Stalevo Film-Coated Tablets 150/37.5/200 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 swallowed whole without dividing or crushing it. The appropriate daily dose for each patient should be carefully determined by adjusting the levodopa dose. It is preferable to select one of the available strengths of Stalevo (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 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 a standard levodopa/dopa decarboxylase inhibitor formulation at a dose equivalent to the Stalevo strength, together with entacapone. 1. Switching patients currently receiving a standard levodopa/dopa decarboxylase inhibitor (carbidopa or benserazide) and entacapone to Stalevo: 1) Patients currently receiving a standard levodopa/carbidopa formulation and entacapone at doses equivalent to a Stalevo strength 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 and entacapone at doses that are not equivalent to a Stalevo strength, 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 following morning. Initiate treatment with a Stalevo dose equivalent to the patient's previous levodopa dose or slightly higher (5~10%). 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/dopa decarboxylase inhibitor therapy, treatment with Stalevo at a dose equivalent to their current treatment may be considered. However, directly switching from standard levodopa/dopa 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 before switching to Stalevo and to 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, 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 or consider increasing the dose within the recommended range, as described above under Dosage and Administration. 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 other levodopa medications are administered concomitantly with Stalevo, observe the maximum recommended dose. - Discontinuation of Stalevo: When discontinuing Stalevo (levodopa/carbidopa/entacapone) and switching the patient to a levodopa/dopa decarboxylase inhibitor, adjustment of the doses of other antiparkinsonian medications, 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. 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 undergoing dialysis.

Child dose

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

This medication is used to treat Parkinson's disease and helps improve motor symptoms. However, serious side effects such as severe dyskinesia or rhabdomyolysis, which can occur after neuroleptic malignant syndrome, have been reported rarely and caution is necessary. Abruptly discontinuing this medication may lead to neuroleptic malignant syndrome-like symptoms such as muscle rigidity, high fever, and changes in mental state; therefore, it is important to taper off gradually. Patients with allergies to this medication's components, those who are pregnant, have severe liver impairment, glaucoma, skin conditions, or chromaffin cell tumors should not take this medication. Additionally, it is risky to use this medication in combination with monoamine oxidase inhibitors, so these should be discontinued at least 2 weeks prior to treatment. Patients with liver or kidney issues, peptic ulcers, cardiovascular diseases, or a history of mental illness should use this medication with caution, especially when taken alongside other dopaminergic medications or if it can cause orthostatic hypotension. While taking this medication, various side effects such as movement disorders, nausea, diarrhea, muscle pain, and discoloration of urine may occur. Rarely, severe hepatitis, rhabdomyolysis, and neuroleptic malignant syndrome can occur; hence, immediate consultation with a physician is required if any unusual symptoms appear. During treatment, changes in mental state, depression, hallucinations, and impulse control disorders may develop, so patients and caregivers should carefully monitor for these symptoms. Regular liver function, blood tests, and cardiovascular and kidney function tests are necessary for long-term use, and it is advisable to avoid operating dangerous machinery such as driving until dizziness or drowsiness has cleared. Interactions with other medications should also be monitored, particularly when taken with antihypertensives, antidepressants, antipsychotics, or iron preparations, as dosage adjustments may be needed after consulting a physician. Pregnant or breastfeeding women should not take this medication, and patients planning to become pregnant should consult their physician. In cases of overdose, symptoms such as coma, cardiac arrhythmias, and changes in skin and urine color may occur, necessitating immediate medical treatment, which may require gastric lavage and supportive care.

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

This medication should be stored in a tightly sealed container to protect it from exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance

Brownish-red oval film-coated tablet

Package unit

30 tablets (30 tablets/bottle)