Trilevo 75/18.75/200 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. It is preferable to select 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) 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 prone to 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. 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 may be used in patients currently treated with a standard levodopa/dopadecarboxylase inhibitor formulation at the same strength as Trilevo, together with entacapone. 1. Switching patients currently receiving levodopa/dopadecarboxylase inhibitor (carbidopa or benserazide) and entacapone to Trilevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation and entacapone at the same strengths as Trilevo may 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 do not match those of Trilevo, titrate the dose carefully to achieve the 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 patients receiving a standard levodopa/benserazide formulation and entacapone to Trilevo, discontinue levodopa/benserazide on the night before starting treatment and begin taking Trilevo the following morning. Start treatment with a Trilevo dose corresponding to the same or a slightly higher amount (5~10%) of levodopa than 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/dopadecarboxylase inhibitor therapy, treatment with Trilevo at the same dose as their current treatment may be considered. However, directly switching from standard levodopa/dopadecarboxylase inhibitor therapy to Trilevo is not recommended in patients with dyskinesia or those taking 800mg or more of levodopa per day. 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, 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 Trilevo. The daily levodopa dose may be reduced by extending the dosing interval or decreasing the dose of levodopa per administration, depending on the patient's clinical condition. 3. Dose adjustment during treatment If an increase in the levodopa dose is needed, consider increasing the frequency of Trilevo administration or increasing the dose within the recommended range, in accordance with the dosage and administration instructions described above. If a reduction in the levodopa dose is needed, reduce the total daily dose of Trilevo by extending the dosing interval to reduce the frequency of administration or by decreasing the dose of Trilevo administered. If another levodopa medication is administered concomitantly 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/dopadecarboxylase inhibitor, adjustment of the doses of other antiparkinsonian medications, particularly levodopa, is required to control the symptoms of Parkinson's disease. - Older adults: Dose adjustment of Trilevo is not required in older adults. - 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. The pharmacokinetics of levodopa and carbidopa in patients with renal impairment have not been specifically reported. Trilevo should be administered with caution to patients with severe renal impairment, including patients receiving dialysis.

Child dose

Patients 18 years of age or younger: Administration of Trilevo is not recommended.

This medication is used for the treatment of Parkinson's disease and serious side effects, such as severe dyskinesia or rhabdomyolysis that can occur after neuroleptic malignant syndrome, have been rarely reported. Abruptly discontinuing this medication can lead to symptoms such as muscle rigidity, hyperthermia, and changes in mental status, so if necessary, it should be tapered slowly, and dosage adjustments should be made if symptoms arise. This medication should not be administered to specific patients, such as those with allergies to the drug components, pregnant and breastfeeding women, patients with severe liver impairment, and those with glaucoma. Patients with impaired liver or kidney function, a history of gastrointestinal disorders, cardiovascular diseases, and mental health issues should use this medication with caution and require regular check-ups as directed by their physician. This medication may cause drowsiness or sudden sleep symptoms, so driving or operating hazardous machinery during treatment should be avoided. Common side effects include motor disorders, vomiting, diarrhea, muscle and joint pain, changes in urine color, and rarely serious side effects such as hepatitis or rhabdomyolysis may occur. Additionally, this medication can interact with other drugs; therefore, if taking other medications, patients must consult their doctor or pharmacist, particularly when used with antihypertensive drugs, antidepressants, or antipsychotic medications. This medication should be avoided during pregnancy as it can harm the fetus, and it should not be used while breastfeeding. Regular blood tests, liver function tests, and heart and kidney function tests should be performed during treatment, and any unusual symptoms should be reported to healthcare professionals immediately. In the event of overdose, immediate medical attention is necessary, including gastric lavage and monitoring of cardiac and respiratory function.

Movement disorders, vomiting, diarrhea, pain in muscles and musculoskeletal and connective tissues, coloruria, gastrointestinal bleeding, angioedema, hepatitis, rhabdomyolysis, neuroleptic malignant 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, muscle rigidity, mental disorders, drowsiness, dizziness, headache, blurred vision, ischemic heart disease, irregular heart rhythm, myocardial infarction, orthostatic hypotension, hypertension, dyspnea, constipation, dyspepsia, abdominal pain and discomfort, dry mouth, colitis, dysphagia, abnormal liver function test results, rash, hyperhidrosis, discoloration other than urine, hives, muscle spasms, arthralgia, urinary tract infection, urinary retention, chest pain, peripheral edema, fainting, gait disturbances, weakness, fatigue, malaise, pathological gambling, increased libido, excessive libido, impulse control disorder, excessive daytime sleepiness, sudden sleep symptoms

This medication can be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to sustain the effectiveness and safety of the medication.

Appearance

Bright reddish-brown oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle