Mirap Sustained Release Tablet 1.5 mg (Pramipexole Hydrochloride Dihydrate)

Adult dose

Idiopathic Parkinson's disease Take this medicine once daily at the same time with water. Swallow it whole without chewing, splitting, or crushing it. It may be taken with or without food. If a dose is missed, take this medicine within 12 hours after the scheduled dosing 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 of therapy Start with a total daily dose of 0.375mg/day and gradually increase it. Increase the dose approximately 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. Week Total daily dose (mg) Dose (mg) 1 0.375 0.375 2 0.75 0.75 3 1.50 1.50 If further increases are needed, the dose may be increased by 0.75mg at weekly intervals up to a maximum of 4.5mg daily. Patients already taking immediate-release pramipexole may switch to this medicine at the same total daily dose, with the switch made overnight. 2) Maintenance therapy The dose per administration ranges from 0.375mg to a maximum of 4.5mg daily. In pivotal clinical trials, efficacy was observed at daily doses starting from 1.5mg during dose titration in both early and advanced Parkinson's disease. Some patients may experience additional therapeutic benefit at doses higher than 1.5mg. This regimen is particularly applicable to patients with advanced Parkinson's disease for whom a reduction in levodopa dose is planned. In patients taking this medicine with levodopa, a reduction in levodopa should be considered during pramipexole dose increases and maintenance therapy, as necessary to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment Pramipexole elimination depends on renal function. The following dosing schedule is proposed for initiation of therapy: Renal function Initial dose (mg) Maximum dose (mg) creatinine CL>50ml/min No adjustment to the daily dose or dosing frequency is required. creatinine CL=30~50ml/min 0.375mg once every 2 days 2.25mg once daily creatinine CL<30ml/min As the use of this medicine in these patients has not been adequately studied, use of immediate-release pramipexole should be considered. If renal function declines during maintenance therapy, follow the recommendations above. 3. Discontinuation Reduce the dose of this medicine 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.

This medication may cause sudden sleep or drowsiness during administration, so special caution is required when driving or operating dangerous machinery. If drowsiness worsens while taking this medication, contact a doctor immediately, especially if sedatives or sleep disorders are present. Mental abnormalities such as hallucinations or confusion may occur, so elderly patients should be closely monitored for these symptoms. This medication may lower blood pressure, leading to symptoms of orthostatic hypotension, such as dizziness or fainting upon standing. Patients with impaired kidney function or cardiovascular disease should adjust the dosage or consult a doctor before administration. This medication may interact with other drugs, so if there are any concomitant medications, ensure to inform your doctor or pharmacist. During pregnancy or breastfeeding, the safety of this medication has not been established, so it should only be administered after consulting a doctor. It is not recommended for children since the safety and efficacy of this medication have not been established in this population. Elderly patients may have reduced kidney function leading to slower drug excretion; therefore, dosage adjustment and monitoring for adverse reactions are necessary. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and low blood pressure may occur, and immediate contact with a healthcare facility is required. When storing this medication, keep it out of the reach of children and store it away from light and moisture, without transferring it to another container.

Drowsiness, hallucinations, confusion, nausea, dizziness, vertigo, insomnia, constipation, weakness, amnesia, perception decline, ataxia, inability to sit still, abnormal thoughts, myoclonic jerks, abnormal vision, erectile dysfunction, general edema, fatigue, weight loss, peripheral edema, movement disorders, extrapyramidal syndrome, headache, confusion, accidental injury, abnormal dreams, increased anxiety, thirst, frequent urination, decreased motor activity, chest pain, sensory disturbances, palpitations, conjunctivitis, paralysis, abnormal near vision control, tinnitus, diplopia, taste distortion, orthostatic hypotension, ataxia, tension headache, sleep disorders, syncope, diplopia, blurred vision, decreased vision, heart failure, hypotension, hiccups, vomiting, pruritus, rash, drug withdrawal symptoms, facial edema, feverish sensation, gallbladder cramps, cholecystitis, cholelithiasis, drug hypersensitivity, abscess, acute tonsillitis, appendicitis, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, dental caries, diverticulitis, otitis media, eye infection, folliculitis, fungal infection, furuncle, necrosis, gastroenteritis, gingivitis, herpes simplex, herpes zoster, molluscum contagiosum, intervertebral discitis, laryngitis, lobar pneumonia, nail infection, onychomycosis, oral candidiasis, orchitis, osteomyelitis, external otitis, otitis media, periorbital cellulitis, pyelonephritis, purulent 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-induced interstitial nephritis, traffic accidents, 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, myofascial syndrome, flank pain, intervertebral disc disorder, disc herniation, joint effusion, joint stiffness, joint swelling, monoarthritis, muscle stiffness, muscle cramps, musculoskeletal rigidity, myopathy, myositis, neck stiffness, osteoarthritis, necrosis of bone, osteoporosis, multiple myalgia, rheumatoid arthritis, shoulder pain, spinal osteoarthritis, tendinitis, tenosynovitis, abdominal tumor, adenoma, benign adenoma, basal cell carcinoma, bladder cancer, breast cancer, breast tumor, chronic lymphocytic leukemia, colon cancer, rectal cancer, endometrial cancer, gallbladder cancer, stomach cancer, gastrointestinal tumors, hemangioma, liver tumor, malignant liver tumor, lip and/or oral cancer, malignant lung tumor, metastatic lung cancer, lymphoma, malignant melanoma, melanocytic nevus, pulmonary metastasis, multiple myeloma, benign oral tumor, tumor, malignant tumor, 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, akinetic syndrome, anticholinergic syndrome, aphasia, balance disorder, brain edema, carotid artery occlusion, carpal tunnel syndrome, cerebral artery embolism, cerebral hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive impairment, coma, seizures, coordination disorders, dementia, decreased perceptual level, attention deficit, orthostatic dizziness, stuttering, writing difficulties, facial paralysis, grand mal seizures, hemiplegia, sensory hypersensitivity, hyperkinesia, hyperreflexia, hypotonia, sleepiness, loss of consciousness, migraine, involuntary muscle contractions, narcolepsy, neuralgia, neuropathy, nystagmus, parosmia, psychomotor agitation, sciatica, sedation, sensory disorders, sleep rhythm disorder, sleepwalking, confusion, vasovagal syncope, tension headache, emotional instability, aggression, anxiety, mental retardation, bruxism, suicide, mental confusion, delusional disorder, paranoid delusion, loss of orientation, dissociation, emotional tension, intoxication, auditory hallucinations, visual hallucinations, early insomnia, increased libido, hypomania, intermediate insomnia, mood swings, nightmares, obsessive thoughts, obsessive-compulsive disorder, panic reactions, hypersomnia, personality disorders, mental disorders, restlessness, somnambulism, suicidal impulses, color urine, dysuria, diabetes, hematuria, urgent urination, 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, signs of menopause, menorrhagia, uterine bleeding, ovarian mass, priapism, prostatitis, sexual dysfunction, uterine hemorrhage, leukorrhea, vaginal bleeding, transient respiratory arrest, inspiratory, asthma, asphyxia, chronic obstructive pulmonary disease, dry throat, speech disorder, exertional dyspnea, epistaxis, hemoptysis, hiccup, tachypnea, bronchial secretions increase, laryngospasm, nasal dryness, nasal polyps, obstructive airway abnormality, pharyngodynia, pleuritis, aspiration pneumonia, pneumothorax, post-nasal drip syndrome, productive cough, pulmonary embolism, pulmonary edema, respiratory alkalosis, respiratory distress syndrome, respiratory failure, respiratory congestion, allergic rhinitis, rhinorrhea, sinus congestion, sleep apnea, sneezing, snoring, hypoventilation, wheezing, acne, alopecia, sweating, skin cyst, dermatitis, vesicular dermatitis, contact dermatitis, dry skin, petechiae, eczema, erythema, corneal pachycephaly, livedoid vasculopathy, hyperhidrosis, periocular edema, petechial hemorrhage, photosensitivity allergic symptoms, psoriasis, purpura, eczematous erythema, papular erythema, rhinophyma, seborrhea, seborrheic dermatitis, skin burning sensation, skin depigmentation, skin hyperpigmentation, skin hypertrophy, skin irritation, skin laceration, body odor, skin ulcer, urticaria, aneurysm, angiopathy, arteriosclerosis, circulatory disorders, deep venous thrombosis, embolism, thrombus, facial flushing, hypertensive dermopathy, lymphatic edema, pallor, phlebitis, Raynaud's disease, shock, thrombophlebitis, thrombus, varicose veins

This medication is sensitive to light and should be stored in a container that can block light. Additionally, it should be stored at room temperature between 1 and 30 degrees Celsius in a dry place with low humidity to maintain its effectiveness.

Appearance

White or light gray, biconvex, rectangular sustained-release tablet

Package unit

PTP - 100 tablets/PTP [100 tablets (10 tablets/PTP packaging x 10)], bottle - 100 tablets/bottle, bottle - 30 tablets/bottle