Tridopa Tablets 50/12.5/200 mg

Adult dose

This medicine should be administered orally as 1 tablet per dose, with or without food. Each tablet is a single dose and should be swallowed whole; do not split or crush 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 (each containing levodopa/carbidopa/entacapone at 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 daily are likely to experience nausea and vomiting. Experience with total daily carbidopa doses 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 at 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 at 200/50/200mg. In general, this medicine may be used in patients currently treated with a standard formulation of levodopa/dopa decarboxylase inhibitor and entacapone at doses equivalent to those in this medicine. 1. Switching patients currently receiving levodopa/dopa decarboxylase inhibitor (carbidopa or benserazide) and entacapone to this medicine: 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 at 50/12.5/200mg 4 times daily. 2) For patients currently receiving a standard formulation of levodopa/carbidopa and entacapone at doses that do not correspond to the strengths of this medicine, carefully titrate the dose to achieve optimal clinical effect. The initial dose of this medicine should be set to correspond as closely 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. Initiate treatment with a dose of this medicine that provides the same amount of levodopa as the patient's previous dose, or a slightly higher amount (5~10%). 2. Switching patients who are not currently taking entacapone to this medicine: For patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved with standard levodopa/dopa decarboxylase inhibitor therapy, treatment with this medicine at a dose equivalent to their current treatment may be considered. However, directly switching from standard levodopa/dopa decarboxylase inhibitor therapy to this medicine is not recommended for 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, if necessary, adjust (reduce) the levodopa dose. 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 day to 1 week after starting this medicine. The daily levodopa dose may be reduced by extending the dosing interval or decreasing the amount of levodopa per dose, 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 according to 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. If another levodopa medicine is administered concomitantly 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/dopa decarboxylase inhibitor, adjustment of the doses of other antiparkinsonian medicines, particularly levodopa, is necessary to control Parkinson's disease symptoms. - Elderly patients: Dose adjustment of this medicine is not required in elderly patients. - Patients with hepatic impairment: Caution is required when administering this medicine 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. No specific reports are available regarding the pharmacokinetics of levodopa and carbidopa in patients with renal impairment. This medicine should be administered with caution to patients with severe renal impairment, including patients undergoing 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 medication is used for the treatment of Parkinson's disease and has been rarely reported to cause serious side effects such as rhabdomyolysis and neuroleptic malignant syndrome, thus caution is required. These side effects may include muscle rigidity, high fever, changes in mental state, and autonomic nervous system abnormalities, and early diagnosis and treatment are very important. Symptoms similar to those mentioned above can occur with sudden discontinuation of this medication; therefore, the dosage should be gradually decreased when stopping. Additionally, it should not be administered to patients who have hypersensitivity to this medication, are pregnant or breastfeeding, have severe liver disease, glaucoma, certain skin conditions, or chromaffin cell tumors. As there may be interactions with other dopaminergic drugs, patients taking other medications should definitely consult with their doctor. Patients with liver or kidney disease, cardiovascular diseases, and mental disorders should use this medication with caution, particularly as orthostatic hypotension symptoms may occur, necessitating extra vigilance. Throughout the treatment, various adverse reactions such as mental changes, depression, hallucinations, drowsiness, and dizziness can occur, hence symptoms should be closely monitored. Regular liver function, blood, cardiovascular, and kidney function tests are recommended during long-term use. This medication is contraindicated during pregnancy and should not be used while breastfeeding. In case of overdose, immediate medical attention is required, and appropriate treatment including gastric lavage and supportive therapy should be applied. It is advisable to avoid driving or operating dangerous machinery while taking this medication, and patients should immediately consult medical personnel if any unusual symptoms occur during treatment.

• Extrapyramidal symptoms
• vomiting
• diarrhea
• pain in muscles
• musculoskeletal and connective tissues
• colored urine
• gastrointestinal bleeding
• angioedema
• hepatitis
• rhabdomyolysis

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to preserve the medication's effectiveness.

Appearance

Reddish brown round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle