Medication info

Entacapone 200 mg (Entacapone)

Prescription medicationTabletOralExpired
Ingredient · strength
Entacapone›200mg / 1 tablet
Manufacturer / importer
Samil Pharmaceutical Co., Ltd.
Appearance
Bright brownish-yellow oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 201902599 · Approved 2019.04.25

This product's status changed to Expired on 2024.04.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunctive treatment of parkinsonism that has not improved with standard therapy
Who takes it
Adults · Children
Adult dose
This medication is administered orally at the same time as each dose of levodopa/dopa decarboxylase inhibitor (benserazide or carbidopa). This medication may be used with standard levodopa formulations. Its efficacy as an adjunct to sustained-release levodopa/dopa decarboxylase inhibitor formulations has not been established. This medication may be administered with or without food. Administer 1 tablet of this medication 200mg with each dose of levodopa/dopa decarboxylase inhibitor. The maximum recommended dose of this medication is 1 dose of 200mg 10 times daily, or 2000mg. This medication enhances the efficacy of levodopa. Therefore, to reduce levodopa-related dopaminergic adverse effects, such as dyskinesia, nausea, vomiting, and hallucinations, it may occasionally be necessary to adjust the levodopa dose during the first 1 day to 1 week after starting this medication. The daily levodopa dose should be reduced by approximately 10 ~ 30% by extending the dosing interval or reducing the dose per administration, depending on the patient's clinical condition. If this medication is discontinued, it may be necessary to adjust the doses of other antiparkinsonian medications, particularly levodopa, to control Parkinson's symptoms. This medication slightly increases the bioavailability of levodopa in standard levodopa/benserazide formulations (5-10%) more than the bioavailability of levodopa in standard levodopa/carbidopa formulations. Therefore, patients receiving standard levodopa/benserazide formulations may require a greater reduction in the levodopa dose when starting this medication. Renal impairment does not affect the pharmacokinetics of this medication; therefore, no dose adjustment is necessary. However, extending the dosing interval may be considered in patients receiving dialysis. Elderly patients: No dose adjustment of this medication is required for elderly patients.
Child dose
Studies have not been conducted in patients aged 18 years or younger; therefore, use in patients in this age group is not recommended.

Ingredients

Manufacturer
Samil Pharmaceutical Co., Ltd.

Efficacy & effects

Adjunctive treatment of parkinsonism that has not improved with standard therapy

  • Parkinson's syndrome
View approved original text

This medication is used as an adjunct therapy for Parkinson's syndrome patients whose symptoms are not sufficiently improved by standard treatment with levodopa and dopa decarboxylase inhibitors. It helps to enhance the effect of existing treatments and further improve symptoms. It contributes to improving the patient's motor function and enhances the quality of daily life. Therefore, it is used for more effective management of Parkinson's syndrome.

How to take

Adult dose

This medication is administered orally at the same time as each dose of levodopa/dopa decarboxylase inhibitor (benserazide or carbidopa). This medication may be used with standard levodopa formulations. Its efficacy as an adjunct to sustained-release levodopa/dopa decarboxylase inhibitor formulations has not been established. This medication may be administered with or without food. Administer 1 tablet of this medication 200mg with each dose of levodopa/dopa decarboxylase inhibitor. The maximum recommended dose of this medication is 1 dose of 200mg 10 times daily, or 2000mg. This medication enhances the efficacy of levodopa. Therefore, to reduce levodopa-related dopaminergic adverse effects, such as dyskinesia, nausea, vomiting, and hallucinations, it may occasionally be necessary to adjust the levodopa dose during the first 1 day to 1 week after starting this medication. The daily levodopa dose should be reduced by approximately 10 ~ 30% by extending the dosing interval or reducing the dose per administration, depending on the patient's clinical condition. If this medication is discontinued, it may be necessary to adjust the doses of other antiparkinsonian medications, particularly levodopa, to control Parkinson's symptoms. This medication slightly increases the bioavailability of levodopa in standard levodopa/benserazide formulations (5-10%) more than the bioavailability of levodopa in standard levodopa/carbidopa formulations. Therefore, patients receiving standard levodopa/benserazide formulations may require a greater reduction in the levodopa dose when starting this medication. Renal impairment does not affect the pharmacokinetics of this medication; therefore, no dose adjustment is necessary. However, extending the dosing interval may be considered in patients receiving dialysis. Elderly patients: No dose adjustment of this medication is required for elderly patients.

