TriLevo Tablets 125/31.25/200 mg (Levodopa, Carbidopa, Entacapone)

Adult dose

Take 1 tablet of Trilevo per dose, orally 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. The daily dose of Trilevo should preferably be one of the available strengths of Trilevo (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), taken as 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 carbidopa doses of 200mg or more is limited, whereas the maximum recommended daily dose of entacapone is 2000mg and that of levodopa is 1500mg. Accordingly, the maximum recommended daily dose is 10 tablets for Trilevo 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, and 150/37.5/200mg, and 7 tablets for Trilevo 200/50/200mg. In general, Trilevo can be used in patients currently treated with a standard levodopa/dopa decarboxylase inhibitor formulation at the same strength as Trilevo, together with entacapone. 1. Switching patients already receiving levodopa/dopa decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Trilevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation and entacapone at strengths equivalent to Trilevo can switch directly to Trilevo. For example, a patient taking levodopa/carbidopa 50/12.5mg and entacapone 200mg 4 times daily may instead take 1 tablet of Trilevo 50/12.5/200mg 4 times daily. 2) For patients currently receiving a standard levodopa/carbidopa formulation and entacapone at strengths that are not equivalent to Trilevo, carefully titrate the dose to achieve optimal clinical effect. The initial dose of Trilevo should be set as close as possible to the patient's current total daily levodopa dose. 3) When switching a patient receiving a standard levodopa/benserazide formulation and entacapone to Trilevo, discontinue levodopa/benserazide on the night before starting treatment and begin Trilevo the following morning. Start treatment with a Trilevo dose corresponding to an amount of levodopa equal to or slightly (5~10%) greater than the amount the patient was previously receiving. 2. Switching patients who are not currently taking entacapone to Trilevo: In patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved with standard levodopa/dopa decarboxylase inhibitor therapy, Trilevo at a dose equivalent to their current treatment may be considered. However, directly switching from standard levodopa/dopa decarboxylase inhibitor therapy to Trilevo is not recommended for patients with dyskinesia or those taking a daily levodopa dose of 800mg or more. In these patients, before switching to Trilevo, 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, especially 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 Trilevo. The total 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 needed, increase the frequency of Trilevo administration according to the dosage and administration instructions above, or consider increasing the dose within the recommended range. If a reduction in levodopa is needed, reduce the total daily dose of Trilevo by extending the dosing interval and reducing the frequency of administration, or by reducing the dose of Trilevo administered. If another levodopa medication is coadministered with Trilevo, observe the maximum recommended dose. - Discontinuation of Trilevo: When Trilevo (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to a levodopa/dopa decarboxylase inhibitor, adjustment of the doses of other antiparkinsonian medications, particularly levodopa, is necessary to control Parkinson's disease symptoms. - Elderly patients: No dose adjustment of Trilevo is required in elderly patients. - Patients with hepatic impairment: Trilevo 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. No specific reports are available regarding the pharmacokinetics of levodopa and carbidopa in patients with renal impairment. Trilevo should be administered with caution to patients with severe renal impairment, including those receiving dialysis.

Child dose

Pediatrics: The safety and efficacy of Trelevo have not been evaluated in patients 18 years of age and under. Therefore, administration of Trelevo is not recommended for patients 18 years of age and under.

This drug is used in the treatment of Parkinson's disease and helps improve motor function. However, it should be noted that serious side effects such as severe motor dysfunction or neuroleptic malignant syndrome may occur while taking this medication. Such symptoms can include muscle rigidity, high fever, changes in mental state, and autonomic nervous system abnormalities. Stopping this medication abruptly can worsen symptoms, so it is safer to taper off under the guidance of a physician. Additionally, this medication should not be taken by individuals with allergies to its ingredients, during pregnancy or breastfeeding, or by patients with severe liver dysfunction or certain eye diseases. Patients with liver or kidney problems, as well as those with heart disease, lung disease, or mental illness, must consult their physician before taking this medication. During treatment, symptoms such as drowsiness, dizziness, or orthostatic hypotension may occur, so it is advisable to avoid driving or operating hazardous machinery. This medication may cause various side effects, including gastrointestinal disturbances, muscle pain, changes in urine color, depression, hallucinations, insomnia, and others, so patients should immediately consult medical personnel if any unusual symptoms occur. Also, interactions with other medications may occur, so it is crucial to inform your healthcare provider of any other medications being used. Women who are pregnant or breastfeeding should not use this medication, and regular liver function tests, blood tests, and heart and kidney function tests may be necessary during treatment. In the case of overdose, serious symptoms such as confusion, cardiac irregularities, and respiratory distress may appear, and immediate emergency treatment is required.

Movement disorders, vomiting, diarrhea, pain in muscles, musculoskeletal and connective tissues, discoloration of urine, gastrointestinal bleeding, angioedema, hepatitis, rhabdomyolysis, neuroleptic malignant syndrome, anemia, thrombocytopenia, weight loss, reduced appetite, depression, hallucinations, confusion, abnormal dreams, anxiety, insomnia, psychosis, agitation, suicidal behavior, dopamine dysregulation syndrome, exacerbation of Parkinson's disease, tremors, on and off phenomena, dystonia, mental disorders, drowsiness, dizziness, headache, blurred vision, ischemic heart disease other than myocardial infarction, irregular heartbeat, myocardial infarction, orthostatic hypotension, hypertension, gastrointestinal bleeding, dyspnea, constipation, dyspepsia, abdominal pain and discomfort, dry mouth, colitis, dysphagia, abnormal liver function tests, rash, hyperhidrosis, discoloration of urine, urticaria, muscle cramps, arthralgia, urinary tract infection, urinary retention, chest pain, peripheral edema, fainting, gait disturbance, weakness, fatigue, lethargy, pathological gambling, increased libido, hypersexuality, impulse control disorder, excessive daytime sleepiness, sudden sleep symptoms

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature.

Appearance

Bright reddish-brown oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle