Mirapex Tablets 0.125 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease Patients with normal renal function The initial total daily dose is 0.375mg/day, divided into 3 doses, and is gradually increased. 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; do not increase it more frequently. Maintenance therapy: Administer a total daily dose of 1.5~4.5mg/day in 3 divided doses, either as monotherapy or in combination with levodopa (approximately 800mg/day). Consider reducing the levodopa dose when this product is used in combination with levodopa. Patients with renal impairment creatinine CL>50ml/min: No adjustment of daily dose or dosing frequency is needed. 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 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. Dose level 1: Daily dose 0.125mg Dose level 2*: Daily dose 0.25mg Dose level 3*: Daily dose 0.50mg *If needed Although some patients in long-term open-label clinical trials of this product received doses increased up to 0.75mg, there is no evidence that 0.75mg provides additional benefit over 0.5mg. Use the lowest effective dose. 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 product was discontinued without dose reduction.

During the use of this medication, sudden sleep onset or excessive daytime drowsiness may occur, so driving or operating dangerous machinery should be avoided. Additionally, hallucinations or confusion may occur, and caution is particularly necessary for the elderly regarding these symptoms. Orthostatic hypotension may suddenly present, so care should be taken to prevent dizziness or lightheadedness when starting or increasing the dose. Patients with poor renal function may require dose adjustment, and those with cardiovascular disease should use it more cautiously. Patients with allergic reactions or hypersensitivity to this drug should not take it. Unusual behaviors or impulse control disorders, such as compulsive gambling or shopping, may occur during the course of treatment, so caution is advised. Nausea, dizziness, insomnia, constipation, and other symptoms may occur during treatment, and if these symptoms are severe or persistent, a doctor should be consulted. This drug works on the dopamine receptors in the brain to improve symptoms, but due to side effects, changes in mental state or muscle tone abnormalities may occur. Therefore, regular monitoring of the condition as per the doctor's instructions before and during treatment is necessary, and any abnormal symptoms should be reported immediately.

• Sudden sleep and drowsiness
• drowsiness
• hallucinations
• confusion
• orthostatic hypotension
• nausea
• dizziness
• insomnia
• constipation
• weakness

This medication should be stored in a tightly sealed container unaffected by air and light. The storage temperature should be maintained between 1 degree and 30 degrees, and it is important to keep it away from direct sunlight.

Appearance

White round tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10 units)