Pidipecsol Tablet 0.5 mg (Pramipexole Hydrochloride Monohydrate)

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: Dose 0.125mg 3 times daily, total daily dose 0.375mg Week 2: Dose 0.25mg 3 times daily, total daily dose 0.75mg Week 3: Dose 0.5mg 3 times daily, total daily dose 1.50mg Week 4: Dose 0.75mg 3 times daily, total daily dose 2.25mg Week 5: Dose 1.0mg 3 times daily, total daily dose 3.0mg Week 6: Dose 1.25mg 3 times daily, total daily dose 3.75mg Week 7: Dose 1.5mg 3 times daily, total daily dose 4.50mg 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 medication may cause sudden sleep attacks or drowsiness in treated patients, therefore caution is advised when engaging in activities such as driving or operating hazardous machinery. If drowsiness occurs during treatment with this medication, immediate consultation with a physician is necessary, and such activities should be avoided if drowsiness is severe. Additionally, this medication may cause hallucinations or confusion, posing a higher risk particularly in the elderly, hence both patients and caregivers should be aware and cautious. Orthostatic hypotension may occur, leading to dizziness or fainting when rising quickly, so blood pressure should be frequently monitored when starting treatment or increasing dosage. Patients with impaired renal function or cardiovascular diseases need dosage adjustments and regular monitoring when using this medication. As a dopamine agonist, caution is necessary as this could exacerbate drowsiness in conjunction with other sedatives or in cases of sleep disorders, and concomitant use with drugs such as cimetidine may increase plasma concentration. Women who are pregnant or breastfeeding should be carefully administered this medication as its safety has not been established, and discontinuation of breastfeeding is recommended. The safety in children has not been established, hence it is advisable not to use in this population. Elderly patients should be cautious as drug elimination may be slowed due to decreased renal function, raising the risk of adverse reactions such as hallucinations. Abrupt discontinuation of this medication may lead to withdrawal symptoms; therefore, when discontinuing, the dosage should be gradually reduced under a physician's guidance. Unusual behavior (e.g., pathological gambling, increased libido, compulsive shopping, etc.) may occur during treatment with this medication, prompting patients and caregivers to recognize these symptoms and consult a physician. In cases of overdose, symptoms such as nausea, vomiting, hallucinations, and hypotension may appear, necessitating appropriate emergency care and medical supervision. This medication should be stored out of reach of children and should not be transferred to other containers.

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

This medication may be sensitive to air and light, so it should be stored in a tightly sealed container. The appropriate storage temperature is room temperature between 1 and 30 degrees Celsius, and it should be kept in a cool, dark place away from direct sunlight.

Appearance

White rectangular tablet

Package unit

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