Medication info
Entacapone 25/100 mg (Benserazide, Levodopa)

Entacapone 25/100 mg (Benserazide, Levodopa)

Prescription medicationTabletOral
Ingredient · strength
Levodopa›100mg / 1 tabletBenserazide Hydrochloride›28.5mg / 1 tablet
Manufacturer / importer
Samil Pharmaceutical Co., Ltd.
Appearance
Pink round tablets with a cross score
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202502528 · Approved 2025.09.24 · Insurance code 643904220

Summary

Main use
Treatment of parkinsonism (excluding drug-induced parkinsonism)
Who takes it
Adults
Adult dose
As with conventional levodopa therapy, treatment with this medicine should be initiated at the lowest possible dose and increased gradually. The dosage and administration should be individualized at every stage of the disease. To prevent dietary protein from competing with levodopa and to promote a more rapid onset of action, it is recommended, if possible, to take this medicine 30 minutes before or 1 hour after a meal. Gastrointestinal adverse reactions may occur early in treatment, but can be managed by taking this medicine with a low-protein meal or beverage or by increasing the dose gradually. The following dosage regimens may be used as a guide. 1. Initial treatment In patients with early-stage Parkinson's disease, it is preferable to initiate treatment with 1/2 tablet per dose, 3~4 times daily. Patients with more advanced disease should receive twice the above amount. Once tolerability of the initial regimen is confirmed, increase the number of daily doses by 1 at weekly intervals (e.g., 4 times daily instead of 3 times daily). If the patient can be monitored closely, the dose may also be adjusted at 2~3-day intervals. Optimal effects are generally achieved with a total daily dose of 4~8 tablets of this medicine, divided into 3~4 doses. If a further increase in the daily dose is required, increase it at monthly intervals. It may take 4~6 weeks to reach the optimal dose. 2. Maintenance treatment The average maintenance dose is 1 tablet, 4~6 times daily. The number of daily doses (at least 3 times daily) and the intervals between doses should be determined and adjusted according to the patient. 3. Special dosage and administration Other medicines for Parkinson's disease besides levodopa may be continued until the therapeutic effect of this medicine is fully established; however, their doses can often be gradually reduced after this medicine begins to take effect. If marked fluctuations in therapeutic effect (the on-off phenomenon) occur during treatment, it is recommended to reduce the amount per dose and increase the number of doses, or to administer HBS capsules (levodopa/benserazide).

Ingredients

Manufacturer
Samil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of parkinsonism (excluding drug-induced parkinsonism)

  • Parkinson's syndrome
View approved original text

This medication is used in the treatment of Parkinson's syndrome. Parkinson's syndrome is a movement disorder caused by a decrease in dopamine neurons, characterized by symptoms such as tremor, rigidity, and bradykinesia. It helps to alleviate these symptoms and improve the patient's daily life through drug therapy.

How to take

Adult dose

As with conventional levodopa therapy, treatment with this medicine should be initiated at the lowest possible dose and increased gradually. The dosage and administration should be individualized at every stage of the disease. To prevent dietary protein from competing with levodopa and to promote a more rapid onset of action, it is recommended, if possible, to take this medicine 30 minutes before or 1 hour after a meal. Gastrointestinal adverse reactions may occur early in treatment, but can be managed by taking this medicine with a low-protein meal or beverage or by increasing the dose gradually. The following dosage regimens may be used as a guide. 1. Initial treatment In patients with early-stage Parkinson's disease, it is preferable to initiate treatment with 1/2 tablet per dose, 3~4 times daily. Patients with more advanced disease should receive twice the above amount. Once tolerability of the initial regimen is confirmed, increase the number of daily doses by 1 at weekly intervals (e.g., 4 times daily instead of 3 times daily). If the patient can be monitored closely, the dose may also be adjusted at 2~3-day intervals. Optimal effects are generally achieved with a total daily dose of 4~8 tablets of this medicine, divided into 3~4 doses. If a further increase in the daily dose is required, increase it at monthly intervals. It may take 4~6 weeks to reach the optimal dose. 2. Maintenance treatment The average maintenance dose is 1 tablet, 4~6 times daily. The number of daily doses (at least 3 times daily) and the intervals between doses should be determined and adjusted according to the patient. 3. Special dosage and administration Other medicines for Parkinson's disease besides levodopa may be continued until the therapeutic effect of this medicine is fully established; however, their doses can often be gradually reduced after this medicine begins to take effect. If marked fluctuations in therapeutic effect (the on-off phenomenon) occur during treatment, it is recommended to reduce the amount per dose and increase the number of doses, or to administer HBS capsules (levodopa/benserazide).

Precautions

This medication should not be used in patients with severe endocrine disorders, liver dysfunction, kidney disorders, heart disease, or mental illness. Patients under 25 years old, pregnant women, patients with a history of malignant melanoma, patients with angle-closure glaucoma, and those allergic to any components of this medication should also not be treated. Caution should be exercised in patients with liver or kidney disorders, open-angle glaucoma, cardiovascular disease history, osteomalacia, or a history of peptic ulcer disease, and diabetes patients. If using this medication for a long period, regular blood tests and liver and kidney function tests should be performed. Mental neurological symptoms such as depression, anxiety, hallucinations, and drowsiness may occur, requiring attention. Drowsiness or somnolence may occur while driving or operating machinery, so caution is advised when such symptoms are present. This medication may interact with other drugs; therefore, it is crucial to consult with a physician, especially when using it in combination with non-selective MAO inhibitors or antihypertensive and antipsychotic medications. Women who are pregnant or nursing should not use this medication, and if pregnancy is confirmed during treatment, the medication should be discontinued immediately. Abruptly stopping this medication can lead to serious side effects, so the dosage should be gradually reduced. If adverse reactions occur, consult medical personnel immediately. Keep this medication out of reach of children and store it sealed in its original container to avoid moisture.

Side effects

  • Hemolytic anemia
  • transient leukopenia
  • thrombocytopenia
  • loss of appetite
  • depression
  • agitation
  • anxiety
  • insomnia
  • hallucinations
  • delusions
Show 26 more
  • transient loss of directional sensation
  • dopamine dysregulation syndrome
  • loss of taste
  • taste disturbance
  • akathisia
  • drowsiness
  • daytime drowsiness
  • lethargy
  • arrhythmia
  • orthostatic hypotension
  • nausea
  • vomiting
  • diarrhea
  • pruritus
  • rash
  • gastrointestinal bleeding
  • flushing
  • sweating
  • elevated serum uric acid
  • elevated BUN
  • mild transaminase elevation
  • elevated ALP
  • elevated gamma-Glutamyltransferase
  • discoloration of fluid or tissue
  • confusion
  • abnormal involuntary movements

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air and humidity. Additionally, it is important to store the medication in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Pink round tablets with a cross score

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.