TriLevo Tablets 50/12.5/200 mg (Levodopa, Carbidopa, Entacapone)

Adult dose

Take 1 tablet of Trilevo per dose, orally with or without food. Each tablet is a single dose; take it whole without splitting or crushing 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 (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 carbidopa doses of 200mg or more is limited. 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 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/dopa decarboxylase inhibitor formulation at a dose equivalent to the Trilevo strength, together with entacapone. 1. Switching patients currently receiving levodopa/dopa decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Trilevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation and entacapone at doses equivalent to the Trilevo strength 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 doses that do not correspond to a Trilevo strength, 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 patients receiving a standard levodopa/benserazide formulation and entacapone to Trilevo, discontinue levodopa/benserazide on the night before starting treatment and begin Trilevo the next morning. Start with a Trilevo dose equivalent to the patient's previous levodopa dose or a slightly higher dose (5~10%). 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 adequately controlled with standard levodopa/dopa decarboxylase inhibitor therapy, a Trilevo 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, it is preferable to administer entacapone as a separate tablet and, if necessary, adjust (reduce) the levodopa dose before switching to Trilevo. 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 intervals 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 amount of Trilevo by extending the dosing intervals and reducing the frequency of administration, or by reducing the Trilevo dose administered. If another levodopa medication is used 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/dopa decarboxylase inhibitor, adjustment of the doses of other antiparkinsonian medications, particularly levodopa, is necessary to control Parkinson's disease symptoms. - Older adults: No adjustment of the Trilevo dose is 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. No specific reports are available on 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 on dialysis.

Child dose

The safety and efficacy of Trelevo in patients 18 years of age or younger have not been evaluated. Therefore, administration of Trelevo is not recommended in patients 18 years of age or younger.

This medication is used to treat Parkinson's disease and primarily helps improve motor symptoms. However, caution is advised, as serious side effects such as severe movement disorders or neuroleptic malignant syndrome can rarely occur while taking this medication. Particularly, if the medication is suddenly stopped or the dose is rapidly reduced, symptoms such as muscle rigidity, high fever, and changes in mental state may occur; therefore, a gradual reduction is important. Patients with known allergies to any of the ingredients in this medication, those who are pregnant or nursing, those with severe liver dysfunction, or patients with glaucoma should not take this medication. Patients with poor liver or kidney function, heart disease, mental disorders, or a history of gastric ulcers need closer monitoring when using this medication. Common side effects include movement disorders, vomiting, diarrhea, muscle pain, color change in urine, blurred vision, tremors, drowsiness, dizziness, headache, depression, hallucinations, confusion, abnormal dreams, anxiety, insomnia, agitation, muscle cramps, joint pain, orthostatic hypotension, hypertension, constipation, dyspepsia, abdominal pain, dry mouth, colitis, dysphagia, abnormal liver function test results, rash, sweating, and discoloration of body parts other than urine (skin, nails, hair). There may be changes in mental state, depression, and impulse control disorders during treatment, so patients and caregivers should monitor closely. Additionally, this medication can induce orthostatic hypotension, so caution should be exercised for dizziness or fainting risks, avoiding hazardous activities until symptoms have eased. Interactions may occur when used in conjunction with other medications, particularly antidepressants, antipsychotics, and antihypertensive medications, so follow the doctor's instructions in these cases. Pregnant or nursing women should not use this medication, and routine liver function, blood tests, cardiovascular, and kidney function tests are recommended for long-term users. In case of overdose, symptoms like confusion, cardiac arrhythmia, and discoloration of the skin and urine may appear, requiring immediate medical attention.

• Movement disorders
• vomiting
• diarrhea
• pain in muscles
• musculoskeletal and connective tissues
• chromaturia
• gastrointestinal bleeding
• angioedema
• hepatitis
• rhabdomyolysis

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness.

Appearance

Red-brown round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle