Stalevo Film-Coated Tablet 75/18.75/200 mg

Adult dose

Stalevo 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 Stalevo 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) and take 1 tablet per dose. Instruct patients to take only 1 tablet per dose. Nausea and vomiting are more likely to occur in patients taking 70mg~100mg or less of carbidopa per day. Experience with a total daily carbidopa dose 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 receiving treatment with a standard levodopa/decarboxylase inhibitor formulation at the same strength as Stalevo, together with entacapone. 1. Switching patients currently receiving levodopa/decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Stalevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation at the same strength as Stalevo, together with entacapone, 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) For patients currently receiving a standard levodopa/carbidopa formulation at a strength different from Stalevo, together with entacapone, carefully titrate the dose to achieve optimal clinical effect. The initial Stalevo dose should be set to provide the closest possible amount 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 treatment with a Stalevo dose corresponding to an amount of levodopa equal to or slightly (5~10%) greater than the amount the patient was previously receiving. 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 controlled with standard levodopa/decarboxylase inhibitor therapy, 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 800mg or more of levodopa per day. In these patients, it is preferable to administer entacapone as a separate tablet before switching to Stalevo and to 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 Stalevo. The daily levodopa dose may be reduced by extending the dosing interval or decreasing the amount of levodopa per dose, depending on the patient's clinical condition. 3. Dose adjustment during treatment If an increase in levodopa is required, 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 required, reduce the total daily amount 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 treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is switched to levodopa/decarboxylase inhibitor therapy, adjustment of other antiparkinsonian medications, particularly the levodopa dose, is necessary to control the symptoms of Parkinson's disease. - Older adults: No adjustment of the Stalevo dose is required in older adults. - 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 patients receiving dialysis.

Child dose

Patients aged 18 years and younger: The safety and efficacy of Stalevo have not been evaluated. Therefore, administration of Stalevo is not recommended for patients aged 18 years and younger.

This medication is used for the treatment of Parkinson's disease and may rarely cause serious side effects such as severe dyskinesia or rhabdomyolysis that can occur after neuroleptic malignant syndrome. If this medication is suddenly discontinued, symptoms such as muscle rigidity, high fever, and changes in mental state may occur, so it is important to taper off the dosage gradually when discontinuing. This medication should not be used in certain patients, such as those allergic to the ingredients, pregnant women, patients with severe liver disease, glaucoma patients, and those taking certain medications. Patients with poor liver or kidney function, those with a history of peptic ulcers or cardiovascular diseases, and those with a history of mental illness should use this medication with caution. It may cause various side effects such as movement disorders, nausea, diarrhea, muscle pain, changes in urine color, anemia, weight loss, loss of appetite, depression, hallucinations, confusion, anxiety, insomnia, tremors, drowsiness, dizziness, headaches, blurred vision, irregular heart rhythms, orthostatic hypotension, hypertension, constipation, dyspepsia, abdominal pain, dry mouth, dysphagia, abnormal liver function tests, rashes, sweating, discoloration not related to urine, fatigue, and chest pain. Additionally, changes in mental state or impulse control disorders may occur during the use of this medication, so patients and caregivers should observe carefully. This medication may interact with other drugs; therefore, particularly patients taking antidepressants, antihypertensives, or antipsychotic medications should consult with their doctor or pharmacist. Pregnant or nursing women should not take this medication, and caution is needed if planning to become pregnant. Regular liver function tests, blood tests, cardiovascular, and kidney function tests should be conducted during long-term use, and it is advisable to avoid driving or operating hazardous machinery until drowsiness or dizziness subsides. In case of overdose, seek immediate medical attention for appropriate treatment such as gastric lavage and activated charcoal, and continuously monitor heart and respiratory function.

• Dyskinesia
• vomiting
• diarrhea
• muscle and musculoskeletal pain
• chromaturia
• gastrointestinal bleeding
• angioedema
• hepatitis
• rhabdomyolysis
• neuroleptic malignant syndrome

Store this medication in a tightly closed container protected from air and moisture. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance

Bright reddish-brown oval film-coated tablets

Package unit

30 tablets (30 tablets/bottle)