Opicapon is a peripheral selective, reversible catechol-O-methyltransferase (COMT) inhibitor. By inhibiting COMT enzyme activity, the metabolism of levodopa in the periphery is reduced, thereby prolonging its action time and enhancing its therapeutic effect.

1、 Drug name and main ingredients

1. Common name: Opicapone

2. Product Name: ONGENTYS ®

3. Dosage form: Capsules

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

2、 Indications

Parkinson's disease (PD): as an adjuvant therapy with levodopa/carbidopa, used to alleviate the "phase off" symptoms in PD patients.

3、 Specifications and characteristics

1. Specifications: 25mg (light blue opaque capsule with "OPC25" blue label) and 50mg (dark blue opaque capsule with "OPC50" white label).

2. Appearance: The content is a bright yellow powder, which forms a uniform suspension after reconstitution.

4、 Usage and dosage

1. Recommended dosage: 50mg once daily, taken orally before bedtime.

2. Dietary requirements: Fasting for at least 1 hour before and after taking medication.

3. Omission treatment: If missed, take according to the original plan the next day without the need for supplementation.

5、 Dose adjustment

1. Liver dysfunction: Moderate liver dysfunction (Child Pugh B) adjusted to 25mg once daily; Severely (Child Pugh C) prohibited.

2. Adverse reaction adjustment: If severe diarrhea or elevated liver enzymes occur, the dosage can be reduced to 25mg or the administration can be suspended.

6、 Medication precautions

1. Cardiovascular risk: The combined use of COMT metabolic drugs (such as adrenaline) may cause arrhythmia or blood pressure fluctuations, which require close monitoring.

2. Daytime drowsiness: Avoid driving or operating machinery during medication.

3. Blood pressure monitoring: Hypotension or fainting may occur, and regular check ups are necessary.

4. Mental symptoms: Be alert to hallucinations, impulsive behavior, etc., and stop taking medication when they occur.

7、 Medication for special populations

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

2. Breastfeeding period: Stop breastfeeding during the treatment period.

3. Children: Safety has not been established.

4. Elderly individuals aged 65 and above do not need to adjust their dosage.

8、 Adverse reactions

1. Common (≥ 4%): Movement disorders (20%), constipation (6%), elevated creatine kinase (5%), hypotension (5%), weight loss (4%).

2. Serious reactions: hepatotoxicity, myocardial infarction (rare).

9、 Contraindications

1. Combination use of non selective MAO inhibitors (such as phenylhydrazine);

2. Patients with pheochromocytoma or paraganglioma.

10、 Drug interactions

1. MAO inhibitors: Do not use in combination (increase cardiovascular risk);

2. COMT metabolic drugs: may enhance their effects, caution should be exercised when using them in combination.

11、 Storage method

Unopened capsules should be stored in a dry and dark place below 30 ° C (86 ° F).

12、 Manufacturer

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

Note: If persistent movement disorders or mental symptoms occur during treatment, seek medical attention immediately. Quitting smoking may improve the efficacy of medication.

Opicaponeinformation