Mirapex Extended-Release Tablet 0.75 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease Take this medication once daily at the same time with water. Swallow the tablet whole; do not chew, divide, or crush it. It may be taken with or without food. If you miss a dose, take it within 12 hours after the scheduled 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 regimen Week Total daily dose (mg) Dose (mg) 1 0.375 0.375 2 0.75 0.75 3 1.50 1.50 The initial total daily dose is 0.375mg/day and should be gradually increased. Increase the dose about 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, 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 medication at the same total daily dose, with the first dose taken the following night. 2) Maintenance therapy The dose per administration is 0.375mg to a maximum of 4.5mg per day. 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 have 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 medication with levodopa, a reduction in the levodopa dose should be considered during pramipexole dose escalation and maintenance therapy, as needed to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment Pramipexole elimination depends on renal function. For initiation therapy, the following dosage regimen is proposed: 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 2 days 2.25mg once daily creatinine CL<30ml/min Use of this medication 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 medication according to the recommendations above. 3. Discontinuation Reduce the daily dose of this medication by 0.75 mg/day until it reaches 0.75 mg, and thereafter reduce it by 0.375 mg/day.

This drug is a dopamine agonist used for the treatment of Parkinson's disease and may cause sudden sleep or drowsiness in patients; special care is needed when driving a vehicle or operating dangerous machinery. Drowsiness may occur suddenly during treatment with this medication, so patients or guardians should be aware of these symptoms and consult a physician. Psychotropic side effects such as hallucinations or confusion may occur, especially in elderly patients or those using it in combination with levodopa, hence caution is advised. Orthostatic hypotension may occur due to sudden drops in blood pressure, so if dizziness or lightheadedness is felt, consult a doctor immediately. Patients with reduced kidney function or cardiovascular diseases may require dose adjustments, and blood pressure should be closely monitored at the beginning of treatment. This medication may interact with specific drugs; if taking other medications, you must inform your physician or pharmacist. Women who are pregnant or nursing should consider the benefits and risks carefully as the safety of this medication has not been established. It is generally not recommended to administer this medication to children as safety and efficacy have not been confirmed. Elderly patients may have delayed drug elimination due to decreased kidney function, necessitating dose adjustments in consideration of this. In cases of overdose, symptoms such as nausea, vomiting, hallucinations, and hypotension may occur, requiring immediate medical attention; self-treatment can be dangerous. When storing this medication, keep it out of the reach of children and protect it from light and moisture.

Drowsiness, hallucinations, confusion, nausea, dizziness, insomnia, constipation, weakness, amnesia, perceptual disturbance, ataxia, restlessness, abnormal thoughts, akathisia, abnormal vision, erectile dysfunction, general edema, fatigue, loss of appetite, dysphagia, peripheral edema, weight loss, confusion, headache, extrapyramidal syndrome, dyskinesia, accidental injuries, abnormal dreams, increased anxiety, thirst, forgetfulness, frequent urination, hypokinesia, chest pain, sensory disturbance, palpitations, conjunctivitis, paralysis, abnormal near vision adjustment, tinnitus, diplopia, taste distortion, orthostatic hypotension, hyperkinesia, syncope, amnesia, forward head posture, sudden sleep onset, sleep disorders, binge eating, compulsive buying, hypersexuality, abnormal dreams, hyperphagia, paranoia, restlessness, diplopia, blurred vision, decreased vision, heart failure, hypotension, hiccups, vomiting, pruritus, rash, spontaneous penile erection, dopamine agonist withdrawal syndrome, bowel obstruction, delirium, insomnia, hypersomnia, abnormal muscle tone, pathological gambling, increased libido, compulsive buying, rhabdomyolysis, cachexia, decreased appetite, dehydration, diabetes, fluid retention, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, vitamin deficiency syndrome, increased appetite, metabolic alkalosis, bone pain, fasciitis, flank pain, intervertebral disc disorder, intervertebral disc protrusion, joint effusion, joint stiffness, joint swelling, monoarthritis, muscle rigidity, muscle cramps, musculoskeletal stiffness, myopathy, myositis, neck stiffness, osteoarthritis, osteonecrosis, osteoporosis, fibromyalgia, rheumatoid arthritis, shoulder pain, spondyloarthritis, tendonitis, tendinitis, abdominal discomfort, abdominal bloating, aphthous ulcer, ascites, cheilitis, colitis, ulcerative colitis, duodenal ulcer, duodenal ulcer bleeding, enteritis, belching, fecal incontinence, gastric ulcer, gastric ulcer bleeding, gastritis, gastrointestinal bleeding, gastroesophageal reflux disease, gingivitis, hematemesis, bloody stool, hemorrhoids, hiatal hernia, hyperchlorhydria, bowel obstruction, inguinal hernia, intestinal obstruction, irritable bowel syndrome, esophageal spasm, esophageal stricture, esophagitis, pancreatitis, periodontitis, rectal bleeding, reflux esophagitis, lingual edema, lingual ulcer, toothache, umbilical hernia, thoracic discomfort, chills, drug withdrawal symptoms, facial edema, feverish feeling, neuralgia, abnormal gait, impaired wound healing, influenza-like symptoms, irritability, localized edema, edema, dependent edema, thirst, biliary colic, cholecystitis, chronic cholecystitis, cholelithiasis, drug hypersensitivity, abscess, acute tonsillitis, appendicitis, bronchitis, bronchiolitis, bronchopneumonia, cellulitis, cystitis, dental caries, diverticulitis, erysipelas, eye infection, folliculitis, fungal infection, furuncle, gangrene, gastroenteritis, herpes simplex, herpes zoster, keratoacanthoma, intervertebral discitis, laryngitis, lobar pneumonia, nail infection, onychomycosis, oral candidiasis, orchitis, osteomyelitis, otitis externa, otitis media, paronychia, pyelonephritis, pustular skin disease, sepsis, skin infection, tonsillitis, dental abscess, dental infection, upper respiratory tract infection, urethritis, vaginal candidiasis, vaginal infection, viral infection, wound infection, fall accidents, medication toxicity-related gastric joint protrusion, traffic accidents, sunburn, tendon rupture, cachexia, decreased appetite, dehydration, diabetes, fluid retention, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, vitamin deficiency syndrome, increased appetite, metabolic alkalosis, hearing loss, otalgia, auditory damage, hearing impairment, motion sickness, vestibular dysfunction, goiter, hyperthyroidism, hypothyroidism, transient dark vision, blepharitis, eyelid spasm, cataract, acquired lacrimal duct obstruction, dry eyes, ocular hemorrhage, ocular irritation, ocular pain, eyelid edema, ptosis, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular disorders, scotoma, blurred vision, decreased vision, vitreous floaters, acne, alopecia, sweating, skin cyst, dermatitis, vesicular dermatitis, contact dermatitis, dry skin, petechiae, eczema, erythema, keratoconus, livedo reticularis, hyperhidrosis, periorbital edema, petechiae, phototoxic allergic reaction symptoms, psoriasis, purpura, erythematous eczema, morbilliform erythema, papular erythema, rhinophyma, seborrhea, seborrheic dermatitis, skin burning sensation, skin depigmentation, skin peeling, skin hyperpigmentation, skin hypertrophy, skin irritation, skin laceration, odor abnormalities, skin ulcer, urticaria, aneurysm, vascular disease, atherosclerosis, circulatory disorders, deep vein thrombosis, embolism, thrombosis, facial flushing, hypertensive crisis, lymphedema, pallor, phlebitis, Raynaud's phenomenon, shock, thrombotic phlebitis, thrombosis, varicose veins

This medication is sensitive to light and 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 or light gray, biconvex, round extended-release tablets

Package unit

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