Pidipeksol Tablet 0.125 mg (Pramipexole Hydrochloride Dihydrate)

Adult dose

Idiopathic Parkinson's disease In all clinical trials, treatment was initiated at a dose below the therapeutic level to avoid excessive adverse reactions and orthostatic hypotension. The dose of this medicine should be increased gradually in all patients. Increase the dose to the level that provides the greatest therapeutic effect while balancing the major adverse reactions 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 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 Dose increases should be made approximately once every 5-7 days, and not more frequently. The increases recommended based on clinical trials are as follows. 2) Maintenance This medicine was effective and well tolerated when administered alone at a total daily dose of 1.5~4.5mg/day in 3 divided doses, or in combination with levodopa (approximately 800mg/day). In a clinical trial in patients with early Parkinson's disease, doses of this medicine totaling 3mg, 4.5mg, or 6mg per day did not provide a significant benefit compared with 1.5mg/day. However, in the same trial, the following adverse reactions were dose-related: postural hypotension, nausea, constipation, somnolence, and amnesia. At doses of 3mg/day or higher, the incidence of these adverse reactions was generally about 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% from the dose used 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 of this medicine by 0.75 mg/day until the daily dose has been reduced to 0.75 mg; 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 compared with 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 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 medicine is used to treat Parkinson's disease and restless legs syndrome and acts as a dopamine agonist. During treatment, symptoms of sudden sleepiness may occur; therefore, activities that require attention, such as driving or operating machinery, should be avoided until drowsiness symptoms completely resolve. Particularly, caution is needed if taking sedatives or if there are sleep disorders, as symptoms of drowsiness may worsen when taken with other medications that can increase blood levels of this drug. This medication can cause psychiatric symptoms such as hallucinations or confusion, and the risk may be higher in the elderly or when used in combination with levodopa, so it is essential to consult a doctor immediately if such symptoms appear. Orthostatic hypotension may occur, meaning that blood pressure can drop suddenly when standing up, leading to dizziness or fainting; therefore, blood pressure changes should be closely monitored, especially when increasing the dosage. Patients with decreased kidney function may have slowed excretion of this drug, necessitating dosage adjustments. Patients with cardiovascular diseases should also monitor blood pressure carefully from the outset and take it cautiously. During treatment, side effects such as nausea, dizziness, insomnia, constipation, weakness, hallucinations, amnesia, perceptual disturbances, ataxia, restlessness, abnormal thinking, abnormal vision, erectile dysfunction, fatigue, decreased appetite, dysphagia, weight loss, sweating, rhinitis, increased cough, frequent urination, vomiting, pruritus, rash, vasodilation, headache, pain, tremors, back pain, diarrhea, abdominal pain, anxiety, syncope, arthralgia, myalgia, muscle cramps, throat pain, pharyngitis, conjunctivitis may occur, and if these symptoms are severe or interfere with daily life, consultation with healthcare providers is necessary. For pregnant women, the safety of this drug has not been established, so it should only be used cautiously when the benefits of treatment exceed the risks, and breastfeeding mothers should consider stopping nursing due to the possibility of drug transmission through breast milk. This medication is not to be used in children, as safety and efficacy have not been confirmed. In the elderly, there may be an increased risk of medication concentration due to decreased kidney function, and the risk of side effects such as hallucinations may be heightened. Abrupt discontinuation of this drug can lead to withdrawal symptoms, so dosages should be gradually reduced as directed by a physician when stopping. This medication may interact with other drugs, so it is essential to inform your doctor or pharmacist of any medications you are taking, especially caution is advised when taken with sedatives, alcohol, or dopamine antagonists. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and hypotension may appear, so dosing should be adhered to, and immediate medical attention should be sought if any abnormal symptoms occur. This medication should be stored out of reach of children and not transferred to other containers for safety.

• Drowsiness
• hallucinations
• 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 it is recommended to be kept at room temperature between 1 degree and 30 degrees Celsius. Thus, it should be stored in a cool place away from direct sunlight.

Appearance

White round tablets

Package unit

100 tablets/box [10 tablets/PTP x 10]