Pramipexole Extended Release Tablet 0.375 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease This medicine should be taken once daily at the same time with water. Swallow it whole without chewing, dividing, or crushing it. It may be taken with or without food. If you miss a dose, take this medicine within 12 hours after the scheduled dose time. If more than 12 hours have passed, skip the missed dose and take the next dose according to the next scheduled dosing plan. 1. Patients with normal renal function 1) Initial treatment Week 1: Total daily dose (mg) 0.375, dose (mg) 0.375 Week 2: Total daily dose (mg) 0.75, dose (mg) 0.75 Week 3: Total daily dose (mg) 1.50, dose (mg) 1.50 The initial dose is a total of 0.375mg/day and should be gradually increased. Increase the dose approximately once every 5-7 days, and do not increase it more frequently than this. If intolerable adverse reactions do not occur, the dose may be increased up to the maximum therapeutic dose. The increases recommended based on clinical trials are as follows. If a further increase is 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 be switched to this medicine at the same total daily dose, with the switch made overnight. 2) Maintenance treatment The dose per administration ranges from 0.375mg per day to a maximum of 4.5mg per day. In pivotal clinical trials, efficacy was observed at daily doses of 1.5mg and above during dose escalation in both early and advanced Parkinson's disease; some patients may experience 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 medicine concomitantly with levodopa, a reduction in the levodopa dose should be considered during pramipexole dose escalation and maintenance treatment, as necessary to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment Pramipexole elimination depends on renal function. For initial treatment, the following dosing schedule is proposed; Renal function: creatinine CL>50ml/min — No adjustment of daily dose or dosing frequency is required. Renal function: creatinine CL=30~50ml/min — Initial dose 0.375mg every 2 days, maximum dose 2.25mg once daily. Renal function: creatinine CL<30ml/min — 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 treatment, administer the medicine according to the recommendations above. 3. Discontinuation Reduce the daily dose by 0.75 mg/day until the daily dose is reduced to 0.75 mg, and thereafter reduce it by 0.375 mg/day each day.

This medication is used for the treatment of Parkinson's disease and works by stimulating dopamine receptors to alleviate symptoms. During treatment, sudden sleepiness or drowsiness may occur, so caution is advised when engaging in hazardous activities such as driving or operating machinery. In particular, if taken with sedatives or if there are sleep disorders, drowsiness may become more severe, so consult a physician. Additionally, this medication can cause psychiatric symptoms such as hallucinations or confusion, which may occur more frequently in older patients. Symptoms of orthostatic hypotension, such as sudden drops in blood pressure, may also appear; thus, careful monitoring of blood pressure is necessary when starting the medication or increasing the dosage. Patients with decreased kidney function may have delayed drug excretion, requiring dosage adjustments, and patients with cardiovascular diseases should also take this medication with caution. This medication may cause side effects in some patients including nausea, dizziness, insomnia, constipation, weakness, hallucinations, confusion, memory loss, sensory loss, ataxia, akathisia, abnormal thinking, abnormal vision, erectile dysfunction, orthostatic hypotension, movement disorders, dizziness, abnormal dreams, accidental injuries, increased tension, forgetfulness, frequent urination, pneumonia, skin diseases, rhinitis, urinary tract infections, urinary incontinence, sweating, itching, rash, fatigue, peripheral edema, headache, and drowsiness. Pregnant or breastfeeding women should consult their physician before taking this medication as its safety has not been sufficiently established. Since this medication can interact with other drugs, caution is necessary, particularly when taken with drugs like cimetidine, sedatives, or alcohol, and it is not recommended to be taken with dopamine antagonists. During treatment, abnormal behavioral changes or impulse control disorders may occur, so patients and their guardians should recognize these symptoms and consult medical personnel immediately if abnormalities arise. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and low blood pressure may appear, and medical attention should be sought immediately. Finally, this medication should be stored in a tightly sealed container protected from light and humidity, out of reach of children, and should not be transferred to another container.

Drowsiness, hallucinations, confusion, nausea, dizziness, insomnia, constipation, weakness, headache, disorientation, extrapyramidal syndrome, amnesia, perceptual decline, ataxia, inability to sit still, abnormal thinking, focal dystonia, abnormal vision, erectile dysfunction, general edema, fatigue, appetite loss, dysphagia, peripheral edema, weight loss, dizziness, insomnia, amnesia, ataxia, movement disorders, vertigo, accidental injury, abnormal dreams, increased tension, frequent urination, hyperkinesia, sudden sleep onset, syncope, diplopia, blurred vision, decreased vision, heart failure, hypotension, hiccups, vomiting, pruritus, rash, accident, confusion, insomnia, hypersomnia, intestinal obstruction, akinesia, aphasia, equilibrium disturbance, cerebral edema, carotid artery occlusion, carpal tunnel syndrome, cerebral embolism, cerebral hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive impairment, coma, seizures, coordination dysfunction, dementia, attention disorder, stuttering, facial paralysis, grand mal seizures, hemiparesis, hypersensitivity, hyperreflexia, hyporeflexia, hypotonia, 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 headaches, emotional instability, aggression, anxiety, mental retardation, bruxism, suicide, mental confusion, delusions, paranoia, disorientation, dissociation, emotional tension, intoxication, auditory hallucinations, visual hallucinations, early insomnia, increased libido, bipolar disorder, intermediate insomnia, mood changes, nightmares, obsessive thoughts, obsessive-compulsive disorder, panic reactions, hypersomnia, personality disorders, mental disorders, restlessness, sleepwalking, suicidal thoughts, color urine syndrome, urinary difficulty, diabetes, hematuria, urgency, nephrolithiasis, neurogenic bladder, nocturia, oliguria, polyuria, proteinuria, renal artery stenosis, renal colic, renal cysts, renal failure, renal impairment, urinary retention, amenorrhea, mastalgia, dysmenorrhea, epididymitis, gynecomastia, menopausal symptoms, menorrhagia, uterine bleeding, ovarian tumors, priapism, prostatitis, sexual dysfunction, intrauterine bleeding, leucorrhea, vaginal bleeding, transient apnea, inhalation, asthma, choking, chronic obstructive pulmonary disease, throat dryness, speech disorders, exertional dyspnea, epistaxis, hemoptysis, hiccups, tachypnea, bronchial secretion increase, laryngospasm, nasal dryness, nasal polyps, obstructive airway abnormalities, throat 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, rhinorrhea, sinus congestion, sleep apnea syndrome, sneezing, snoring, hyperventilation, wheezing, acne, hair loss, sweating, skin cysts, dermatitis, vesicular dermatitis, contact dermatitis, dry skin, petechiae, eczema, erythema, corneal thickening, livedo reticularis, diaphoresis, periorbital edema, petechiae, photophobic allergy symptoms, psoriasis, purpura, erythematous eczema, maculopapular erythema, papular erythema, rhinophyma, seborrhea, seborrheic dermatitis, skin burning sensation, skin depigmentation, skin exfoliation, skin hyperpigmentation, skin hypertrophy, skin irritation, skin laceration, abnormal body odor, skin ulcers, urticaria, aneurysm, vascular diseases, atherosclerosis, circulatory disorders, deep vein thrombosis, embolism, thrombus, facial flushing, hypertensive onset, lymphedema, pallor, phlebitis, Raynaud's disease, shock, thrombotic phlebitis, thrombus, varicose veins, anemia, iron deficiency anemia, leukocytosis, leukopenia, lymphadenitis, lymphadenopathy, thrombocytosis, thrombocytopenia, angina pectoris, ventricular arrhythmias, atrial fibrillation, first-degree AV block, second-degree AV block, bradycardia, ventricular block, cardiac arrest, congestive heart failure, cardiomegaly, coronary artery occlusion, cyanosis, ectopic beats, left ventricular failure, myocardial infarction, nodular arrhythmia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, ventricular ectopy, ventricular tachycardia, tachycardia, ventricular fibrillation, ventricular ectopy, ventricular hypertrophy, hearing loss, ear pain, auditory damage, hearing impairment, motion sickness, vestibular dysfunction, goiter, hyperthyroidism, hypothyroidism, transient dark adaptation, blepharitis, eyelid spasms, cataracts, acquired lacrimal duct obstruction, dry eyes, ocular hemorrhage, ocular irritation, eye pain, eyebrow edema, ptosis, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular disorders, scotoma, blurred vision, vision impairment, vitreous floaters, 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, hematochezia, hemorrhoids, hiatal hernia, hyperchlorhydria, intestinal obstruction, inguinal hernia, bowel obstruction, irritable bowel syndrome, esophageal spasms, esophageal stricture, esophagitis, pancreatitis, periodontitis, rectal bleeding, reflux esophagitis, glossitis, tongue ulcer, toothache, umbilical hernia, chest discomfort, chills, drug withdrawal symptoms, facial edema, fever, neuroexcitability, wound healing dysfunction, influenza-like symptoms, irritability, localized edema, lymphedema, thirst, biliary colic, cholecystitis, chronic cholecystitis, cholelithiasis, drug hypersensitivity, abscess, acute tonsillitis, appendicitis, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, dental caries, diverticulitis, otitis media, external otitis, middle ear infection, paronychia, pyelonephritis, pyoderma, sepsis, skin infections, tonsillitis, dental abscess, tooth infection, upper respiratory tract infection, urethritis, vaginal candidiasis, vaginal infection, viral infection, wound site infection, fall accidents, drug toxicity-related gastric wall erosions, traffic accidents, sunburn, tendon rupture, cachexia, loss of appetite, dehydration, diabetes mellitus, fluid retention, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, vitamin deficiency, increased appetite, metabolic alkalosis, bone pain, fascia inflammation, flank pain, intervertebral disc disorders, intervertebral disc protrusion, joint effusion, joint stiffness, joint swelling, monoarthritis, muscle stiffness, muscle cramps, musculoskeletal rigidity, myopathy, myositis, nuchal stiffness, osteoarthritis, osteonecrosis, osteoporosis, polymyalgia rheumatica, rheumatoid arthritis, shoulder pain, spondyloarthritis, tendonitis, tenosynovitis, abdominal tumors, adenoma, benign adenoma, basal cell carcinoma, bladder cancer, breast cancer, breast tumors, chronic lymphocytic leukemia, colorectal cancer, rectal cancer, endometrial cancer, gallbladder cancer, stomach cancer, gastrointestinal tumors, hemangioma, liver tumors, malignant liver tumors, lip and oral cancer, malignant lung tumors, metastatic lung cancer, lymphoma, malignant melanoma, melanocytic nevi, pulmonary metastasis, multiple myeloma, benign oral tumors, tumors, malignant tumors, prostate tumors, skin tumors, neuroma, ovarian cancer, prostate cancer, prostatic adenoma, pseudolymphoma, kidney tumors, skin cancer, skin papilloma, squamous cell carcinoma, thyroid tumors, uterine leiomyoma

This medication should be stored in a closed container that blocks light, at room temperature between 1 to 30 degrees Celsius. It should also be kept in a dry place free from moisture to maintain its effectiveness.

Appearance

White or light gray, double convex, round extended-release tablet

Package unit

100 tablets (10 tablets/PTP x 10)