EasyLevo Tablet 125/31.25/200mg

Adult dose

Easyrevo is administered orally as 1 tablet per dose, 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 Easyrevo strengths (levodopa/carbidopa/entacapone, respectively: 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 a total daily carbidopa dose 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 Easyrevo 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, and 150/37.5/200mg, and 7 tablets for Easyrevo 200/50/200mg. In general, Easyrevo can be used in patients currently treated with a standard levodopa/dopa decarboxylase inhibitor formulation at a dose equivalent to that of Easyrevo, together with entacapone. 1. Switching patients currently receiving levodopa/dopa decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Easyrevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation and entacapone at doses equivalent to those in Easyrevo can switch directly to Easyrevo. For example, a patient taking levodopa/carbidopa 50/12.5mg and entacapone 200mg 4 times daily may instead take 1 tablet of Easyrevo 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 those in Easyrevo, carefully titrate the dose to achieve the optimal clinical effect. The initial dose of Easyrevo should be set to the strength that most closely matches the patient's current total daily levodopa dose. 3) When switching patients receiving a standard levodopa/benserazide formulation and entacapone to Easyrevo, discontinue levodopa/benserazide on the night before starting treatment and begin Easyrevo the next morning. Start with an Easyrevo dose equivalent to, or slightly (5~10%) higher than, the amount of levodopa previously taken. 2. Switching patients who are not currently taking entacapone to Easyrevo: For patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved with standard levodopa/dopa decarboxylase inhibitor therapy, treatment with Easyrevo at the same dose as their current treatment may be considered. However, directly switching from standard levodopa/dopa decarboxylase inhibitor therapy to Easyrevo is not recommended in patients with dyskinesia or those taking a daily levodopa dose of 800mg or more. In these patients, before switching to Easyrevo, 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 day to 1 week after starting Easyrevo. The 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 Easyrevo administration 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 Easyrevo by extending the dosing interval and decreasing the frequency of administration, or by reducing the Easyrevo dose administered. When another levodopa medication is used concomitantly with Easyrevo, observe the maximum recommended dose. - Discontinuation of Easyrevo: When Easyrevo (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 Easyrevo is required in elderly patients. - Patients with hepatic impairment: Easyrevo 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. There are no specific reports on the pharmacokinetics of levodopa and carbidopa in patients with renal impairment. Easyrevo should be administered with caution to patients with severe renal impairment, including patients receiving dialysis.

Child dose

Administration of Ezilevo is not recommended in patients 18 years of age or younger.

This medication is used for the treatment of Parkinson's disease and serious side effects such as severe movement disorders or rhabdomyolysis that may occur after neuroleptic malignant syndrome have been rarely reported. Sudden discontinuation of this medication may result in symptoms similar to neuroleptic malignant syndrome, including muscle rigidity, high fever, and changes in mental state, so it should be tapered off gradually, and it is important to switch to dopaminergic therapy if necessary. This medication should not be administered to specific patients, such as those who are hypersensitive to any of its components, women who are pregnant or breastfeeding, patients with severe liver impairment, glaucoma patients, chromaffin cell tumor patients, and those taking certain medications concurrently. Patients with impaired liver or kidney function, those with a history of gastric ulcers, patients with cardiovascular diseases, and those with mental illnesses should be particularly cautious when administering this drug. This medication can commonly cause side effects such as movement disorders, gastrointestinal symptoms (nausea, diarrhea), muscle pain, and discoloration of urine, while serious side effects such as hepatitis, rhabdomyolysis, and neuroleptic malignant syndrome may infrequently occur. Furthermore, this medication may induce drowsiness or sudden sleep symptoms, so caution is necessary when driving or operating dangerous machinery. This drug can interact with other medications, so it must be carefully monitored, especially when taken in conjunction with antihypertensive agents, antidepressants, and antipsychotics. It should not be used during pregnancy or breastfeeding, and regular monitoring of liver function, blood tests, and cardiovascular examinations are recommended during administration. In case of overdose, immediate visit to a medical facility is required for appropriate treatment such as gastric lavage and the administration of activated charcoal, with careful monitoring of cardiac and respiratory status.

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

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is important to maintain a storage temperature between 1°C and 30°C. This helps to preserve the effectiveness of the medication over time.

Appearance

Bright reddish-brown oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle