Pramipexole Tablet 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. This medicine should be gradually increased in all patients. The dose should be increased to achieve maximum therapeutic benefit while balancing the main adverse effects of dyskinesia, hallucinations, somnolence, and dry mouth. 1. Patients with normal renal function 1) Initiation The initial total daily dose is 0.375mg/day, divided into 3 doses, and is 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 as a total daily dose of 1.5~4.5mg/day, divided into 3 doses, either alone 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 total daily did not provide a 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 approximately twice that with placebo. The incidence of somnolence reported at a dose of 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% compared with the dose immediately before initiation of this medicine (baseline). 2. Patients with renal impairment creatinine CL>50ml/min: No adjustment of the daily dose or dosing frequency is necessary. creatinine CL=20~50ml/min: Initial dose 0.125mg tablet twice daily, maximum dose 2.25mg daily creatinine CL<20ml/min: Initial dose 0.125mg tablet once daily, maximum dose 1.5mg daily 3. Discontinuation Reduce the dose 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. Idiopathic restless legs syndrome 1. The recommended initial 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. In long-term open-label clinical trials of this medicine, some patients had their dose increased to 0.75mg; however, there is no evidence that 0.75mg provides additional benefit over 0.5mg. Take 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 who received 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, sudden drowsiness may occur, so driving a car or operating dangerous machinery should be avoided until drowsiness completely resolves. Particularly, the risk of drowsiness may increase if this medication is taken together with sedatives or other drugs that elevate its blood concentration. Additionally, mental abnormalities such as hallucinations or confusion may occur, and these symptoms are notably more common in the elderly, so careful monitoring is necessary. This medication can lower blood pressure, potentially causing dizziness or orthostatic hypotension, so blood pressure changes should be monitored regularly, and if severe symptoms develop, a physician should be consulted. Dose adjustment is necessary for patients with impaired kidney function or those with cardiovascular disease, and closer observation is required during the early stages of treatment. While taking this medication, side effects such as nausea, constipation, insomnia, and weakness may occur, and patients should inform healthcare professionals if these symptoms persist or worsen. During pregnancy or breastfeeding, the safety of this medication has not been established, so it is essential to consult with a physician before taking it. Additionally, sudden discontinuation of this medication may result in withdrawal symptoms, so dosage should be gradually adjusted according to a physician's instructions when stopping. There may be interactions with other medications, so all medications being taken should be communicated to healthcare professionals, particularly with sedatives, antipsychotics, and blood pressure medications. Elderly patients may experience delayed drug elimination due to declining kidney function, requiring careful dosage adjustments and monitoring for side effects. Finally, this medication should be stored out of the reach of children, and it is safer not to transfer it to another container.

Drowsiness, hallucinations, confusion, orthostatic hypotension, nausea, dizziness, insomnia, constipation, weakness, headache, extrapyramidal syndrome, amnesia, perception impairment, ataxia, inability to sit still, abnormal thinking, abnormal vision, erectile dysfunction, general edema, fatigue, fever, peripheral edema, weight loss, confusion, dyskinesia, accidental injury, abnormal dreams, heightened tension, thirst, increased urination, urinary tract infection, urinary incontinence, arthritis, seizure, bursitis, myasthenia, dyspnea, rhinitis, pneumonia, skin disorders, abnormal near and far vision control, diplopia, increased urination, urinary tract infection, urinary incontinence, influenza, headache, diarrhea, indigestion, congestion, limb pain, sudden sleep occurrence, syncope, restless legs syndrome, amnesia, tilted head symptoms, hyperkinesia, syncope, diplopia, blurred vision, vision reduction, heart failure, hypotension, hiccups, vomiting, pruritus, rash, drug withdrawal syndrome, weight loss, accident, confusion, insomnia, hypersomnia, intestinal obstruction, upper abdominal discomfort, gastroesophageal reflux, weakness, abnormal muscle tone, rhabdomyolysis, pathological gambling, increased libido, hypersexuality, compulsive shopping, drug withdrawal syndrome, ageusia, akinesia, anticholinergic syndrome, aphasia, balance disorders, brain edema, carotid artery occlusion, carpal tunnel syndrome, cerebral embolism, intracranial hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive impairment, coma, seizure, coordination movement disorder, dementia, decreased perceptual level, attention deficit, positional dizziness, stuttering, writing disorder, facial paralysis, grand mal seizure, hemiplegia, sensory hyperesthesia, hyperkinesia, hyperreflexia, hyporeflexia, hypotonia, somnolence, loss of consciousness, amnesia, migraine, involuntary muscle contractions, narcolepsy, neuralgia, neuropathy, nystagmus, dysosmia, psychomotor agitation, sciatica, sedation, sensory disorders, sleep rhythm disorder, sleep talking, confusion, vagal syncope, tension headaches, emotional instability, aggression, anxiety, mental retardation, bruxism, suicide, mental confusion, delusional disorder, paranoia, disorientation, dissociation, emotional tension, euphoria, auditory hallucinations, visual hallucinations, early insomnia, increased libido, hypomania, mid insomnia, mood changes, nightmares, obsessive thoughts, obsessive-compulsive disorder, panic response, hypersomnia, personality disorders, mental disorders, restlessness, somnambulism, suicidal impulses, chromaturia, urination difficulties, diabetes, hematuria, urinary urgency, nephrolithiasis, neurogenic bladder, nocturia, oliguria, polyuria, proteinuria, renal artery stenosis, nephralgia, renal cysts, renal failure, renal impairment, urinary retention, amenorrhea, mastalgia, dysmenorrhea, epididymitis, gynecomastia, menopause symptoms, menorrhagia, uterine bleeding, ovarian mass, priapism, prostatitis, sexual dysfunction, intrauterine bleeding, leukorrhea, vaginal bleeding, transient respiratory arrest, inspiration, asthma, asphyxia, chronic obstructive pulmonary disease, throat dryness, speech disorders, exertional dyspnea, epistaxis, hemoptysis, hiccups, hyperventilation, increased bronchial secretion, laryngeal spasm, nasal dryness, nasal polyps, obstructive airway abnormalities, throat pain, 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 cysts, dermatitis, vesicular dermatitis, contact dermatitis, dry skin, petechiae, eczema, erythema, corneal thickening, livedoid dermatitis, flushing, periorbital edema, petechial hypersensitivity allergic symptoms, psoriasis, purpura, erythematous eczema, maculopapular erythema, erythema nodosum, rhinophyma, seborrhea, seborrheic dermatitis, skin burning sensation, skin depigmentation, skin hyperpigmentation, skin hypertrophy, skin irritation, skin laceration, body odor abnormalities, skin ulcers, urticaria, aneurysm, vascular pathology, arteriosclerosis, circulatory disorders, deep vein thrombosis, embolism, thrombus, facial flushing, hypertensive posturing, lymphedema, pallor, phlebitis, Raynaud's disease, shock, thrombotic phlebitis, thrombus, varicose veins

This medication should be stored in a tightly sealed container to protect it from air and light exposure. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius to maintain the drug's efficacy and safety for an extended period.

Appearance

White round tablet

Package unit

For oral use - 100 tablets/box [10 tablets/PTP x 10 packs]