Pramipexole 0.5 mg Tablets (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease In all clinical trials, treatment was initiated at a dose lower than the therapeutic dose (subtherapeutic level) to avoid excessive adverse effects and orthostatic hypotension. This medicine should be gradually increased in all patients. The dose should be increased 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, given in 3 divided doses, and 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, and do not increase it more frequently than this. The recommended dose increments based on clinical trials are as follows. Maintenance regimen This medicine was effective and well tolerated at a total daily dose of 1.5~4.5mg/day, given in 3 divided doses, either alone or in combination with levodopa (approximately 800mg/day). In clinical trials in patients with early Parkinson's disease, doses of 3mg, 4.5mg, and 6mg total per day did not provide significant benefits compared with 1.5mg/day. At doses of 3mg/day or more, the incidence of these adverse reactions was generally approximately 2 times higher than with placebo. The incidence of somnolence reported with this medicine 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 necessary. creatinine CL=20~50ml/min: Initial dose 0.125mg tablet twice daily, maximum dose 2.25mg per day creatinine CL<20ml/min: Initial dose 0.125mg tablet once daily, maximum dose 1.5mg per day Discontinuation Reduce the dose of this medicine by 0.75 mg/day until the daily dose has been reduced to 0.75 mg, and thereafter 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 In long-term open-label clinical trials of this medicine, the dose was increased to 0.75mg in a few patients; however, there is no evidence demonstrating additional benefit with 0.75mg compared with 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 medicine was discontinued without dose reduction.

This medication may cause sudden sleep onset or severe drowsiness during use, so be particularly careful when engaging in hazardous activities such as driving or operating machinery. Additionally, mental disturbances such as hallucinations or confusion may occur, so it is important to consult with healthcare providers immediately if these symptoms occur. This medication can lower blood pressure and may cause orthostatic hypotension, so caution is needed, especially when starting treatment or increasing dosage, particularly if dizziness or lightheadedness occurs. Patients with impaired kidney function need to adjust the dose of this medication, and those with heart conditions should frequently monitor their blood pressure before and during treatment. During treatment with this medication, symptoms such as drowsiness, hallucinations, and dizziness may appear, and if symptoms are severe, it may be necessary to stop the medication or adjust the dosage. Women who are pregnant or breastfeeding should discuss the use of this medication with a physician before taking it, as the medication may pass into breast milk and affect the infant. This medication may interact with other drugs, so if taken alongside sedatives, antihypertensives, or medications excreted via the kidneys, it should be reported to healthcare providers for careful monitoring. Elderly patients may have slower excretion of this medication, increasing the risk of side effects, so careful management is required during treatment. Sudden discontinuation of this medication can lead to withdrawal symptoms, so when stopping treatment, it should be gradually reduced according to a physician's instructions. Finally, the safety and efficacy of this medication in children have not been established, so it is advisable not to use it in children.

• Drowsiness
• hallucination
• confusion
• orthostatic hypotension
• nausea
• dizziness
• insomnia
• constipation
• weakness
• headache

This medication should be stored in a tightly closed container to prevent exposure to air or light and kept at temperatures between 1°C and 30°C. Storing it this way will help maintain the effectiveness of the medication for a long time.

Appearance

White oval-shaped tablet

Package unit

100 tablets (10 tablets/PTP ×10)