Levodopa/Carbidopa/Entacapone 75/18.75/200mg

Adult dose

Easyrevo is administered orally as 1 tablet per dose, with or without food. One tablet is a single dose and should be swallowed whole; do not divide or crush it. The appropriate daily dose for each patient should be carefully determined by adjusting the levodopa dose. The daily dose of Easyrevo should preferably be selected from the available 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), with 1 tablet taken per dose. Instruct patients to take only 1 tablet per dose. Nausea and vomiting are more likely in patients taking 70mg~100mg or less of carbidopa per day. 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 of Easyrevo 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, or 150/37.5/200mg, and 7 tablets of Easyrevo 200/50/200mg. In general, Easyrevo may be used in patients currently treated with a standard levodopa/dopa-decarboxylase inhibitor formulation at the same strength as Easyrevo, together with entacapone. 1. Switching patients currently receiving a levodopa/dopa-decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Easyrevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation at the same strength as Easyrevo, together with entacapone, may 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 at a different strength from Easyrevo, together with entacapone, carefully titrate the dose to achieve optimal clinical effect. The initial dose of Easyrevo 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 Easyrevo, discontinue levodopa/benserazide on the night before starting treatment, and begin Easyrevo the following morning. Start with a dose of Easyrevo that provides the same amount of levodopa as the patient’s previous dose, or a slightly higher amount (5~10%). 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 by standard levodopa/dopa-decarboxylase inhibitor therapy, Easyrevo at a dose equivalent to 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 800mg or more of levodopa per day. 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 decreasing the levodopa dose per administration, depending on the patient’s clinical condition. 3. Dose adjustment during treatment If an increase in levodopa is required, increase the frequency of Easyrevo administration as described above under Dosage and Administration, or consider increasing the dose within the recommended range. If a reduction in levodopa is required, reduce the total daily dose of Easyrevo by extending the dosing interval to decrease the frequency of administration or by reducing the dose of Easyrevo administered. When other levodopa products are administered 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, the doses of other antiparkinsonian medicines, particularly levodopa, may need to be adjusted to control symptoms of Parkinson’s disease. - Older adults: No dose adjustment of Easyrevo is required in older adults. - Patients with hepatic impairment: Use Easyrevo with caution in 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. Easyrevo should be administered with caution to patients with severe renal impairment, including those receiving dialysis.

Child dose

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

This medication is used to treat Parkinson's disease and severe adverse effects such as severe movement disorders or rhabdomyolysis can occur rarely after neuroleptic malignant syndrome. If this medication is stopped suddenly, symptoms such as muscle rigidity, high fever, and changes in mental state may occur, so it is important to taper off gradually. This medication should not be administered to certain patients; for example, those who are allergic to the drug components, pregnant women, patients with severe liver disorders, or patients with glaucoma should not use this medication. Caution is needed when using this medicine for patients with liver or kidney function issues, peptic ulcer disease, or cardiovascular diseases. Common side effects include movement disorders, nausea, diarrhea, myalgia, discoloration of urine, thrombocytopenia, weight loss, loss of appetite, depression, hallucinations, confusion, abnormal dreams, anxiety, insomnia, psychosis, agitation, worsening of Parkinson's disease, tremors, on and off phenomenon, dystonia, mental disorders, drowsiness, dizziness, headaches, blurred vision, ischemic heart disease other than myocardial infarction, irregular heart rhythms, orthostatic hypotension, hypertension, and constipation. Serious adverse reactions such as hepatitis or rhabdomyolysis can occur rarely. Patients and caregivers should closely monitor for signs of mental changes or impulse control disorders. It is advisable to avoid driving or operating hazardous machinery during the use of this medication. Additionally, this medication may interact with other drugs, so be sure to inform healthcare providers of any other medications being taken. Pregnant or breastfeeding women should not use this medication, and regular tests for liver function, blood, cardiovascular, and kidney function should be done during long-term use. In case of overdose, visit a hospital immediately for appropriate treatment and avoid self-treatment.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to preserve the drug's effectiveness and safety over a longer period.

Appearance

Bright reddish-brown oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle