Mirapex Tablets 0.25 mg (Pramipexole Hydrochloride Trihydrate)

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 Dose (mg) Total daily dose (mg) 1 0.125mg 3 times daily 0.375 2 0.25mg 3 times daily 0.75 3 0.5mg 3 times daily 1.50 4 0.75mg 3 times daily 2.25 5 1.0mg 3 times daily 3.0 6 1.25mg 3 times daily 3.75 7 1.5mg 3 times daily 4.50 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. However, the following adverse reactions were dose-related in the same trial: postural hypotension, nausea, constipation, somnolence, and amnesia. 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 Renal function Initial dose (mg) Maximum dose (mg) creatinine CL>50ml/min No adjustment of daily dose or dosing frequency is needed. creatinine CL=20~50ml/min 0.125mg tablet twice daily 2.25mg daily creatinine CL<20ml/min 0.125mg tablet once daily 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 Daily dose (mg) 1 0.125 2* 0.25 3* 0.50 *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 may cause sudden sleep episodes during administration, especially when performing activities that require concentration, such as driving or operating machinery. Before administration, patients should be thoroughly informed about the possibility of drowsiness, and extra caution is needed if they are taking sedatives, have sleep disorders, or are taking medications that increase this drug's blood concentration. This medication can cause hallucinations or confusion, so elderly patients need to be especially cautious of these symptoms. If hallucinations occur, seek medical advice immediately. Orthostatic hypotension may occur, which can lead to dizziness or fainting when standing up suddenly; thus, when starting or increasing the dosage, patients should move slowly and be attentive. Patients with poor kidney function may need to adjust the dosage, and those with cardiovascular disease should carefully monitor their blood pressure from the start of treatment. During treatment, side effects such as nausea, dizziness, drowsiness, insomnia, constipation, weakness, hallucinations, confusion, amnesia, sensory impairment, ataxia, inability to sit still, abnormal thoughts, visual disturbances, erectile dysfunction, fatigue, weight loss, loss of appetite, dysphagia, unusual dreams, abnormal gait, agitation, frequent urination, urinary tract infections, incontinence, thirst, forgetfulness, accidental injuries, leg cramps, double vision, taste distortion, chest pain, neck pain, conjunctivitis, and pruritus may occur; if these symptoms persist or worsen, inform healthcare personnel. Moreover, as this medication is a dopamine agonist, it may cause or worsen dopamine-related side effects such as muscle rigidity or movement disorders; dosage adjustment may be needed if these symptoms manifest. While taking this medication, if excessive daytime drowsiness or sudden sleep episodes occur during daily activities, stop driving or dangerous tasks and consult a doctor. Stopping this medication suddenly may lead to serious side effects, so any discontinuation or dosage adjustment must be done under the physician's directions. This medication can cause various side effects; therefore, if any unusual symptoms occur while taking it, it is important to consult healthcare personnel immediately.

• Drowsiness
• hallucinations
• confusion
• orthostatic hypotension
• nausea
• dizziness
• insomnia
• constipation
• weakness
• extrapyramidal syndrome

This medication should be stored in a tightly closed container to avoid exposure to air or light, and it is recommended to keep it in a cool place between 1 to 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness for a longer time.

Appearance

White oval-shaped tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)