Stalevo Film-Coated Tablets 200/50/200 mg

Adult dose

Stalevo is administered orally as 1 tablet per dose, with or without food. One tablet is one 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 Stalevo (each containing levodopa/carbidopa/entacapone at 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 Stalevo 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, and 150/37.5/200mg, and 7 tablets for Stalevo 200/50/200mg. In general, Stalevo may be used in patients currently treated with standard levodopa/decarboxylase inhibitor formulations and entacapone at doses equivalent to those in Stalevo. 1. Switching patients currently receiving levodopa/decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Stalevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation and entacapone at doses equivalent to those in Stalevo may switch directly to Stalevo. For example, a patient taking levodopa/carbidopa 50/12.5mg and entacapone 200mg 4 times daily may instead take 1 tablet of Stalevo 50/12.5/200mg 4 times daily. 2) In patients currently receiving a standard levodopa/carbidopa formulation and entacapone at doses that are not equivalent to those in Stalevo, carefully titrate the dose to achieve optimal clinical effect. The initial dose of Stalevo 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 Stalevo, discontinue levodopa/benserazide on the night before starting treatment and begin Stalevo the next morning. Start with a Stalevo dose that provides the same or a slightly higher amount (5~10%) of levodopa than the amount previously received. 2. Switching patients not currently taking entacapone to Stalevo: In patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved with standard levodopa/decarboxylase inhibitor therapy, switching to Stalevo at a dose equivalent to their current treatment may be considered. However, directly switching from standard levodopa/decarboxylase inhibitor therapy to Stalevo is not recommended in 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 adjust (reduce) the levodopa dose if necessary before switching to Stalevo. 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 Stalevo. 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 Stalevo 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 dose of Stalevo by extending the dosing interval and reducing the frequency of administration, or by reducing the Stalevo dose administered. If another levodopa product is used concomitantly with Stalevo, observe the maximum recommended dose. - Discontinuation of Stalevo: When Stalevo (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to a levodopa/decarboxylase inhibitor, adjustment of the doses of other antiparkinsonian medicines, particularly levodopa, is necessary to control the symptoms of Parkinson's disease. - Elderly patients: No dose adjustment of Stalevo is required in elderly patients. - Patients with hepatic impairment: Stalevo 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. Stalevo should be administered with caution to patients with severe renal impairment, including those receiving dialysis.

Child dose

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

This medication is used for the treatment of Parkinson's disease and helps improve motor function. While taking this medication, there may be rare severe side effects such as severe motor disturbance or neuroleptic malignant syndrome accompanied by rhabdomyolysis, so caution is advised. Sudden discontinuation of the medication may lead to symptoms such as muscle rigidity, high fever, and changes in mental state, so it should be tapered off gradually according to a doctor's instructions. Those who are allergic to any components of this medication, pregnant or breastfeeding, have severe liver dysfunction, or suffer from certain glaucoma, skin disorders, or chromaffin cell tumors should not take this medication. Taking it with other specific antidepressants or neuroleptics can also be dangerous; therefore, consultation with a doctor is essential. Caution should be exercised when prescribing to patients with impaired liver or kidney function, a history of peptic ulcers, heart disease, or mental illness, as drug interactions may also pose a risk. Common side effects include nausea, diarrhea, muscle pain, movement disorders, drowsiness, and dizziness, while rare side effects can include hepatitis, rhabdomyolysis, and serious allergic reactions. It is advised to avoid driving or operating dangerous machinery if drowsiness or dizziness occurs, and to closely monitor any changes in mental state, depression, or impulse control disorders. In addition, if taking this medication for a long time, regular monitoring of liver function, blood, heart, and kidney function tests is recommended. If any unusual symptoms such as weight changes, persistent diarrhea, or impulsive behavior occur during medication, consult a physician immediately. In case of overdose, seek medical help immediately, and self-treatment may be dangerous. This medication may interact with other drugs, so inform the healthcare provider of all medications being taken and consult before starting or stopping any new medications.

Movement disorders, vomiting, diarrhea, pain in muscles, musculoskeletal and connective tissues, discoloration of urine, gastrointestinal bleeding, angioedema, hepatitis, rhabdomyolysis, neuroleptic malignant syndrome, anemia, thrombocytopenia, weight loss, decreased appetite, depression, hallucinations, confusion, abnormal dreams, anxiety, insomnia, psychosis, agitation, suicidal behavior, dopamine dysregulation syndrome, worsening of Parkinson's disease, tremors, on and off phenomenon, dystonia, mental disorders, drowsiness, dizziness, headache, blurred vision, ischemic heart disease other than myocardial infarction, irregular heartbeat, myocardial infarction, orthostatic hypotension, hypertension, dyspnea, constipation, indigestion, abdominal pain and discomfort, dry mouth, colitis, dysphagia, abnormal liver function test results, rash, hyperhidrosis, discoloration other than urine, urticaria, muscle cramps, arthralgia, urinary tract infections, urinary retention, chest pain, peripheral edema, fainting, gait disturbances, weakness, fatigue, lethargy

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1°C and 30°C.

Appearance

Dark reddish-brown oval film-coated tablet

Package unit

30 tablets (30 tablets/bottle)