Rasagiline Tablets 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. This medicine should be gradually increased in all patients. The dose should be increased to achieve maximum therapeutic benefit while balancing the main adverse effects of dyskinesia, hallucinations, somnolence, and dry mouth. 1. Patients with normal renal function 1) Initiation 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 0.75 Week 3: 0.5mg 3 times daily, total daily dose 1.50 Week 4: 0.75mg 3 times daily, total daily dose 2.25 Week 5: 1.0mg 3 times daily, total daily dose 3.0 Week 6: 1.25mg 3 times daily, total daily dose 3.75 Week 7: 1.5mg 3 times daily, total daily dose 4.50 Increase the dose approximately once every 5-7 days, and do not increase it more frequently. The dose increments recommended based on clinical trials are as follows. 2) Maintenance This medicine was effective and well tolerated when administered as a total daily dose of 1.5~4.5mg/day, divided into 3 doses, either alone 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 total daily did not provide a significant benefit compared with 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 a dose of 1.5mg/day was similar to that with placebo. When this medicine is used in combination with levodopa, a reduction in the levodopa dose should be considered. In a clinical trial in patients with advanced Parkinson's disease, the levodopa dose was reduced by an average of 27% compared with the dose immediately before initiation of this medicine (baseline). 2. 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 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, and thereafter 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. In long-term open-label clinical trials of this medicine, some patients had their dose increased to 0.75mg; however, there is no evidence that 0.75mg provides additional benefit over 0.5mg. Take 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 who have severe or moderate renal impairment (creatinine clearance 20~60mL/min), the dose should be increased 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 medicine was discontinued without dose reduction.

This medication may cause patients who receive it to unexpectedly fall asleep or experience severe drowsiness. Extra caution should be taken when engaging in activities that require attention, such as driving or operating machinery. If drowsiness occurs while taking this medication, it is advised to avoid driving or hazardous tasks, and to consult a doctor if symptoms are severe. Caution is also needed as drowsiness may worsen when taking sedatives or in cases of sleep disorders, or when taken with certain medications. Additionally, this medication can cause hallucinations or confusion, which may occur more frequently in older patients. If symptoms of hallucination appear, it is important to inform the doctor as they may affect driving ability or daily life. Orthostatic hypotension, which causes dizziness or a drop in blood pressure when standing up suddenly, may occur, so special care is needed, particularly when increasing the dosage. Blood pressure changes should be closely monitored, and if symptoms arise, it is advisable to consult a doctor. Patients with impaired kidney function or cardiovascular diseases should have their dosage adjusted and blood pressure monitored carefully when administering this medication. If you are pregnant or breastfeeding, this medication's safety has not been established, so it should be given only after consulting with a doctor. In particular, during breastfeeding, the medication may transfer into breast milk and affect the baby. This medication should not be used in children, as safety and efficacy have not been confirmed. Elderly patients may experience delayed drug excretion due to decreased kidney function, necessitating dose adjustments and increased caution due to a higher risk of hallucinations. Sudden discontinuation of this medication may cause withdrawal symptoms, so when stopping, the dosage should be gradually reduced according to the doctor’s instructions. This medication may interact with other drugs, so if you are taking any other medications, it is crucial to inform your doctor or pharmacist. Particular caution is needed when taken alongside dopamine antagonists, sedatives, or certain gastrointestinal medications. Finally, abnormal behaviors or impulse control disorders may manifest during treatment with this medication, so patients or caregivers should carefully monitor for such changes.

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

This medication should be stored in a tightly closed container to protect it from air and light exposure, and should be kept at room temperature between 1°C to 30°C. It is advisable to avoid direct sunlight and store it in a cool place.

Appearance

White round tablet

Package unit

For domestic use - 100 tablets/box [10 tablets/PTP x 10 pieces]