Tri-Dopa Tablets 100/25/200 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. 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, while 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 200/50/200mg. In general, this medicine may be used in patients currently treated with a standard levodopa/dopa decarboxylase inhibitor formulation at the same dose as this medicine, together with entacapone. 1. Switching patients previously 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 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 are not equivalent to 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 corresponding to the same amount of levodopa as the patient was previously receiving, or a slightly greater 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, 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 to 7 days after starting this medicine. The daily levodopa dose may be reduced by extending the dosing interval or decreasing the levodopa dose per administration, depending on the patient's clinical condition. 3. Dose adjustment during treatment If an increase in levodopa is needed, increase the frequency 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 needed, reduce the total daily amount of this medicine by extending the dosing interval and reducing the number of doses, 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 treatment with this medicine (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to levodopa/dopa decarboxylase inhibitor therapy, adjustment of the doses of other antiparkinsonian medicines, particularly levodopa, is needed to control Parkinson's disease symptoms. - Elderly patients: Dose adjustment of this medicine is not required in elderly patients. - 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. There are no specific reports on the pharmacokinetics of levodopa and carbidopa in patients with renal impairment. Use this medicine with caution in patients with severe renal impairment, including those receiving 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 for treating Parkinson's disease, aiding in the improvement of motor function by affecting the nervous system. When taking this medication, one should be cautious as severe motor symptoms or rhabdomyolysis related to neuroleptic malignant syndrome may rarely occur. Particularly, abruptly discontinuing this medication can lead to serious symptoms such as muscle rigidity, high fever, and changes in mental state, so it is important to taper the dosage gradually. Individuals who are allergic to any ingredients in this medication, pregnant or breastfeeding, those with severely impaired liver function, or patients with glaucoma should not take this medication. Patients with liver or kidney problems, heart diseases, mental illnesses, or a history of seizures require careful monitoring while on this medication. This medication may induce orthostatic hypotension; therefore, extra attention should be paid when taking it alongside other medications that can cause low blood pressure. During treatment, drowsiness or sudden sleep symptoms may occur, thus it is advisable to avoid driving or operating hazardous machinery. While taking this medication, mental health status should be carefully monitored for changes in mental state, depression, suicidal thoughts, and other concerning symptoms. Long-term use of this medication necessitates regular liver function tests, blood tests, as well as heart and kidney function assessments. This medication can interact with other drugs; therefore, especially when taking antidepressants, antipsychotics, or antihypertensives, consulting with a doctor or pharmacist is advised. In case of overdose, symptoms such as confusion, cardiac arrhythmias, skin and urine color changes may occur, and immediate medical treatment should be received. Finally, pregnant or breastfeeding women should refrain from taking this medication, and if any abnormalities such as weight changes or persistent diarrhea occur during treatment, it is essential to consult the healthcare provider.

Extrapyramidal symptoms, vomiting, diarrhea, pain in muscles and musculoskeletal and connective tissue, discoloration of urine, gastrointestinal bleeding, angioedema, hepatitis, rhabdomyolysis, malignant neuroleptic 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 phenomena, dystonia, mental disorders, drowsiness, dizziness, headache, blurry vision, ischemic heart disease other than myocardial infarction, irregular heartbeat, myocardial infarction, orthostatic hypotension, hypertension, gastrointestinal bleeding, dyspnea, constipation, indigestion, abdominal pain and discomfort, dry mouth, colitis, dysphagia, abnormal liver function test results, rash, hyperhidrosis, discoloration apart from urine, hives, muscle spasms, arthralgia, urinary tract infections, urinary retention, chest pain, peripheral edema, fainting, gait disorders, weakness, fatigue, malaise, pathological gambling, increased libido, excessive libido, impulse control disorders, excessive daytime sleepiness, sudden onset of sleep symptoms

Store this medication in a tightly sealed container to prevent air and moisture exposure. It is recommended to keep it at room temperature between 1°C and 30°C.

Appearance

Brownish-red oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle