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Opicapone

Brand: Bial
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Opicapone is a peripherally selective, reversible catechol-O-methyltransferase (COMT) inhibitor. By inhibiting COMT enzyme activity, it reduces the peripheral metabolism of levodopa, thereby prolonging its action time and enhancing its efficacy.

1. Drug name and main ingredients

1. Generic name :Opicapone (Opicapone)

2. Trade name :ONGENTYS®

3. Dosage form : Capsule

4. Main ingredients : Each capsule contains 25 mg or 50 mg of opicapone (in the form of ethanesulfonate), and excipients include lactose, magnesium stearate, pregelatinized starch, etc.

2. Indications

Parkinson's disease (PD) : As an adjuvant treatment with levodopa/carbidopa, it is used to relieve the "off period" symptoms of PD patients.

3. Specifications and properties

1. Specifications : 25mg (light blue opaque capsules, printed with "OPC25" blue logo) and 50mg (dark blue opaque capsules, printed with "OPC50" white logo).

2. Characteristics of : The content is bright yellow powder, which becomes a uniform suspension after reconstitution.

IV. Usage and dosage

1. Recommended dosage of : 50mg once a day, taken orally before going to bed.

2. Dietary requirements : Fasting 1 hour before taking the medicine and at least 1 hour after taking the medicine.

3. What to do if you miss a dose : If you miss a dose, take it according to the originally planned time the next day, and there is no need to make up for it.

5. Dose adjustment

1. Hepatic insufficiency : Adjust to 25 mg once a day for moderate hepatic insufficiency (Child-PughB); disabled for severe hepatic insufficiency (Child-PughC).

2. Adverse reaction adjustment : If severe diarrhea or liver enzyme elevation occurs, the dose can be reduced to 25mg or the administration can be suspended.

6. Medication precautions

1. Cardiovascular risk : Combined use of COMT metabolic drugs (such as epinephrine) may cause arrhythmia or blood pressure fluctuations, and requires close monitoring.

2. Daytime sleepiness : Avoid driving or operating machinery while taking medication.

3. Blood pressure monitoring : Hypotension or syncope may occur, and regular check-ups are required.

4. Psychiatric symptoms : Be wary of hallucinations, impulsive behaviors, etc., and discontinue medication when they occur.

7. Medication for special groups

1. Pregnant women: : Disabled (animal experiments show fetal toxicity).

2. Lactation : Stop breastfeeding during treatment.

3. Children : Safety has not been established.

4. U200c for the elderly: No dose adjustment is required for those aged ≥65 years.

8. Adverse reactions

1. Common (≥4%) : Dyskinesia (20%), constipation (6%), increased creatine kinase (5%), hypotension (5%), weight loss (4%).

2. Severe reactions : Hepatotoxicity, myocardial infarction (rare).

9. Contraindications

1. Combined use of non-selective MAO inhibitors (such as phenelzine);

2. Patients with pheochromocytoma or paraganglioma.

10. Drug interactions

1. MAO inhibitor : Prohibited combination (increases cardiovascular risk);

2. COMT metabolism drug : may enhance its effect, so combination use with caution is required.

11. Storage method

Store unopened capsules in a dry place below 30°C (86°F) and away from light.

12. Manufacturer

Original manufacturer :BIAL-Portela&Ca, S.A. (Portugal);

Note : If persistent movement disorders or mental symptoms occur during treatment, you should seek medical treatment immediately. Quitting smoking may improve the effectiveness of medications.