Tri-Levo Tablet 200/50/200 mg (Levodopa, Carbidopa, Entacapone)

Adult dose

Trilevo is administered orally as 1 tablet per dose, with or without food. Each tablet is a single dose and must be swallowed whole without splitting or crushing. 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 Trilevo strengths (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 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. 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 being treated with a standard levodopa/dopa decarboxylase inhibitor formulation and entacapone at the same doses as those in Trilevo. 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 the same doses as those in 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 doses that do not match those in Trilevo, carefully titrate the dose to achieve optimal clinical effect. The initial dose of Trilevo should be set to most closely match 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 an amount of levodopa equal to or slightly (5~10%) greater than the amount the patient had been receiving. 2. Switching patients who are not currently taking entacapone to Trilevo: In patients with Parkinson's disease whose end-of-dose motor fluctuation is not improved with standard levodopa/dopa decarboxylase inhibitor therapy, Trilevo may be considered at a dose equivalent to their current treatment. However, directly switching from standard levodopa/dopa decarboxylase inhibitor therapy to Trilevo is not recommended for 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 effect 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 Trilevo. The daily levodopa dose may be reduced by extending the dosing interval or decreasing the dose of levodopa per administration, according to the patient's clinical condition. 3. Dose adjustment during treatment If an increase in levodopa is needed, the number of Trilevo doses may be increased according to the dosage and administration instructions described above, or a dose increase within the recommended range should be considered. If a decrease in levodopa is needed, reduce the total daily dose of Trilevo by extending the dosing interval to reduce the number of doses, or by reducing the dose of Trilevo administered. If another levodopa product is used concomitantly with Trilevo, do not exceed 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 drugs, particularly levodopa, is necessary to control the symptoms of Parkinson's disease. - 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 to moderate hepatic impairment. Dose adjustment (reduction) may be necessary. - Renal impairment: Renal impairment does not affect the pharmacokinetics of entacapone. No specific information has been reported 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 patients on dialysis.

Child dose

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

This medication is used for the treatment of Parkinson's disease and contains ingredients that affect the nervous system. During the course of taking this medication, rare side effects such as severe movement disorders or neuroleptic malignant syndrome may occur, so if symptoms appear, consult a healthcare professional immediately. Patients who are allergic to any ingredients in this medication, pregnant, nursing, or those with severely impaired liver function, certain types of glaucoma, history of skin diseases, or melanoma should not take this medication. Patients with liver or kidney problems, history of stomach ulcers, cardiovascular diseases, or mental disorders should use this medication cautiously, and regular health status checks are necessary during treatment. This medication can cause side effects related to dopamine, so patients and caregivers should carefully observe for changes in mental state, depression, and impulse control disorders. Drowsiness or sudden sleep symptoms may occur while taking this medication, so it is advisable to avoid driving or operating dangerous machinery. There may be interactions when taken with other medications, so especially when combined with antidepressants, antipsychotics, or antihypertensives, consult with a healthcare professional. Pregnant or nursing women should not take this medication, and comprehensive clinical tests and liver function tests should be regularly conducted during treatment. In case of overdose, immediate medical intervention is required, and gastric lavage or supportive therapy may be implemented depending on the symptoms. When taking this medication, it is essential to adjust the dosage according to the instructions of healthcare professionals, avoid sudden discontinuation, and taper off gradually.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and the storage temperature must remain between 1°C and 30°C. Storing under appropriate temperature and conditions helps maintain the effectiveness and safety of the medication.

Appearance

Dark reddish-brown oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle