Pramipexole Extended-Release Tablets 1.5 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinsonism Take this medicine once daily at the same time with water. Swallow it whole; do not chew, divide, or crush it. It may be taken with or without food. If you miss a dose, 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 scheduled dosing plan. 1. Patients with normal renal function 1) Initiation regimen Week Total daily dose (mg) Dose (mg) 1 0.375 0.375 2 0.75 0.75 3 1.50 1.50 Start with a total daily dose of 0.375mg/day and gradually increase the dose. 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. If further dose increases are needed, the dose may be increased by 0.75mg at 1-week intervals, up to a maximum daily dose of 4.5mg. Patients already taking immediate-release pramipexole may switch to this medicine at the same daily dose, beginning the following night. 2) Maintenance therapy The dose per administration is 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 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 levodopa dose is planned. In patients taking this medicine with levodopa, a reduction in levodopa dose should be considered during pramipexole dose escalation and maintenance therapy, as needed to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment Pramipexole clearance depends on renal function. For initiation therapy, the following dosage schedule is suggested; Renal function Starting 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 every 2 days 2.25mg once daily creatinine CL<30ml/min Use of this medicine in these patients has not been adequately studied; therefore, treatment with immediate-release pramipexole should be considered. If renal function declines during maintenance therapy, follow the recommendations above. 3. Discontinuation Reduce the daily dose by 0.75 mg/day until the daily dose reaches 0.75 mg, and thereafter reduce it by 0.375 mg/day.

This medication is a dopamine agonist used for the treatment of Parkinson's disease. During treatment, symptoms such as sudden sleep attacks or severe drowsiness may occur, so extreme caution is necessary when driving a vehicle or operating dangerous machinery. If there are sedatives or sleep disturbances, or if taken with other medications, drowsiness may increase, so be sure to inform your doctor. This medication may cause psychological symptoms such as hallucinations or confusion, which may occur more frequently in elderly patients, so patients and caregivers should closely monitor for these symptoms. Orthostatic hypotension, characterized by a sudden drop in blood pressure, may occur, so blood pressure should be frequently checked, especially when beginning treatment or increasing the dose. Patients with impaired kidney function or cardiovascular diseases require dose adjustments and careful observation when administering this medication. Women who are pregnant or breastfeeding should be cautious as the safety of this medication is not established, and it should be used under medical supervision; discontinuation of breastfeeding is recommended during treatment. This medication may interact with other drugs, so inform your doctor or pharmacist if you are taking any other medications. Additionally, abruptly stopping this medication may cause serious side effects, so doses should be adjusted gradually according to your doctor's instructions. Elderly patients may have slower drug elimination due to decreased kidney function, increasing the risk of adverse reactions, thus caution is advised. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and hypotension may occur, requiring immediate medical attention, and as there is no specific antidote, treatment will be based on symptoms. Finally, this medication should be stored out of reach of children and protected from light and moisture.

