Mirap 0.125 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 medication is used to treat Parkinson's disease and restless legs syndrome, and there are several precautions to take when using it. First, during treatment, sudden sleepiness or increased drowsiness may occur, so driving or operating hazardous machinery should be avoided until drowsiness completely clears after taking the medication. Second, psychiatric symptoms such as hallucinations or confusion may arise, so older patients should be particularly cautious about these symptoms, and if they are severe, they should consult a doctor immediately. Third, this medication can lower blood pressure, potentially leading to dizziness or orthostatic hypotension, so blood pressure changes should be monitored carefully, especially when starting treatment or increasing the dosage. Fourth, patients with impaired kidney function may require dosage adjustments, and patients with cardiovascular diseases should monitor blood pressure closely from the onset of treatment. Fifth, this medication may interact with other drugs, so especially when taking sedatives, cimetidine, and other medications, doctors should be informed and caution should be exercised. Sixth, women who are pregnant or breastfeeding should only use this medication if necessary due to uncertain safety, and during breastfeeding, consideration should be given to either stopping breastfeeding or reassessing the need for medication because the drug may pass into breast milk. Seventh, special caution is needed for children and the elderly, as older individuals might experience increased drug concentration due to decreased kidney function, requiring dosage adjustments. Finally, stopping this medication abruptly may lead to withdrawal symptoms, so dosage reduction should be done gradually following the doctor's instructions and any adverse reactions should be reported to healthcare providers immediately.

