Rasagiline Extended-Release Tablet 0.75 mg (Pramipexole Dihydrochloride Monohydrate)

Adult dose

Idiopathic Parkinson's disease Take this medicine once daily at the same time with water. Swallow it whole without chewing, splitting, or crushing. It may be taken with or without food. If a dose is missed, take this medicine within 12 hours after the scheduled dose time. If 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) 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 it. 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 increases are needed, increase by 0.75mg at 1-week intervals, up to a maximum of 4.5mg daily. Patients already taking immediate-release pramipexole tablets may be switched overnight to this medicine at the same total daily dose. 2) Maintenance therapy The dose per administration ranges from 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, and some patients may experience additional therapeutic benefit at doses higher than 1.5mg. This regimen applies particularly to patients with advanced Parkinson's disease in whom a reduction in the levodopa dose is planned. In patients taking this medicine in combination with levodopa, consider reducing the levodopa dose during dose escalation and maintenance therapy with pramipexole, as this is necessary to avoid excessive dopaminergic stimulation. 2. Patients with renal impairment The elimination of pramipexole varies depending on renal function. For initiation therapy, the following dosing schedule is suggested; Renal function / Initial dose (mg) / Maximum dose (mg) creatinine CL>50ml/min / No adjustment of the daily dose or dosing frequency is necessary. 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, consider use of immediate-release pramipexole tablets. If renal function declines during maintenance therapy, follow the above recommendations for dosing. 3. Discontinuation Reduce the dose by 0.75 mg/day until the daily dose is reduced to 0.75 mg, then reduce it by 0.375 mg/day thereafter.

This medication may cause some patients to suddenly fall asleep or experience severe drowsiness. Care should be taken, especially during daily activities such as driving or operating machinery, as there is a risk of sudden sleep. During the use of this medication, if drowsiness increases, patients should refrain from driving or operating dangerous machinery. Furthermore, care should be taken when used in conjunction with sedatives or in cases of sleep disorders. This medication can cause hallucinations or confusion, which may occur more frequently in elderly patients. Both patients and caregivers should be aware of the potential for hallucinations and consult a doctor immediately if unusual symptoms arise. Orthostatic hypotension may occur, so blood pressure changes should be monitored closely while taking this medication, especially when increasing the dosage. Patients with renal impairment or cardiovascular disease need to adjust the dosage and monitor blood pressure when using this medication. This medication acts as a dopamine agonist, and stopping it abruptly can cause serious symptoms such as neuroleptic malignant syndrome. Therefore, it must be reduced gradually according to a doctor's instructions when discontinuing use. Pregnant or breastfeeding women should administer this medication with caution, considering the potential effects on the fetus or infant. It is particularly recommended to discontinue breastfeeding or the medication during lactation. Safety and efficacy in children and adolescents have not been established, so it is not recommended for use in this population. Elderly patients may experience slower drug elimination due to impaired renal function and should adjust doses accordingly, as the risk of hallucinations may increase. This medication may interact with other medications, so it is crucial to consult a doctor, especially when combined with sedatives, dopamine antagonists, or cimetidine. In case of overdose, symptoms such as nausea, vomiting, hallucinations, and hypotension may appear, so caution is needed. If an overdose occurs, visit a medical facility immediately. This medication should be stored in a tightly closed container that blocks light and kept in a dry place at room temperature between 1°C and 30°C. Proper storage helps maintain the medication's effectiveness over time.

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

This medication should be stored in a light-blocking, tightly closed container and kept in a dry place at room temperature, ideally between 1°C and 30°C. This storage method helps to preserve the medication's efficacy for an extended period.

Appearance

White or light gray, biconvex, round extended-release tablet

Package unit

100 tablets/box [10 tablets/PTP x 10 packs]