Easy Levo Tablet 50/12.5/200mg

Adult dose

Take 1 tablet of Easylevo per dose, orally 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 strengths of Easylevo (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, 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 Easylevo 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, and 150/37.5/200mg, and 7 tablets for Easylevo 200/50/200mg. In general, Easylevo may be used in patients currently treated with a standard levodopa/decarboxylase inhibitor formulation and entacapone at doses equivalent to those in Easylevo. 1. Switching patients previously receiving a levodopa/decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Easylevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation and entacapone at doses equivalent to those in Easylevo may switch directly to Easylevo. For example, a patient taking levodopa/carbidopa 50/12.5mg and entacapone 200mg 4 times daily may instead take 1 tablet of Easylevo 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 Easylevo, carefully titrate the dose to achieve optimal clinical effect. The initial dose of Easylevo 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 Easylevo, discontinue levodopa/benserazide on the night before starting treatment and begin Easylevo the following morning. Start treatment with an Easylevo dose equivalent to the current levodopa dose or a dose that is slightly (5~10%) higher. 2. Switching patients who are not currently taking entacapone to Easylevo: In patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved with standard levodopa/decarboxylase inhibitor therapy, treatment with Easylevo at a dose equivalent to their current treatment may be considered. However, directly switching from standard levodopa/decarboxylase inhibitor therapy to Easylevo is not recommended in patients with dyskinesia or in those taking a daily levodopa dose of 800mg or more. In these patients, before switching to Easylevo, 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 Easylevo. The daily levodopa dose may be reduced by extending the dosing interval or reducing the levodopa dose per administration, according to the patient's clinical condition. 3. Dose adjustment during treatment If an increase in levodopa is needed, increase the frequency of Easylevo administration according to the dosage and administration instructions described above, or consider increasing the dose within the recommended limits. If a reduction in levodopa is needed, reduce the total daily dose of Easylevo by extending the dosing interval and reducing the frequency of administration, or by reducing the Easylevo dose administered. If other levodopa products are administered concomitantly with Easylevo, comply with the maximum recommended dose. - Discontinuation of Easylevo: When Easylevo (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to a levodopa/decarboxylase inhibitor, adjustment of the doses of other antiparkinsonian drugs, particularly levodopa, is necessary to control Parkinson's disease symptoms. - Older adults: No adjustment of the Easylevo dose is required in older adults. - Patients with hepatic impairment: Easylevo 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. Easylevo should be administered with caution to patients with severe renal impairment, including those receiving dialysis.

Child dose

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

This drug is used for the treatment of Parkinson's disease and has been rarely reported to cause serious side effects such as severe motor disorders or rhabdomyolysis, which can occur after neuroleptic malignant syndrome. Sudden discontinuation of this drug may lead to symptoms similar to neuroleptic malignant syndrome, such as high fever, muscle rigidity, and changes in mental status, so it is important to taper off gradually. This drug should not be administered to patients with hypersensitivity to levodopa, carbidopa, entacapone, pregnant or breastfeeding women, those with severe liver disease, or patients with glaucoma. Patients with compromised liver or kidney function, a history of heart disease, or a history of psychiatric disorders should use this drug with caution. This drug can cause orthostatic hypotension, so caution is advised in patients at risk of low blood pressure, and dose adjustments may be necessary when used in combination with other dopaminergic drugs. During treatment with this drug, various side effects such as vomiting, diarrhea, muscle pain, discoloration of urine, drowsiness, dizziness, and changes in mental status may occur, so it is imperative to consult healthcare professionals immediately if symptoms arise. Long-term use requires regular monitoring of liver function, blood tests, and heart and kidney function, and patients should avoid driving or operating hazardous machinery until drowsiness or dizziness resolves. There are potential interactions with other medications, and particularly when taken together with antihypertensives, antidepressants, antipsychotics, or iron supplements, patients should inform healthcare professionals and be managed carefully. Use during pregnancy or breastfeeding is contraindicated as it could pose risks to the fetus or newborn. In case of an overdose, seek medical attention immediately for appropriate emergency measures such as gastric lavage, administration of activated charcoal, and close monitoring of heart and respiratory status.

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

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius (room temperature) to preserve the drug's effectiveness.

Appearance

reddish-brown round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle