Rasagiline Extended-Release Tablets 0.375 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

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 dose 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 regimen Week 1: Total daily dose 0.375mg, dose 0.375mg Week 2: Total daily dose 0.75mg, dose 0.75mg Week 3: Total daily dose 1.50mg, dose 1.50mg The initial total daily dose is 0.375mg/day and should be increased gradually. Dose increases should be made approximately once every 5-7 days and no more frequently. 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 further 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 be switched to the same daily dose of this product, with the first dose taken the following night. 2) Maintenance regimen The dose per administration is 0.375mg to a maximum of 4.5mg daily. In pivotal clinical trials, efficacy was observed at a daily dose of 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 the levodopa dose is planned. In patients taking this product in combination with levodopa, a reduction in levodopa should be considered during pramipexole dose escalation and maintenance therapy, as needed to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment Pramipexole elimination varies according to renal function. For initiation therapy, the following dosage schedule is recommended; creatinine CL>50ml/min: No adjustment to the daily dose or dosing frequency is necessary. creatinine CL=30~50ml/min: 0.375mg every other day, 2.25mg once daily creatinine CL<30ml/min: Use of this product in these patients has not been adequately studied; use of immediate-release pramipexole should be considered. If renal function declines during maintenance therapy, administer the dose 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.

This drug acts as a dopamine agonist and is used for the treatment of Parkinson's disease. During treatment, there may be sudden sleep episodes or increased drowsiness, therefore driving or operating hazardous machinery should be avoided until mental status stabilizes. Particular caution is required when taken with sedatives, when sleep disorders are present, or when taken with other drugs that increase blood concentration. This drug may cause hallucinations or confusion more frequently in elderly patients, and if these symptoms appear, consultation with a doctor is immediately necessary. Orthostatic hypotension may occur due to a sudden drop in blood pressure, so blood pressure should be checked periodically when starting treatment or increasing doses, and caution should be exercised in case of dizziness or fainting. Patients with impaired kidney function may have delayed drug elimination, thus requiring dose adjustments, and patients with cardiovascular diseases should also take the drug cautiously. Side effects such as nausea, dizziness, insomnia, constipation, weakness, hallucinations, etc. may occur in some patients, and consultation with a doctor is important if symptoms are severe. Abnormal behaviors or impulse control disorders, excessive libido, and pathological gambling may appear during treatment, so family members or caregivers should observe and report any anomalies. Safety during pregnancy has not been established, so consultation with a doctor is essential if pregnancy is planned or if a patient is pregnant. Women who are breastfeeding should consider that this drug may be excreted in breast milk and should carefully decide whether to continue breastfeeding or use the drug. The safety of this drug in children has not been established, hence it should not be used in pediatric patients. Elderly patients should be carefully monitored for dose adjustments and adverse effects due to potential decreased kidney function leading to slower drug elimination. Overdosing can lead to symptoms such as nausea, vomiting, hallucinations, hypotension, therefore it is crucial to adhere to the prescribed dosage. During treatment, there may be potential drug interactions with other medications, particularly with dopamine antagonists, sedatives, cimetidine, etc., so it is advised to inform the doctor and proceed with caution.

• Drowsiness
• hallucinations
• confusion
• orthostatic hypotension
• nausea
• dizziness
• insomnia
• constipation
• weakness
• headache

This drug should be stored in a tightly sealed container that blocks light and kept at a temperature between 1°C and 30°C. It should be stored in a dry place with low humidity to maintain its efficacy.

Appearance

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

Package unit

100 tablets/PTP [10 tablets/PTP x 10 units]