Mirapex Tablet 1.0 mg (Pramipexole Hydrochloride Dihydrate)

Adult dose

Idiopathic Parkinson's disease In all clinical trials, treatment was initiated at a subtherapeutic dose to avoid excessive adverse effects and orthostatic hypotension. The dose should be increased gradually in all patients. Increase the dose to achieve the greatest therapeutic effect while balancing the main adverse effects of dyskinesia, hallucinations, somnolence, and dry mouth. 1. Patients with normal renal function 1) Initial dosage 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. The recommended dose increments based on clinical trials are as follows. 2) Maintenance dosage This product was effective and well tolerated at a total daily dose of 1.5~4.5mg/day, given in 3 divided doses, either as monotherapy or in combination with levodopa (approximately 800mg/day). In a clinical trial in patients with early Parkinson's disease, doses of 3mg, 4.5mg, and 6mg daily in total did not provide a significant benefit over 1.5mg/day. At doses of 3mg/day or more, the incidence of these adverse reactions was generally approximately twice that with placebo. The incidence of somnolence reported at 1.5mg/day was similar to that with placebo. Consider reducing the levodopa dose when this product is used in combination with levodopa. In a clinical trial in patients with advanced Parkinson's disease, the levodopa dose was reduced by an average of 27% from baseline, immediately before initiation of this product. 2. 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 3. 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 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. 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. Dose level 1: Daily dose 0.125mg Dose level 2*: Daily dose 0.25mg Dose level 3*: Daily dose 0.50mg *If needed 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 product was discontinued without dose reduction.

This medication is a dopamine agonist used in patients with Parkinson's disease and restless legs syndrome. While taking this medication, sudden sleep onset during the day or severe drowsiness may occur, so caution is advised, especially during activities such as driving or operating machinery. Patients may not recognize their drowsiness, so the healthcare provider should regularly monitor the patient's drowsiness state. If sedatives or sleep disorders exist, or if other medications that increase the blood concentration of this drug are taken, the risk of drowsiness may increase, so this must be reported. Additionally, this medication may cause psychiatric symptoms such as hallucinations or confusion, which may be more dangerous, especially in elderly patients, so this should be communicated to the patient and caregiver in advance. Orthostatic hypotension, which is a drop in blood pressure that can cause dizziness or fainting upon standing, should be monitored carefully, and symptoms should be reported immediately if they occur. Patients with impaired kidney function or cardiovascular disease require dose adjustment and blood pressure monitoring when using this medication. Side effects such as nausea, dizziness, insomnia, constipation, weakness, etc., may occur during the use of this medication, and if symptoms are severe, consultation with a doctor is necessary. Abruptly stopping the medication can lead to severe side effects such as neuroleptic malignant syndrome, so dose adjustments or discontinuation should always follow the doctor's instructions. Finally, since this medication is a dopamine agonist, behavioral changes such as increased libido, compulsive behavior, or gambling addiction may occur; hence, if such symptoms arise, notify the healthcare staff immediately.

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

This medication can be sensitive to air and light, so it should be stored in a tightly sealed container. It is also preferable to store it at a cool temperature between 1 to 30 degrees Celsius. Keeping it out of direct sunlight can help maintain the medication's efficacy longer.

Appearance

White round tablet

Package unit

100 tablets (10 tablets in PTP packaging x 10 packs)