Tridopa Tablet 125/31.25/200 mg

Adult dose

This medicine is administered orally as 1 tablet per dose, with or without food. Each tablet is a single dose and should be swallowed whole; do not divide or crush it. The appropriate daily dose for each patient should be determined carefully by adjusting the levodopa dose. The daily dose of this medicine should preferably consist of 1 tablet of one of the available strengths (each containing 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). 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 a total daily carbidopa dose 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 strengths of 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 in the 200/50/200mg strength. In general, this medicine may be used in patients currently treated with a standard levodopa/dopa decarboxylase inhibitor formulation 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 levodopa/carbidopa formulation and entacapone at doses equivalent to those in this medicine may be switched 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 strengths of this medicine, carefully titrate the dose to achieve optimal clinical effect. The initial dose of this medicine should be set as close as possible to 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 following morning. Start with a dose of this medicine equivalent to, or slightly (5~10%) greater than, the amount of levodopa the patient was previously receiving. 2. Switching patients who are not currently taking entacapone to this medicine: For patients with Parkinson's disease whose end-of-dose motor fluctuation is not improved with standard levodopa/dopa decarboxylase inhibitor therapy, a dose of this medicine equivalent to their current treatment may be considered. However, directly switching from standard levodopa/dopa 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 day 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 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 other levodopa medicines are 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 a 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: This medicine should be administered with caution to patients with mild to moderate hepatic impairment. Dose adjustment (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 on dialysis.

Child dose

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

This medication is used in the treatment of Parkinson's disease and contains components that assist in the action of dopamine. Caution is needed as severe side effects such as severe dyskinesia or neuroleptic malignant syndrome may rarely occur when taking this medication. Abruptly stopping this medication can lead to dangerous symptoms such as muscle rigidity, high fever, and changes in mental state; therefore, it should be tapered off according to a doctor's instructions. This medication should not be taken by patients with severely impaired liver or kidney function, pregnant women, nursing mothers, or patients with certain ophthalmic conditions. Additionally, it should not be administered to individuals allergic to this medication or similar components. Occasionally, it may affect mental health, causing symptoms such as hallucinations, depression, confusion, or insomnia, and careful observation is required. This medication can cause orthostatic hypotension, which may lead to dizziness or fainting; caution is especially necessary when taking antihypertensive medications. Commonly reported side effects include motor disorders, nausea, diarrhea, muscle pain, discoloration of urine, blurred vision, irregular heartbeat, orthostatic hypotension, high blood pressure, constipation, dyspepsia, abdominal pain, dry mouth, colitis, liver function test abnormalities, rashes, sweating, discoloration (other than urine), muscle cramps, joint pain, urinary tract infections, urinary retention, chest pain, peripheral edema, fainting, gait disturbances, weakness, fatigue, malaise, weight loss, decreased appetite, depression, and hallucinations. During treatment, regular monitoring of liver function tests, blood tests, and heart and kidney function tests is recommended. Furthermore, this medication may interact with other drugs, so it is crucial to inform the doctor or pharmacist about any other medications being taken. Pregnant or nursing women should not take this medication, and counseling regarding pregnancy plans is necessary during treatment. In the event of overdose, symptoms such as coma, arrhythmia, and discoloration of skin and urine may appear, necessitating immediate medical attention. While taking this medication, avoid driving or operating hazardous machinery, and consult a doctor immediately if symptoms worsen or unusual reactions occur.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is best to keep the medication at room temperature, between 1 and 30 degrees Celsius. This will help maintain the drug's effectiveness over time.

Appearance

Bright reddish-brown oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle