Mirap 0.25 mg (Pramipexole Hydrochloride Trihydrate)

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. Patients with normal renal function 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. The increases recommended based on clinical trials are as follows. 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. 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 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 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. 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. Dose level 1: Daily dose 0.125mg Dose level 2*: Daily dose 0.25mg Dose level 3*: Daily dose 0.50mg *If needed 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. 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 medication is used to treat Parkinson's disease or restless legs syndrome. During the use of this medication, there is a possibility of suddenly falling asleep or experiencing severe drowsiness during the daytime, so extra caution should be taken when driving a car or operating hazardous machinery. In particular, when taken with sedatives, in cases of sleep disorders, or when taking other medications that increase the blood concentration of this drug, the risk of drowsiness may be increased. This medication can cause hallucinations or confusion, which occurs more frequently in elderly Parkinson's patients, so if such symptoms occur, consult a physician immediately. Additionally, this medication may cause orthostatic hypotension, therefore dizziness or fainting may occur when standing up suddenly. Blood pressure should be closely monitored when starting or increasing the dose. Patients with impaired kidney function or severe cardiovascular diseases should have their dosage adjusted and monitored carefully while using this medication. The safety of this medication has not been established in pregnant or breastfeeding women, so it should be used cautiously only when necessary, and breastfeeding may need to be discontinued or the medication stopped as it can transfer into breast milk. This medication should not be used in children as its safety and effectiveness have not been confirmed. Elderly patients may experience prolonged retention of the medication in the body due to decreased kidney function, requiring dose adjustments and caution, with higher risks of hallucinations in this population. Discontinuing this medication suddenly may lead to withdrawal symptoms, so it should be reduced gradually according to a physician's instructions. Additionally, there may be interactions if this medication is taken alongside other drugs, so it is essential to consult a physician or pharmacist regarding any other medications being taken. During treatment, adverse reactions such as nausea, dizziness, drowsiness, hallucinations, insomnia, constipation, and weakness may occur, and if these symptoms become severe, a physician should be consulted.

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

This medication may be sensitive to air or light, so it should be stored in a tightly sealed container. The suitable storage temperature is in a cool place between 1°C and 30°C, avoiding direct sunlight.

Appearance

White oval tablet

Package unit

100 tablets (10 tablets/ PTP packaging x 10)