Rasagiline Tablets 0.5mg (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 is a dopamine agonist used in the treatment of Parkinson's disease and Restless Legs Syndrome. During treatment with this medication, there may be sudden drowsiness or episodes of falling asleep, so driving or operating dangerous machinery should be avoided until drowsiness completely resolves. Caution should be exercised when used with sedatives or in cases of sleep disorders, or with other medications that increase the blood concentration of this drug as the risk of drowsiness may increase. Additionally, this medication may cause psychiatric symptoms like hallucinations or confusion, particularly in the elderly or when used in conjunction with levodopa. Orthostatic hypotension, i.e., falling blood pressure when standing up, may occur, causing dizziness or fainting; symptoms should be reported immediately, and blood pressure should be closely monitored at the initiation of therapy and during dosage increases. Patients with decreased kidney function may have delayed excretion of this medication, requiring dosage adjustments, and extra caution is necessary in patients with cardiovascular diseases. In cases of pregnancy or nursing, since the effects on the fetus or baby are not clearly understood, administration should be discussed with a physician. This medication can cause a variety of adverse reactions, including common side effects such as nausea, dizziness, drowsiness, constipation, hallucinations, and insomnia; consultation with a physician is necessary if adverse reactions are severe or interfere with daily life. Moreover, abrupt discontinuation of this medication may lead to withdrawal symptoms, so the dosage should be gradually reduced according to the physician's instructions. There are interactions with other medications, so it is essential to inform healthcare providers of any other medications being taken, especially when used with sedatives, cimetidine, or dopamine antagonists. Elderly patients should be more careful as kidney function may decline, leading to slower excretion of this medication and an increased risk of hallucinations and other side effects. Finally, keep out of reach of children and do not transfer to other containers for safety.

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

This medication must be stored in tightly closed containers to prevent exposure to air and light. Storage temperature should be maintained at room temperature between 1°C and 30°C, and it should be kept in a cool, dark place away from direct sunlight.

Appearance

White oval tablets

Package unit

Domestic use - 100 tablets/box [10 tablets/PTP x 10 packs]