Madopar Dispersible Tablets 125

Adult dose

1. This drug is administered to patients with dysphagia, patients who prefer to take it dissolved in water, or patients who require a more rapid onset of action, such as when taking the first dose in the morning or when a trough in blood concentration occurs. 2. Treatment with this drug should be gradually titrated, as with conventional levodopa treatment. Furthermore, regardless of the stage of the disease, the dosage and administration should be individualized, and treatment should be initiated at the lowest possible dose. The following dosage regimen may therefore be used as a guide. 3. Dissolve this drug in 1/4 cup of water (25 - 50ml)—not fruit juice, milk, or hot water. This drug dissolves rapidly and completely within a few minutes, forming a milky-white solution. Since sediment forms quickly, stir the solution before taking it and take it promptly. Take this drug within 30 minutes after dissolution. When switching from standard therapy, differences in pharmacokinetics (rapid absorption) should be considered. To prevent dietary protein from competing with levodopa and to promote a more rapid onset of action, it is recommended, if possible, to take this drug 30 minutes before or 1 hour after meals. Gastrointestinal adverse reactions may occur early in treatment, but can be managed by taking this drug with a low-protein meal or drink, or by increasing the dose slowly. Initial therapy In patients with early-stage Parkinson's disease, it is advisable to initiate treatment with 1/2 tablet 3-4 times daily. Patients with more advanced disease should receive twice the above dose. Once tolerability of the initial regimen is established, increase the number of daily doses by 1 at weekly intervals (e.g., 4 times daily instead of 3 times daily). If the patient can be closely monitored, the dose may also be adjusted at intervals of 2-3 days. Optimal effects are generally achieved with a total daily dose of 4-8 tablets of this drug, divided into 3-4 doses. If a further increase in the daily dose is required, increase it at monthly intervals. It may take 4-6 weeks to reach the optimal dose. Maintenance therapy The average maintenance dose is 1 tablet 4-6 times daily. The number of daily doses (at least 3 times daily) and the dosing intervals should be determined and adjusted for each patient. Special dosage and administration Antiparkinsonian drugs other than levodopa may be continued until the full therapeutic effect of this drug is achieved, but their doses can often be gradually reduced after this drug takes effect. If marked fluctuations in therapeutic effect (on-off phenomenon) occur during treatment, it is recommended to reduce the dose per administration and increase the frequency of administration, or to administer HBS capsules (levodopa/benserazide).

This drug should not be used in patients with severe endocrine disorders. It should also be avoided in patients with severely impaired liver or kidney function. It is safer not to administer this drug to patients with severe heart disease or mental disorders. Patients under 25 years of age should ensure their skeletal development is complete before using it, and treatment should be stopped if pregnancy is suspected or occurred. Patients with a history of malignant melanoma or closed-angle glaucoma should not use this drug. Patients with hypersensitivity to this drug or those currently taking non-selective MAO inhibitors should avoid this drug. Patients with mild liver or kidney impairment, open-angle glaucoma, a history of myocardial infarction or heart failure, osteomalacia or peptic ulcer, and diabetic patients should take this drug cautiously, with regular monitoring and examinations required. This drug may cause side effects such as decreased blood cell counts, loss of appetite, depression, anxiety, hallucinations, drowsiness, arrhythmias, hypotension, nausea, vomiting, diarrhea, skin rashes, and so on. Elderly patients or those with a history of mental or neurological conditions should be particularly careful as they are more likely to experience mental abnormalities. Additionally, regular blood tests and liver and kidney function tests should be conducted during extended usage. This drug should be discontinued before surgery, and abrupt discontinuation can lead to serious neurological side effects, so it should be gradually tapered down. Caution is required during driving or operating machinery as drowsiness or lethargy may occur. Behavioral changes such as impulse control disorders may present, which should be recognized and observed by the patient and caregiver. This drug may interact with other medications, so caution should be exercised particularly when used with non-selective MAO inhibitors, sympathomimetics, antihypertensives, antipsychotics, vitamin B6, antacids, and iron supplements. Taking it with high-protein food may reduce its efficacy. Women who are pregnant or breastfeeding should ideally avoid this drug, and women of childbearing potential should employ appropriate contraceptive methods. This drug may affect the results of clinical tests, so it should be disclosed to the healthcare personnel during tests. In case of overdose, serious cardiovascular, psychiatric, gastrointestinal symptoms, and abnormal involuntary movements may occur, necessitating immediate medical attention.

• Hemolytic anemia
• transient leukopenia
• thrombocytopenia
• loss of appetite
• depression
• agitation
• anxiety
• insomnia
• hallucinations
• delusions

This drug should be stored in an airtight container to protect from air exposure and kept away from humid areas. It is also advisable to store it in a cool place below 25 degrees Celsius.

Appearance

Almost white, round tablet

Package unit

100 tablets/bottle