Drowsiness, hallucinations, confusion, orthostatic hypotension, nausea, dizziness, insomnia, constipation, weakness, headache, disorientation, amnesia, sensory diminution, ataxia, inability to sit still, abnormal thinking, extrapyramidal muscle spasms, abnormal vision, erectile dysfunction, generalized edema, fatigue, appetite loss, dysphagia, peripheral edema, weight loss, confusion, movement disorder, extrapyramidal syndrome, vertigo, accidental injury, abnormal dreams, increased tension, frequent urination, hypokinesia, sudden sleep onset, syncope, diplopia, blurred vision, vision loss, heart failure, hypotension, tinnitus, vomiting, pruritus, rash, incident, delirium, intestinal obstruction, hyperkinesia, headache, sudden sleep onset, syncope, amnesia, movement disorder, drowsiness, insomnia, hallucinations, confusion, orthostatic hypotension, thirst, forgetfulness, accidental injury, chest pain, arthritis, convulsions, bursitis, myasthenia gravis, rhinitis, pneumonia, skin conditions, frequent urination, urinary tract infection, urinary incontinence, fall accident, drug toxicity-related gastric joint bulging, traffic accident, sunburn, tendon rupture, cachexia, appetite decrease, dehydration, diabetes, fluid retention, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, vitamin deficiency, increased appetite, metabolic alkalosis, bone pain, fasciitis, flank pain, intervertebral disc disorder, intervertebral disc herniation, joint effusion, joint stiffness, joint swelling, monoarthritis, muscle rigidity, muscle cramps, musculoskeletal rigidity, myopathy, myositis, neck stiffness, osteoarthritis, osteonecrosis, osteoporosis, fibromyalgia, rheumatoid arthritis, shoulder pain, spinal osteoarthritis, tendinitis, tenosynovitis, abdominal discomfort, abdominal bloating, aphthous ulcer, ascites, cheilitis, colitis, ulcerative colitis, duodenal ulcer, duodenal ulcerative hemorrhage, enteritis, belching, fecal incontinence, gastric ulcer, gastric ulcerative hemorrhage, gastritis, gastrointestinal bleeding, gastroesophageal reflux disease, gingivitis, hematemesis, melena, hemorrhoids, hiatal hernia, excessive hydrochloric 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, drug withdrawal symptoms, facial edema, fever, neuroexcitability, abnormal gait, impaired wound healing, influenza-like symptoms, irritability, localized edema, edema, characteristic edema, thirst, gallbladder spasm, cholecystitis, chronic cholecystitis, cholelithiasis, drug hypersensitivity, abscess, acute tonsillitis, appendicitis, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, cavity, diverticulitis, otitis, eye infection, folliculitis, fungal infection, furuncle, gangrene, gastroenteritis, gingivitis, herpes simplex, shingles, chalazion, intervertebral discitis, laryngitis, lobar pneumonia, nail infection, onychomycosis, oral candidiasis, orchitis, osteomyelitis, otitis externa, otitis media, perionychitis, pyelonephritis, purulent skin disease, sepsis, skin infection, tonsillitis, dental abscess, dental infection, upper respiratory infection, urethritis, vaginal candidiasis, vaginitis, viral infection, wound site infection, fall accident, drug toxicity-related gastric joint bulging, traffic accident, sunburn, tendon rupture, 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, extrasystole, left ventricular failure, myocardial infarction, nodal arrhythmia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, ventricular extrasystole, ventricular tachycardia, tachycardia, ventricular fibrillation, ventricular extrasystole, left ventricular hypertrophy, palpitations, hearing loss, earache, auditory damage, hearing impairment, motion sickness, vestibular dysfunction, goiter, hyperthyroidism, hypothyroidism, transient darkening of vision, blepharitis, eyelid spasm, cataract, acquired nasolacrimal duct obstruction, dry eyes, ocular hemorrhage, ocular irritation, ocular pain, eyebrow edema, ptosis, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular disorder, scotoma, blurred vision, vision loss, vitreous floaters, abdominal tumors, adenoma, benign adenoma, basal cell carcinoma, bladder cancer, breast cancer, breast tumor, chronic lymphocytic leukemia, colon cancer, rectal cancer, endometrial cancer, gallbladder cancer, gastric cancer, gastrointestinal tumors, hemangioma, liver tumors, malignant liver tumors, oral cavity and lip cancer, malignant lung tumors, metastatic lung cancer, lymphoma, malignant melanoma, melanocytic nevi, lung metastasis, multiple myeloma, benign oral tumors, tumors, malignant tumors, prostate tumors, skin tumors, neuroma, ovarian cancer, prostate cancer, prostate adenoma, pseudolymphoma, kidney tumors, skin cancer, skin papilloma, squamous cell carcinoma, thyroid tumors, uterine leiomyoma, ageusia, akinesia, anticholinergic syndrome, aphasia, dysbalance, cerebral edema, carotid artery occlusion, carpal tunnel syndrome, cerebral artery embolism, cerebral hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive impairment, coma, convulsions, coordination dysfunction, dementia, decreased perception level, attention deficit, orthostatic dizziness, stuttering, writing disability, facial paralysis, grand mal seizures, hemiparesis, hypersensitivity, hyperkinesia, hyperreflexia, hyporeflexia, hypotonia, drowsiness disorder, loss of consciousness, migraine, involuntary muscle contractions, narcolepsy, neuralgia, neuropathy, nystagmus, abnormal olfaction, psychomotor excitability, sciatica, sedation, sensory impairment, sleep rhythm disorder, somniloquy, stupor, vasovagal syncope, tension headache, emotional instability, aggression, anxiety, mental retardation, bruxism, suicide, mental confusion, delusional disorder, persecution complex, disorientation, dissociation, emotional tension, euphoria, auditory hallucinations, visual hallucinations, initial insomnia, increased libido, hypomania, middle insomnia, mood swings, nightmares, obsessive thinking, obsessive-compulsive disorder, panic reactions, hypersomnia, personality disorders, mental disorders, restlessness, sleepwalking, suicidal impulses, chromaturia, 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 mass, persistent erection, prostatitis, sexual dysfunction, uterine bleeding, leucorrhea, vaginal bleeding, transient apnea, inhalation, asthma, asphyxia, chronic obstructive pulmonary disease, dry throat, speech disorders, motor dyspnea, epistaxis, hemoptysis, tinnitus, hyperventilation, increased bronchial secretions, laryngismus, 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, shallow breathing, wheezing, acne, hair loss, sweating, skin cysts, dermatitis, vesicular dermatitis, contact dermatitis, dry skin, petechial hemorrhage, eczema, erythema, keratoconus, livedoid vasculitis, sweating, periorbital edema, petechiae, phototoxic allergy symptoms, psoriasis, purpura, erythematous eczema, maculopapular erythema, papular erythema, rhinophyma, seborrhea, seborrheic dermatitis, skin burning sensation, skin depigmentation, skin peeling, skin hyperpigmentation, skin hypertrophy, skin irritation, skin laceration, body odor abnormalities, skin ulcer, urticaria

This medication is sensitive to light and should be stored in a special container that prevents light exposure. Additionally, it should be stored at room temperature between 1 degree Celsius and 30 degrees Celsius in a dry place without moisture in order to maintain its efficacy.

Appearance

White or light gray, bilaterally convex, round extended-release tablets

Package unit

100 tablets (10 tablets/PTP x 10)