Drowsiness, hallucinations, confusion, orthostatic hypotension, nausea, dizziness, insomnia, constipation, weakness, generalized edema, fatigue, memory loss, decreased perception, ataxia, inability to sit still, abnormal thinking, convulsions, abnormal vision, erectile dysfunction, dyskinesia, extrapyramidal syndrome, accidental injury, abnormal dreams, disorientation, abnormal gait, hypertonia, thirst, forgetfulness, frequent urination, urinary tract infection, incontinence, headache, diarrhea, dyspepsia, influenza, congestion, limb pain, diplopia, dyspnea, rhinitis, pneumonia, skin disorders, anemia, iron deficiency anemia, leukocytosis, leukopenia, lymphadenitis, lymphadenopathy, thrombocytosis, thrombocytopenia, angina, ventricular arrhythmia, atrial fibrillation, first-degree atrioventricular block, second-degree atrioventricular block, bradycardia, complete block, cardiac arrest, heart failure, congestive heart failure, cardiomegaly, coronary artery occlusion, cyanosis, premature contraction, left ventricular failure, myocardial infarction, nodal arrhythmia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, ventricular premature contraction, ventricular tachycardia, tachycardia, ventricular fibrillation, ventricular ectopic beats, left ventricular hypertrophy, hearing loss, ear pain, hearing damage, hearing impairment, motion sickness, vestibular function disorder, goiter, hyperthyroidism, hypothyroidism, transient darkening of vision, blepharitis, eyelid spasms, cataract, acquired canalicular obstruction, dry eye syndrome, conjunctival hemorrhage, eye irritation, ocular pain, eyelid edema, drooping eyelids, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular disorder, scotoma, blurred vision, decreased vision, vitreous floaters, abdominal discomfort, abdominal bloating, aphthous ulcers, 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 stools, hemorrhoids, hiatal hernia, hypersecretion of gastric acid, intestinal obstruction, inguinal hernia, bowel obstruction, irritable bowel syndrome, esophageal spasm, esophageal stricture, esophagitis, pancreatitis, periodontitis, rectal bleeding, reflux esophagitis, tongue swelling, tongue ulcer, toothache, umbilical hernia, chest discomfort, chills, death, drug withdrawal symptoms, facial edema, fever, nervous hyperactivity, abnormal gait, impaired wound healing, influenza-like symptoms, irritation, localized edema, edema, lymphatic edema, thirst, biliary colic, cholecystitis, chronic cholecystitis, cholelithiasis, drug hypersensitivity, abscess, acute tonsillitis, appendicitis, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, dental caries, diverticulitis, otitis, folliculitis, fungal infection, furuncle, necrosis, gastroenteritis, gingivitis, herpes simplex, herpes zoster, millia, intervertebral discitis, laryngitis, lobar pneumonia, nail infection, onychomycosis, oral candidiasis, orchitis, osteomyelitis, otitis externa, otitis media, perionychia, pyelonephritis, pyoderma, sepsis, skin infection, tonsillitis, dental abscess, dental infection, upper respiratory tract infection, urethritis, vaginal candidiasis, vaginal infection, viral infection, wound infection, fall accident, drug toxicity-related gastric joint myopathy, 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 disorders, disc herniation, joint effusion, joint stiffness, joint swelling, monoarthritis, muscle stiffness, muscle cramps, musculoskeletal stiffness, myopathy, myositis, neck stiffness, osteoarthritis, osteonecrosis, osteoporosis, fibromyalgia, rheumatoid arthritis, shoulder pain, spinal osteoarthritis, tendinitis, tendinopathy, 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, gastric cancer, gastrointestinal tumors, hemangioma, liver tumor, malignant liver tumor, oral cavity and lip cancer, malignant lung tumor, metastatic lung cancer, lymphoma, malignant melanoma, melanocytic nevi, pulmonary metastasis, multiple myeloma, benign oral tumors, tumors, malignant tumors, prostate tumor, skin tumor, neuroma, ovarian cancer, prostate cancer, prostate 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 embolism, cerebral hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive impairment, coma, convulsions, coordination dysfunction, dementia, decreased perceptual level, attention deficit disorder, position-induced dizziness, stuttering, writing disorder, facial paralysis, grand mal seizures, hemiparesis, hypersensitivity, hyperkinesia, hyperreflexia, hyporeflexia, hypotonia, somnolence, loss of consciousness, migraine, involuntary muscle contractions, narcolepsy, neuralgia, neuropathy, nystagmus, abnormal olfaction, psychomotor agitation, sciatica, sedation, sensory disorders, sleep rhythm disorders, sleep talking, confusion, vasovagal syncope, tension headache, emotional instability, aggression, anxiety, mental retardation, bruxism, suicide, mental confusion, delusional disorders, paranoia, loss of orientation, dissociation, emotional tension, euphoria, auditory hallucinations, visual hallucinations, early insomnia, increased libido, hypomania, middle insomnia, mood changes, nightmares, obsessive thoughts, obsessive-compulsive disorder, panic reaction, hypersomnia, personality disorders, mental disorders, restlessness, sleepwalking, suicidal ideation, chromaturia, dysuria, diabetes, hematuria, urgency, nephrolithiasis, neurogenic bladder, enuresis, oliguria, polyuria, proteinuria, renal artery stenosis, nephralgia, renal cyst, renal failure, kidney dysfunction, urinary retention, amenorrhea, mastalgia, dysmenorrhea, epididymitis, gynecomastia, menopausal symptoms, menorrhagia, uterine bleeding, ovarian cyst, priapism, prostatitis, sexual dysfunction, uterine bleeding, leukorrhea, vaginal bleeding, transient respiratory arrest, inhalation, asthma, asphyxia, chronic obstructive pulmonary disease, dry throat, speech disorder, exertional dyspnea, epistaxis, hemoptysis, hiccups, hyperventilation, increased bronchial secretions, laryngospasm, nasal dryness, nasal polyps, obstructive airway disorders, pharyngodynia, pleurisy, aspiration pneumonia, pneumothorax, postnasal 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, hypoventilation, wheezing, acne, hair loss, sweating, skin cyst, dermatitis, bullous dermatitis, contact dermatitis, skin dryness, petechiae, eczema, erythema, keratoconus, livedo, flushing, periorbital edema, petechial hemorrhage, photoreactive allergy symptoms, psoriasis, purpura, erythematous eczema, papular erythema, strawberry nose, seborrhea, seborrheic dermatitis, skin burning, skin depigmentation, skin peeling, skin pigmentation excess, skin hypertrophy, skin irritation, skin lacerations, body odor abnormalities, skin ulcers, urticaria

This medication should be stored in a container that does not allow light exposure because it is sensitive to light. It is also important to maintain a storage temperature between 1 and 30 degrees Celsius to keep the drug's effectiveness for a long time.

Appearance

White round tablet

Package unit

100 tablets (10 tablets/PTP packaging x 10)