Mirap 1.0 mg (Pramipexole Hydrochloride Dihydrate)

Adult dose

Idiopathic Parkinsonism In all clinical trials, treatment was started at a subtherapeutic dose to avoid excessive adverse effects and orthostatic hypotension. The dose of this medicine should be increased gradually in all patients. Increase the dose to achieve the greatest therapeutic effect while balancing the major adverse effects of dyskinesia, hallucinations, somnolence, and dry mouth. 1. Patients with normal renal function 1) Initial treatment The initial total daily dose is 0.375mg/day, divided into 3 doses, and is increased gradually. Week 1: 0.125mg 3 times daily, total daily dose 0.375mg Week 2: 0.25mg 3 times daily, total daily dose 0.75mg Week 3: 0.5mg 3 times daily, total daily dose 1.50mg Week 4: 0.75mg 3 times daily, total daily dose 2.25mg Week 5: 1.0mg 3 times daily, total daily dose 3.0mg Week 6: 1.25mg 3 times daily, total daily dose 3.75mg Week 7: 1.5mg 3 times daily, total daily dose 4.50mg Increase the dose approximately once every 5-7 days, and do not increase it more frequently. 2) Maintenance treatment This medicine was effective and well tolerated when administered alone at a total daily dose of 1.5~4.5mg/day in 3 divided doses, or in combination with levodopa (approximately 800mg/day). Clinical trials in patients with early Parkinson's disease showed no significant benefit from total daily doses of 3mg, 4.5mg, or 6mg compared with 1.5mg/day. At doses of 3mg/day or higher, the incidence of these adverse reactions was generally approximately twice that with placebo. The incidence of somnolence reported at a dose of 1.5mg/day was similar to that with placebo. When this medicine is used in combination with levodopa, consider reducing the levodopa dose. In clinical trials in patients with advanced Parkinson's disease, the levodopa dose was reduced by an average of 27% from baseline, immediately before starting this medicine. 2. Patients with renal impairment creatinine CL>50ml/min: No adjustment of the daily dose or dosing frequency is required. creatinine CL=20~50ml/min: Initial dose 0.125mg tablet twice daily, maximum dose 2.25mg daily creatinine CL<20ml/min: Initial dose 0.125mg tablet once daily, maximum dose 1.5mg daily 3. Discontinuation Reduce the dose of this medicine by 0.75 mg/day until the daily dose has been reduced to 0.75 mg, then reduce it by 0.375 mg/day. Idiopathic Restless Legs Syndrome 1. The recommended initial dose is 0.125mg once daily, taken 2~3 hours before bedtime. If additional symptom relief is needed, the dose may be increased every 4~7 days according to the following schedule. Dose level 1: Daily dose 0.125mg Dose level 2*: Daily dose 0.25mg Dose level 3*: Daily dose 0.50mg *If needed Although a few patients in long-term open-label clinical trials of this medicine had their dose increased to 0.75mg, there is no evidence that 0.75mg provides additional benefit over 0.5mg. Use the lowest effective dose. 2. Patients with renal impairment In patients with restless legs syndrome and severe or moderate renal impairment (creatinine clearance 20~60mL/min), increase the dose every 14 days. 3. Discontinuation of treatment In clinical trials in patients with restless legs syndrome who received up to 0.75mg once daily, this medicine was discontinued without dose reduction.

This drug is a dopamine agonist used for the treatment of Parkinson's disease and Restless Legs Syndrome, and patients may experience sudden sleep episodes during daily activities, so caution is needed when driving or operating machinery. Furthermore, psychiatric symptoms such as hallucinations or confusion may occur, particularly in elderly patients, necessitating careful observation. It can affect blood pressure control, potentially leading to orthostatic hypotension, so blood pressure should be frequently checked, especially at the initial dosing or when increasing the dose. Patients with known allergies or hypersensitivity to this drug should not take it, and those with impaired kidney function or cardiovascular diseases require dose adjustments and blood pressure monitoring. During treatment, side effects such as nausea, dizziness, drowsiness, insomnia, and constipation may occur. If symptoms are severe, consult a physician to adjust the dose or discontinue the medication. This drug may interact with other medications, so it is essential to inform your doctor of any other drugs being taken, especially when used with sedatives or antihypertensives. Pregnant or breastfeeding women should consult a doctor before taking this medication as its safety is not established, and breastfeeding mothers may need to discontinue breastfeeding or the medication. Safety and efficacy in children have not been established, and elderly patients may require dose adjustments due to decreased kidney function. Overdosage may result in symptoms such as nausea, vomiting, hyperactivity, hallucinations, or hypotension; immediate medical assistance should be sought, as hemodialysis is not effective. Store this medication out of the reach of children and ensure it is not transferred to other containers.

• Drowsiness
• hallucinations
• confusion
• orthostatic hypotension
• nausea
• dizziness
• insomnia
• constipation
• asthenia
• headache

This medication should be stored in a tightly sealed container to prevent air and moisture ingress, maintaining a temperature between 1°C and 30°C. Additionally, it is advisable to store it in a dark place away from direct sunlight.

Appearance

White round tablet

Package unit

100 tablets (10 tablets per PTP packaging x 10)