Medication info
Comtan 200 mg (Entacapone)

Comtan 200 mg (Entacapone)

Prescription medicationTabletOral
Ingredient · strength
Entacapone›200mg / 1 tablet
Manufacturer / importer
Alvogen Korea Co., Ltd.
Appearance
Brownish-orange oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 199906916 · Approved 1999.04.08 · Insurance code 652606920

Summary

Main use
Adjunctive treatment of Parkinsonian syndrome that does not improve with standard therapy
Who takes it
Adults · Children
Adult dose
This drug should be administered orally at the same time as each levodopa/dopa decarboxylase inhibitor (benserazide or carbidopa). This drug can be used with standard levodopa preparations. The efficacy of this drug as an adjunct to sustained-release levodopa/dopa decarboxylase inhibitor preparations has not been established. This drug may be administered with or without food. Administer 1 tablet of this drug 200mg with each dose of levodopa/dopa decarboxylase inhibitor. The maximum recommended dose of this drug is 1 dose of 200mg 10 times daily, or 2000mg. This drug enhances the effects 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 within the first day to 1 week after starting this drug. 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 drug is discontinued, it may be necessary to adjust the doses of other antiparkinsonian drugs, particularly levodopa, to control Parkinson's symptoms. This drug increases the bioavailability of levodopa in standard levodopa/benserazide preparations slightly more (5-10%) than the bioavailability of levodopa in standard levodopa/carbidopa preparations. Therefore, patients receiving standard levodopa/benserazide preparations may require a greater reduction in the levodopa dose when starting this drug. Renal impairment does not affect the pharmacokinetics of this drug; therefore, no dose adjustment is necessary. However, for patients undergoing dialysis, extending the dosing interval may be considered. Elderly patients: No dose adjustment of this drug is required for elderly patients.
Child dose
Patients 18 years of age or younger: Studies have not been conducted; therefore, use in patients in this age group is not recommended.

Ingredients

Importer
Alvogen Korea Co., Ltd.

Efficacy & effects

Adjunctive treatment of Parkinsonian syndrome that does not improve with standard therapy

View approved original text

This medication is used as an adjunct treatment for patients with Parkinson's syndrome who do not improve with standard therapy including levodopa and dopa decarboxylase inhibitors. It can help improve symptoms more effectively.

How to take

Adult dose

This drug should be administered orally at the same time as each levodopa/dopa decarboxylase inhibitor (benserazide or carbidopa). This drug can be used with standard levodopa preparations. The efficacy of this drug as an adjunct to sustained-release levodopa/dopa decarboxylase inhibitor preparations has not been established. This drug may be administered with or without food. Administer 1 tablet of this drug 200mg with each dose of levodopa/dopa decarboxylase inhibitor. The maximum recommended dose of this drug is 1 dose of 200mg 10 times daily, or 2000mg. This drug enhances the effects 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 within the first day to 1 week after starting this drug. 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 drug is discontinued, it may be necessary to adjust the doses of other antiparkinsonian drugs, particularly levodopa, to control Parkinson's symptoms. This drug increases the bioavailability of levodopa in standard levodopa/benserazide preparations slightly more (5-10%) than the bioavailability of levodopa in standard levodopa/carbidopa preparations. Therefore, patients receiving standard levodopa/benserazide preparations may require a greater reduction in the levodopa dose when starting this drug. Renal impairment does not affect the pharmacokinetics of this drug; therefore, no dose adjustment is necessary. However, for patients undergoing dialysis, extending the dosing interval may be considered. Elderly patients: No dose adjustment of this drug is required for elderly patients.

Child dose

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

Precautions

This medicine should not be used by patients who are allergic to the active ingredient or other components. Women who are pregnant or breastfeeding should also avoid taking this medicine. It should not be administered to patients with poor liver function. There is a risk of a sudden increase in blood pressure in patients with certain rare tumors like pheochromocytoma. It should not be taken in conjunction with specific types of antidepressants or monoamine oxidase inhibitors, and some drugs may require dosage adjustments. Patients with a history of neuroleptic malignant syndrome or rhabdomyolysis should not take this medication. This medicine contains sugar, so it should not be administered to patients with certain metabolic disorders involving sugars. Early in the course of treatment, motor disturbances may arise due to increased dopamine activity, and gastrointestinal symptoms such as nausea, vomiting, abdominal pain, constipation, and diarrhea may frequently occur. In some patients, this medication may cause urine to appear reddish-brown; this is not harmful. Long-term use may result in slight reductions in hemoglobin and red blood cell counts, necessitating periodic blood tests. Liver function tests may rarely show elevated levels, so liver health should be monitored closely. Interactions may occur with other medications taken concurrently, so patients must inform their healthcare provider of all medications being taken. Drowsiness or dizziness may occur while driving or operating machinery, so caution is needed. If diarrhea persists, weight should be frequently checked to prevent weight loss, and if symptoms are severe, consulting a doctor is advisable. Patients may experience impulse control disorders, such as gambling or overeating, during treatment, and this needs to be monitored by patients and caregivers. Patients with cardiovascular diseases should use this medication with caution. In case of overdose, symptoms such as confusion, drowsiness, decreased muscle tone, and skin changes may occur, and immediate medical attention should be sought. This medication is not recommended for children under 18 years old.

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 tone disorder, excessive dreaming, tremors, leg cramps, sensory disturbances, urinary issues, hyperkinesis, reduced motor function, lightheadedness, abnormal gait, anxiety, ischemic heart disease other than myocardial infarction, myocardial infarction, loss of appetite, colitis, abnormalities in liver function tests, erythematous rash, papular rash, itching, skin discoloration, urine discoloration, fainting, weight loss, drowsiness, sudden sleep symptoms, neuroleptic malignant syndrome, rhabdomyolysis, pathological gambling, increased libido, hypersexuality, nausea, constipation, dizziness, headache, confusion, auditory hallucinations, abdominal pain, dry mouth, indigestion, gastrointestinal disorders, oral sensory disturbances, movement disorder, muscle tone abnormalities, gait disturbances, on-off phenomenon, sensory abnormalities, depression, sleep disorders, low back pain, musculoskeletal rigidity, myalgia, distal pain, erythema, itching, rash, cataract, blurred vision, abnormalities in liver function test results, peripheral edema, cataract surgery, hypertension, confusion, nightmares, anxiety, coma, tachycardia, unstable blood pressure, elevated serum CPK, disorientation, decreased activity, reduced muscle tone, skin discoloration, hives

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

Storage

This medicine should be stored in a tightly closed container to prevent exposure to air and moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Brownish-orange oval film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

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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.