Mirapex Extended Release Tablet 1.5 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease 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 this medicine 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 your regular schedule. 1. Patients with normal renal function 1) Initiation Week / Total daily dose (mg) / Dose (mg) 1 / 0.375 / 0.375 2 / 0.75 / 0.75 3 / 1.50 / 1.50 Gradually increase the initial total daily dose from 0.375mg/day. Dose increases should occur about once every 5-7 days and should not be more frequent. If intolerable adverse reactions do not occur, the dose may be increased to the maximum therapeutic dose. The increases 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 switch to this medicine at the same total 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 of 1.5mg and above during dose titration in both early and advanced Parkinson's disease; some patients may experience additional therapeutic benefit at doses higher than 1.5mg. This regimen is particularly applicable to patients with advanced Parkinson's disease for whom a reduction in levodopa dose is planned. In patients taking this medicine with levodopa, consider reducing the levodopa dose during pramipexole dose increases and maintenance therapy, as needed to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment The elimination of pramipexole depends on renal function. For initiation, the following dosing schedule is suggested; Renal function / Initial dose (mg) / Maximum dose (mg) creatinine CL>50ml/min / No adjustment to the daily dose or dosing frequency is necessary. 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; consider using immediate-release pramipexole. If renal function declines during maintenance therapy, follow the recommendations above. 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.

This medication is used for the treatment of Parkinson's disease and may cause sudden drowsiness or episodes of unexpected sleep while taking it. Caution is advised during activities that require concentration, such as driving a car or operating machinery, and if daytime drowsiness worsens or if symptoms of falling asleep during routine activities occur, it is essential to consult a physician immediately. This medication can cause mental disturbances such as hallucinations or confusion, which may occur more frequently in elderly patients. If a patient experiences hallucinations, they should refrain from driving or dangerous activities and follow their doctor's instructions. Additionally, this medication may lower blood pressure, potentially causing dizziness or orthostatic hypotension, so blood pressure changes should be closely monitored during initial use or when increasing the dosage. Patients with renal impairment should adjust the dosage of this medication, and it should be used with caution in those with cardiovascular disease. Side effects such as nausea, dizziness, insomnia, constipation, weakness, hallucinations, etc., can occur during use, so patients should consult their physician if abnormal symptoms occur. This medication can interact with other drugs, particularly sedatives, antihypertensives, and neuroleptics, so it is vital to inform the doctor or pharmacist if these are also being taken. Women who are pregnant or breastfeeding should use this medication cautiously after consulting their physician, as its safety has not been established. It is not administered to children as its safety and effectiveness have not been confirmed. Elderly patients may have reduced kidney function, leading to delayed drug excretion, necessitating dosage adjustments, and they are at higher risk for side effects like hallucinations. Symptoms such as nausea, vomiting, hallucinations, and low blood pressure may occur in case of overdose, so care must be taken not to exceed the prescribed dose. If an overdose is suspected, contact a medical facility immediately. This medication should be stored away from light and moisture, and out of reach of children.

• Drowsiness
• hallucinations
• confusion
• nausea
• dizziness
• insomnia
• constipation
• weakness
• headache
• disorientation

This medication is sensitive to light, so it should be stored in a container that blocks light. Additionally, it should be kept at room temperature between 1°C and 30°C, preferably in a dry place with low humidity.

Appearance

White or light gray, oval, convex, extended-release tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10 packs)