Ropirinol Sustained Release Tablet 2mg (Ropinirole Hydrochloride)

Adult dose

1. Adults The recommended dose should be individualized based on efficacy and tolerability. This medicine should be taken once daily at the same time each day. It may be taken with or without food. Swallow this medicine whole. Do not chew, crush, or split it. 1) Initial therapy For the first week, administer 2mg of this medicine (extended-release tablet) once daily. Starting in the second week of treatment, increase the dose to 4mg once daily. A therapeutic response may occur at 4mg per day. 2) Maintenance therapy When administering this medicine (extended-release tablet), continue treatment at the lowest dose that controls symptoms. If symptom control is inadequate or is not maintained with 4mg once daily, increase the dose in increments of 2mg each week (or over a longer period) until the daily dose reaches 8mg. If symptom control is inadequate or is not maintained with 8mg once daily, increase the daily dose in increments of 2mg or 4mg at intervals of 2 weeks or longer. The maximum daily dose of this medicine is 24mg. If treatment is interrupted for 1 day or more, restarting treatment should be considered according to the initial therapy dosing schedule. When ropinirole is administered concomitantly with levodopa, the levodopa dose may be gradually reduced according to the clinical response. In clinical trials, the levodopa dose was gradually reduced by up to approximately 30% in patients receiving this medicine (extended-release tablet) concomitantly with levodopa. In patients with advanced Parkinson's disease receiving concomitant levodopa, dyskinesia may occur early in treatment with this medicine (extended-release tablet). In such cases, the levodopa dose should be reduced. If ropinirole is to be used as a substitute for another dopamine agonist, the other dopamine agonist should be discontinued according to its recommended method before starting ropinirole. As with other dopamine agonists, ropinirole should be discontinued by gradually reducing the daily dose over 1 week. 3) Switching from ropinirole immediate-release tablets to this medicine (extended-release tablet) Ropinirole immediate-release tablets may be replaced with this medicine (extended-release tablet) overnight. The dose of this medicine should be selected according to the following dosage table, based on the patient's total daily dose of ropinirole immediate-release tablets. Total daily dose of ropinirole immediate-release tablets (mg) → Total daily dose of ropinirole extended-release tablets (mg) 0.75-2.25 → 2 3-4.5 → 4 6 → 6 7.5-9 → 8 12 → 12 15-18 → 16 21 → 20 24 → 24 After switching from ropinirole immediate-release tablets to this medicine (extended-release tablet), the dose should be adjusted according to the therapeutic response. 2. Administration to elderly patients Because ropinirole clearance is decreased in patients aged 65 years or older, the dose should be increased more gradually according to the clinical response. In very elderly patients, slower dose escalation during the initial period of treatment should be considered. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance 30-50mL/min), as ropinirole clearance is unchanged.

This drug should be used with caution in patients with serious heart or vascular problems. When used in conjunction with antihypertensive medications or medications that regulate heart rhythm, there may be a risk of side effects such as hypotension or arrhythmias. Patients with significant mental illnesses should carefully weigh the risks and benefits of using this drug. Sudden daytime sleepiness or drowsiness may occur during treatment, so patients should avoid hazardous activities such as driving or operating machinery if these symptoms appear. Patients who are allergic to this drug, those with severe kidney or liver dysfunction, pregnant or breastfeeding women, and those with lactose intolerance should not use this drug. Patients with severe heart disease or allergies to specific dyes in this drug should use it with caution. Various side effects such as drowsiness, dizziness, hypotension, indigestion, and swelling may occur while taking this drug, and patients should consult with their doctor if any abnormal symptoms arise. Symptoms like mental confusion, hallucinations, or impulse control disorders may appear, so careful observation is necessary. If sudden drowsiness or sleep occurs during treatment, a dose reduction or discontinuation may be necessary. This drug should not be abruptly discontinued but should be tapered gradually, as abrupt cessation can lead to severe side effects. It is advisable not to use this drug in combination with other dopamine agonists, and it may interact with certain antibiotics, smoking, hormone therapies, etc., so patients should inform their doctor about other medications or lifestyle habits. It should not be used during pregnancy or lactation, and its safety has not been confirmed for children or adolescents under 18 years of age. In cases of overdose, there may be heart and nervous system issues, so immediate medical attention should be sought.

Hallucinations, drowsiness, akathisia, dizziness, sudden sleep, orthostatic hypotension, hypotension, nausea, constipation, peripheral edema, hypersensitivity reactions (including urticaria, angioedema, rash, itching), confusion, delusions, hallucinations, psychiatric reactions including paranoia, impulse control disorder, hypersexuality, pathological gambling, compulsive shopping, binge eating, aggression, syncope, excessive daytime sleepiness, vomiting, chest pain, abdominal pain, liver reactions, primarily elevated liver enzymes, lower limb edema

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is also recommended to keep the medication at room temperature between 1 to 30 degrees Celsius, avoiding locations that are too hot or too cold.

Appearance

Pink, double-convex, film-coated sustained release tablet in rectangular shape

Package unit

28 tablets/box [14 tablets/PTP*2]