Tridopa Tablets 75/18.75/200 mg

Adult dose

Take 1 tablet per dose orally, with or without food. Each tablet is a single dose and should be taken whole; do not split or crush it. The appropriate daily dose for each patient should be determined carefully by adjusting the levodopa dose. Preferably, select one of the available strengths of this medicine (50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, 150/37.5/200mg, or 200/50/200mg of levodopa/carbidopa/entacapone, respectively) 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 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 in the 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, and 150/37.5/200mg strengths, and 7 tablets for this medicine in the 200/50/200mg strength. In general, this medicine may be used in patients currently treated with a standard levodopa/decarboxylase inhibitor formulation at the same dose as this medicine, together with entacapone. 1. Switching patients currently receiving levodopa/decarboxylase inhibitor (carbidopa or benserazide) and entacapone to this medicine: 1) Patients currently receiving a standard levodopa/carbidopa formulation and entacapone at doses corresponding to the strength of 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 levodopa/carbidopa formulation and entacapone at doses that do not correspond to the strength of this medicine, carefully titrate the dose to achieve optimal clinical effect. The initial dose of this medicine should be set to most closely match the patient's current total daily levodopa dose. 3) When switching patients receiving a standard levodopa/benserazide formulation and entacapone to this medicine, discontinue levodopa/benserazide on the night before starting treatment, and begin taking this medicine the next morning. Initiate treatment with a dose of this medicine that provides the same amount of levodopa as the patient was previously receiving, or a slightly higher amount (5~10%). 2. Switching patients who are not currently taking entacapone to this medicine: In patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved with standard levodopa/decarboxylase inhibitor therapy, a dose of this medicine equivalent to their current treatment may be considered. However, directly switching from standard levodopa/decarboxylase inhibitor therapy to this medicine is not recommended in patients with dyskinesia or those taking a daily levodopa dose of 800mg or more. In these patients, before switching to this medicine, it is preferable to administer entacapone as a separate tablet and adjust (reduce) the levodopa dose if necessary. Entacapone enhances the effects of levodopa. Therefore, particularly in patients with dyskinesia, it may be necessary to reduce the levodopa dose by approximately 10-30% within 1 to 1 week after starting this medicine. The daily levodopa dose may be reduced by extending the dosing interval or reducing the levodopa dose per administration, depending on the patient's clinical condition. 3. Dose adjustment during treatment If an increase in levodopa is required, increase the frequency of administration of this medicine in accordance with the dosage and administration instructions described above, or consider increasing the dose within the recommended range. If a reduction in levodopa is required, 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 co-administered with this medicine, observe the maximum recommended dose. - Discontinuation of this medicine: When treatment with this medicine (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to levodopa/decarboxylase inhibitor therapy, adjustment of the doses of other antiparkinsonian medicines, particularly levodopa, is necessary to control the symptoms of Parkinson's disease. - Elderly patients: No dose adjustment of this medicine is required in elderly patients. - Patients with hepatic impairment: This medicine should be administered with caution to patients with mild or moderate hepatic impairment. Dose adjustment (reduction) may be necessary. - Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone. The pharmacokinetics of levodopa and carbidopa in patients with renal impairment have not been specifically reported. This medicine should be administered with caution to patients with severe renal impairment, including patients on dialysis.

Child dose

The safety and efficacy of this medicine have not been evaluated in patients 18 years of age or younger. Therefore, use of this medicine is not recommended in patients 18 years of age or younger.

This medicine is used for treating Parkinson's disease and contains ingredients that help the action of dopamine. While taking this medicine, serious side effects such as severe movement disorders or neuroleptic malignant syndrome can occur rarely, so if these symptoms occur, consult a doctor immediately. Suddenly stopping the medication can lead to dangerous symptoms such as muscle rigidity, high fever, and changes in mental state, so it is very important to gradually reduce the dosage according to the doctor's instructions. This medicine should not be administered to specific patients, such as those with severe liver dysfunction, pregnant or breastfeeding women, patients with specific ophthalmic diseases, and patients who are allergic to the ingredients of this medicine. Patients with weak liver or kidney function, cardiovascular disease, and a history of mental illness should be especially cautious when using this medicine and may require regular testing under the doctor's guidance. This medicine can cause orthostatic hypotension (a drop in blood pressure upon standing), so symptoms such as dizziness or fainting should be monitored, and special caution should be exercised when taken with other antihypertensives. Drowsiness or sudden sleep episodes may occur during treatment, so it is safe to avoid driving or operating dangerous machinery until symptoms have completely resolved. This medication can cause various side effects such as nausea, diarrhea, muscle pain, urine discoloration, thrombocytopenia, weight loss, decreased appetite, depression, hallucinations, confusion, abnormal dreams, anxiety, insomnia, psychosis, agitation, suicidal behavior, dopamine dysregulation, worsening of Parkinson's disease, tremors, on and off phenomenon, dystonia, mental disorder, drowsiness, dizziness, headaches, blurred vision, ischemic heart disease other than myocardial infarction, irregular heart rhythms, and orthostatic. Severe allergic reactions (urticaria, angioedema, severe swelling, and severe allergic reactions), serious liver problems (accompanied by cholestatic hepatitis), liver abnormalities (jaundice), rhabdomyolysis, neuroleptic malignant syndrome, severe neurological symptoms (muscle rigidity, generalized muscle spasms, changes in mental status, agitation, confusion, coma, high fever, autonomic nervous system abnormalities, increased serum creatine phosphokinase), and severe skin reactions (severe rashes, blisters, skin peeling, mouth ulcers) may occur as serious side effects. Consult a doctor immediately if any severe symptoms develop. If you are pregnant or breastfeeding, it is safest not to take this medicine and you should consult a doctor before taking. In case of overdose, symptoms such as confusion, heart arrhythmias, skin or urine discoloration may occur, so immediate medical treatment is required, and self-treatment is dangerous. Regularly monitoring liver, heart, and kidney functions is important for patients taking this medication over a long period.

Exercise intolerance, vomiting, diarrhea, muscle and musculoskeletal pain, discoloration of urine, gastrointestinal bleeding, angioedema, hepatitis, rhabdomyolysis, neuroleptic malignant syndrome, anemia, thrombocytopenia, weight loss, loss of 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 except myocardial infarction, irregular heart rhythm, 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, urticaria, muscle spasms, arthralgia, urinary tract infection, urinary retention, chest pain, peripheral edema, fainting, gait disturbance, weakness, fatigue, lethargy

This medicine may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. Storing it this way helps maintain the efficacy of the medicine for a longer period.

Appearance

Bright reddish-brown oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle