Mirap 0.5 mg (Pramipexole Hydrochloride Dihydrate)

Adult dose

Idiopathic Parkinson's disease In all clinical trials, treatment was initiated at a subtherapeutic dose to avoid excessive adverse effects and orthostatic hypotension. The dose of this medicine should be increased gradually in all patients. Increase the dose to the level that provides the maximum therapeutic effect while maintaining a balance with the major adverse effects of dyskinesia, hallucinations, somnolence, and dry mouth. 1. Patients with normal renal function 1) Initiation The starting total daily dose is 0.375mg/day, divided into 3 doses per day, and gradually increased. 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 Increase the dose approximately once every 5-7 days, and do not increase it more frequently. The dose increments recommended based on clinical trials are as follows. 2) Maintenance This medicine 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 a clinical trial in patients with early Parkinson's disease, doses of 3mg, 4.5mg, and 6mg per day did not provide significant benefit compared with 1.5mg/day. However, the following adverse reactions were dose-related in the same trial: postural hypotension, nausea, constipation, somnolence, and amnesia. At doses of 3mg/day or more, the incidence of these adverse reactions was generally about 2 times higher than with placebo. The incidence of somnolence reported with this medicine at 1.5mg/day was similar to that with placebo. When this medicine is used in combination with levodopa, a reduction in the levodopa dose should be considered. In a clinical trial in patients with advanced Parkinson's disease, the levodopa dose was reduced by an average of 27% from the dose immediately before initiation of this medicine (baseline). 2. Patients with renal impairment creatinine CL>50ml/min: No adjustment of daily dose or dosing frequency is required. creatinine CL=20~50ml/min: Starting dose 0.125mg tablet 2 times daily, maximum dose 2.25mg daily creatinine CL<20ml/min: Starting dose 0.125mg tablet once daily, maximum dose 1.5mg daily 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. Idiopathic restless legs syndrome 1. The recommended starting 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 some patients in long-term open-label clinical trials of this medicine had their dose increased up to 0.75mg, there is no evidence that 0.75mg provides additional benefit over 0.5mg. Use the lowest effective dose. 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 patients with restless legs syndrome treated with up to 0.75mg once daily, this medicine was discontinued without dose reduction.

This drug is a dopamine agonist used for the treatment of Parkinson's disease and Restless Legs Syndrome. During treatment with this medication, there is a risk of suddenly falling asleep or experiencing severe drowsiness, so caution is especially advised when driving or operating hazardous machinery. Sedatives or sleep disorders may exacerbate drowsiness, and if taken with specific medications, it is essential to consult with a physician. Hallucinations may occur and are particularly more common in older patients, so immediate reporting of such symptoms is necessary. Due to a potential drop in blood pressure causing orthostatic hypotension, patients should move slowly when experiencing dizziness or light-headedness and consult a doctor. Patients with poor renal function or cardiovascular disease should have their dosage adjusted and blood pressure monitored regularly. Before taking this medication, it is crucial to check for any allergic reactions. If allergic, do not take this medication. In pregnant or nursing women, the safety of this medication has not been established, so careful decision after consulting a doctor is necessary. During treatment, abnormal behaviors such as pathological gambling, excessive sexual urges, or compulsive shopping may appear, so monitoring by family or guardians is essential. Drug interactions may exist, so if currently taking other medications, inform your doctor or pharmacist. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and low blood pressure may occur, so immediate medical attention is necessary, and be cautious as hemodialysis is not effective. This drug should be kept out of reach of children and should not be transferred to other containers for safety.

