Medication info

Dopapro 2.0 mg (Ropinirole Hydrochloride)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Ropinirole Hydrochloride›2.28mg / 1 tablet
Manufacturer / importer
Jeil Pharmaceutical Co., Ltd.
Appearance
Pink pentagonal film-coated tablets
Packaging
21 tablets (21 tablets/PTP*1)
Approval status
Approval withdrawn

MFDS item code 200803811 · Notified 2008.04.04 · Insurance code 645403320

This product's status changed to Approval withdrawn on 2025.07.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of idiopathic Parkinson's disease and moderate-to-severe primary restless legs syndrome
Who takes it
Adults · Children
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 the medication 3 times daily with food to improve gastrointestinal tolerability. Initial treatment: Take 0.25mg 3 times daily. The treatment regimen for the first 4 weeks is as follows: Week (weeks) 1 2 3 4 Dose per administration (mg) Daily dose (mg) 0.25 0.75 0.5 1.5 0.75 2.25 1.0 3.0 Maintenance treatment: After the initial treatment, the dose may be increased at 1-week intervals up to 3mg per day. The therapeutic effect is seen at doses of 3-9mg per day. 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 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 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 at bedtime, 1~3 hours before bedtime. Initial treatment (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, the dose may be increased from the 3rd day of administration up to 0.5mg once daily through the last day of the first week of treatment (7th day of administration). Maintenance treatment (from week 2): After the initial treatment, the daily dose may be increased according to the following schedule until the optimal therapeutic response is achieved. Week (weeks) 2 3 4 5 6 7 Dose per administration (mg) 1 1.5 2 2.5 3 4 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 medication should be discontinued gradually while reducing the daily dose. If administration of this medication has been interrupted significantly, it is recommended that treatment be restarted using the dose adjustment described above. 2. Patients with renal impairment: Since ropinirole clearance is unchanged in patients with mild or moderate renal impairment (creatinine clearance 30-50mL /min), dose adjustment is not necessary. Use of this medication 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 medication in patients with hepatic impairment has not been studied; 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
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.

Ingredients

Manufacturer
Jeil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of idiopathic Parkinson's disease and moderate-to-severe primary restless legs syndrome

  • Parkinson's disease
  • on-off phenomenon
  • primary restless legs syndrome
View approved original text

This medication can be used as monotherapy for the treatment of idiopathic Parkinson's disease and, when used in combination with levodopa, can reduce the on-off phenomenon, which is a side effect of the drug, and decrease the dosage of levodopa. It is also used for the treatment of moderate to severe primary restless legs syndrome.

How to take

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 the medication 3 times daily with food to improve gastrointestinal tolerability. Initial treatment: Take 0.25mg 3 times daily. The treatment regimen for the first 4 weeks is as follows: Week (weeks) 1 2 3 4 Dose per administration (mg) Daily dose (mg) 0.25 0.75 0.5 1.5 0.75 2.25 1.0 3.0 Maintenance treatment: After the initial treatment, the dose may be increased at 1-week intervals up to 3mg per day. The therapeutic effect is seen at doses of 3-9mg per day. 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 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 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 at bedtime, 1~3 hours before bedtime. Initial treatment (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, the dose may be increased from the 3rd day of administration up to 0.5mg once daily through the last day of the first week of treatment (7th day of administration). Maintenance treatment (from week 2): After the initial treatment, the daily dose may be increased according to the following schedule until the optimal therapeutic response is achieved. Week (weeks) 2 3 4 5 6 7 Dose per administration (mg) 1 1.5 2 2.5 3 4 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 medication should be discontinued gradually while reducing the daily dose. If administration of this medication has been interrupted significantly, it is recommended that treatment be restarted using the dose adjustment described above. 2. Patients with renal impairment: Since ropinirole clearance is unchanged in patients with mild or moderate renal impairment (creatinine clearance 30-50mL /min), dose adjustment is not necessary. Use of this medication 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 medication in patients with hepatic impairment has not been studied; 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

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.

Precautions

This medication should be used with caution in patients with severe cardiovascular disease. When used in combination with other antihypertensive agents or antiarrhythmic agents, there is a risk of hypotension, bradycardia, or arrhythmia, so caution is advised. It should only be used in patients with severe mental illness when the benefits outweigh the risks. While taking this medication, there may be a sudden onset of drowsiness or sleep, so activities that are dangerous, such as driving or operating machinery, should be avoided. It should not be used in patients with hypersensitivity to this medication, during pregnancy or breastfeeding, or in certain genetically intolerant lactase patients. Side effects such as nausea, vomiting, drowsiness, dizziness, hypotension, or peripheral edema may occur, so consult a doctor if any unusual symptoms arise. Particularly in patients with Parkinson's disease, there may be a risk of dyskinesia, hallucinations, or confusion, hence caution is needed. Drug interactions may occur with this medication, so if other medications are being taken, it is essential to inform the healthcare provider. Pregnant or breastfeeding women should not take this medication, and it is not recommended for children under 18 years of age as safety has not been established. In case of overdose, severe drowsiness, hallucinations, hypotension, or chorea may occur, and medical attention should be sought immediately. This medication should be stored out of the reach of children and kept in a cool, dry place away from direct sunlight.

Side effects

  • Dizziness
  • drowsiness
  • leg swelling
  • abdominal pain
  • vomiting
  • syncope
  • dyskinesia
  • hallucinations
  • confusion
  • vertigo
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  • sudden sleep
  • indigestion
  • constipation
  • orthostatic hypotension
  • hypotension
  • peripheral edema
  • anxiety
  • delusions
  • paranoia
  • delirium
  • impulse control disorders
  • hypersexuality
  • pathological gambling
  • compulsive shopping
  • binge eating
  • aggression
  • hypersensitivity
  • urticaria
  • angioedema
  • rash
  • itching
  • fatigue
  • upper respiratory infection
  • joint pain
  • injury
  • dry mouth
  • pain
  • diarrhea
  • myalgia
  • paresthesia
  • increased sweating
  • cough
  • viral infection
  • migraine
  • rhinitis
  • sinusitis
  • insomnia
  • weakness
  • tremor
  • anxiety
  • confusion
  • fever
  • chest pain
  • muscle hypertonia
  • frequent urination
  • dysgeusia
  • abnormal gait
  • illusion
  • urinary difficulty
  • facial edema
  • peripheral ischemia
  • loss of appetite
  • dyspnea
  • weight loss
  • sleep disorder
  • visual hallucinations
  • hyperhidrosis
  • claustrophobia
  • chorea
  • palpitations
  • nightmares
  • vasovagal syncope
  • state of confusion
  • dizziness
  • indigestion
  • motor impairment
  • constipation
  • insomnia
  • weakness
  • tremor
  • anxiety
  • confusion
  • fever
  • chest pain
  • appendicitis
  • weight loss
  • thirst
  • ocular pain
  • increased salivation
  • melena
  • amnesia
  • intestinal air trapping
  • urine discoloration
  • blisters

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a cool place below 25 degrees Celsius, in a container that does not allow light or air to enter. Storing it in this manner will maintain its effect for a longer period.

Appearance and packaging

Appearance

Pink pentagonal film-coated tablets

Package unit

21 tablets (21 tablets/PTP*1)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.