Opcapone (Ongentys) is a selective and reversible catechol-O-methyltransferase (COMT) inhibitor, used as an adjunctive treatment for Parkinson's disease (PD).

Indications for Opcapone (Ongentys)

Core Uses

As an adjunctive therapy to levodopa/carbidopa, it is indicated for patients with Parkinson's disease who experience "off" periods (motor symptom fluctuations).

By inhibiting the COMT enzyme, it reduces the metabolism of levodopa and prolongs its therapeutic effect, thereby improving motor fluctuation symptoms.

Dosage Forms, Specifications and Properties of Opcapone (Ongentys)

Dosage Forms and Specifications

Capsules: Available in two specifications, 25mg and 50mg.

50mg capsules: Dark blue opaque caps and dark pink opaque bodies, printed with white "OPC50" marking.

25mg capsules: Light blue opaque caps and light pink opaque bodies, printed with blue "OPC25" marking.

Ingredients and Properties

Active ingredient: Each capsule contains 25mg or 50mg of opicapone.

Excipients: Lactose, magnesium stearate, pregelatinized starch, etc.; capsule shells contain gelatin, titanium dioxide and colorants (FD&C Blue No. 2, Red No. 3).

Storage conditions: Store below 30°C (86°F) and avoid exposure to high-temperature environments.

Dosage and Administration of Opcapone (Ongentys)

Routine Dosage

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

Dietary requirements: Fasting for 1 hour before and after taking the medicine to avoid the impact of food on drug absorption.

Patients with Hepatic Impairment

Moderate impairment (Child-Pugh Class B): Reduce the dosage to 25mg per day.

Severe impairment (Child-Pugh Class C): Contraindicated.

Patients with Renal Impairment

No dosage adjustment is required for mild to moderate impairment, but patients with end-stage renal disease (ESRD) should avoid using it.

Management of Missed Doses or Discontinuation

If a dose is missed, take the missed dose at the originally scheduled time on the next day; do not double the dose.

When discontinuing the medicine, monitor the patient's symptoms and gradually adjust the dosage of other dopaminergic drugs to prevent withdrawal reactions (such as high fever, confusion).