Pramipexole Extended-Release Tablets 0.75 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinsonism Take this medicine once daily at the same time with water. Swallow it whole without chewing, splitting, or crushing. It may be taken with or without food. If you miss a dose, take it within 12 hours of the scheduled dose time. If more than 12 hours have passed, skip the missed dose and take the next dose according to the regular schedule. 1. Patients with normal renal function 1) Initiation therapy Week Total daily dose (mg) Dose (mg) 1 0.375 0.375 2 0.75 0.75 3 1.50 1.50 Start with a total daily dose of 0.375mg/day and gradually increase it. Dose increases should occur approximately once every 5-7 days and should not be more frequent than this. If intolerable adverse reactions do not occur, the dose may be increased to the maximum therapeutic dose. The dose increments recommended based on clinical trials are as follows. If further increases are needed, the dose may be increased by 0.75mg at 1-week intervals up to a maximum of 4.5mg per day. Patients already taking immediate-release pramipexole may be switched to this medicine at the same daily dose, with the switch made overnight. 2) Maintenance therapy The dose is 0.375mg to a maximum of 4.5mg per day. In pivotal clinical trials, efficacy was observed at daily doses starting from 1.5mg during dose escalation in both early and advanced Parkinson's disease; some patients may experience additional therapeutic benefit at doses higher than 1.5mg. This regimen applies particularly to patients with advanced Parkinson's disease for whom a reduction in the levodopa dose is planned. In patients taking this medicine with levodopa, a reduction in the levodopa dose should be considered during pramipexole dose escalation and maintenance therapy, as this is necessary to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment The elimination of pramipexole depends on renal function. The following dosage schedule is proposed for initiation therapy: Renal function Starting dose (mg) Maximum dose (mg) creatinine CL>50ml/min No adjustment of daily dose or dosing frequency is required. creatinine CL=30~50ml/min 0.375mg every other day 2.25mg once daily creatinine CL<30ml/min Use of this medicine in these patients has not been adequately studied; therefore, use of immediate-release pramipexole should be considered. If renal function declines during maintenance therapy, administer the medicine according to the recommendations above. 3. Discontinuation Reduce the dose of this medicine by 0.75 mg/day until the daily dose is reduced to 0.75 mg, and thereafter reduce it by 0.375 mg/day.

This medication is used in the treatment of Parkinson's disease. During the use of this medication, patients may suddenly fall asleep or experience drowsiness, thus it is advised to avoid driving or operating dangerous machinery. It is particularly important to consult a doctor immediately if drowsiness occurs. Psychological symptoms such as hallucinations or confusion may occur, and these symptoms may be more frequent in elderly patients, so caution is advised. Orthostatic hypotension, which is a sudden drop in blood pressure, may occur, so blood pressure should be closely monitored when starting the medication or increasing the dosage. Patients with poor kidney function or cardiovascular disease may require dosage adjustments and careful monitoring. During treatment, side effects such as nausea, dizziness, insomnia, constipation, and weakness may occur, and in severe cases, dosage adjustment or discontinuation should be considered in consultation with a doctor. This medication may interact with other drugs; thus, it is essential to inform your doctor or pharmacist when taking sedatives, alcohol, or certain medications together. Pregnant or breastfeeding women should consult a doctor before taking this medication, and it should be used cautiously as safety has not been established. Safety in children has not been confirmed, and caution is advised for the elderly as the elimination of the drug may be delayed due to decreased kidney function. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and low blood pressure may appear, and immediate medical attention is required. This medication should be stored away from light and moisture, out of reach of children, and should not be transferred to other containers.

• Sudden sleep
• drowsiness
• hallucinations
• confusion
• orthostatic hypotension
• nausea
• dizziness
• insomnia
• constipation
• weakness

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, it should be kept at room temperature between 1 degree and 30 degrees Celsius, avoiding areas with high humidity and placing it in a dry location.

Appearance

White round extended-release tablet

Package unit

100 tablets/box [(10 tablets/PTP) x 10], 30 tablets/bottle