Pidipecsol Tablet 1 mg (Pramipexole Dihydrochloride 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 Dose (mg) Total daily dose (mg) 1 0.125mg 3 times daily 0.375 2 0.25mg 3 times daily 0.75 3 0.5mg 3 times daily 1.50 4 0.75mg 3 times daily 2.25 5 1.0mg 3 times daily 3.0 6 1.25mg 3 times daily 3.75 7 1.5mg 3 times daily 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 Renal function Initial dose (mg) Maximum dose (mg) creatinine CL>50ml/min No adjustment of the daily dose or dosing frequency is necessary. creatinine CL=20~50ml/min 0.125mg tablet twice daily 2.25mg daily creatinine CL<20ml/min 0.125mg tablet once daily 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 Daily dose (mg) 1 0.125 2* 0.25 3* 0.50 *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 drug is used for the treatment of Parkinson's disease or restless legs syndrome, and it plays a role in alleviating symptoms by stimulating dopamine receptors. During the use of this drug, sudden sleep during the day may occur, so special precautions should be taken when driving or operating dangerous machinery. If a sedative or sleep disorder exists, or if other medications that increase the blood concentration of this drug are taken together, the risk of drowsiness may increase, so consultation with a physician is advised. Psychological symptoms such as hallucinations or confusion may occur, and particularly in older patients, these symptoms may appear more frequently, so caution is required. This drug can lower blood pressure, leading to dizziness or orthostatic hypotension, so blood pressure status should be carefully monitored, especially when starting or increasing the dosage. In patients with reduced kidney function, the excretion of this drug may be slowed, so dosage adjustment may be necessary. Patients with cardiovascular diseases should carefully monitor their blood pressure and heart condition before and during the use of this drug. Discontinuing this drug suddenly may result in withdrawal symptoms, so when stopping, the dosage should be gradually reduced according to a physician's instructions. Pregnant or breastfeeding women should consult with a physician before use, as the effects on the fetus or newborn have not been sufficiently studied. This drug may interact with other medications, so if any other medications are currently being taken, it is essential to inform healthcare professionals. Elderly patients may have an increased risk of side effects due to higher drug concentrations caused by declining kidney function and should take this drug more cautiously. If any unusual symptoms or side effects occur while taking this drug, immediate consultation with a physician is needed, especially in cases of severe dizziness, hallucinations, excessive drowsiness, or low blood pressure. This drug is not to be used in children, as safety and efficacy have not been established. When taking this drug, it should be stored out of reach of children, and it is advisable not to transfer the medication to another container.

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

This drug should be stored in a tightly sealed container to protect it from exposure to air and light, and it is best kept at room temperature between 1 degree and 30 degrees Celsius. By doing so, the drug's effects can be maintained for a longer period.

Appearance

White round tablet

Package unit

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