Stalevo Film-Coated Tablets 100/25/200 mg

Adult dose

Stalevo is administered orally, one 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 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. 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. Accordingly, 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/decarboxylase inhibitor formulation at the same strength as Stalevo, together with entacapone. 1. Switching patients already 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 approximate the patient's current total daily levodopa dose as closely as possible. 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. Start with a Stalevo dose that provides 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: For patients with Parkinson's disease whose end-of-dose motor fluctuations are not improved with standard levodopa/decarboxylase inhibitor therapy, Stalevo at a dose equivalent to their current treatment may be considered. However, direct 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, 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, 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 to reduce the number of doses, 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 a levodopa/decarboxylase inhibitor, adjustment of other antiparkinsonian medications, particularly the levodopa dose, is required 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

Patients 18 years of age or younger: The safety and efficacy of Stalevo have not been evaluated. Therefore, 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 contains components that affect the nervous system. During the use of this medication, serious muscle problems such as rhabdomyolysis or neuroleptic malignant syndrome may rarely occur; therefore, if symptoms such as muscle pain, high fever, or changes in mental state occur, medical attention should be sought immediately. This medication should not be used in patients with certain diseases or those who are hypersensitive to the drug, as well as in pregnant or nursing women, patients with severe liver dysfunction, and patients with glaucoma. Special caution is required when using this medication in patients with impaired liver or kidney function, history of gastrointestinal ulcers, or history of cardiovascular or psychiatric disorders. As this medication enhances the action of dopamine, side effects such as drowsiness, sudden sleep attacks, orthostatic hypotension, and impulse control disorders may occur; thus, driving or operating hazardous machinery should be avoided if such symptoms are present. Gastrointestinal symptoms such as vomiting, diarrhea, and weight loss or skin rash, muscle pain, and discoloration of urine may occur; therefore, if abnormal symptoms persist, consultation with a doctor is recommended. This medication may interact with other drugs; therefore, it is essential to inform the doctor or pharmacist about all medications being taken, particularly when used with antipsychotics, antidepressants, antihypertensives, and iron supplements. It is advised not to take this medication during pregnancy or breastfeeding unless necessary, and in such cases, it must be discussed with a healthcare provider. Regular monitoring of liver function, blood tests, heart, and kidney function tests is recommended during long-term use. In case of overdose, promptly visit a medical institution for appropriate treatment, which may include gastric lavage, activated charcoal administration, or ECG monitoring, depending on symptoms.

Movement disorders, 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, 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, irregular heartbeat, myocardial infarction, orthostatic hypotension, hypertension, dyspnea, constipation, dyspepsia, abdominal pain and discomfort, dry mouth, colitis, dysphagia, abnormal liver function tests, rash, hyperhidrosis, discoloration other than urine, urticaria, muscle cramps, arthralgia, urinary tract infection, urinary retention, chest pain, peripheral edema, fainting, gait disturbance, weakness, fatigue, malaise, pathological gambling, increased libido, hypersexuality, impulse control disorder, compulsive shopping, echopraxia, obsessive thoughts, compulsive behaviors, excessive daytime sleepiness, sudden sleep symptoms, seizures, discoloration of skin, nails, hair, and sweat, agitation, coma, high fever, muscle rigidity, myotonic cramps, tremors, changes in mental state, autonomic nervous system abnormalities, elevated serum creatine phosphokinase, elevated blood urea nitrogen, abnormal creatinine, abnormal uric acid, elevated serum AST, ALT, LDH, bilirubin, alkaline phosphatase, positive Coombs test, hemolytic anemia, elevated blood sugar, leukocytosis, bacteria and hematuria in urine, agitation, confusion state, coma, bradycardia, ventricular tachycardia, Cheyne-Stokes respiration, discoloration of skin, tongue, conjunctiva

This medication should be stored in a tightly closed container to prevent air or moisture from entering. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness and safety of the medication for a long time.

Appearance

Reddish brown oval film-coated tablets

Package unit

30 tablets (30 tablets/bottle)