Pidifexol Tablets 0.25 mg (Pramipexole Hydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease In all clinical trials, dosing was initiated below the therapeutic dose (at a subtherapeutic level) to avoid excessive adverse effects and orthostatic hypotension. The dose of this drug should be increased gradually in all patients. The dose should be increased to the level that provides the maximum therapeutic effect while maintaining a balance with the major 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, given in 3 divided doses, and should be increased gradually. Week 1: Dose (mg) 0.125mg 3 times daily, total daily dose (mg) 0.375 Week 2: Dose (mg) 0.25mg 3 times daily, total daily dose (mg) 0.75 Week 3: Dose (mg) 0.5mg 3 times daily, total daily dose (mg) 1.50 Week 4: Dose (mg) 0.75mg 3 times daily, total daily dose (mg) 2.25 Week 5: Dose (mg) 1.0mg 3 times daily, total daily dose (mg) 3.0 Week 6: Dose (mg) 1.25mg 3 times daily, total daily dose (mg) 3.75 Week 7: Dose (mg) 1.5mg 3 times daily, total daily dose (mg) 4.50 Dose increases should be made approximately once every 5-7 days and should not be made more frequently. The dose increases recommended based on clinical trials are as follows. 2) Maintenance This drug 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 conducted in patients with early Parkinson's disease, administration of this drug at total daily doses of 3mg, 4.5mg, and 6mg provided no significant benefit compared with administration at 1.5mg/day. However, the following adverse reactions were dose-related in the same clinical trial: postural hypotension, nausea, constipation, somnolence, and amnesia. At doses of 3mg/day or higher, the incidence of these adverse reactions was generally approximately 2 times higher than with placebo. The incidence of somnolence reported with this drug at 1.5mg/day was similar to that with placebo. When this drug is administered in combination with levodopa, a reduction in the levodopa dose should be considered. In a clinical trial conducted in patients with advanced Parkinson's disease, the levodopa dose was reduced by an average of 27% from the dose administered immediately before initiation of this drug (baseline). 2. Patients with renal impairment creatinine CL>50ml/min: No adjustment of the daily dose or dosing frequency is required. creatinine CL=20~50ml/min: Initial dose 0.125mg tablet 2 times daily, maximum dose 2.25mg daily creatinine CL<20ml/min: Initial dose 0.125mg tablet 1 time daily, maximum dose 1.5mg daily 3. Discontinuation Reduce the dose of this drug 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 starting dose is 0.125mg taken once daily, 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. Although the dose was increased to 0.75mg in a few patients in long-term open-label clinical trials of this drug, there is no evidence demonstrating additional benefit with 0.75mg compared with 0.5mg. The lowest effective dose should be used. Dose level 1: Daily dose (mg) 0.125 Dose level 2*: Daily dose (mg) 0.25 Dose level 3*: Daily dose (mg) 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 drug was discontinued without dose reduction.

This medication is a dopamine agonist used for the treatment of Parkinson's disease and restless legs syndrome. During the use of this medication, sudden drowsiness or unexpected sleep symptoms may occur, so special caution should be taken when engaging in hazardous activities such as driving or operating machinery. Patients taking sedatives or those with sleep disorders, or those taking medications that can increase the blood concentration of this medication may have a higher risk of drowsiness, so they must consult with their physician. Some patients taking this medication may experience hallucinations or confusion, especially among older Parkinson's disease patients, where such symptoms may appear more frequently. There is a risk of orthostatic hypotension, meaning dizziness or fainting may occur when standing up suddenly, so dosage adjustments and careful monitoring of blood pressure changes are necessary. Patients with reduced kidney function or cardiovascular diseases may require dosage adjustments or special caution when using this medication. This medication may interact with other drugs, so if you are taking any other medications, be sure to inform your healthcare provider. If you are pregnant or breastfeeding, the safety of this medication has not been established, so the benefits and risks of treatment should be carefully considered. It is not used in children, as its safety and efficacy have not been confirmed. Elderly patients may experience slower renal clearance of the medication due to decreased kidney function, so dose adjustments are necessary, and hallucinations may occur more frequently. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and hypotension may occur, so you should visit a medical institution immediately. Abnormal behavior or impulse control disorders may occur during the course of this medication, so patients and caregivers should carefully monitor for these symptoms. Finally, this medication should be stored out of reach of children in a safe place, and it is advisable not to transfer it to other containers.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or light. It is best to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a long time.

Appearance

White, rod-shaped tablet

Package unit

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