Drowsiness, hallucination, confusion, orthostatic hypotension, nausea, dizziness, insomnia, constipation, weakness, headache, extrapyramidal syndrome, amnesia, sensory reduction, ataxia, inability to sit still, abnormal thinking, dystonic muscle spasm, abnormal vision, erectile dysfunction, accidental injuries, generalized edema, fatigue, chest pain, movement disorders, abnormal dreams, confusion, abnormal gait, tension increase, frequent urination, urinary tract infection, incontinence, diarrhea, dyspepsia, influenza, headache, congestion, limb pain, diplopia, dyspnea, rhinitis, pneumonia, skin disease, anemia, iron deficiency anemia, leukocytosis, leukopenia, lymphadenitis, lymphadenopathy, thrombocytosis, thrombocytopenia, angina pectoris, ventricular arrhythmia, atrial fibrillation, first-degree atrioventricular block, second-degree atrioventricular block, bradycardia, block of conduction, cardiac arrest, heart failure, congestive heart failure, cardiomegaly, coronary artery occlusion, cyanosis, extrasystole, left ventricular failure, myocardial infarction, nodal arrhythmia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, ventricular extrasystole, ventricular tachycardia, tachycardia, ventricular fibrillation, ventricular extrasystole, ventricular hypertrophy, hearing loss, ear pain, auditory damage, hearing impairment, motion sickness, vestibular dysfunction, goiter, hyperthyroidism, hypothyroidism, transient dark vision, blepharitis, eyelid twitching, cataract, acquired lacrimal duct obstruction, dry eyes, retinal hemorrhage, eye irritation, ocular pain, brow edema, drooping eyelids, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular disorder, scotoma, blurred vision, decreased eyesight, vitreous floaters, abdominal discomfort, abdominal bloating, aphthous ulcer, ascites, cheilitis, colitis, ulcerative colitis, duodenal ulcer, duodenal hemorrhage, enteritis, belching, fecal incontinence, gastric ulcer, gastric hemorrhage, gastritis, gastrointestinal bleeding, gastroesophageal reflux disease, gingivitis, hematemesis, melena, hemorrhoids, hiatal hernia, hyperchlorhydria, intestinal obstruction, inguinal hernia, bowel obstruction, irritable bowel syndrome, esophageal spasm, esophageal stricture, esophagitis, pancreatitis, periodontitis, rectal bleeding, reflux esophagitis, tongue edema, tongue ulcer, toothache, umbilical hernia, thoracic discomfort, chills, death, drug withdrawal symptoms, facial swelling, fever, neurosensitivity, 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, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, caries, diverticulitis, otitis media, folliculitis, fungal infection, furuncle, gangrene, gastroenteritis, gingivitis, herpes simplex, herpes zoster, xanthelasma, spondylitis, laryngitis, lobar pneumonia, nail infection, onychomycosis, oral candidiasis, orchitis, osteomyelitis, external otitis, otitis media, paronychia, pyelonephritis, pyoderma, sepsis, skin infection, tonsillitis, dental abscess, dental infection, upper respiratory tract infection, urethritis, vaginal candidiasis, vaginal infection, viral infection, wound infection, falling accident, drug toxicity-related gastric-pyloric ulcer, traffic accident, sunburn, tendon rupture, cachexia, decreased appetite, dehydration, diabetes, fluid retention, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, vitamin deficiency, increased appetite, metabolic alkalosis, bone pain, myofascitis, flank pain, intervertebral disc disorder, intervertebral disc herniation, 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, tendinitis, tenosynovitis, abdominal tumor, adenoma, benign adenoma, basal cell carcinoma, bladder cancer, breast cancer, breast tumor, chronic lymphocytic leukemia, colorectal cancer, rectal cancer, endometrial cancer, gallbladder cancer, stomach cancer, gastrointestinal tumors, angioma, liver tumor, malignant liver tumor, oral and lip cancer, malignant lung tumor, metastatic lung cancer, lymphoma, malignant melanoma, melanocytic nevus, lung metastasis, multiple myeloma, benign oral tumor, tumor, malignant tumor, prostate tumor, skin tumor, neuroma, ovarian cancer, prostate cancer, prostatic adenoma, pseudolymphoma, kidney tumor, skin cancer, skin papilloma, squamous cell carcinoma, thyroid tumor, uterine leiomyoma, ageusia, akinesia, anticholinergic syndrome, aphasia, balance disorder, cerebral edema, carotid artery occlusion, carpal tunnel syndrome, cerebral artery embolism, cerebral hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive impairment, coma, convulsion, coordination disorder, dementia, decreased perceptual level, attention deficit, position-related dizziness, stuttering, writing disorder, facial paralysis, generalized tonic-clonic seizure, hemiplegia, sensory hypersensitivity, hyperkinesia, hyperreflexia, hyporeflexia, hypotonia, somnolence, loss of consciousness, migraine, involuntary muscle contraction, narcolepsy, neuralgia, neuropathy, nystagmus, abnormal olfaction, psychomotor agitation, sciatica, sedation, sensory disturbance, sleep rhythm disturbance, sleep talking, stupor, vasovagal syncope, tension headache, emotional instability, aggression, anxiety, mental retardation, bruxism, suicide, mental confusion, delusion disorder, paranoid delusion, loss of direction, dissociation, emotional tension, euphoria, auditory hallucinations, visual hallucinations, initial insomnia, increased libido, hypomania, mid insomnia, mood changes, nightmares, obsessive thoughts, obsessive-compulsive disorder, panic response, hypersomnia, personality disorder, mental illness, restlessness, sleepwalking, suicidal ideation, color incontinence, dysuria, diabetes, hematuria, urgency, nephrolithiasis, neurogenic bladder, enuresis, oliguria, polyuria, proteinuria, renal artery stenosis, renal colic, renal cyst, renal failure, renal impairment, urinary retention, amenorrhea, mastalgia, dysmenorrhea, epididymitis, gynecomastia, menopausal symptoms, menorrhagia, uterine bleeding, ovarian tumor, priapism, prostatitis, sexual dysfunction, uterine hemorrhage, leukorrhea, vaginal bleeding, transient respiratory arrest, inhalation, asthma, asphyxia, chronic obstructive pulmonary disease, pharyngeal dryness, speech disorder, exertional dyspnea, epistaxis, hemoptysis, hiccups, tachypnea, airway secretions increase, laryngospasm, nasal dryness, nasal polyps, obstructive airway abnormalities, pharyngeal pain, pleuritis, aspiration pneumonia, pneumothorax, postnasal drip syndrome, productive cough, pulmonary embolism, pulmonary edema, respiratory alkalosis, respiratory distress syndrome, respiratory failure, pulmonary congestion, allergic rhinitis, postnasal drip, sinus congestion, sleep apnea, sneezing, snoring, hyperventilation, wheezing, acne, hair loss, sweating, skin cyst, dermatitis, vesicular dermatitis, contact dermatitis, dry skin, purpura, eczema, erythema, corneal thickening, reticular pigmentary disorder, sweating, periorbital edema, petechiae, phototoxic allergy symptoms, psoriasis, purpura, erythematous eczema, papular erythema, strawberry nose, seborrhea, seborrheic dermatitis, skin burning sensation, skin depigmentation, skin peeling, skin hyperpigmentation, skin overgrowth, skin irritation, skin laceration, body odor abnormality, skin ulcer, urticaria, aneurysm, vascular disease, atherosclerosis, circulatory disorders, deep vein thrombosis, embolism, thrombus, facial flushing, hypertensive eruptions, lymphatic edema, pallor, phlebitis, Raynaud's disease, shock, thrombotic phlebitis, thrombus, varicose veins

This medication is sensitive to light, so it should be kept in a special container that does not allow light to enter. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness over time.

Appearance

White oval tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)