents, as it may cause heart problems such as hypotension or bradycardia. Patients with mental disorders should only use this medication if the benefits are deemed greater than the risks. During treatment, sudden severe drowsiness or sudden sleep may occur, so dangerous activities such as driving or operating machinery should be avoided. Patients who are allergic to this drug, pregnant or breastfeeding women, and patients with certain genetic lactose metabolism disorders should not take this medication. Side effects such as nausea, drowsiness, swelling, abdominal pain, hallucinations, confusion, dizziness, orthostatic hypotension, and fainting may occur. These symptoms have been more frequently reported in patients with Parkinson's disease or Restless Legs Syndrome. If drowsiness becomes severe during administration, the dosage should be reduced, and any symptoms should be consulted with a healthcare professional immediately. In addition, patients should be aware that this medication may induce hallucinations or mental disturbances, and should report any such symptoms. Do not take this medication with other dopamine drugs, and caution is needed with concomitant use with dopamine antagonists such as neuroleptics, as the efficacy may be reduced. This drug is metabolized in the liver, so dosage adjustments may be necessary when taken with medications that inhibit or induce certain liver metabolic enzymes. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant should consult before taking. Safety and efficacy have not been established in children under 18 years of age, so it is not recommended for this population. In case of overdose, symptoms such as nausea, dizziness, hallucinations, chorea, low blood pressure, drowsiness, and confusion may occur, requiring immediate medical attention and appropriate treatment. This medication should be stored out of the reach of children and in a dry place below 25 degrees Celsius.

Nausea, drowsiness, leg edema, abdominal pain, vomiting, syncope, movement disorders, hallucinations, delusions, dizziness, sudden sleep, dyspepsia, constipation, orthostatic hypotension, hypotension, peripheral edema, anxiety, symptom amplification, early morning rebound, delusions, paranoia, delirium, psychiatric reactions, impulse control disorder, increased libido, pathological gambling, compulsive buying, binge eating, aggression, hypersensitivity reactions, urticaria, angioedema, rash, itching, extreme drowsiness, delusions, paranoia, delirium, impulse control disorder, increased libido, pathological gambling, compulsive buying, binge eating, aggression, visual hallucinations, hyperhidrosis, claustrophobia, chorea, palpitations, weakness, nightmares, increased cough, fatigue, vasovagal syncope, movement disorders, insomnia, weakness, tremors, anxiety, confusion, fever, chest pain, other edema, dystonia, frequent urination, dysgeusia, abnormal gait, illusion, urinary difficulty, facial edema, peripheral ischemia, loss of appetite, dyspnea, dizziness, urine discoloration, vesicles, air swallowing in the gastrointestinal tract

This medication should be stored in a cool place below 25 degrees Celsius, and it is important to keep it in a tightly closed container that is protected from light and air. Storing it this way helps to maintain the effectiveness of the drug for a longer period.

Appearance

Green pentagonal film-coated tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)