Mirapex Sustained Release Tablet 0.375 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 1: Total daily dose (mg) 0.375, dose (mg) 0.375 Week 2: Total daily dose (mg) 0.75, dose (mg) 0.75 Week 3: Total daily dose (mg) 1.50, dose (mg) 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; 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 drug is a dopamine agonist used to treat Parkinson's disease, and patients may experience drowsiness or sudden sleep symptoms, so caution is advised when driving a car or operating hazardous machinery. Additionally, psychiatric symptoms such as hallucinations or confusion may occur, particularly in elderly patients, so if these symptoms appear, medical consultation should be sought immediately. Orthostatic hypotension, meaning a drop in blood pressure when standing that can lead to dizziness or fainting, should be carefully monitored, especially in patients with cardiovascular diseases. This drug should not be used in patients who have had allergic reactions to it, and dosage adjustment is needed for patients with reduced kidney function. During treatment, there may be potential interactions with other medications, particularly if taken with sedatives, antihypertensive drugs, or antipsychotics, so consultation with a professional is necessary. Women who are pregnant or breastfeeding should consult a doctor before taking this drug, and safety in children has not been established. Elderly patients may need to be careful as drug elimination may be delayed due to impaired kidney function. Overdosage may cause symptoms such as vomiting, hallucinations, and hypotension, so it is important to strictly adhere to the prescribed dosage. During treatment, abnormal behavior changes, impulse control disorders, increased libido, and other symptoms may appear, so family members or caregivers should monitor closely. When storing, keep it out of reach of children and store it away from direct sunlight and moisture.

Drowsiness, hallucination, confusion, nausea, dizziness, insomnia, constipation, weakness, headache, extrapyramidal syndrome, amnesia, perceptual decrease, ataxia, inability to sit still, abnormal thinking, akathisia, abnormal vision, erectile dysfunction, general edema, fatigue, decreased appetite, dysphagia, peripheral edema, weight loss, disorientation, abnormal dreams, accidental injury, dyskinesia, hypertonia, frequent urination, ataxia, abnormal gait, forgetfulness, chest pain, sensory abnormalities, palpitations, conjunctivitis, paralysis, abnormal near vision, tinnitus, double vision, taste distortion, depression, dry mouth, orthostatic hypotension, hypokinesia, increased creatine phosphokinase, neuroexcitability, abnormal dreams, neck pain, infection, headache, tremor, back pain, syncope, hypertonia, anxiety, dyspepsia, bloating, diarrhea, rash, hypokinesia, leg cramps, spasms, pharyngitis, sinusitis, sweating, rhinitis, urinary tract infection, vasodilation, flu-like syndrome, increased salivation, dental disease, shortness of breath, increased cough, abnormal gait, vomiting, allergic reaction, hypertension, pruritus, hypokinesia, neuroexcitability, abnormal dreams, chest pain, neck pain, sensory abnormalities, palpitations, dizziness, voice changes, conjunctivitis, paralysis, abnormal near vision, tinnitus, double vision, taste distortion, orthostatic hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucination, confusion, constipation, weakness, drowsiness, ataxia, abnormal gait, hypertonia, dry mouth, forgetfulness, frequent urination, accidental injury, weakness, general edema, chest pain, fatigue, orthostatic hypotension, constipation, dry mouth, peripheral edema, increased CPK, arthritis, cramps, bursitis, myasthenia, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucination, abnormal dreams, confusion, drowsiness, ataxia, abnormal gait, hypertonia, amnesia, inability to sit still, abnormal thinking, paranoid reaction, fantasy, sleep disorder, shortness of breath, rhinitis, pneumonia, skin diseases, abnormal near vision, abnormal vision, double vision, frequent urination, urinary tract infection, incontinence, pneumonia, abnormal secretion of antidiuretic hormone, binge eating, compulsive buying, hypersexuality, abnormal dreams, confusion, delusion, hallucination, hyperphagia, insomnia, sexual dysfunction, paranoia, restlessness, amnesia, head tilt-forward symptom, dyskinesia, headache, hyperactivity, drowsiness, sudden onset of sleep, syncope, double vision, blurred vision, decreased vision, heart failure, hypotension, hiccups, natural penile erection, fatigue, peripheral edema, dopamine agonist withdrawal syndrome, intestinal obstruction, confusion, hypomania, pathological gambling, increased libido, compulsive buying, muscle tension disorder, rhabdomyolysis, neuroleptic malignant syndrome, apathy, anxiety, depression, sweating, pain, dopamine agonist withdrawal syndrome

This drug is sensitive to light, so it should be stored in a tightly closed container that blocks light. 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, biconvex, round sustained-release tablet

Package unit

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