Pramipexole Prolonged-Release Tablets 1.5 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 and acts as a dopamine agonist, stimulating dopamine receptors in the brain to alleviate symptoms. During treatment with this medication, sudden sleep onset may occur, so it is important to avoid driving or operating dangerous machinery until drowsiness completely dissipates. Patients should regularly consult with their doctor regarding symptoms of drowsiness or sleep attacks, particularly if they are using sedatives or have sleep disorders. Additionally, this medication may induce psychiatric symptoms such as hallucinations or confusion; these symptoms should be reported to medical personnel immediately. Orthostatic hypotension may occur, which can cause dizziness or fainting when standing up suddenly, so blood pressure changes should be observed closely. Patients with impaired kidney function or cardiovascular diseases need dose adjustment and blood pressure monitoring. Women who are pregnant or breastfeeding should consult their doctor regarding the use of this medication as its safety has not been established. The safety of this medication has not been confirmed for children and adolescents, so its use should be avoided. Elderly patients may experience delayed excretion of the drug due to decreased kidney function, making dose adjustment and monitoring for side effects important. This medication may interact with other drugs, so patients should inform their doctor of any other medications they are taking, especially when combined with sedatives, cimetidine, or dopamine antagonists. Sudden discontinuation of this medication can lead to withdrawal symptoms, hence it should be tapered gradually according to the healthcare provider's instructions. When storing this medication, keep it out of reach of children and protect it from light and moisture.

Drowsiness, hallucinations, confusion, orthostatic hypotension, nausea, dizziness, insomnia, constipation, weakness, headache, extrapyramidal syndrome, amnesia, sensory reduction, ataxia, inability to sit still, abnormal thinking, tardive dyskinesia, abnormal vision, erectile dysfunction, general edema, fatigue, loss of appetite, dysphagia, peripheral edema, weight loss, confusion, abnormal dreams, accidental injuries, dyskinesia, ataxia, abnormal gait, increased muscle tension, thirst, forgetfulness, frequent urination, chest pain, arthritis, seizures, bursitis, myasthenia, dyspnea, rhinitis, pneumonia, skin disorders, abnormal near vision control, diplopia, urinary tract infection, urinary incontinence, depression, headache, tremor, back pain, syncope, postural hypotension, hypertonia, depression, dyspepsia, bloating, diarrhea, rash, decreased exercise tolerance, leg cramping, twitching, pharyngitis, sinusitis, sweating, rhinitis, urinary tract infection, vasodilation, flu-like syndrome, increased saliva, dental disease, increased cough, abnormal gait, frequent urination, vomiting, allergic reactions, hypertension, pruritus, decreased exercise tolerance, increased creatine phosphokinase, hypersensitivity, abnormal dreams, chest pain, neck pain, sensory abnormalities, palpitations, dizziness, voice changes, conjunctivitis, paralysis, abnormal near vision control, tinnitus, diplopia, taste distortion, accidental injuries, chest pain, fatigue, weakness, general edema, orthostatic hypotension, constipation, thirst, peripheral edema, increased CPK, arthritis, seizures, bursitis, myasthenia, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, abnormal dreams, confusion, drowsiness, ataxia, abnormal gait, increased muscle tension, amnesia, inability to sit still, abnormal thinking, paranoid reactions, illusions, sleep disturbances, dyspnea, rhinitis, pneumonia, skin disorders, abnormal near vision control, abnormal vision, diplopia, frequent urination, urinary tract infection, urinary incontinence, amnesia, symptoms of head leaning forward, dyskinesia, headache, hyperkinesia, drowsiness, sudden sleep episodes, fainting, 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, accident, delirium, insomnia, stupor, intestinal obstruction, muscle tone disorder, pathological gambling, increased libido, hypersexuality, impulsive buying, rhabdomyolysis, drug withdrawal syndrome, apathy, anxiety, depression, sweating, pain, drug toxicity-related gastric joint protrusion, fall accidents, traffic accidents, sunburn, tendon rupture

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

Appearance

White oval prolonged-release tablet

Package unit

100 tablets/box[(10 tablets/PTP)X10], 30 tablets/bottle