Tridopa Tablets 200/50/200 mg

Adult dose

This medicine should be taken orally as 1 tablet per dose, with or without food. Each tablet constitutes one 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 marketed 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 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 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 being treated with a standard levodopa/dopa decarboxylase inhibitor preparation and entacapone at doses equivalent to those of this medicine. 1. Switching patients who are already receiving a levodopa/dopa decarboxylase inhibitor (carbidopa or benserazide) and entacapone to this medicine: 1) Patients currently receiving a standard levodopa/carbidopa preparation and entacapone at doses equivalent to those of this medicine may switch directly to this medicine. For example, a patient taking levodopa/carbidopa 50/12.5mg and entacapone 200mg 4 times a day may instead take 1 tablet of this medicine at 50/12.5/200mg 4 times a day. 2) In patients currently receiving a standard levodopa/carbidopa preparation and entacapone at doses that are not equivalent to those of this medicine, carefully titrate the dose to achieve the 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 preparation and entacapone to this medicine, discontinue levodopa/benserazide on the night before starting treatment and begin taking this medicine the following morning. Start with a dose of this medicine that provides the same or a slightly (5~10%) higher amount of levodopa than the amount previously taken. 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 by standard levodopa/dopa decarboxylase inhibitor therapy, treatment with this medicine at a dose equivalent to their current treatment may be considered. However, direct switching from standard levodopa/dopa decarboxylase inhibitor therapy to this medicine is not recommended in patients with dyskinesia or in patients 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 potentiates 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, according to the patient's clinical condition. 3. Dose adjustment during treatment If an increase in levodopa is needed, 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 needed, reduce the total daily dose 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: If this medicine (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to a levodopa/dopa decarboxylase inhibitor, the doses of other antiparkinsonian medicines, particularly levodopa, need to be adjusted to control the symptoms of Parkinson's disease. - Elderly patients: Dose adjustment of this medicine is not 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 (dose reduction) may be necessary. - Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone. There are no specific reports on 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 receiving dialysis.

Child dose

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

This medication is used for the treatment of Parkinson's disease and serious side effects such as severe dyskinesia and rhabdomyolysis associated with neuroleptic malignant syndrome have been rarely reported. Sudden discontinuation of this drug may lead to symptoms associated with neuroleptic malignant syndrome, including muscle rigidity, high fever, and changes in mental status; therefore, if necessary, the dose should be gradually reduced while switching to other dopaminergic treatments. Patients with known allergies to the components of this medication, those who are pregnant or breastfeeding, patients with severe liver disease, and those with angle-closure glaucoma should not be administered this drug. Patients with a history of liver disease, renal impairment, gastric ulcers, cardiovascular diseases, or psychiatric disorders should exercise caution when using this medication, and considerations for the possibility of orthostatic hypotension or interactions with other drugs should be made. During treatment with this drug, side effects such as movement disorders, nausea, diarrhea, myalgia, discoloration of urine, thrombocytopenia, weight loss, decreased appetite, depression, hallucinations, confusion, abnormal dreams, anxiety, insomnia, psychosis, agitation, worsening of Parkinson's disease, tremors, on-off phenomenon, dystonia, psychiatric disorders, drowsiness, dizziness, headache, blurred vision, ischemic heart disease other than myocardial infarction, irregular heart rhythms, orthostatic hypotension, and hypertension may occur. If there are changes in mental status or symptoms of depression or suicidal thoughts during treatment, medical personnel should be notified immediately. Additionally, this medication may cause drowsiness or sudden sleep onset, so driving or operating hazardous machinery should be avoided until these symptoms resolve. Regular tests for liver function, blood counts, cardiovascular, and renal function are recommended during the use of this medication. Interactions with other drugs may occur, so patients taking other medications should notify their healthcare provider. This medication should not be taken during pregnancy or lactation, especially since safety for newborns during breastfeeding has not been established. In the case of overdose, immediate medical intervention is required, including gastric lavage and supportive therapy, along with cardiac monitoring.

• Movement disorders
• vomiting
• diarrhea
• pain in the muscles
• musculoskeletal and connective tissues
• discoloration of urine
• gastrointestinal bleeding
• angioedema
• hepatitis
• rhabdomyolysis

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is recommended to store the medication at room temperature, ideally between 1 and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

Dark reddish-brown oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle