Stalevo Film-Coated Tablets 50/12.5/200 mg

Adult dose

Stalevo is administered orally at a dose of 1 tablet per dose, with or without food. Each tablet is a single dose and should 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 strengths of Stalevo (50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, 125/31.25/200mg, 150/37.5/200mg, or 200/50/200mg of levodopa/carbidopa/entacapone, respectively) 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 doses of carbidopa 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 a standard formulation of levodopa/decarboxylase inhibitor at a dose equivalent to the Stalevo dose, together with entacapone. 1. Switching patients already receiving levodopa/decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Stalevo: 1) Patients currently receiving a standard formulation of levodopa/carbidopa and entacapone at doses equivalent to the Stalevo dose may be switched 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) For patients currently receiving a standard formulation of levodopa/carbidopa and entacapone at doses that are not equivalent to the Stalevo dose, 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 formulation of levodopa/benserazide and entacapone to Stalevo, discontinue levodopa/benserazide on the night before starting treatment and begin Stalevo the following morning. Initiate treatment with a Stalevo dose equivalent to the previous levodopa dose or one that is slightly higher (5~10%). 2. Switching patients who are not currently taking entacapone to Stalevo: In patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved by standard therapy with levodopa/decarboxylase inhibitor, Stalevo at a dose equivalent to their current treatment may be considered. However, direct switching from standard therapy with levodopa/decarboxylase inhibitor to Stalevo is not recommended in patients with dyskinesia or those taking a daily levodopa dose of 800mg or more. In these patients, before switching to Stalevo, 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 Stalevo. 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 Stalevo administration according to the dosage 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 Stalevo by extending the dosing interval and reducing the frequency of administration, or by reducing the Stalevo dose administered. When other levodopa products are administered concomitantly with Stalevo, observe the maximum recommended dose. - Discontinuation of Stalevo: When Stalevo (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to levodopa/decarboxylase inhibitor, adjustment of the doses of other antiparkinsonian drugs, particularly levodopa, is necessary to control the symptoms of Parkinson's disease. - Elderly patients: Dose adjustment of Stalevo is not 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. The pharmacokinetics of levodopa and carbidopa in patients with renal impairment have not been specifically reported. Stalevo should be administered with caution to patients with severe renal impairment, including patients receiving dialysis.

Child dose

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

This medicine has been reported to have serious side effects, such as rhabdomyolysis, which rarely occurs after severe dyskinesia or neuroleptic malignant syndrome. Symptoms may include muscle rigidity, high fever, altered mental state, and autonomic nervous system abnormalities, making early diagnosis and treatment very important. Discontinuing this medication abruptly can worsen symptoms, so it should be tapered off gradually, and transition to alternative dopaminergic therapy may be necessary. This medication should not be administered to certain patients, such as those allergic to any of its components, pregnant women, patients with severe liver dysfunction, patients with narrow-angle glaucoma, and those with undiagnosed skin conditions or a history of melanoma. Furthermore, serious side effects may occur when used in combination with certain drugs, so consulting a physician is essential. Patients with weakened liver or kidney function, those with peptic ulcers or heart disease, and patients with a history of mental disorders should use this medication cautiously, as it may cause orthostatic hypotension. Common side effects of this medication include movement disorders, nausea, diarrhea, muscle pain, changes in urine color, anemia, weight loss, decreased appetite, depression, hallucinations, confusion, abnormal dreams, anxiety, insomnia, worsening of Parkinson's disease, tremors, on and off phenomenon, dystonia, psychiatric disorders, drowsiness, dizziness, headache, blurred vision, ischemic heart disease other than myocardial infarction, irregular heart rhythms, orthostatic hypotension, hypertension, diarrhea, constipation, and indigestion. Patients should be carefully monitored for changes in mental state, suicidal tendencies, and hallucinations while taking this medication, and regular liver, blood, and cardiovascular examinations are recommended for long-term use. This medication may interact with other drugs, so if you are taking any other medications, be sure to inform your doctor or pharmacist, especially if combined with certain antidepressants or antipsychotic medications. Pregnant or nursing women should not take this medication, and its safety regarding fertility is unclear. In case of overdose, go to the hospital immediately for appropriate treatment such as gastric lavage and activated charcoal administration, and closely monitor heart and respiratory status. While taking this medication, avoid driving or operating hazardous machinery, and consult your healthcare provider immediately if symptoms occur.

Extrapyramidal symptoms, vomiting, diarrhea, pain in muscles and 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, restlessness, suicidal behavior, dopamine dysregulation syndrome, worsening of Parkinson's disease, tremors, on and off phenomenon, muscle rigidity, mental disorders, drowsiness, dizziness, headache, blurred vision, ischemic heart disease, irregular heartbeat, myocardial infarction, orthostatic hypotension, hypertension, shortness of breath, constipation, dyspepsia, abdominal pain and discomfort, dry mouth, colitis, dysphagia, abnormal liver function test results, rash, hyperhidrosis, discoloration other than urine, urticaria, muscle cramping, arthralgia, urinary tract infection, urinary retention, chest pain, peripheral edema, fainting, gait disturbance, weakness, fatigue, malaise

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness and safety.

Appearance

Brownish-red, convex, round film-coated tablet

Package unit

30 tablets (30 tablets/bottle)