Mirapex Tablets 0.5 mg (Pramipexole Hydrochloride Dihydrate)

Adult dose

Idiopathic Parkinsonism In all clinical trials, treatment was initiated at a dose below the therapeutic dose (subtherapeutic level) to avoid excessive adverse effects and orthostatic hypotension. The dose of this drug should be increased gradually in all patients. The dose should be increased to a level that provides the greatest therapeutic effect while balancing the major adverse effects of dyskinesia, hallucinations, somnolence, and dry mouth. 1. Patients with normal renal function 1) Initiation The initial total daily dose is 0.375mg/day, divided into 3 doses per day, and should be increased gradually. Week 1: 0.125mg 3 times daily, total daily dose 0.375mg Week 2: 0.25mg 3 times daily, total daily dose 0.75mg Week 3: 0.5mg 3 times daily, total daily dose 1.50mg Week 4: 0.75mg 3 times daily, total daily dose 2.25mg Week 5: 1.0mg 3 times daily, total daily dose 3.0mg Week 6: 1.25mg 3 times daily, total daily dose 3.75mg Week 7: 1.5mg 3 times daily, total daily dose 4.50mg Dose increases should be made approximately once every 5-7 days and should not be made more frequently. The increases recommended based on clinical trials are as follows. 2) Maintenance This drug was effective and well tolerated when administered alone at a total daily dose of 1.5~4.5mg/day in 3 divided doses, or in combination with levodopa (approximately 800mg/day). In clinical trials in patients with early Parkinson's disease, doses of this drug totaling 3mg, 4.5mg, and 6mg per day did not provide a significant benefit compared with a dose of 1.5mg/day. At doses of this drug of 3mg/day or more, the incidence of these adverse reactions was generally approximately 2 times higher than with placebo. The incidence of somnolence reported at a dose of 1.5mg/day of this drug was similar to that with placebo. When this drug is used in combination with levodopa, a reduction in the levodopa dose should be considered. In clinical trials in patients with advanced Parkinson's disease, the levodopa dose was reduced by an average of 27% compared with the dose immediately before initiation of this drug (baseline). 2. Patients with renal impairment creatinine CL>50ml/min: No adjustment of the daily dose or dosing frequency is necessary. creatinine CL=20~50ml/min: Initial dose 0.125mg tablet 2 times daily, maximum dose 2.25mg per day creatinine CL<20ml/min: Initial dose 0.125mg tablet once daily, maximum dose 1.5mg per day 3. Discontinuation Reduce the dose of this drug by 0.75 mg/day until the daily dose has been reduced to 0.75 mg, and thereafter reduce it by 0.375 mg/day. Idiopathic Restless Legs Syndrome 1. The recommended initial dose is 0.125mg once daily, taken 2~3 hours before bedtime. If additional symptom relief is needed, the dose may be increased every 4~7 days according to the following schedule. Although the dose was increased to as much as 0.75mg in a few patients in long-term open-label clinical trials of this drug, there is no evidence that 0.75mg provides additional benefit over 0.5mg. The lowest effective dose should be used. Dose level 1: Daily dose 0.125mg Dose level 2*: Daily dose 0.25mg Dose level 3*: Daily dose 0.50mg *If needed 2. Patients with renal impairment In patients with restless legs syndrome who have severe or moderate renal impairment (creatinine clearance 20~60mL/min), the dose should be increased every 14 days. 3. Discontinuation of treatment In clinical trials in which patients with restless legs syndrome received up to 0.75mg once daily, this drug was discontinued without dose reduction.

This medication may cause sudden daytime sleep episodes in some patients. Such occurrences can be dangerous when performing activities that require attention, such as driving or operating machinery, so patients should avoid these activities until drowsiness has completely resolved. Additionally, during the use of this medication, patients may experience psychiatric symptoms such as hallucinations or confusion. These symptoms may occur more frequently in elderly patients or those taking other medications, so caution is advised. This medication can cause orthostatic hypotension, which may lead to dizziness or lightheadedness when starting treatment or increasing the dosage. Therefore, patients should frequently monitor their blood pressure and consult a doctor if symptoms are severe. Patients with impaired kidney function may have difficulty excreting this medication, requiring dosage adjustment, and those with heart disease should carefully monitor their blood pressure and heart status during treatment. Possible side effects during treatment include nausea, dizziness, drowsiness, constipation, and weakness, and it is important to consult medical personnel if these symptoms are severe or interfere with daily life. Finally, if this medication is abruptly discontinued, symptoms may worsen, so it should be stopped or dosage adjusted according to a doctor's instructions.

Sudden sleep, drowsiness, automobile accidents, hallucinations, confusion, orthostatic hypotension, nausea, dizziness, insomnia, constipation, weakness, hallucinations, disorientation, amnesia, sensory deficits, ataxia, inability to sit still, abnormal thinking, headache, erectile dysfunction, generalized edema, fatigue, peripheral edema, weight loss, hyperkinesia, extrapyramidal syndrome, accidental injury, abnormal dreams, anxiety, thirst, forgetfulness, frequent urination, dyspnea, rhinitis, pneumonia, skin diseases, abnormal near-far adjustment, diplopia, urinary tract infection, urinary incontinence, vomiting, pruritus, rash, natural penile erection, dopamine agonist withdrawal syndrome, accident, confusion, insomnia, sleep paralysis, intestinal obstruction, dyspepsia, upper abdominal discomfort, gastroesophageal reflux, edema, weakness, binge eating, compulsive shopping, hypersexuality, pathological gambling, abnormal behavior, strange dreams, delusions, hyperphagia, sexual dysfunction, paranoia, restlessness, symptoms of head bending forward, hyperactivity, sudden onset of sleep, fainting, restless legs syndrome, diplopia, blurred vision, decreased vision, heart failure, hypotension, hiccups, constipation, vomiting, fatigue, peripheral edema, dopamine agonist withdrawal syndrome, anemia, iron deficiency anemia, leukocytosis, leukopenia, lymphadenitis, lymphadenopathy, thrombocytosis, thrombocytopenia, angina, ventricular dysrhythmia, atrial fibrillation, first-degree atrioventricular block, second-degree atrioventricular block, bradycardia, bundle branch block, cardiac arrest, congestive heart failure, cardiomegaly, coronary artery occlusion, cyanosis, extrasystole, left ventricular failure, myocardial infarction, nodular dysrhythmia, sinus dysrhythmia, sinus bradycardia, sinus tachycardia, ventricular extrasystole, ventricular tachycardia, tachycardia, ventricular fibrillation, ventricular extrasystole, left ventricular hypertrophy, atrial septal defect, congenital foot deformity, spinal deformity, hearing loss, ear pain, auditory damage, hearing impairment, motion sickness, vestibular function disorder, goiter, hyperthyroidism, hypothyroidism, transient dark vision, eyelid inflammation, eyelid spasms, cataract, acquired tear duct obstruction, dry eyes, ocular hemorrhage, eye irritation, ocular pain, eyelid swelling, drooping eyelids, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular impairment, scotoma, visual impairment, floaters, abdominal discomfort, abdominal bloating, aphthous ulcers, ascites, cheilitis, colitis, ulcerative colitis, duodenal ulcer, duodenal ulcer hemorrhage, enteritis, belching, fecal incontinence, gastric ulcer, gastric ulcer hemorrhage, gastritis, gastrointestinal bleeding, gastroesophageal reflux disease, gingivitis, hematemesis, melena, hemorrhoids, hiatal hernia, hyperchlorhydria, intestinal obstruction, inguinal hernia, intestinal occlusion, irritable bowel syndrome, esophageal spasm, esophageal stricture, esophagitis, pancreatitis, periodontitis, rectal bleeding, reflux esophagitis, glossitis, glossal ulcer, toothache, umbilical hernia, chest discomfort, chills, death, drug withdrawal symptoms, facial swelling, fever sensation, neuralgia, abnormal gait, impaired wound healing function, influenza-like symptoms, irritability, localized swelling, edema, lymphedema, thirst, gallbladder spasm, cholecystitis, chronic cholecystitis, cholelithiasis, drug hypersensitivity, abscess, acute tonsillitis, appendicitis, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, dental caries, diverticulitis, ear infections, folliculitis, fungal infections, furuncles, necrosis, gastroenteritis, gingivitis, herpes simplex, shingles, meibomian cyst, discitis, laryngitis, lobar pneumonia, nail infections, onychomycosis, oral candidiasis, orchitis, osteomyelitis, external otitis, otitis media, periorbital cellulitis, pyelonephritis, pyoderma, septicemia, skin infections, tonsillitis, dental abscess, tooth infection, upper respiratory tract infections, urethritis, vaginal candidiasis, vaginal infections, viral infections, wound site infections, fall accidents, drug toxicity-related gastric joint hypertrophy, traffic accidents, sunburn, tendon rupture, cachexia, appetite loss, dehydration, diabetes, fluid retention, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, vitamin deficiency, increased appetite, metabolic alkalosis, bone pain, myofasciitis, flank pain, intervertebral disc disorder, intervertebral disc protrusion, joint effusion, joint stiffness, joint swelling, monoarthritis, muscle stiffness, muscle cramps, musculoskeletal rigidity, myopathy, myositis, neck stiffness, osteoarthritis, osteonecrosis, osteoporosis, fibromyalgia, rheumatoid arthritis, shoulder pain, spinal osteoarthritis, tendinitis, tendinosis, aneurysm, vasculopathy, atherosclerosis, circulatory disorder, deep vein thrombosis, embolism, thrombus, facial flushing, hypertensive crisis, lymphedema, pallor, phlebitis, Raynaud's disease, shock, thrombophlebitis, thrombus, varicose veins, emotional instability, aggression, anxiety, mental delay, bruxism, suicide, mental confusion, delusional disorder, persecution delusion, loss of orientation, dissociation, emotional tension, euphoria, auditory hallucination, visual hallucination, initial insomnia, increased libido, hypomania, mid-stage insomnia, mood changes, nightmares, obsessive thoughts, obsessive-compulsive disorder, panic response, hypersomnia, personality disorder, mental disorder, restlessness, somnambulism, suicidal impulses, hematuria, urinary difficulties, diabetes, blood in urine, urgency, nephrolithiasis, neurogenic bladder, enuresis, oliguria, polyuria, proteinuria, renal artery stenosis, renal colic, renal cyst, kidney failure, kidney dysfunction, urinary retention, amenorrhea, breast pain, dysmenorrhea, epididymitis, gynecomastia, signs of menopause, menorrhagia, uterine bleeding, ovarian mass, prolonged erection, prostatitis, sexual dysfunction, intrauterine bleeding, leucorrhea, vaginal bleeding, transient respiratory arrest, inhalation, asthma, asphyxia, chronic obstructive pulmonary disease, dry throat, speech impairment, exertional dyspnea, epistaxis, hemoptysis, hiccups, hyperventilation, increased bronchial secretions, laryngospasm, nasal dryness, nasal polyps, obstructive airway abnormalities, throat pain, pleuritis, pneumonia-related inhalation, pneumothorax, post-nasal drip syndrome, productive cough, pulmonary embolism, pulmonary edema, respiratory alkalosis, respiratory distress syndrome, respiratory failure, pulmonary congestion, allergic rhinitis, rhinorrhea, sinus congestion, sleep apnea, sneezing, snoring, hypopnea, wheezing, acne, hair loss, sweating, skin cysts, dermatitis, vesicular dermatitis, contact dermatitis, dry skin, petechiae, eczema, erythema, corneal thickening, livedo reticularis, sweating, periorbital edema, spotty bleeding, photosensitive allergic symptoms, psoriasis, purpura, erythematous eczema, maculopapular erythema, papular erythema, rhinophyma, seborrhea, seborrheic dermatitis, skin burning sensation, skin depigmentation, hyperpigmentation, skin hypertrophy, skin irritation, skin cuts, body odor abnormalities, skin ulcers, urticaria

This medication should be stored in a tightly closed container to protect it from exposure to air and light. The storage temperature should be in a cool place between 1 to 30 degrees Celsius.

Appearance

White oval tablet

Package unit

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