Child dose

Studies have not been conducted in patients aged 18 years or younger; therefore, use in patients in this age group is not recommended.

Precautions

This medication should not be used by patients who are allergic to the active ingredient or other components. Women who are pregnant or breastfeeding should not take this medication. Patients with liver function problems should not use this medication. There is a risk of serious hypertensive crisis when administered to patients with specific types of tumors called pheochromocytoma. It may be risky to use in combination with some antidepressants or certain enzyme inhibitors, so it should never be co-administered. Patients with a history of neuroleptic malignant syndrome or rhabdomyolysis should not take this medication. This medication contains lactose, so patients with lactose intolerance or related genetic disorders should avoid it. In the initial period of use, side effects related to increased dopamine action, such as movement disorders, may frequently occur, and gastrointestinal disturbances such as nausea, vomiting, abdominal pain, constipation, and diarrhea are also common. Side effects are generally mild to moderate, and discontinuation of the medication often leads to improvement of symptoms. The frequency of side effects may be higher with high doses. Taking this medication may cause urine to turn reddish-brown, but this is a non-harmful phenomenon. Long-term use may lead to a slight decrease in hemoglobin levels in the blood, necessitating periodic monitoring. Liver function test values may rarely increase, so the liver's health status should be monitored. This medication may cause drowsiness or sudden sleep symptoms due to dopamine action when used in conjunction with other Parkinson's disease treatments, and caution is needed when driving or operating machinery. Especially, it can cause a drop in blood pressure, so patients with orthostatic hypotension should be careful. There may be possible interactions with other medications taken with this medication, so it is essential to inform healthcare providers about the medications being used. Women who are pregnant or breastfeeding should not take this medication, and safety in pediatric patients under 18 years of age has not been established, so it is not recommended. In the case of overdose, confusion, drowsiness, muscle relaxation, and skin reactions may occur, and immediate medical attention should be sought. During the use of this medication, unusual physical symptoms or behavioral changes such as impulse control disorders may appear, so both patients and caregivers should observe closely. If abnormal symptoms occur, it is important to consult with healthcare professionals to adjust the treatment plan.

Side effects

Movement disorders, nausea, diarrhea, abdominal pain, thirst, constipation, vomiting, fatigue, increased sweating, headache, insomnia, worsening of Parkinson's disease, hallucinations, dizziness, confusion, muscle rigidity, hyperactivity, tremors, leg cramps, sensory disturbances, urinary disturbances, hyperkinetic syndrome, reduced motor function, vertigo, abnormal gait, nausea, constipation, vertigo, headache, confusion, auditory hallucinations, abdominal pain, dry mouth, indigestion, gastrointestinal disorders, oral sensory disturbances, movement disorders, muscle rigidity, gait disorders, on-off phenomenon, sensory disturbances, worsening of Parkinson's disease, depression, sleep disorders, back pain, musculoskeletal rigidity, myalgia, distal pain, erythema, pruritus, rash, cataract, blurred vision, abnormal liver function test results, peripheral edema, cataract surgery, hypertension, ischemic heart disease excluding myocardial infarction, myocardial infarction, loss of appetite, colitis, abnormal liver function test values, erythematous rash, papular rash, pruritus, skin discoloration, hair discoloration, beard discoloration, nail discoloration, urine discoloration, fainting, weight loss, drowsiness, sudden sleep symptoms, neuroleptic malignant syndrome, rhabdomyolysis, pathological gambling, increased libido, hypersexuality, confusion, anxiety

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is best to store it at room temperature between 1 to 30 degrees Celsius. Proper storage helps to maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Bright brownish-yellow oval film-coated tablets

Package unit

30 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.