Pramipexole Extended Release Tablet 0.375 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinsonism Take this drug 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 a dose is missed, take this drug within 12 hours after the scheduled dosing time. If more than 12 hours have passed, skip the missed dose and take the next dose according to the next scheduled dosing plan. 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. Increase the dose approximately once every 5-7 days, and do not increase it more frequently. 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, increase by 0.75mg at weekly intervals, up to a maximum of 4.5mg daily. Patients already taking immediate-release pramipexole tablets may be switched to this drug at the same total daily dose, with the first dose taken the following night. 2) Maintenance therapy The dose per administration should range from 0.375mg to a maximum of 4.5mg daily. In pivotal clinical trials, efficacy was observed at a daily dose of 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 levodopa dose is planned. In patients taking this drug in combination with levodopa, a reduction in levodopa 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. For initiation therapy, the following dosage schedule is suggested; Renal function status | 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 2 days | 2.25mg once daily creatinine CL<30ml/min | Use of this drug in these patients has not been adequately studied; use of immediate-release pramipexole tablets should be considered. If renal function declines during maintenance therapy, administer the drug according to the recommendations above. 3. Discontinuation Reduce the daily dose by 0.75 mg/day until the daily dose is reduced to 0.75 mg, and then reduce it by 0.375 mg/day thereafter.

This drug is a dopamine agonist used for the treatment of Parkinson's disease, and patients may experience drowsiness or sudden sleep episodes, so caution is needed when driving or operating dangerous machinery. Hallucinations or confusion may occur while taking this medication, particularly in older patients, so caution should be exercised. Orthostatic hypotension, which can lead to dizziness or fainting when suddenly standing up, requires careful monitoring of blood pressure, and any symptoms should be reported immediately. Patients with poor kidney function or cardiovascular disease require dose adjustments and blood pressure monitoring, and this medication should not be prescribed to patients with hypersensitivity to it. Side effects such as nausea, dizziness, insomnia, constipation, and weakness may occur, and if symptoms are severe, a doctor should be consulted. This drug may interact with other medications, so patients taking sedatives, antihypertensives, or other drugs should inform their healthcare provider. The safety of this drug during pregnancy or breastfeeding is not established, and a doctor should be consulted before taking it, as the medication may pass into breast milk. Safety and efficacy in children have not been confirmed, and elderly patients may require dose adjustments due to decreased kidney function. In cases of overdose, symptoms such as nausea, vomiting, hallucinations, and hypotension may occur, and immediate medical help should be sought. When storing this medication, keep it out of reach of children, protect it from light and moisture, and do not transfer it to another container.

Drowsiness, hallucinations, confusion, orthostatic hypotension, nausea, dizziness, insomnia, constipation, weakness, headache, extrapyramidal syndrome, amnesia, perceptual disturbance, ataxia, inability to sit still, abnormal thoughts, dystonic reactions, abnormal vision, erectile dysfunction, general edema, fatigue, decreased appetite, dysphagia, peripheral edema, weight loss, confusion, abnormal dreams, accidental injury, movement disorders, hypertonia, thirst, forgetfulness, frequent urination, bradykinesia, chest pain, sensory disturbance, palpitations, conjunctivitis, paralysis, abnormal accommodation, tinnitus, diplopia, taste distortion, orthostatic hypotension, ataxia, abnormal gait, hypertonia, amnesia, inability to sit still, abnormal thoughts, paranoid reactions, hallucinations, sleep disturbances, respiratory distress, rhinitis, pneumonia, skin disorders, erectile dysfunction, frequent urination, urinary tract infections, incontinence, depression, headache, tremors, syncope, orthostatic hypotension, hypertonia, anxiety, dyspepsia, abdominal distension, diarrhea, rash, ataxia, thirst, extrapyramidal syndrome, leg cramps, fasciculations, pharyngitis, sinusitis, sweating, rhinitis, urinary tract infections, vasodilation, influenza-like syndrome, increased saliva, dental disorders, respiratory distress, increased coughing, abnormal gait, vomiting, allergic reactions, hypertension, pruritus, bradykinesia, increased creatine phosphokinase, neuroexcitation, abnormal dreams, chest pain, neck pain, sensory disturbance, palpitations, dizziness, voice changes, conjunctivitis, paralysis, abnormal accommodation, tinnitus, diplopia, taste distortion, accidental injuries, weakness, general edema, chest pain, fatigue, orthostatic hypotension, constipation, thirst, peripheral edema, increase in CPK, arthritis, seizures, bursitis, myasthenia gravis, movement disorders, extrapyramidal syndrome, insomnia, dizziness, hallucinations, abnormal dreams, confusion, drowsiness, ataxia, abnormal gait, hypertonia, amnesia, inability to sit still, abnormal thoughts, paranoid reactions, hallucinations, sleep disturbances, respiratory distress, rhinitis, pneumonia, skin disorders, abnormal accommodation, abnormal vision, diplopia, frequent urination, urinary tract infections, incontinence, pneumonia, defective secretion of antidiuretic hormone, binge eating, impulse buying, hypersexuality, abnormal dreams, confusion, delusions, hallucinations, hyperphagia, insomnia, sexual dysfunction, paranoia, restlessness, amnesia, forward bending of the head, movement disorders, headache, hyperactivity, drowsiness, sudden onset of sleep, syncope, diplopia, blurred vision, decreased vision, heart failure, hypotension, hiccups, constipation, nausea, vomiting, pruritus, rash, fatigue, peripheral edema, drug withdrawal syndrome, decreased appetite, weight loss, weight gain, accidents, intestinal obstruction, confusion, insomnia, surface tension, pathological gambling symptoms, increased sexual desire, impulse buying, muscle rigidity, neuroleptic malignant syndrome, rhabdomyolysis, muscle rigidity, dopamine hypersensitivity syndrome, nausea, vomiting, hyperactivity, excitement, hypotension

This medication is sensitive to light, so it should be stored in a light-protective container. Additionally, it should be kept at room temperature between 1 and 30 degrees Celsius, in a dry place with low humidity.

Appearance

White round extended-release tablet

Package unit

100 tablets/box [10 tablets/PTPX10], 30 tablets/bottle