Pramipexole 0.125 mg Tablets (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease In all clinical trials, treatment was initiated at a dose lower than the therapeutic dose (subtherapeutic level) to avoid excessive adverse effects and orthostatic hypotension. This medicine should be gradually increased in all patients. The dose should be increased to achieve the greatest therapeutic effect while balancing the major adverse effects of dyskinesia, hallucinations, somnolence, and dry mouth. Patients with normal renal function Initiation regimen: The initial total daily dose is 0.375mg/day, given in 3 divided doses, 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 than this. Maintenance regimen: Administer a total daily dose of 1.5~4.5mg/day of this medicine in 3 divided doses, either alone or in combination with levodopa (approximately 800mg/day). When this medicine is used in combination with levodopa, consider reducing the levodopa dose. In patients with advanced Parkinson's disease, the levodopa dose was reduced by an average of 27% from baseline immediately before starting this medicine. 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 per day creatinine CL<20ml/min: Initial dose 0.125mg tablet once daily, maximum dose 1.5mg per day 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. Idiopathic restless legs syndrome 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. Dose level 1: Daily dose 0.125mg Dose level 2*: Daily dose 0.25mg Dose level 3*: Daily dose 0.50mg *If needed In long-term open-label clinical trials, the dose was increased to 0.75mg in a few patients; however, there is no evidence demonstrating additional benefit with 0.75mg compared with 0.5mg. Use the lowest effective dose. Patients with renal impairment: In patients with restless legs syndrome and severe or moderate renal impairment (creatinine clearance 20~60mL/min), increase the dose every 14 days. 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 medication poses a risk that treated patients may suddenly fall asleep during everyday activities such as driving a car or operating machinery. Even if there are no severe drowsiness symptoms, patients and caregivers should be aware of this possibility. Increased caution is necessary when used with sedatives or medications that raise the blood concentration of this drug. If drowsiness is felt or sudden sleep episodes occur during the day while taking this medication, patients should stop driving or dangerous tasks and consult a physician. Additionally, this drug may cause psychiatric adverse reactions such as hallucinations or confusion, and these effects are more common in older patients. Should hallucinations occur, they may affect the ability to drive or perform daily activities; therefore, patients and caregivers should carefully monitor for these symptoms. This drug can affect blood pressure control, potentially leading to orthostatic hypotension, which can cause dizziness or fainting when standing up suddenly. Patients, particularly those with cardiovascular disease or reduced kidney function, should have their blood pressure status frequently checked and dosage adjusted accordingly. As this drug is excreted via the kidneys, patients with impaired kidney function may require a dose reduction, and it should be administered with caution in those with severe heart disease. During treatment, symptoms of dyskinesia or muscle rigidity may occur due to the characteristics of dopamine agonists; if symptoms arise, patients should consult their physician. Sudden discontinuation of this drug may lead to withdrawal symptoms such as apathy, anxiety, depression, and fatigue; therefore, it should be gradually reduced under a physician's directive. The safety of this drug during pregnancy has not been established, and it may affect the fetus, so women who are pregnant or planning to become pregnant should consult their physician. Women who are nursing should discuss whether to continue breastfeeding, as this drug may be excreted in breast milk. It is generally advised not to administer this medication to children as its safety and efficacy have not been confirmed. Elderly patients may experience slower excretion of this drug due to declining kidney function, and the risk of side effects like hallucinations is increased, hence caution is warranted. There may be interactions with other medications while taking this drug, so patients should inform their physician or pharmacist of other medications they are using. Overdose may lead to symptoms such as nausea, vomiting, hyperactivity, hallucinations, excitement, and hypotension; in case of doubt, immediate medical attention should be sought. Finally, this drug should be stored out of the reach of children and not transferred to other containers for safety.

• Sudden sleep and drowsiness
• hallucinations
• confusion
• orthostatic hypotension
• nausea
• dizziness
• insomnia
• constipation
• lethargy
• headache

This drug may be sensitive to air and light, so it should be kept in a tightly sealed container. It is advisable to maintain storage temperature between 1°C and 30°C at room temperature. To maintain the drug's efficacy, store it in a dark place away from direct light.

Appearance

White round tablets

Package unit

100 tablets (10 tablets/PTP × 10)