Tridopa Tablets 150/37.5/200 mg

Adult dose

Take 1 tablet per dose orally, with or without food. Each tablet is a single dose; take it whole without splitting or crushing it. The appropriate daily dose for each patient should be determined carefully by adjusting the levodopa dose. It is preferable to select one of the available strengths of this medicine (levodopa/carbidopa/entacapone 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, 150/37.5/200mg, or 200/50/200mg) and take 1 tablet per dose. Instruct patients to take only 1 tablet per dose. Patients taking 70mg~100mg or less of carbidopa per day are more likely to experience nausea and vomiting. Experience with total daily doses of carbidopa of 200mg or more is limited, whereas the maximum recommended daily dose of entacapone is 2000mg and the maximum recommended daily dose of levodopa is 1500mg. Therefore, the maximum recommended daily dose is 10 tablets for this medicine 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, and 150/37.5/200mg, and 7 tablets for this medicine 200/50/200mg. In general, this medicine may be used in patients currently being treated with a standard formulation of levodopa/a dopa decarboxylase inhibitor and entacapone at doses equivalent to those in this medicine. 1. Switching to this medicine in patients previously receiving levodopa/a dopa decarboxylase inhibitor (carbidopa or benserazide) and entacapone: 1) Patients currently receiving a standard formulation of levodopa/carbidopa and entacapone at doses equivalent to those in this medicine may switch directly to this medicine. For example, a patient taking levodopa/carbidopa 50/12.5mg and entacapone 200mg 4 times daily may instead take 1 tablet of this medicine 50/12.5/200mg 4 times daily. 2) For patients currently receiving a standard formulation of levodopa/carbidopa and entacapone at doses that are not equivalent to those in this medicine, carefully titrate the dose to achieve the optimal clinical effect. The initial dose of this medicine should be set to be as close as possible to the patient's current total daily levodopa dose. 3) When switching patients receiving a standard formulation of levodopa/benserazide and entacapone to this medicine, discontinue levodopa/benserazide on the night before starting treatment and begin taking this medicine the next morning. Start treatment with a dose of this medicine equivalent to, or slightly (5~10%) greater than, the patient's previous levodopa dose. 2. Switching to this medicine in patients not currently taking entacapone: In patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved by standard therapy with levodopa/a dopa decarboxylase inhibitor, treatment with this medicine at a dose equivalent to their current therapy may be considered. However, direct switching from standard therapy with levodopa/a dopa decarboxylase inhibitor to this medicine is not recommended in patients with dyskinesia or those taking a daily levodopa dose of 800mg or more. In these patients, it is preferable to administer entacapone as a separate tablet and adjust (reduce) the levodopa dose if necessary before switching to this medicine. Entacapone enhances the effect of levodopa. Therefore, a reduction in the levodopa dose of approximately 10-30% may be necessary within 1 to 1 week after starting this medicine, particularly in patients with dyskinesia. The daily levodopa dose may be reduced by extending the dosing interval or reducing the levodopa dose per administration, according to the patient's clinical condition. 3. Dose adjustment during treatment If an increase in levodopa is necessary, increase the frequency of administration of this medicine according to the dosage and administration described above, or consider increasing the dose within the recommended range. If a reduction in levodopa is necessary, reduce the total daily amount of this medicine by extending the dosing interval and reducing the frequency of administration, or by reducing the dose of this medicine administered. If another levodopa medicine is administered concomitantly with this medicine, observe the maximum recommended dose. - Discontinuation of this medicine: When discontinuing this medicine (levodopa/carbidopa/entacapone) and switching the patient to levodopa/a dopa decarboxylase inhibitor, adjustment of the doses of other antiparkinsonian medicines, particularly levodopa, is necessary to control the symptoms of Parkinson's disease. - Older adults: Dose adjustment of this medicine is not required in older adults. - Patients with hepatic impairment: Use this medicine with caution in patients with mild to moderate hepatic impairment. Dose adjustment (reduction) may be necessary. - Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone. No specific reports are available on the pharmacokinetics of levodopa and carbidopa in patients with renal impairment. Use this medicine with caution in patients with severe renal impairment, including patients undergoing dialysis.

Child dose

- Pediatric patients: The safety and efficacy of this drug in patients 18 years of age or younger have not been evaluated. Therefore, administration of this drug is not recommended in patients 18 years of age or younger.

This medication contains multiple components and is used in the treatment of Parkinson's disease. Serious side effects such as rhabdomyolysis, which can occur after severe extrapyramidal symptoms or neuroleptic malignant syndrome, have been reported rarely. These symptoms include muscle stiffness, high fever, changes in mental status, and autonomic nervous system dysfunction, and early detection and treatment are very important. If this medication is suddenly discontinued, symptoms may worsen, so the dosage should be gradually reduced, and other dopaminergic medications should be considered if necessary. This medication should not be administered to specific patients, such as those allergic to it, pregnant or breastfeeding women, individuals with severe liver disease, patients with glaucoma, and those with a history of certain neurological disorders. Additionally, it should not be combined with specific antidepressants or neuroleptics, and consultation with a pharmacist or physician is mandatory before administration. Patients with impaired liver or kidney function, a history of heart disease or mental disorders, and those with a history of gastrointestinal ulcers should use this medication cautiously, with regular check-ups as needed. Patients may experience drowsiness, dizziness, or orthostatic hypotension while taking this medication, so driving or operating dangerous machinery should be avoided. Since this medication is used with dopaminergic drugs, behavioral changes such as gambling, increased sexual desire, and impulse control disorders may occur, so patients and caregivers should observe carefully. Various side effects can occur, including gastrointestinal disturbances (nausea, vomiting, diarrhea), movement disorders, muscle pain, urine color changes, blood pressure changes, and rare serious side effects such as severe hepatitis or rhabdomyolysis have been reported. Long-term use of this medication necessitates regular monitoring of liver function, blood tests, cardiovascular, and kidney function evaluation. This medication may interact with other drugs, so if other medications are being taken, it is crucial to inform medical personnel. Particular caution is required when combined with antihypertensives, antidepressants, and antipsychotics. Pregnant or breastfeeding women should not take this medication and must consult with medical personnel if planning to become pregnant or if pregnant. In case of overdose, symptoms such as confusion, heart abnormalities, and respiratory distress may occur, and immediate hospitalization and appropriate treatment are needed. To use this medication safely, it is important to follow medical instructions and report any abnormal symptoms immediately.

Extrapyramidal symptoms, vomiting, diarrhea, pain in muscles and musculoskeletal and connective tissues, discoloration of urine, gastrointestinal bleeding, angioedema, hepatitis, rhabdomyolysis, neuroleptic malignant syndrome, anemia, thrombocytopenia, weight loss, decreased appetite, depression, hallucinations, confusion, abnormal dreams, anxiety, insomnia, psychosis, agitation, suicidal behavior, dopamine dysregulation syndrome, worsening of Parkinson's disease, tremors, on and off phenomenon, dystonia, mental disorders, drowsiness, dizziness, headache, blurred vision, ischemic heart disease, irregular heart rhythms, myocardial infarction, orthostatic hypotension, hypertension, dyspnea, constipation, dyspepsia, abdominal pain and discomfort, dry mouth, colitis, dysphagia, abnormal liver function test results, rash, hyperhidrosis, discoloration other than urine, hives, muscle cramps, arthralgia, urinary tract infection, urinary retention, chest pain, peripheral edema, fainting, gait disturbances, weakness, fatigue, malaise

This medication should be stored in a tightly closed container to prevent air or moisture from entering, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will safely maintain the medication's efficacy.

Appearance

Brownish-red oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle